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Cisplatin-Lomustine-Vincristine (Packer LCV3)

Description: Chemotherapy Protocol Central Nervous System CISPLATIN-LOMUSTINE-VINCRISTINE (Packer LCV3) Regimen • CNS
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DRC-Cyclophosphamide-Dexamethasone-Rituximab

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE - DEXAMETHASONE – RITUXIMAB (DRC) Regimen • Lymphoma – DRC – Cyclophosphamide –
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/DRC-Cyclophosphamide-Dexamethasone-Rituximab.pdf

MyelomaBortezomib IV DexamethasonePabinostatThalidomide 21day Ver1.1

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (IV)-DEXAMETHASONE-PANOBINOSTAT-THALIDOMIDE Regimen (21 day) • Multiple Myeloma – B
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Myeloma/MyelomaBortezomib-IV-DexamethasonePabinostatThalidomide-21day-Ver1.1.pdf

MyelomaBortezomib SC DexamethasonePabinostatThalidomide 21day Ver1.1

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (SC)-DEXAMETHASONE-PANOBINOSTAT-THALIDOMIDE Regimen (21 day) • Multiple Myeloma – Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Indication • Panobinostat in combination with bortezomib, dexamethasone and thalidomide is recommended, within its marketing authorisation, as an option for treating multiple myeloma. That is, for adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent, when the company provides panobinostat with the discount agreed in the patient access scheme. • Performance status 0, 1, 2 Toxicity Drug Bortezomib Dexamethasone Panobinostat Thalidomide Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance QT interval prolongation, diarrhoea, nausea, vomiting, thrombocytopenia, anaemia Drowsiness, constipation, dizziness, increased risk of thromboembolic events, dry skin/rash, peripheral neuropathy, teratogenicity, syncope, bradycardia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC should be checked prior to each dose of bortezomib, that is on days 1 and 8. • LFTs and U&Es prior to day 1 of each cycle. • Paraprotein or light chains every 3 weeks • Regular monitoring of blood glucose is considered good practice but optional • Women of childbearing potential must have a negative pregnancy test at screening and men who are sexually active with a woman of childbearing potential must agree to use barrier methods of contraception Version 1.1 (Dec 2016) Page 1 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) • Prior to starting treatment with panobinostat do an ECG. QTcF must be less than 480ms before initiation of treatment with panobinostat. This should be repeated on day one of cycle two, a single ECG is acceptable if no apparent QTcF prolongation is noted. In the following cycles no further ECG is required for patients with no apparent QTcF prolongation. Periodical ECGs are recommended as clinically indicated Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Drug Initial dose Dose Level -1 Dose Level - 2 Action Panobinostat 20mg 15mg 10mg Discontinue Bortezomib 1.3mg/m2 1mg/m2 0.7 mg/m2 Discontinue Drug Bortezomib Neutrophils Dose Modifications 0.75 – 1x109/L Maintain the same dose If the neutrophils are less than 1 with febrile neutropenia or less than 0.5x109/L Interrupt treatment until febrile neutropenia resolves and the neutrophil count is greater than or equal to 1x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose. If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose Version 1.1 (Dec 2016) Page 2 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Panobinostat 0.75 – 1x109/L 0.5-0.75x109/L less than 1x109/L with febrile neutropenia less than 0.5x109/L Maintain the same dose If single occurrence within cycle then maintain the same dose level. If there are two or more episodes within cycle then interrupt treatment until levels are 1x109/L or above and then restart at same dose level Interrupt treatment until febrile neutropenia resolves and the neutrophils are equal to or greater than 1x109/L then restart at reduced dose level Interrupt treatment until neutrophils are 1x109/L or greater, then restart at reduced dose level Drug Bortezomib Platelets Dose Modifications 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) or platelets less than 25x109/L (grade 4) Maintain the same dose Interrupt treatment until platelets are equal to or greater than 75x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose level If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose level Panobinostat 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) Maintain the same dose, monitor platelet counts every seven days Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level less than 25x109/L (grade 4) Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Version 1.1 (Dec 2016) Page 3 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Drug Bortezomib Bilirubin µmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. Panobinostat Thalidomide Bilirubin 1-1.5xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 15mg and increase in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Bilirubin between 1.5-3xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 10mg and increase to 15mg in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level No adjustments necessary Renal Impairment Drug Bortezomib Creatinine Clearance (ml/min) greater than 20 20 and below Dose (% of original dose) 100% Clinical decision Panobinostat No dose adjustments are necessary in those with mild to moderate renal impairment Thalidomide No adjustments necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1.1 (Dec 2016) Page 4 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Gastrointestinal Gastrointestinal toxicity is particularly problematic with panobinostat Adverse drug reaction Diarrhoea Grade 2 despite antidiarrhoeals 3 despite antidiarrhoeals 4 despite antidiarrhoeals Panobinostat Modifications Omit dose until recovery to grade 1 or less then resume at the same dose Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose Permanently discontinue Bortezomib Modifications Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level or change to once weekly Omit dose until recovery to grade 1 or less then resume treatment with the same dose on a once weekly schedule Permanently discontinue Bortezomib Neuropathic pain and/or peripheral neuropathy For patients experiencing NCI-CTC grade 1 neuropathy continue with full dose. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2 or switch to a weekly bortezomib at the standard dose of 1.3mg/m2. For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Panobinostat QTc Prolongation If a prolonged QT interval is found on ECG prior to initiation of panobinostat (QTcF greater than or equal to 480ms or above 60ms from baseline), the start of therapy should be delayed until pre-dose average QTcF has returned to less than 480 msec and abnormal serum Version 1.1 (Dec 2016) Page 5 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) potassium, magnesium or phosphorus values corrected. In the event of QT prolongation during treatment: • The dose should be omitted if the QTcF is greater than or equal to 480ms or above 60ms from baseline. • If the QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent • If QT prolongation is unresolved within 7 days, treatment should be discontinued. • If any QTcF value is above 500 msec, panobinstat should be permanently discontinued Thalidomide Peripheral Neuropathy If NCI-CTC grade 1 neurological toxicity occurs treatment may be continued, if symptoms worsen consider dose reduction or interruption. Treatment may be reintroduced at a reduced dose if symptoms resolve. If NCI-CTC grade 2 neurological toxicity occurs suspend treatment or reduce the dose by at least 50%. Treatment may be reintroduced at a reduced dose if symptoms resolve to grade 1 or below. For NCI-CTC neurological toxicity grade 3 or above or toxicity that does not resolve despite treatment interruption / dose reduction thalidomide treatment should be stopped. Thromboembolism The thrombotic risk for patients commencing on thalidomide must be assessed. Appropriate thromboprophylaxis must be prescribed according to local policies. Thromboprophylaxis is generally recommended for at least the first 5 months of thalidomide treatment, especially in patients with additional thrombotic risk factors. Patients and their carers should be made aware of the symptoms of thromboembolism and advised to report sudden breathlessness, chest pain, or swelling of a limb. The occurrence of a thromboembolic event such as a DVT or thromboembolism, notably pulmonary embolism, is an indication for full anticoagulation following standard treatment guidelines. Thalidomide may be stopped, but can be re-introduced, initially at 50mg daily with escalation at subsequent cycles to 100mg, assuming good anticoagulant control and no other untoward side effects. All patients should be initially prescribed a low molecular weight heparin at the appropriate prophylactic dose. Therapeutic warfarin is an alternative to low molecular heparin. Teratogenicity Thalidomide is highly teratogenic. Version 1.1 (Dec 2016) Page 6 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) All prescribers, patients and pharmacy staff must comply with the manufacturer’s Pregnancy Prevention Programme. Women of child-bearing potential taking thalidomide must use one agreed effective method of contraception for at least 4 weeks before starting thalidomide, while on thalidomide and for one month after. They must have a negative pregnancy test within 3 days prior to starting treatment. Pregnancy testing should be repeated monthly thereafter until one month after stopping thalidomide (or every 2 weeks in women with irregular menstrual cycles). If a woman taking thalidomide thinks she may be pregnant she must stop the drug immediately and seek medical advice. Men taking thalidomide must use a barrier method of contraception throughout treatment and for one week after stopping, if their partner is capable of bearing children. Other For other thalidomide related toxicities of NCI-CTC grade 3 or above. Stop thalidomide until recovery to NCI-CTC grade 1 or below. Cautious reintroduction of thalidomide at a dose of 50mg a day may be considered with dose escalation if tolerated. Regimen 21 day cycle for up to 16 cycles Drug Bortezomib Dexamethasone Dose 1.3mg/m2 20mg Days 1, 8 1, 2, 8, 9 Administration Subcutaneous injection Oral Panobinostat 20mg 1, 3, 5, 8, 10, 12 Oral 50mg – Thalidomide 100mg once a 1-21 inclusive Oral day at night Dose Information • Bortezomib will be dose rounded to the agreed bands • At least 72 hours must elapse between bortezomib doses • Dexamethasone is available as 500mcg and 2mg tablets • Panobinostat is available as 10mg, 15mg and 20mg capsules • Thalidomide dose is started at 50mg. This may be increased to 100mg if well tolerated during the first cycle. • Thalidomide is available as 50mg capsules Version 1.1 (Dec 2016) Page 7 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Administration Information • Dexamethasone should be taken in the morning, with or after food • Panobinostat should be administered orally once daily on scheduled days only, at the same time each day. The capsules should be swallowed whole with water, with or without food, and they should not be opened, crushed or chewed. If a dose is missed, it can be taken up to 12 hours after the specified dose time. If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose. • Thalidomide should be taken at night to avoid daytime drowsiness. • Thalidomide prescriptions must be accompanied by a completed Prescription Authorisation Form. Additional Therapy • Anti-emetics As take home medication - cyclizine 50mg three times a day oral when required • Allopurinol 300mg once a day for seven days for cycle one only • Thromboprophylaxis according to local formulary choices. For example; - dalteparin 5000units subcutaneous injection once a day - enoxaparin 40mg subcutaneous injection once a day - heparin 5000units subcutaneous injection twice a day • Anti-infective prophylaxis with - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once day on Monday, Wednesday and Friday oral • Loperamide 4mg after the first loose stool then 2mg after each loose stool thereafter to a maximum of 16mg/24hours oral • Bisphosphonates in accordance with local policies • Mouthwashes according to local or national policy on the treatment of mucositis. • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1.1 (Dec 2016) Page 8 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • For all patients taking thalidomide the patient, prescriber and supplying pharmacy must comply with an appropriate pregnancy prevention programme. • Panobinostat prolongs the QT interval. Agents that are also associated with this adverse effect should be used with caution. This includes many anti-emetics such as ondansetron, metoclopramide and domperidone Coding • Procurement – X70.8, X72.9 • Delivery – X72.4 References 1. San-Miguel JF, Hungria VTM, Yoon S-S et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicenter randomized double-blind phase 3 trial. Lancet Oncol, 2014; 15(11): 1195-1206. 2. National Institute for Health and Care Excellence. Panobinostat for treating multiple myeloma after at least two other treatments (TA 380). January 2016 DOH:London Version 1.1 (Dec 2016) Page 9 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) REGIMEN SUMMARY Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21day) Cycle 1 Day 1, 8 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. 3. Dexamethasone 20mg once a day on days 1, 2, 8, 9 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 4. Panobinostat 20mg once a day on days 1, 3, 5, 8, 10, 12 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 5. Thalidomide 50mg once a day at night for 21 days Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. 6. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 7. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or nearest original pack size 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 9. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. 10. Loperamide capsules as directed Administration Instructions When required for the relief of diarrhoea. Take 4mg initially followed by 2mg after each loose stool. Maximum 16mg per day. Please supply 60 capsules or 2 original packs if appropriate. . Version 1.1 (Dec 2016) Page 10 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) 11. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 21 days or nearest original pack. 10. Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formularly choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 21 days or nearest equivalent original pack size. Cycle 2 onwards Day 1, 8 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Warning – Pregnancy Prevention Programme Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. 3. Dexamethasone 20mg once a day on days 1, 2, 8, 9 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 4. Panobinostat 20mg once a day on days 1, 3, 5, 8, 10, 12 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 5. Thalidomide 50mg once a day at night for 21 days Administration Instructions Thalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. 6. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 7. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or nearest original pack size Version 1.1 (Dec 2016) Page 11 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) 8. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 9. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 21 days or nearest original pack. 10. Thromboprophylaxis according to local formulary choice; Administration Instructions The choice of thromboprophylaxis is dependent on local formularly choice and may include; - dalteparin 5000units once a day subcutaneous injection - enoxaparin 40mg once a day subcutaneous injection - heparin 5000units twice a day subcutaneous injection Please supply 21 days or nearest equivalent original pack size. Version 1.1 (Dec 2016) Page 12 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By “Oral chemotherapy” added to panobinostat admin instructions 1.1 Quantity of cyclizine to be issued Dec 2016 standardised to 28 tablets. Quantity of loperamide to be issued Rebecca Wills Pharmacist standardised to 60 capsules and admin instructions clarified. 1 Nov 2016 None Dr Deborah Wright Pharmacist Dr Deborah Wright Pharmacist Dr Mathew Jenner Consultant Haematologist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.1 (Dec 2016) Page 13 of 13 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat-Thalidomide (21 day)
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MyelomaBortezomib SC DexamethasonePabinostat 28 day

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (SC)-DEXAMETHASONE-PANOBINOSTAT (28 day) Regimen • Multiple Myeloma – Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Indication • Panobinostat in combination with bortezomib and dexamethasone is recommended, within its marketing authorisation, as an option for treating multiple myeloma. That is, for adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent, when the company provides panobinostat with the discount agreed in the patient access scheme. • Performance status 0, 1, 2 Toxicity Drug Bortezomib Dexamethasone Panobinostat Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance QT interval prolongation, diarrhoea, nausea, vomiting, thrombocytopenia, anaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC should be checked prior to each dose of bortezomib, that is on days 1, 8, 15 and 22 for the first cycle and then prior to day 1 thereafter • LFTs and U&Es prior to day 1 of each cycle • ECG prior to day 1 of each cycle • Paraprotein or light chains every 4 weeks • Regular monitoring of blood glucose is considered good practice but optional • Women of childbearing potential must have a negative pregnancy test at screening and men who are sexually active with a woman of childbearing potential must agree to use barrier methods of contraception Version 1.2 (Dec 2015) Page 1 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) • Prior to starting treatment with panobinostat do an ECG. QTcF must be less than 480ms before initiation of treatment with panobinostat. This should be repeated on day one of cycle two, a single ECG is acceptable if no apparent QTcF prolongation is noted. In the following cycles no further ECG is required for patients with no apparent QTcF prolongation. Periodical ECGs are recommended as clinically indicated Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Drug Initial dose Dose Level -1 Dose Level - 2 Action Panobinostat 20mg 15mg 10mg Discontinue Bortezomib 1.3mg/m2 1mg/m2 0.7 mg/m2 Discontinue Drug Bortezomib Neutrophils Dose Modifications 0.75 – 1x109/L If the neutrophils are less than 1 with febrile neutropenia or less than 0.5x109/L Maintain the same dose Interrupt treatment until febrile neutropenia resolves and the neutrophil count is greater than or equal to 1x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose. If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose Version 1.2 (Dec 2015) Page 2 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Panobinostat 0.75 – 1x109/L 0.5-0.75x109/L less than 1x109/L with febrile neutropenia less than 0.5x109/L Maintain the same dose If single occurrence within cycle then maintain the same dose level. If there are two or more episodes within cycle then interrupt treatment until levels are 1x109/L or above and then restart at same dose level Interrupt treatment until febrile neutropenia resolves and the neutrophils are equal to or greater than 1x109/L then restart at reduced dose level Interrupt treatment until neutrophils are 1x109/L or greater, then restart at reduced dose level Drug Bortezomib Platelets Dose Modifications 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) or platelets less than 25x109/L (grade 4) Maintain the same dose Interrupt treatment until platelets are equal to or greater than 75x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose level If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose level Panobinostat 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) Maintain the same dose, monitor platelet counts every seven days Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level less than 25x109/L (grade 4) Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level Version 1.2 (Dec 2015) Page 3 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bortezomib Bilirubin µmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. Panobinostat Bilirubin 1-1.5xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 15mg and increase in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Bilirubin between 1.5-3xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 10mg and increase to 15mg in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Renal Impairment Drug Bortezomib Creatinine Clearance (ml/min) greater than 20 20 and below Dose (% of original dose) 100% Clinical decision Panobinostat No dose adjustments are necessary in those with mild to moderate renal impairment Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1.2 (Dec 2015) Page 4 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Gastrointestinal Gastrointestinal toxicity is particularly problematic with panobinostat Adverse drug reaction Diarrhoea Grade 2 despite antidiarrhoeals 3 despite antidiarrhoeals 4 despite antidiarrhoeals Panobinostat Modifications Omit dose until recovery to grade 1 or less then resume at the same dose Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose Permanently discontinue Bortezomib Modifications Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level Permanently discontinue Bortezomib Neuropathic pain and/or peripheral neuropathy For patients experiencing NCI-CTC grade 1 neuropathy continue with full dose. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2 or switch to a weekly bortezomib at the standard dose of 1.3mg/m2. For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Panobinostat QTc Prolongation If a prolonged QT interval is found on ECG prior to initiation of panobinostat (QTcF greater than or equal to 480ms or above 60ms from baseline), the start of therapy should be delayed until pre-dose average QTcF has returned to less than 480 ms and abnormal serum potassium, magnesium or phosphorus values corrected. In the event of QT prolongation during treatment: Version 1.2 (Dec 2015) Page 5 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) • The dose should be omitted if the QTcF is greater than or equal to 480ms or above 60ms from baseline. • If the QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent. • If QT prolongation is unresolved within 7 days, treatment should be discontinued. • If any QTcF value is above 500 msec, panobinstat should be permanently discontinued Regimen 28 day cycle for cycle 1, 2, 3, 4, 5, 6, 7, 8 Drug Bortezomib Dexamethasone Panobinostat Dose 1.3mg/m2 20mg 20mg Days 1, 8, 15, 22 1, 2, 8, 9, 15, 16, 22, 23 1, 3, 5, 15, 17, 19 Administration Subcutaneous injection Oral Oral 28 day cycle for cycles 9, 10, 11, 12, 13, 14, 15, 16 Drug Bortezomib Dexamethasone Panobinostat Dose 1.3mg/m2 20mg 20mg Days 1, 8 1, 2, 8, 9 1, 3, 5, 15, 17, 19 Administration Subcutaneous injection Oral Oral Dose Information • Bortezomib will be dose rounded to the agreed bands • At least 72 hours must elapse between bortezomib doses • Dexamethasone is available as 500mcg and 2mg tablets • Panobinostat is available as 10mg, 15mg and 20mg capsules Administration Information • Dexamethasone should be taken in the morning, with or after food • Panobinostat should be administered orally once daily on scheduled days only, at the same time each day. The capsules should be swallowed whole with water, with or without food, and they should not be opened, crushed or chewed. If a dose is missed, it can be taken up to 12 hours after the specified dose time. If vomiting Version 1.2 (Dec 2015) Page 6 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) occurs the patient should not take an additional dose, but should take the next usual prescribed dose. Additional Therapy • Anti-emetics As take home medication - Cyclizine 50mg three times a day oral when required • Allopurinol 300mg once a day for seven days for cycle one only • Anti-infective prophylaxis with - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once day on Monday, Wednesday and Friday oral • Loperamide 4mg after the first loose stool then 2mg after each loose stool thereafter to a maximum of 16mg/24hours oral • Bisphosphonates in accordance with local policies • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • Panobinostat prolongs the QT interval. Agents that are also associated with this adverse effect should be used with caution. This includes many anti-emetics such as ondansetron, metoclopramide and domperidone Coding • Procurement – X70.8, X72.9 • Delivery – X72.4 References 1.San-Miguel JF, Hungria VTM, Yoon S-S et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicenter randomized double-blind phase 3 trial. Lancet Oncol, 2014; 15(11): 1195-1206. 2. National Institute for Health and Care Excellence. Panobinostat for treating multiple myeloma after at least two other treatments (TA 380). January 2016 DOH:London Version 1.2 (Dec 2015) Page 7 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) REGIMEN SUMMARY Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Cycle 1 Day 1, 8, 15, 22 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15, 16, 22, 23 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. 8. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. 9. Loperamide capsules as directed Administration Instructions When required for the relief of diarrhoea. Take 4mg initially followed by 2mg after each loose stool. Maximum 16mg per day. Please supply 60 capsules or 2 original packs if appropriate. Version 1.2 (Dec 2015) Page 8 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Cycle 2, 3, 4, 5, 6, 7, 8 Day 1, 8, 15, 22 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15, 16, 22, 23 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. Cycles 9, 10, 11, 12, 13, 14, 15, 16 Day 1, 8 8. Bortezomib 1.3mg/m2 subcutaneous injection Version 1.2 (Dec 2015) Page 9 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) Take Home Medicines (day 1 only) 9. Dexamethasone 20mg once a day on days 1, 2, 8, 9 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 10. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 11. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 12. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 13. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 14. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. Version 1.2 (Dec 2015) Page 10 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Days of dexamethasone in the 1.2 Dec 2017 regimen summary changed on cycles 2, 3, 4, 5, 6, 7, 8 Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician “Oral chemotherapy” added to panobinostat admin instructions 1.1 Quantity of cyclizine to be issued Dec 2016 standardised to 28 tablets. Quantity of loperamide to be issued Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist standardised to 60 capsules and admin instructions clarified. Dr Mathew Jenner Consultant 1 Nov 2016 None Dr Deborah Wright Pharmacist Haematologist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.2 (Dec 2015) Page 11 of 11 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (28 day)
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MyelomaBortezomib SC DexamethasonePabinostat 21day Ver1.1

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (SC)-DEXAMETHASONE-PANOBINOSTAT (21 day) Regimen • Multiple Myeloma – Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Indication • Panobinostat in combination with bortezomib and dexamethasone is recommended, within its marketing authorisation, as an option for treating multiple myeloma. That is, for adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent, when the company provides panobinostat with the discount agreed in the patient access scheme. • Performance status 0, 1, 2 Toxicity Drug Bortezomib Dexamethasone Panobinostat Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance QT interval prolongation, diarrhoea, nausea, vomiting, thrombocytopenia, anaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC should be checked prior to each dose of bortezomib, that is on days 1 and 8. Consider before days 15 and / or 18 in patients who are 65 years or older or who have platelets less than 150x109/L. • LFTs and U&Es prior to day 1 of each cycle. • ECG prior to day 1 • Paraprotein or light chains every 3 weeks • Regular monitoring of blood glucose is considered good practice but optional Version 1.1 (Dec 2016) Page 1 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) • Women of childbearing potential must have a negative pregnancy test at screening and men who are sexually active with a woman of childbearing potential must agree to use barrier methods of contraception • Prior to starting treatment with panobinostat do an ECG. QTcF must be less than 480ms before initiation of treatment with panobinostat. This should be repeated on day one of cycle two, a single ECG is acceptable if no apparent QTcF prolongation is noted. In the following cycles no further ECG is required for patients with no apparent QTcF prolongation. Periodical ECGs are recommended as clinically indicated Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Drug Initial dose Dose Level -1 Dose Level - 2 Action Panobinostat 20mg 15mg 10mg Discontinue Bortezomib 1.3mg/m2 1mg/m2 0.7 mg/m2 Discontinue Version 1.1 (Dec 2016) Page 2 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Drug Bortezomib Neutrophils Dose Modifications 0.75 – 1x109/L If the neutrophils are less than 1 with febrile neutropenia or less than 0.5x109/L Maintain the same dose Interrupt treatment until febrile neutropenia resolves and the neutrophil count is greater than or equal to 1x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose. If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose Panobinostat 0.75 – 1x109/L 0.5-0.75x109/L less than 1x109/L with febrile neutropenia less than 0.5x109/L Maintain the same dose If single occurrence within cycle then maintain the same dose level. If there are two or more episodes within cycle then interrupt treatment until levels are 1x109/L or above and then restart at same dose level Interrupt treatment until febrile neutropenia resolves and the neutrophils are equal to or greater than 1x109/L then restart at reduced dose level Interrupt treatment until neutrophils are 1x109/L or greater, then restart at reduced dose level Drug Bortezomib Platelets Dose Modifications 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) or platelets less than 25x109/L (grade 4) Maintain the same dose Interrupt treatment until platelets are equal to or greater than 75x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose level If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose level Version 1.1 (Dec 2016) Page 3 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Panobinostat 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) Maintain the same dose, monitor platelet counts every seven days Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level less than 25x109/L (grade 4) Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bortezomib Bilirubin µmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. Panobinostat Bilirubin 1-1.5xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 15mg and increase in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Bilirubin between 1.5-3xULN and any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 10mg and increase to 15mg in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Version 1.1 (Dec 2016) Page 4 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Renal Impairment Drug Bortezomib Creatinine Clearance (ml/min) greater than 20 20 and below Dose (% of original dose) 100% Clinical decision Panobinostat No dose adjustments are necessary in those with mild to moderate renal impairment Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Gastrointestinal Gastrointestinal toxicity is particularly problematic with panobinostat Adverse drug reaction Diarrhoea Grade 2 despite antidiarrhoeals 3 despite antidiarrhoeals 4 despite antidiarrhoeals Panobinostat Modifications Omit dose until recovery to grade 1 or less then resume at the same dose Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose Permanently discontinue Bortezomib Modifications Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level or change to once weekly Omit dose until recovery to grade 1 or less then resume treatment with the same dose on a once weekly schedule Permanently discontinue Version 1.1 (Dec 2016) Page 5 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Bortezomib Neuropathic pain and/or peripheral neuropathy For patients experiencing NCI-CTC grade 1 neuropathy continue with full dose. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2 or switch to a weekly bortezomib at the standard dose of 1.3mg/m2 For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Panobinostat QTc Prolongation If a prolonged QT interval is found on ECG prior to initiation of panobinostat (QTcF greater than or equal to 480ms or above 60ms from baseline), the start of therapy should be delayed until pre-dose average QTcF has returned to less than 480 ms and abnormal serum potassium, magnesium or phosphorus values corrected. In the event of QT prolongation during treatment: • The dose should be omitted if the QTcF is greater than or equal to 480ms or above 60ms from baseline. • If the QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent. • If QT prolongation is unresolved within 7 days, treatment should be discontinued. • If any QTcF value is above 500 ms, panobinstat should be permanently discontinued Regimen 21 day cycle for cycle 1, 2, 3, 4, 5, 6, 7, 8 Drug Bortezomib Dexamethasone Panobinostat Version 1.1 (Dec 2016) Dose 1.3mg/m2 20mg 20mg Days 1, 4, 8, 11 1, 2, 4, 5, 8, 9, 11, 12 1, 3, 5, 8, 10, 12 Administration Subcutaneous injection Oral Oral Page 6 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) 21 day cycle for cycles 9, 10, 11, 12, 13, 14, 15, 16 Drug Bortezomib Dexamethasone Panobinostat Dose 1.3mg/m2 20mg 20mg Days 1, 8 1, 2, 8, 9 1, 3, 5, 8, 10, 12 Administration Subcutaneous injection Oral Oral Dose Information • Bortezomib will be dose rounded to the agreed bands • At least 72 hours must elapse between bortezomib doses • Dexamethasone is available as 500mcg and 2mg tablets • Panobinostat is available as 10mg, 15mg and 20mg capsules Administration Information • Dexamethasone should be taken in the morning, with or after food • Panobinostat should be administered orally once daily on scheduled days only, at the same time each day. The capsules should be swallowed whole with water, with or without food, and they should not be opened, crushed or chewed. If a dose is missed, it can be taken up to 12 hours after the specified dose time. If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose. Additional Therapy • Anti-emetics As take home medication - cyclizine 50mg three times a day oral when required • Allopurinol 300mg once a day for seven days for cycle one only • Anti-infective prophylaxis with - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once day on Monday, Wednesday and Friday oral • Loperamide 4mg after the first loose stool then 2mg after each loose stool thereafter to a maximum of 16mg/24hours oral • Bisphosphonates in accordance with local policies • Mouthwashes according to local or national policy on the treatment of mucositis. Version 1.1 (Dec 2016) Page 7 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • Panobinostat prolongs the QT interval. Agents that are also associated with this adverse effect should be used with caution. This includes many anti-emetics such as ondansetron, metoclopramide and domperidone Coding • Procurement – X70.8, X72.9 • Delivery – X72.4 References 1. San-Miguel JF, Hungria VTM, Yoon S-S et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicenter randomized double-blind phase 3 trial. Lancet Oncol, 2014; 15(11): 1195-1206. 2. National Institute for Health and Care Excellence. Panobinostat for treating multiple myeloma after at least two other treatments (TA 380). January 2016 DOH:London Version 1.1 (Dec 2016) Page 8 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) REGIMEN SUMMARY Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Cycle 1 Day 1, 4, 8, 11 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 4, 5, 8, 9, 11, 12 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 8, 10, 12 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. 8. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 21 days or nearest original pack. 9. Loperamide capsules as directed Administration Instructions When required for the relief of diarrhoea. Take 4mg initially followed by 2mg after each loose stool. Maximum 16mg per day. Please supply 60 capsules or 2 original packs if appropriate. . Version 1.1 (Dec 2016) Page 9 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) Cycle 2, 3, 4, 5, 6, 7, 8 Day 1, 4, 8, 11 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 4, 5, 8, 9, 11, 12 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 8, 10, 12 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 21 days or nearest original pack. Cycles 9, 10, 11, 12, 13, 14, 15, 16 Day 1, 8 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one Version 1.1 (Dec 2016) Page 10 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 8, 10, 12 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 21 days oral Administration Instructions Please supply 21 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 21 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 21 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 21 days or nearest original pack. Version 1.1 (Dec 2016) Page 11 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By “Oral chemotherapy” added to panobinostat admin instructions 1.1 Quantity of cyclizine to be issued Dec 2016 standardised to 28 tablets. Quantity of loperamide to be issued Rebecca Wills Pharmacist standardised to 60 capsules and admin instructions clarified. 1 Nov 2016 None Dr Deborah Wright Pharmacist Dr Deborah Wright Pharmacist Dr Mathew Jenner Consultant Haematologist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.1 (Dec 2016) Page 12 of 12 Multiple Myeloma-Bortezomib (SC)-Dexamethasone-Panobinostat (21 day)
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MyelomaBortezomib IV DexamethasonePabinostat 28 day

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (IV)-DEXAMETHASONE-PANOBINOSTAT (28 day) Regimen • Multiple Myeloma – Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Indication • Panobinostat in combination with bortezomib and dexamethasone is recommended, within its marketing authorisation, as an option for treating multiple myeloma. That is, for adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent, when the company provides panobinostat with the discount agreed in the patient access scheme. • Performance status 0, 1, 2 Toxicity Drug Bortezomib Dexamethasone Panobinostat Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance QT interval prolongation, diarrhoea, nausea, vomiting, thrombocytopenia, anaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC should be checked prior to each dose of bortezomib, that is on days 1, 8, 15 and 22 for the first cycle and then prior to day 1 thereafter • LFTs and U&Es prior to day 1 of each cycle • ECG prior to day 1 of each cycle • Paraprotein or light chains every 4 weeks • Regular monitoring of blood glucose is considered good practice but optional • Women of childbearing potential must have a negative pregnancy test at screening and men who are sexually active with a woman of childbearing potential must agree to use barrier methods of contraception Version 1.2 (Dec 2017) Page 1 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) • Prior to starting treatment with panobinostat do an ECG. QTcF must be less than 480ms before initiation of treatment with panobinostat. This should be repeated on day one of cycle two, a single ECG is acceptable if no apparent QTcF prolongation is noted. In the following cycles no further ECG is required for patients with no apparent QTcF prolongation. Periodical ECGs are recommended as clinically indicated Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Drug Initial dose Dose Level -1 Dose Level - 2 Action Panobinostat 20mg 15mg 10mg Discontinue Bortezomib 1.3mg/m2 1mg/m2 0.7 mg/m2 Discontinue Drug Bortezomib Neutrophils Dose Modifications 0.75 – 1x109/L If the neutrophils are less than 1 with febrile neutropenia or less than 0.5x109/L Maintain the same dose Interrupt treatment until febrile neutropenia resolves and the neutrophil count is greater than or equal to 1x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose. If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose Version 1.2 (Dec 2017) Page 2 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Panobinostat 0.75 – 1x109/L 0.5-0.75x109/L less than 1x109/L with febrile neutropenia less than 0.5x109/L Maintain the same dose If single occurrence within cycle then maintain the same dose level. If there are two or more episodes within cycle then interrupt treatment until levels are 1x109/L or above and then restart at same dose level Interrupt treatment until febrile neutropenia resolves and the neutrophils are equal to or greater than 1x109/L then restart at reduced dose level Interrupt treatment until neutrophils are 1x109/L or greater, then restart at reduced dose level Drug Bortezomib Platelets Dose Modifications 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) or platelets less than 25x109/L (grade 4) Maintain the same dose Interrupt treatment until platelets are equal to or greater than 75x109/L. If only 1 dose was omitted prior to correction to these levels, restart at same dose level If 2 or more doses were omitted consecutively, or within the same cycle, treatment should be restarted at a reduced dose level Panobinostat 25 – 50x109/L (grade 3) 25 – 50x109/L (grade 3 with haemorrhage) Maintain the same dose, monitor platelet counts every seven days Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level less than 25x109/L (grade 4) Interrupt treatment. Monitor platelet counts at least weekly until they are equal to or greater than 50x109/L, then restart at reduced dose level Version 1.2 (Dec 2017) Page 3 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bortezomib Bilirubin µmol/L 1.5xULN or below greater than 1.5xULN AST/ALT units/L N/A N/A Dose (% of original dose) 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. Panobinostat Bilirubin 1-1.5xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 15mg and increase in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Bilirubin between 1.5-3xULN and / or any abnormal AST For the first treatment cycle start panobinostat at a reduced dose of 10mg and increase to 15mg in subsequent cycles as tolerated. If this occurs during treatment then temporarily discontinue dosing until resolved to grade 2 or less or baseline and then restart treatment, reduced by one dose level Renal Impairment Drug Bortezomib Creatinine Clearance (ml/min) greater than 20 20 and below Dose (% of original dose) 100% Clinical decision Panobinostat No dose adjustments are necessary in those with mild to moderate renal impairment Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Version 1.2 (Dec 2017) Page 4 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Gastrointestinal Gastrointestinal toxicity is particularly problematic with panobinostat Adverse drug reaction Diarrhoea Grade 2 despite antidiarrhoeals 3 despite antidiarrhoeals 4 despite antidiarrhoeals Panobinostat Modifications Omit dose until recovery to grade 1 or less then resume at the same dose Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose Permanently discontinue Bortezomib Modifications Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level Omit dose until recovery to grade 1 or less then resume treatment at a reduced dose level Permanently discontinue Bortezomib Neuropathic pain and/or peripheral neuropathy Subcutaneous administration should also be considered as the incidence and severity of peripheral neuropathy has been shown to be less when bortezomib is given by this route. For patients experiencing NCI-CTC grade 1 neuropathy continue with full dose. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2 or switch to a weekly bortezomib at the standard dose of 1.3mg/m2. For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Panobinostat QTc Prolongation If a prolonged QT interval is found on ECG prior to initiation of panobinostat (QTcF greater than or equal to 480ms or above 60ms from baseline), the start of therapy should be delayed until pre-dose average QTcF has returned to less than 480 ms and abnormal serum Version 1.2 (Dec 2017) Page 5 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) potassium, magnesium or phosphorus values corrected. In the event of QT prolongation during treatment: • The dose should be omitted if the QTcF is greater than or equal to 480ms or above 60ms from baseline. • If the QT prolongation is resolved within 7 days, resume treatment at prior dose for initial occurrence or at reduced dose if QT prolongation is recurrent • If QT prolongation is unresolved within 7 days, treatment should be discontinued. • If any QTcF value is above 500 ms, panobinstat should be permanently discontinued Regimen 28 day cycle for cycle 1, 2, 3, 4, 5, 6, 7, 8 Drug Bortezomib Dexamethasone Panobinostat Dose 1.3mg/m2 20mg 20mg Days 1, 8, 15, 22 1, 2, 8, 9, 15, 16, 22, 23 1, 3, 5, 15, 17, 19 Administration Intravenous injection Oral Oral 28 day cycle for cycles 9, 10, 11, 12, 13, 14, 15, 16 Drug Bortezomib Dexamethasone Panobinostat Dose 1.3mg/m2 20mg 20mg Days 1, 8 1, 2, 8, 9 1, 3, 5, 15, 17, 19 Administration Intravenous injection Oral Oral Dose Information • Bortezomib will be dose rounded to the agreed bands • At least 72 hours must elapse between bortezomib doses • Dexamethasone is available as 500mcg and 2mg tablets • Panobinostat is available as 10mg, 15mg and 20mg capsules Administration Information • Dexamethasone should be taken in the morning, with or after food Version 1.2 (Dec 2017) Page 6 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) • Panobinostat should be administered orally once daily on scheduled days only, at the same time each day. The capsules should be swallowed whole with water, with or without food, and they should not be opened, crushed or chewed. If a dose is missed, it can be taken up to 12 hours after the specified dose time. If vomiting occurs the patient should not take an additional dose, but should take the next usual prescribed dose. Additional Therapy • Anti-emetics As take home medication - Cyclizine 50mg three times a day oral when required • Allopurinol 300mg once a day for seven days for cycle one only • Anti-infective prophylaxis with - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once day on Monday, Wednesday and Friday oral • Loperamide 4mg after the first loose stool then 2mg after each loose stool thereafter to a maximum of 16mg/24hours oral • Bisphosphonates in accordance with local policies • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Additional Information • The National Patient Safety Agency alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • Panobinostat prolongs the QT interval. Agents that are also associated with this adverse effect should be used with caution. This includes many anti-emetics such as ondansetron, metoclopramide and domperidone Coding • Procurement – X70.8, X72.9 • Delivery – X72.4 Version 1.2 (Dec 2017) Page 7 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) References 1.San-Miguel JF, Hungria VTM, Yoon S-S et al. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicenter randomized double-blind phase 3 trial. Lancet Oncol, 2014; 15(11): 1195-1206. 2. National Institute for Health and Care Excellence. Panobinostat for treating multiple myeloma after at least two other treatments (TA 380). January 2016 DOH:London Version 1.2 (Dec 2017) Page 8 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) REGIMEN SUMMARY Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Cycle 1 Day 1, 8, 15, 22 1. Bortezomib 1.3mg/m2 intravenous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15, 16, 22, 23 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. 8. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. Version 1.2 (Dec 2017) Page 9 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) 9. Loperamide capsules as directed Administration Instructions When required for the relief of diarrhoea. Take 4mg initially followed by 2mg after each loose stool. Maximum 16mg per day. Please supply 60 capsules or 2 original packs if appropriate. Cycle 2, 3, 4, 5, 6, 7, 8 Day 1, 8, 15, 22 1. Bortezomib 1.3mg/m2 intravenous injection Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15, 16, 22, 23 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. Cycles 9, 10, 11, 12, 13, 14, 15, 16 Day 1, 8 1. Bortezomib 1.3mg/m2 intravenous injection Version 1.2 (Dec 2017) Page 10 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) Take Home Medicines (day 1 only) 2. Dexamethasone 20mg once a day on days 1, 2, 8, 9 oral Administration Instructions Take in the morning with or after food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. 3. Panobinostat 20mg once a day on days 1, 3, 5, 15, 17, 19 oral Administration Instructions Take in the morning, with or without food. Please dispense all days on day 1 of the cycle. This may be dispensed in one bottle or individual bottles according to local practice. Oral chemotherapy. 4. Cyclizine 50mg up to three times a day when required oral Administration Instructions When required for the relief of nausea. Please dispense 28 tablets or nearest original pack size. 5. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 6. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 7. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; a. esomeprazole 20mg once a day oral b. omeprazole 20mg once a day oral c. lansoprazole 15mg once a day oral d. pantoprazole 20mg once a day oral e. rabeprazole 20mg once a day oral f. cimetidine 400mg twice a day oral g. famotidine 20mg once a day oral h. nizatidine 150mg twice a day oral i. ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack. Version 1.2 (Dec 2017) Page 11 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By Days of dexamethasone changed on Donna Kimber 1.2 Dec 2017 cycles 1 through to 8 in the regimen Pharmacy summary Technician “Oral chemotherapy” added to panobinostat admin instructions 1.1 Dec 2016 Quantity of cyclizine to be issued standardised to 28 tablets. Quantity of loperamide to be issued Rebecca Wills Pharmacist standardised to 60 capsules and admin instructions clarified. 1 Nov 2016 None Dr Deborah Wright Pharmacist Dr Deborah Wright Pharmacist Dr Deborah Wright Pharmacist Dr Mathew Jenner Consultant Haematologist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.2 (Dec 2017) Page 12 of 12 Multiple Myeloma-Bortezomib (IV)-Dexamethasone-Panobinostat (28 day)
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MyelomaBortezomib IV DexamethasonePabinostat 21day Ver1.1

Description: Chemotherapy Protocol MULTIPLE MYELOMA BORTEZOMIB (IV)-DEXAMETHASONE-PANOBINOSTAT (21 day) Regimen • Multiple Myeloma – Bortezomib (I
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Lomustine-Procarbazine-Vincristine (PCV) ver 1.1

Description: Chemotherapy Protocol Central Nervous System LOMUSTINE-PROCARBAZINE-VINCRISTINE (PCV) Regimen CNS – Lomusti
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MyelomaVCD(SC28)Bortezomib(SC)CyclophosphamideDexamethasone28dayVer1

Description: Chemotherapy Protocol MULTIPLE MYELOMA VCD (SC-28) - BORTEZOMIB (SC)-CYCLOPHOSPHAMIDE-DEXAMETHASONE (28 day) Regimen Multiple Myeloma – VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide (PO)Dexamethasone (28 day) Indication First or subsequent line treatment of multiple myeloma. This schedule is recommended for elderly patients or if there is any suggestion of neuropathy or postural hypotension. Toxicity Drug Bortezomib Cyclophosphamide Dexamethasone Adverse Effect GI disturbances, peripheral neuropathy, hypotension, dizziness, blurred vision, headache, musculoskeletal pain, pyrexia Dysuria, haemorrragic cystitis (rare), taste disturbances Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring FBC, LFTs and U&Es prior to day 1 of each cycle. Days 8, 15 and 22 are optional. Paraprotein and / or light chains prior to each cycle. Blood glucose on day 1 is considered good practice but is optional. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1 (June 2016) Page 1 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion or erythropoietin if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to bortezomib and cyclophosphamide only. Neutrophils (x109/L) Dose Modifications (bortezomib and cyclophosphamide) 1 or greater 0.9 - 0.5 less than 0.5 Platelets (x109/L) 100% 1st occurrence Omit cyclophosphamide, continue with bortezomib and dexamethasone. If neutrophils have recovered to 1x109/L within 7 days continue with full dose cyclophosphamide. 2nd occurrence or neutrophils remain below 1x109/L for greater than 7 days. Omit cyclophosphamide, continue with bortezomib and dexamethasone. Once neutrophils have recovered to 1x109/L or greater continue cyclophosphamide at a reduced dose or discontinue as appropriate. For those with heavy marrow infiltration it may be more appropriate to continue at full dose bortezomib and use growth factors. 1st occurrence Withhold cyclophosphamide until neutrophils have recovered to 1x109/L or greater. Continue with a reduced dose of cyclophosphamide and full dose bortezomib. 2nd occurrence Withhold cyclophosphamide until neutrophils have recovered to 1x109/L or greater. Stop cyclophosphamide and continue with bortezomib, consider a dose reduction to 1mg/m2 or 0.7mg/m2. For those with heavy marrow infiltration it may be more appropriate to continue at full dose bortezomib and use growth factors. Dose Modifications (bortezomib and cyclophosphamide) 50 or above 30 - 49 100% 1st occurrence Omit cyclophosphamide, continue with bortezomib and dexamethasone. If platelets have recovered to 50x109/L within 7 days continue with full dose cyclophosphamide. 2nd occurrence or platelets remain below 50x109/L for greater than 7 days. Omit cyclophosphamide, continue with bortezomib and dexamethasone. Version 1 (June 2016) Page 2 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) less than 30 Once platelets have recovered to 50x109/L or greater continue cyclophosphamide at a reduced dose or discontinue as appropriate 1st occurrence Consider withholding bortezomib or administering platelets. Omit the cyclophosphamide until platelets have recovered to 50x109/L or greater. Continue with a reduced dose of cyclophosphamide and full dose bortezomib. 2nd occurrence Consider withholding bortezomib or administering platelets Withhold the cyclophosphamide until platelets have recovered to 50x109/L or greater. Once platelets have recovered to 50x109/L or greater continue cyclophosphamide at a reduced dose or discontinue as appropriate Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bilirubin μmol/L AST/ALT units/L Dose (% of original dose) Clinical decision. Evidence that exposure to Cyclophosphamide more than 30 or 2-3xULN active metabolites may not be increased, suggesting dose reduction may not be necessary. Bortezomib 1.5xULN or below greater than 1.5xULN N/A 100% Initiate treatment at 0.7mg/m2. The dose may be escalated to N/A 1mg/m2 or reduced to 0.5mg/m2 in subsequent cycles based on patient tolerability. Renal Impairment Drug Cyclophosphamide Creatinine Clearance (ml/min) More than 20 10-20 Less than 10 Dose (% of original dose) 100% 75% omit Bortezomib greater than 20 20 and below 100% Clinical decision Version 1 (June 2016) Page 3 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Bortezomib For patients experiencing NCI-CTC grade 1 neuropathy without loss of function or pain continue with full dose bortezomib. For NCI-CTC grade 1 with pain or grade 2 neuropathy reduce the dose of bortezomib to 1mg/m2. For NCI-CTC grade 2 with pain or grade 3 neuropathy discontinue treatment until symptoms have resolved to NCI-CTC grade 1 or less then reinitiate bortezomib at a dose of 0.7mg/m2 For NCI-CTC grade 4 neuropathy and/or severe autonomic neuropathy discontinue bortezomib. For any other NCI-CTC grade 3 non haematological toxicity bortezomib should be discontinued until symptoms have resolve to NCI-CTC grade 1 or below. On the first occurrence treatment may be reinitiated at a dose of 1mg/m2. Following second occurrence to dose should be further reduced to 0.7mg/m2 once symptoms have resolved. If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk. Dexamethasone For patients who are unable to tolerate the standard dose of dexamethasone the dose given the day after bortezomib may be omitted or the dose reduced. Regimen 28 day cycle for up to 8 cycles Response to bortezomib should be assessed after a maximum of four cycles of treatment, treatment should only be continued to eight cycles in people who have a complete or partial response. Drug Bortezomib Cyclophosphamide Dexamethasone Dose 1.3mg/m2 350mg/m2 (maximum dose 500mg) 20mg once a day Days 1, 8, 15, 22 1, 8, 15, 22 1, 2, 8, 9, 15, 16, 22, 23 Administration Subcutaneous injection Oral Oral Version 1 (June 2016) Page 4 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) At least 72 hours should elapse between consecutive doses of bortezomib. Dose Information Bortezomib dose will be dose banded according to agreed bands Cyclophosphamide is available as 50mg tablets Dexamethasone is available as 2mg and 500microgram tablets Administration Information Cyclophosphamide tablets should be swallowed whole with a full glass of water Dexamethasone should be taken in the morning, with or after food Additional Therapy Anti-emetics As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg once a day on days 1, 8, 15, 22 oral Anti-infective prophylaxis; - aciclovir 400mg twice a day oral - consider co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only Consider allopurinol 300mg once a day for seven days for the first cycle only Bisphosphonates in accordance with local policies Mouthwashes according to local or national policy on the treatment of mucositis. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Coding Procurement – X71.5 Delivery – X72.3, X72.4 References 1. Leiba M, Kedml M, Duek A et al. Bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, thalidomide and dexamethasone (VTD) based regimens as induction therapies in newly diagnosed transplant eligible patients with multiple myeloma: a meta-analysis. Br J Haematol 2014; 166 (5): 702-710. Version 1 (June 2016) Page 5 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) REGIMEN SUMMARY VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) Cycle 1 Day 1, 8, 15, 22 1. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 2. Cyclophosphamide 350mg/m2 (max 500mg) once a day on day 1, 8, 15, 22 of the cycle oral Administration Instructions Please supply four doses of cyclophosphamide; ONE dose to be taken on days 1, 8, 15 and 22 of the cycle. This may be dispensed as a single supply in one container or as separate supplies according to local practice. Oral chemotherapy. Only available as 50mg tablets, please ensure dose modifications occur in multiples of 50mg. Swallow whole, not chewed with plenty of water. 3. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15,16, 22 & 23 of the cycle oral Administration Instructions Please supply eight doses of dexamethasone; ONE dose to be taken on days 1, 2, 8, 9, 15, 16, 22 & 23 of the cycle This may be dispensed as a single supply in one container or as separate supplies according to local practice. Take in the morning with or after food. 4. Metoclopramide 10mg three times a day when required for the relief of nausea oral Administration Instructions When required for the relief of nausea. Please supply 28 tablets or nearest original pack size 5. Ondansetron 8mg once a day on day 1, 8, 15 and 22 of the cycle oral Administration Instructions Please supply four doses of ondansetron; ONE dose to be taken on days 1, 8, 15 and 22 of the cycle. This may be dispensed as a single supply in one container or as separate supplies according to local practice. Take 15-30 minutes prior to cyclophosphamide administration. 6. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 7. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. 8. Allopurinol 300mg once a day for 7 days oral Administration Instructions Take with or after food with plenty of water. Please supply 7 days. Version 1 (June 2016) Page 6 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) 9. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack size. Cycle 2, 3, 4, 5, 6, 7, 8 Day 1, 8, 15, 22 10. Bortezomib 1.3mg/m2 subcutaneous injection Take Home Medicines (day 1 only) 11. Cyclophosphamide 350mg/m2 (max 500mg) once a day on day 1, 8, 15, 22 of the cycle oral Administration Instructions Please supply four doses of cyclophosphamide; ONE dose to be taken on days 1, 8, 15 and 22 of the cycle. This may be dispensed as a single supply in one container or as separate supplies according to local practice. Oral chemotherapy. Only available as 50mg tablets, please ensure dose modifications occur in multiples of 50mg. Swallow whole, not chewed with plenty of water. 12. Dexamethasone 20mg once a day on days 1, 2, 8, 9, 15,16, 22 & 23 of the cycle oral Administration Instructions Please supply eight doses of dexamethasone; ONE dose to be taken on days 1, 2, 8, 9, 15, 16, 22 & 23 of the cycle This may be dispensed as a single supply in one container or as separate supplies according to local practice. Take in the morning with or after food. 13. Metoclopramide 10mg three times a day when required for the relief of nausea oral Administration Instructions When required for the relief of nausea. Please supply 28 tablets or nearest original pack size 14. Ondansetron 8mg once a day on day 1, 8, 15 and 22 of the cycle oral Administration Instructions Please supply four doses of ondansetron; ONE dose to be taken on days 1, 8, 15 and 22 of the cycle. This may be dispensed as a single supply in one container or as separate supplies according to local practice. Take 15-30 minutes prior to cyclophosphamide administration. 15. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 16. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday for 28 days oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. Version 1 (June 2016) Page 7 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) 17. Gastric Protection Administration Instructions The choice of gastric protection is dependent on local formulary choice and may include; - esomeprazole 20mg once a day oral - omeprazole 20mg once a day oral - lansoprazole 15mg once a day oral - pantoprazole 20mg once a day oral - rabeprazole 20mg once a day oral - cimetidine 400mg twice a day oral - famotidine 20mg once a day oral - nizatidine 150mg twice a day oral - ranitidine 150mg twice a day oral Please dispense 28 days or nearest original pack size. Version 1 (June 2016) Page 8 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 June 2016 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Dr Mathew Jenner Consultant Haematologist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1 (June 2016) Page 9 of 9 Myeloma–VCD (SC-28)-Bortezomib (SC)-Cyclophosphamide-Dexamethasone (28 day)
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