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Carfilzomib(14 day)-Dexamethasone(20) Ver1

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Chemotherapy Protocol MYELOMA Carfilzomib (14 day)-Dexamethasone (20) Regimen  Myeloma – Carfilzomib-Dexamethasone (20) Indication  Carfilzomib in combination with dexamethasone is an
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Mechanical thrombectomy - patient information

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This factsheet contains information about a procedure known as a 'mechanical thrombectomy'.
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/Media/UHS-website-2019/Patientinformation/Brain-and-spine/Mechanical-thrombectomy-1957-PIL.pdf

Troubleshooting video consultations for UHS patients

Description
Troubleshooting Attend Anywhere video calls Can't hear others? Others can't hear you? Speakers/headset: Volume at audible level? (If external) Plugged
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/Media/UHS-website-2019/Docs/For-patients/Troubleshooting-video-consultations-for-UHS-patient.pdf

Visiting guidelines: Burley and Lyndhurst wards - patient information

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This factsheet outlines the visiting guidelines on the maternity wards at Princess Anne Hospital.
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Atezolizumab1680mg

Description
Chemotherapy Protocol LUNG CANCER Atezolizumab (1680mg 28 days) Regimen • Lung – Atezolizumab Indication • Atezolizumab is indicated for treating previously platinum-treated locally advanced/ metastatic non-small cell lung cancer where all the following criteria are met; - the patient has a histologically- or cytologically-confirmed diagnosis of stage IIIB or IV non-small cell lung cancer and is either non-squamous or squamous in type. - the patient has either progressed after previously receiving at least 2 cycles of platinum-containing chemotherapy for stage IIIB or IV non-small cell lung cancer and also a targeted treatment if the tumour is EGFR positive or ALK positive or progressed within 6 months of completing platinum-based chemotherapy given as adjuvant or neoadjuvant therapy or concurrent with radiotherapy. - PD-L1 testing with an approved and validated test to determine the Tumour Proportion Score (TPS) has been attempted prior to this application. Either; the TPS score will be documented or the TPS score cannot be documented as the TPS result was unquantifiable or PD-L1 testing was not possible as the pathologist has documented that there is insufficient tissue for PD-L1 analysis. - the patient has no symptomatically active brain metastases or leptomeningeal metastases. - atezolizumab will be administered as monotherapy - the patient has not received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody - atezolizumab will be stopped at 2 years of treatment or on loss of clinical benefit or unacceptable toxicity, whichever occurs first. - a formal medical review as to whether treatment with atezolizumab should continue or not will be scheduled to occur at least by the end of the first 9 weeks of treatment - treatment breaks of up to 12 weeks beyond the expected cycle length of atezolizumab are allowed solely to allow immune toxicities to settle Version 1 (Sept 2020) Page 1 of 9 Lung – Atezolizumab (1680mg 28 days) - WHO performance status 0, 1 and be otherwise fit for second line docetaxel therapy Toxicity Drug Atezolizumab Adverse Effect Fatigue, rash, pruritis, pneumonitis, colitis, pancreatitis, diarrhoea, diabetes mellitus, adrenal insufficiency, thyroid disorders, nausea, electrolyte disturbances, hepatitis, myasthenic syndrome, Guillain Barre syndrome The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen • FBC, LFTs and U&Es prior to day one of each cycle • Thyroid function tests prior to starting treatment and then every 6 weeks or when clinically indicated. Dose Modifications The dose modifications listed are for haematological, liver and renal function and some drug specific toxicities. Dose adjustments may be necessary for other toxicities as well. In principle no dose reductions are recommended for atezolizumab. The preference is to delay the dose or discontinue treatment. Please discuss all treatment delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Consider blood transfusion or erythropoietin if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL (80g/L). There are no standard dose adjustments for haematological toxicity with atezolizumab treatment. Hepatic Impairment Drug Atezolizumab Version 1 (Sept 2020) Bilirubin (μmol/L) 1.5-3xULN OR Greater than 3xULN OR AST/ALT units Dose 3-5xULN Delay – see notes below Greater than 5xULN Discontinue – see notes below Page 2 of 9 Lung – Atezolizumab (1680mg 28 days) For patients with pre-existing mild hepatic impairment no dose adjustment is recommended. Atezolizumab has not been studied in patients with moderate or severe hepatic impairment. For a NCI-CTC grade 2 hepatitis (ALT or AST between 3-5xULN or a bilirubin between 1.5-3xULN) that persists for between 5-7 days then withhold the atezolizumab and consider treatment with a corticosteroid. The corticosteroid may be tapered over at least one month if the LFTs improve. Treatment with atezolizumab may be resumed when the event improves to grade 1 or below within 12 weeks and the corticosteroid dose has been reduced to the equivalent of oral prednisolone 10mg per day or less. For a grade 3 or above hepatitis (ALT or AST greater than 5xULN or bilirubin greater than 3xULN) permanently discontinue atezolizumab). Renal Impairment No dose adjustment is required in patients with pre-existing renal impairment. Other Atezolizumab belongs to the immunotherapy class of cancer treatments. Autoimmune toxicities are most frequently noted and can be life threatening. If autoimmune toxicities occur delaying treatment should be considered while investigations or treatments are organised. Some, but not all, toxicities mandate cessation of treatment. Please seek guidance from relevant site specific specialist teams or oncologists / haematologists with experience of prescribing these agents. Clinicians should be aware that the current funding approval precludes further treatment after an interruption of 12 weeks or longer; this situation may change. Refer to the latest version of the European Society of Medical Oncology guidelines; Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up(2). 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. Immune-related adverse reactions, which can be severe or life-threatening, may involve the gastrointestinal, liver, skin, nervous, endocrine, or other organ systems. Most occur during treatment, however, onset month’s after the last dose has been reported. Unless an alternate aetiology has been identified, diarrhoea, increased stool frequency, bloody stool, LFT elevations, rash and endocrinopathy must be considered inflammatory and atezolizumab-related. Early diagnosis and appropriate management are essential to minimise life-threatening complications. Atezolizumab should be permanently discontinued for: any NCI-CTC grade 3 or 4 pneumonitis or hepatitis; any other life threatening NCI-CTC grade 4 reaction (including colitis and renal impairment); any recurrence of a severe or NCI-CTC grade 3 reaction; any persistent NCI-CTC grade 2 or 3 treatment-related adverse reaction that does not recover to grade 1 or resolve within 12 weeks after the last dose. Version 1 (Sept 2020) Page 3 of 9 Lung – Atezolizumab (1680mg 28 days) Immune-related adverse reaction Severity Immune-related pneumonitis Grade 2 pneumonitis Treatment modification Withhold until symptoms resolve and radiographic abnormalities improve. Consider treatment with oral prednisolone 1-2mg/kg or equivalent per day Treatment may be resumed if the event improves to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to 10mg or less oral prednisone equivalent per day. Immune-related colitis Immune-related pancreatitis Grade 3 or 4 pneumonitis Grade 2 or 3 diarrhoea or symptomatic colitis Permanently discontinue atezolizumab. Consider treatment with corticosteroids. Withhold the atezolizumab initially. For a grade 2 diarrhoea or colitis, if the symptoms persist for more than 5 days or recur, start treatment with 1-2mg/kg oral prednisolone or equivalent per day For a grade 3 diarrhoea or colitis treatment with intravenous corticosteroids should be started, this may be converted to oral treatment as symptoms improve. If the symptoms improve to grade 1 or less taper the corticosteroids over one month Grade 4 diarrhoea or colitis Grade 3 or 4 serum amylase or lipase levels increased (more than 2xULN) or grade 2 or 3 pancreatitis Treatment may be resumed if the event improves to grade 0 or grade 1 within 12 weeks, and corticosteroids have been reduced to 10mg or less oral prednisone equivalent per day Permanently discontinue atezolizumab. Consider treatment with corticosteroids. Withhold atezolizumab Treatment with atezolizumab may be resumed if serum amylase and lipase levels improve to grade 0 or grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have Version 1 (Sept 2020) Page 4 of 9 Lung – Atezolizumab (1680mg 28 days) been reduced to 10mg or less oral prednisone or equivalent per day Grade 4 or any grade of recurrent pancreatitis Permanently discontinue atezolizumab. Consider treatment with corticosteroids. Immune-related thyroid disorders Symptomatic Withhold atezolizumab Hypothyroidism Treatment may be resumed when symptoms are controlled by thyroid replacement therapy and TSH levels are decreasing Hyperthyroidism Treatment may be resumed when symptoms are controlled by cabimazole or equivalent and thyroid function is improving Immune-related Symptomatic adrenal insufficiency Withhold atezolizumab Treatment may be resumed if the symptoms improve to grade 0 or grade 1 within 12 weeks and corticosteroids have been reduced to the equivalent of 10mg or less of oral prednisone or equivalent per day and patient is stable on replacement therapy Immune-related diabetes mellitus Grade 3 or 4 hyperglycaemia (fasting Withhold atezolizumab glucose more than 250-500mg/dL or 13.9 mmol/L Treatment may be resumed if metabolic control is achieved on insulin replacement therapy Immune-related All grades myasthenic syndrome / myasthenia gravis, Guillain-Barre syndrome and meningoencephalitis Myositis Grade 2-3 Permanently discontinue atezolizumab Withhold for a moderate to severe myositis and discontinue Grade 3-4 Permanently discontine Version 1 (Sept 2020) Page 5 of 9 Lung – Atezolizumab (1680mg 28 days) Infusion related reactions Grade 1 Grade 2 Grade 4 Immune-related rash Grade 3 rash Grade 4 rash Reduce the infusion rate to half Once the event has resolved, wait for 30minutes while delivering the infusion at the reduced rate. If tolerated, the infusion rate may then be increased to original rate Withhold atezolizumab Restart at half of the infusion rate only after the symptoms have resolved Permanently discontinue atezolizumab Withhold atezolizumab Treatment may be resumed if the rash is resolved and corticosteroids have been reduced to 10mg or less oral prednisone equivalent per day Permanently discontinue atezolizumab. Consider treatment with corticosteroids Regimen 28 day cycle until loss of clinical benefit or unmanageable toxicity to a maximum of 26 cycles (two years) Drug Dose Atezolizumab 1680mg Days 1 Route Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Dose Information • If a planned dose of atezolizumab is missed for reasons other than toxicity, it should be administered as soon as possible. Do not wait until the next planned dose. The schedule of administration must be adjusted to maintain a 28 day period between doses. Version 1 (Sept 2020) Page 6 of 9 Lung – Atezolizumab (1680mg 28 days) Administration Information Extravasation • Atezolizumab – neutral Other • The first infusion of atezolizumab should be administered over 60 minutes. If this is well tolerated subsequent infusions can be administered over 30minutes. • Please refer to the toxicity table above for the actions to be taken in relation to infusion related reactions. Additional Therapy • No antiemetics are required • As required for the treatment of infusion related reactions; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • Loperamide 4mg oral initially followed by 2mg after each loose stool when required for the relief of diarrhoea (maximum 16mg/24 hours). • 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 use of systemic corticosteroids, before starting treatment with atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of the agent. However, systemic corticosteroids can be used after starting atezolizumab to treat immune-related adverse reactions. The use of systemic corticosteroids after starting treatment does not appear to impair the efficacy of atezolizumab. • Patients must be given an atezolizumab Patient Alert Card. References 1. National Institute for Health and Clinical Excellence (2018). Technology Appraisal 520. Atezolizumab for treating locally advanced or metastatic non-small cell lung cancer after chemotherapy. NICE:DOH. 2. Haanen J, Carbonnel F, Robert C, Kerr K.M , Peters S, Larkin J, Jordan J on behalf of the ESMO Guidelines Committee. Management of toxicities from immunotherapy. ESMO clinical practice guidelines for diagnosis, treatment and follow up. Ann Oncol 2017; 28 (suppl 4): 119-142. Version 1 (Sept 2020) Page 7 of 9 Lung – Atezolizumab (1680mg 28 days) REGIMEN SUMMARY Atezolizumab (1680mg 28 days) Day One 1. Atezolizumab 1680mg intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions The first infusion of atezolizumab should be administered over 60 minutes. If this is well tolerated subsequent infusions can be administered over 30minutes. Ensure the patient has been an atezolizumab patient alert card. 2. Chlorphenamine 10mg intravenous when required for the treatment of infusion related reactions 3. Hydrocortisone sodium succinate 100mg intravenous when required for the treatment of infusion related reactions 4. Paracetamol 1000mg oral when required for the relief of infusion related reactions Version 1 (Sept 2020) Page 8 of 9 Lung – Atezolizumab (1680mg 28 days) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Sept 2020 None Nanda Basker Haematology Pharmacist Dr Judith Cave Consultant Medical Oncologist 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 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. These protocols are only one source of information. They should be read in conjunction with the latest Summary of Product Characteristics and published information. Version 1 (Sept 2020) Page 9 of 9 Lung – Atezolizumab (1680mg 28 days)
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Atezolizumab(1680-28days)

Description
Chemotherapy Protocol GENITOURINARY CANCER Atezolizumab (1680mg-28 days) Regimen • Urothelial– Atezolizumab (1680mg-28 days) Indication • This protocol was developed in response
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Lenalidomide-RituximabIV/SC

Description
Chemotherapy Protocol LYMPHOMA LENALIDOMIDE-RITUXIMAB (IV/SC) There are multiple versions of this protocol in use. Please ensure you have the
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Lenalidomide-Rituximab IV

Description
Chemotherapy Protocol LYMPHOMA LENALIDOMIDE-RITUXIMAB (IV) There are multiple versions of this protocol in use. Please ensure you have the correct protocol for the relevant diagnosis. Regimen • Lymphoma – Lenalidomide-Rituximab (IV) Indication • Follicular Lymphoma - anti-CD20 antibody sensitive (responded to the last anti-CD20 antibody containing regimen and had progressive disease more than six months after completion of that anti-CD20 antibody containing regimen) or - anti-CD20 antibody resistant (failed to respond to the last anti-CD20 antibody- containing regimen or had progressive disease within six months of completion of that anti-CD20 antibody-containing regimen - the patient has had no previous treatment with lenalidomide - the patient will be treated with a maximum of twelve 4-weekly cycles of lenalidomide - lenalidomide is only to be used in combination with rituximab and that it is not to be used in combination with any other agents. Note: if rituximab has to be discontinued for toxicity, lenalidomide can be continued up to the maximum of 12 cycles - prior to cycle 1 the patient will receive tumour lysis syndrome prophylaxis (allopurinol, rasburicase or equivalent as per institutional guideline) and that the patient will be counselled as to be well orally hydrated during the 1st week of the 1st cycle or longer if clinically indicated. - the patient will have routine biochemistry tests performed weekly during cycle 1 and as clinically indicated and these results will be reviewed on day of testing to check for tumour lysis syndrome (TLS) and its consequences. - the patient will be treated for any Tumour Flare Reaction as set out in the Summary of Product Characteristics (SmPC) for lenalidomide. - that a formal medical review as to whether treatment with lenalidomide in combination with rituximab should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment. Toxicity Drug Lenalidomide Rituxumab Adverse Effect Peripheral neuropathy, pneumonia, infections, venous thrombotic events, respiratory dysfunction, rashes, hypokalaemia, hypomagnesaemia, hypocalcaemia, teratogenic risk, GI disturbances, flu-like symptoms. Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy, skin reactions The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (October 2020) Page 1 of 10 Lymphoma- Lenalidomide-Rituximab (IV) Monitoring Drugs • FBC, LFTs and U&Es prior to day one of treatment • Tumour lysis screen weekly during 1st cycle, this should be reviewed on the day bloods are taken • Perform a venous thromboembolism (VTE) risk assessment prior to starting treatment. Prescribe thromboprophylaxis for patients with additional risk factors. • Consider monitoring serum immunoglobulin levels • Check hepatitis B status before starting treatment with rituximab • Calcium and magnesium levels at regular intervals throughout treatment • Thyroid function tests at baseline and at regular intervals throughout treatment 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 if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL (80g/L). Version 1 (October 2020) Page 2 of 10 Lymphoma- Lenalidomide-Rituximab (IV) Lenalidomide Neutrophils (x109/L) 1 or more Less than 1 Platelets (x109/L) 50 or more Less than 50 Dose Modifications 100% 1st Occurrence Delay until recovery has occurred. Restart at full dose. 2nd Occurrence Delay until recovery has occurred. Restart at a dose of 15mg 3rd Occurrence Delay until recovery has occurred. Restart at a dose of 10mg 3rd Occurrence Delay until recovery has occurred. Restart at a dose of 5mg Dose Modifications 100% 1st Occurrence Delay until recovery has occurred. Restart at a dose of 15mg 2nd Occurrence Delay until recovery has occurred. Restart at a dose of 10mg 3rd Occurrence Delay until recovery has occurred. Restart at a dose of 5mg Hepatic Impairment Drug Lenalidomide Rituximab Bilirubin μmol/L N/A AST/ALT units/L N/A Dose (% of original dose) No dose adjustments needed No dose adjustment needed Renal Impairment Drug Creatinine Clearance (ml/min) Greater than 50 Lenalidomide 30-50 Rituximab Less than 30 Less than 30 and requiring dialysis N/A Dose (% of original dose) 100% Start treatment with 10mg once a day Lenalidomide dose can be increased to 15mg after 2 cycles if patient shows no response. Start treatment with 15mg on alternate days 5 mg once a day. On dialysis days, the dose should be administered following dialysis. No dose adjustment needed Version 1 (October 2020) Page 3 of 10 Lymphoma- Lenalidomide-Rituximab (IV) 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. Lenalidomide Lenalidomide may be continued (maintain dose) in patients with laboratory TLS or NCI-CTC grade 1 clinical TLS, or at the physician's discretion, reduce dose by one level and continue lenalidomide. Vigorous intravenous hydration should be provided and appropriate medical management according to the local standard of care, until correction of electrolyte abnormalities. Rasburicase therapy may be needed to reduce hyperuricaemia. Hospitalisation of the patient will be at physician's discretion. In patients with Grade 2 to 4 clinical TLS, interrupt lenalidomide and obtain a chemistry panel weekly or as clinically indicated. Vigorous intravenous hydration should be provided and appropriate medical management according to the local standard of care, until correction of electrolyte abnormalities. Rasburicase therapy and hospitalisation will be at physician's discretion. When the TLS resolves to Grade 0, restart lenalidomide at next lower dose per physician's discretion In general for all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. Reduce the daily dose to 15mg. On subsequent occurrences delay until recovery the dose may then be reduced to 10mg and 5mg consecutively. If a dose of 5mg is not tolerated treatment should be stopped. Allergic or hypersensitivity reactions that occur at NCI-CTC grade 2, withhold treatment until the symptoms have resolved to NCI-CTC grade 1 or below. Treatment may be cautiously restarted at a daily dose of 15mg. For NCI-CTC grade 3 or above reactions discontinue the lenalidomide. Lenalidomide should be discontinued if a desquamating rash of NCI-CTC grade 3 or above or NCI-CTC grade 4 non-desquamating rash develops. Where a venous thrombosis or embolism develops at NCI-CTC grade 3 or above, stop treatment and start anticoagulation. Lenalidomide may be reinstated at the clinician’s discretion. Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Version 1 (October 2020) Page 4 of 10 Lymphoma- Lenalidomide-Rituximab (IV) Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection at the time of treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu-like symptoms prior to treatment Regimen 28 day cycle for 12 cycles Cycle 1 Drug Lenalidomide Dose 20mg Days 1-21 incl. Administration Oral Rituximab 375mg/m2 1,8,15,22 Intravenous infusion in 500ml sodium chloride 0.9% Cycles 2, 3, 4, 5 Drug Lenalidomide Rituximab Dose 20mg 375mg/m2 Days 1-21 incl. day 1 Administration Oral Intravenous infusion in 500ml sodium chloride 0.9% Cycles 6, 7, 8, 9, 10, 11, 12 Drug Lenalidomide Dose 20mg Days 1-21 incl. Administration Oral Dose Information • Lenalidomide is available as 20mg, 15mg, 10mg, 7.5mg, 5mg and 2.5mg capsules • Rituximab (intravenous) will be dose rounded to the nearest 100mg (up if halfway) Version 1 (October 2020) Page 5 of 10 Lymphoma- Lenalidomide-Rituximab (IV) Administration Information Extravasation • Rituximab – neutral Other • Lenalidomide should be swallowed whole, preferably with water, either with or without food at about the same time each day. The capsules should not be opened, broken or chewed. If less than 12 hours has elapsed since missing a dose, the patient can take the dose. If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day • The rate of administration of rituximab (intravenous) varies. Please refer to the rituximab administration guidelines Additional Therapy • Antiemetics - metoclopramide 10mg three times a day when required oral • Allopurinol 300mg once a day for 7 days cycle one only in patients at risk of tumour lysis syndrome • Adequate hydration in view of potential for tumour lysis syndrome • Thromboprophylaxis in patients with additional risk factors for VTE • Rituximab (intravenous) pre medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • Rituximab infusion reactions - hydrocortisone 100mg intravenous bolus when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous bolus for rituximab related rigors that fail to respond to steroids. Version 1 (October 2020) Page 6 of 10 Lymphoma- Lenalidomide-Rituximab (IV) Additional Information • Patient, prescriber and pharmacy must comply with the pregnancy prevention programme. • 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. References 1. John P. Leonard, MD; Marek Trneny, MD; Koji Izutsu, MD; Nathan H. Fowler, MD; Xiaonan Hong, MD; Jun Zhu, PhD;Huilai Zhang, MD7; Fritz Offner, MD, PhD; Adriana Scheliga, MD; Grzegorz S. Nowakowski, MD; Antonio Pinto, MD;Francesca Re, MD; Laura Maria Fogliatto, MD, PhD; Phillip Scheinberg, MD; Ian W. Flinn, MD, PhD; Claudia Moreira, MD; Jos´e Cabeçadas, MD; David Liu, MD, PhD; Stacey Kalambakas, MD; Pierre Fustier, PhD19; Chengqing Wu, PhD; and John G. Gribben, MD, DSc; for the AUGMENT Trial Investigators. 2019. J Clin Oncol 37:1188-1199. 2. Revlimid® (lenalidomide) 25mg capules. eMC UK Summary of Product Characteristics for Revlimid 25mg, Celgene, 8 January 2020 3. UCLH - Dosage Adjustment for Cytotoxics in Hepatic Impairment (Version 3 - updated January 2009). 4. UCLH - Dosage Adjustment for Cytotoxics in Renal Impairment (Version 3 - updated January 2009). Version 1 (October 2020) Page 7 of 10 Lymphoma- Lenalidomide-Rituximab (IV) REGIMEN SUMMARY Lenalidomide-Rituximab (intravenous) Cycle 1 Day 1, 8, 15, 22 1. Chlorphenamine 10mg intravenous 2. Hydrocortisone 100mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 6. Salbutamol 2.5mg nebule once only when required for the relief of rituximab infusion related reactions Take Home Medicines (day 1 only) 7. Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 8. Lenalidomide 20mg once a day for 21 days oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral SACT Available as 20mg, 15mg, 10mg, 7.5mg, 5mg and 2.5mg capsules, please ensure dose modifications occur in multiples of these strengths. Swallow whole, not chewed with plenty of water. 9. Metoclopramide 10mg three times a day when required oral* *The metoclopramide will be supplied on cycle one only. Thereafter it can be added from supportive treatments if further supplies are required. Cycles 2, 3, 4, 5 Day One 10. Chlorphenamine 10mg intravenous 11. Hydrocortisone 100mg intravenous 12. Paracetamol 1000mg oral 13. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines Version 1 (October 2020) Page 8 of 10 Lymphoma- Lenalidomide-Rituximab (IV) 14. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 15. Salbutamol 2.5mg nebule once only when required for the relief of rituximab infusion related reactions Take Home Medicines 16. Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 17. Lenalidomide 20mg once a day for 21 days oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral SACT. Available as 20mg, 15mg, 10mg, 7.5mg, 5mg and 2.5mg capsules, please ensure dose modifications occur in multiples of these strengths. Swallow whole, not chewed with plenty of water. Cycle 6, 7, 8, 9, 10, 11, 12 Take Home Medicines 18. Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 19. Lenalidomide 20mg once a day for 21 days oral Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. Oral chemotherapy. Available as 20mg, 15mg, 10mg, 7.5mg, 5mg and 2.5mg capsules, please ensure dose modifications occur in multiples of these strengths. Swallow whole, not chewed with plenty of water. Version 1 (October 2020) Page 9 of 10 Lymphoma- Lenalidomide-Rituximab (IV) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 April 2020 None Nanda Basker Haematology Pharmacist Dr Rob Lown Consultant Medical Oncologist 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 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 (October 2020) Page 10 of 10 Lymphoma- Lenalidomide-Rituximab (IV)
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InP-Ifosfamide-Liposomal Doxorubicin (Caelyx) v1

Description
Chemotherapy Protocol SARCOMA IFOSFAMIDE-LIPOSOMAL DOXORUBICIN (Caelyx) In-Patient Regimen Please note this protocol is based on information for the use of the Caelyx brand of liposomal doxorubicin. Brands may not be interchangeable. This is not a licensed indication for Caelyx at the time of writing. This protocol may require funding. Regimen Sarcoma – InP-Liposomal Doxorubicin (Caelyx) - Ifosfamide Indication First or second line treatment of sarcoma in patients with a cardiac impairment requiring an anthracycline WHO performance status 0,1, 2 Palliative intent Toxicity Drug Liposomal Doxorubicin Ifosfamide Adverse Effect Palmar plantar erythrodysthesia (hand and foot syndrome), rash, GI disturbances, cardiotoxicity, asthenia, paresthesia Haemorrragic cystitis, encephalopathy, nephrotoxicity The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs and U&Es (including uric acid, albumin, calcium, magnesium, bicarbonate and phosphate) prior to day one of treatment Urine dip test for protein every four hours the day of and the day after ifosfamide administration EDTA or calculated creatinine clearance prior to each cycle Version 1 (September 2015) Page 1 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin Fluid balance monitoring every four hours the day of and the day after ifosfamide administration. Urine output should be maintained above 100ml/hour Ensure adequate cardiac function before starting therapy. Baseline ECG and LVEF should be measured in patients with a history of cardiac problems or in the elderly. Discontinue liposomal doxorubicin if cardiac failure develops 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 Consider blood transfusion or erythropoietin if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to cycle 1 the following criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L Day 1 Neutrophils (x109/L) 1 or greater 100% Dose Modifications 0.5 - 1 less than 0.5 Platelets (x109/L) Delay until recovery to 1x109/L or greater then continue at full dose Delay until recovery to 1x109/L or greater then continue at 75% of the original dose Dose Modifications 100 or greater 50 - 99 less than 50 100% Delay until recovery to 100x109/L or greater then continue at full dose Delay until recovery to 100x109/L or greater then continue at 75% of the original dose Version 1 (September 2015) Page 2 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin Hepatic Impairment Doses recommended below are for initial dosing. If the first dose of liposomal doxorubicin is well tolerated with minimal toxicity and no increase in bilirubin or liver enzymes the dose may be increased from 75% to 100% and from 50% to 75% at the next cycle (and from 75% to 100% on subsequent cycles where appropriate.) Drug Ifosfamide Liposomal Doxorubicin Bilirubin (μmol/L) more than 20 or more than 2.5xULN or ALP more than 2.5xULN less than 20 Dose (% of original dose) Not recommended 100% 21-51 75% 51 or greater 50% Renal Impairment Drug Ifosfamide Liposomal Doxorubicin Creatinine Clearance (ml/min) more than 60 40-59 Less than 40 30 or greater less than 30 Dose (% of original dose) 100% 70% or consider using cyclophosphamide at a dose of 1500mg/m2 Clinical decision, consider using cyclophosphamide at a dose of 1500mg/m2 No dose modification needed Clinical decision 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. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose should then be reduced to 75% of the original dose or discontinued as appropriate. Version 1 (September 2015) Page 3 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin NCI-CTC Toxicity Grade 1 2 3 4 Palmer-Plantar Erythrodesia / Stomatitis Number of Weeks after the Dose of Liposomal Doxorubicin 4 5 6 Re-dose unless patient Re-dose unless Decrease dose by 25 has experienced a patient has % and return to 4 previous grade 3 or 4 experienced a week interval or stop skin toxicity, in which previous grade 3 or 4 treatment case wait an additional skin toxicity, in which week case wait an additional week Wait an additional Wait an additional Decrease dose by 25 week week % and return to 4 week interval or stop treatment Wait an additional Wait an additional Stop treatment week week Wait an additional Wait an additional Stop treatment week week Ifosfamide In the case of a NCI-CTC grade 1 neurological toxicity to ifosfamide, consider reducing the dose of ifosfamide for the next cycle. If a NCI-CTC grade 2 neurologic toxicity appears or neurologic toxicity worsens despite dose reduction consider stopping the ifosfamide. In the case of NCI-CTC grade 3 or 4 mucositis/GI toxicity reduce dose to 80% on first occurrence and to 60% on second occurrence. In the case of NCI-CTC grade 3 or 4 neutropenic sepsis reduce dose to 80% on first occurrence and to 60% on second occurrence. In the case of delayed recovery of greater than 6 days, reduce dose to 80% on first occurrence and to 60% on second occurrence. Risk factors for CNS toxicity include a low albumin, renal impairment, prior administration of cisplatin, poor performance status, CNS tumour, bulky pelvic disease, concomitant psychotropic drugs and younger age. Methylene blue 50mg four times a day intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes can be used to prevent or treat ifosfamide induced encephalopathy. Regimen 21 day cycle for 6 cycles Drug Mesna Ifosfamide Mesna Dose 600mg/m2 3000mg/m2 3000mg/m2 Mesna 1800mg/m2 Version 1 (September 2015) Days 1, 2, 3 1, 2, 3 1, 2, 3 1, 2, 3 Administration Intravenous bolus in 100ml sodium chloride 0.9% over 15 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 240 minutes (the ifosfamide and mesna are in the same bag) Intravenous infusion in 1000ml sodium chloride 0.9% over 12 hours Page 4 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin Liposomal Doxorubicin 40mg/m2 Intravenous infusion in 250ml glucose 5%. The first infusion to be given at a 1 maximum rate of 1mg/minute. If well tolerated subsequent infusions may be given over 60 minutes. The default time on Aria is 120 minutes. Dose Information Ifosfamide will be dose banded according to the agreed bands Mesna will be dose banded according to the agreed bands. Liposomal Doxorubicin will be dose banded according to the agreed bands The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal/pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m². Also consider previous anthracycline exposure. Administration Information Extravasation Liposomal Doxorubicin – exfoliant Ifosfamide – neutral Other The first infusion of liposomal doxorubicin is to be given at a maximum rate of 1mg/minute. If this is well tolerated subsequent infusions may be given over 60 minutes. The default time on Aria is 120 minutes. If the patient experiences early symptoms or signs of infusion reaction immediately discontinue the infusion and administer appropriate treatment with chlorpheniramine and hydrocortisone. Once the patient has fully re-covered the infusion may be restarted slowly by infusing 5% of the total dose over the first 15 minutes. If tolerated without reaction, the infusion rate may then be doubled for the next 15 minutes. If tolerated, the infusion may then be completed over the next hour for a total infusion time of 90 minutes. Liposomal doxorubicin is incompatible with sodium chloride 0.9%. Always use a glucose 5% flush. Do not use in-line filters during the administration of liposomal doxorubicin. Doses of liposomal doxorubicin less than 90mg may be diluted in 250ml of glucose 5%. Doses of 90mg and above should be diluted in 500ml of glucose 5%. Version 1 (September 2015) Page 5 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin Additional Therapy This is an inpatient regimen please ensure all supportive and take home medicines are prescribed on the inpatient chart or general electronic prescribing system. Antiemetics Starting 15-30 minutes prior to chemotherapy - dexamethasone 4mg twice a day for 5 days oral or intravenous - metoclopramide 10mg three times a day for 5 days then when required oral or intravenous - ondansetron 8mg twice a day for 5 days oral or intravenous Growth factors according to local formulary choice. For example: - filgrastim or bioequivalent 30 million units once a day from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous Ciprofloxacin 500mg twice a day for 7 days starting on day 8 of the cycle The final dose of mesna on day 3 may be replaced with oral mesna at a dose of 1200mg/m2 (rounded upwards to the nearest 400mg capsule) at 0, 2 and 6 hours after the end of the ifosfamide infusion. 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 – not relevant References De Sanctis, Bertuzzi A, Basso U et al. Non-pegylated liposomal doxorubicin plus ifosfamide in metastatic soft tissue sarcoma: results from a phase II trial. Anticancer Res 2015; 35 (1): 543-547. Version 1 (September 2015) Page 6 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin REGIMEN SUMMARY InP-Ifosfamide - Liposomal Doxorubicin (Caelyx) Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day 1 1. Warning – Check supportive medication prescribed Administration Instructions 1. Dexamethasone 4mg twice a day day for 5 days oral or intravenous bolus 2. Metoclopramide 10mg three times a day for 5 days oral or intravenous bolus 3. Ondansetron 8mg twice a day for 5 days oral or intravenous bolus 4. Ciprofloxacin 500mg twice a day days 8-15 oral 5. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous 6. Consider gastric protection 7. Consider mouthwashes 2. Liposomal doxorubicin 40mg/m2 intravenous infusion in 250ml glucose 5% over 120 minutes Administration Instructions The first infusion of liposomal doxorubicin is to be given at a maximum rate of 1mg/minute. If this is well tolerated subsequent infusions may be given over 60 minutes. The default time on Aria is 120 minutes. 3. Mesna 600mg/m2 intravenous bolus in 100ml sodium chloride 0.9% over 15 minutes 4. Ifosfamide 3000mg/m2 and mesna 3000mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 240 minutes 5. Mesna 1800mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 720 minutes Administration Instructions On day 3 of the cycle (after the last of the ifosfamide infusions) this may be substituted by oral mesna at a dose of 1200mg/m2 rounded upwards to the nearest 400mg capsule given 0, 2 and 6 hours after the end of the ifosfamide infusion. Day 2, 3 6. Warning – Check supportive medication prescribed Administration Instructions 1. Dexamethasone 4mg twice a day day for 5 days oral or intravenous bolus 2. Metoclopramide 10mg three times a day for 5 days oral or intravenous bolus 3. Ondansetron 8mg twice a day for 5 days oral or intravenous bolus 4. Ciprofloxacin 500mg twice a day days 8-15 oral 5. Growth factor according to local formulary choice. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 4 subcutaneous 6. Consider gastric protection 7. Consider mouthwashes 7. Mesna 600mg/m2 intravenous bolus in 100ml sodium chloride 0.9% over 15 minutes Version 1 (September 2015) Page 7 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin 8. Ifosfamide 3000mg/m2 and mesna 3000mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 240 minutes 9. Mesna 1800mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 720 minutes Administration Instructions On day 3 of the cycle (after the last of the ifosfamide infusions) this may be substituted by oral mesna at a dose of 1200mg/m2 rounded upwards to the nearest 400mg capsule given 0, 2 and 6 hours after the end of the ifosfamide infusion. Version 1 (September 2015) Page 8 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin Version Date 1 September 2015 DOCUMENT CONTROL Amendment None Written By Dr Deborah Wright Pharmacist Approved By Dr Nicola Keay Consultant Medical Oncologist 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 which occur as a result of following these guidelines. Version 1 (September 2015) Page 9 of 9 Sarcoma-InP-Ifosfamide-Liposomal Doxorubicin
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IRD(40)-Dexamethasone_40_Ixazomib-Lenalidomide

Description
Chemotherapy Protocol Myeloma IRD (40) - Dexamethasone (40)-Ixazomib-Lenalidomide Regimen • Myeloma – IRD (40) - Dexamethasone (40)-Ixazomib-Lenalidomide Indication • Ixazomib and lenalidomide, in combination with dexamethasone, is recommended as an option for treating multiple myeloma provided the following criteria are met: - the patient has received two or three prior lines* of treatment and that the numbering of these lines of treatment is in accordance with the International Myeloma Workshop Consensus recommendations. Patients previously treated with only one or more than three lines of treatment are not eligible for ixazomib. *A line of therapy is defined as one or more cycles of a planned treatment program. This may consist of one or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner (eg induction chemotherapy and stem cell transplantation is considered to be one line of therapy). A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse or toxicity. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. - the patient is neither refractory to previous proteasome inhibitor-based nor lenalidomide-based treatment at any line of therapy (in this context, refractory disease is defined as disease progression on treatment or disease progression within 60 days of the last dose of a proteasome inhibitor or lenalidomide). As lenalidomide is only commissioned by NHS England after two prior therapies, the only eligible patients who have had prior lenalidomide must have received it in the context of a clinical trial in an earlier line of therapy. Such patients must not be refractory to lenalidomide according to the above definition. - the patient has either been refractory to one or more lines of therapy or has responded and relapsed after each line of therapy - the patient must be treatment naïve to any therapy with ixazomib - ixazomib must only be used in combination with lenalidomide and dexamethasone. All three drugs must be commenced at the same time. Ixazomib cannot be added as an additional agent in the treatment of patients who have previously been treated with lenalidomide and dexamethasone. • no treatment break beyond six weeks of the expected cycle length • WHO performance status of 0, 1 or 2 Version 1 (May 2018) Page 1 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Toxicity Drug Dexamethasone Ixazomib Lenalidomide Adverse Effect Weight gain, gastrointestinal disturbances, hyperglycaemia, CNS disturbances, Cushingoid changes, glucose intolerance. Peripheral neuropathy, posterior reversible encephalopathy syndrome, rash, GI symptoms, peripheral oedema, thrombocytopenia, hepatotoxicity, Herpes zoster re-activation Peripheral neuropathy, pneumonia, infections, venous thrombotic events, respiratory dysfunction, rashes, hypokalaemia, hypomagnesaemia, hypocalcaemia, teratogenic risk, GI disturbances, flu-like symptoms. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC at baseline. Thereafter monitor prior to each cycle. • U&Es, Ca2+ and LFTs prior to day one of each cycle of treatment. • Paraprotein and/or light chains prior to each cycle. • For all women of childbearing potential a negative pregnancy test must be obtained within the 3 days prior to starting lenalidomide. The test must be repeated every 4 weeks (every 2 weeks in women with irregular menstrual cycles) with the final test 4 weeks after the last dose of lenalidomide. • Perform a venous thromboembolism (VTE) risk assessment prior to starting treatment with lenalidomide. Prescribe thromboprophylaxis for patients with additional risk factors. • Regular monitoring of blood glucose is considered good practice. 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. The following table describes dose adjustments for ixazomib and lenalidomide based on toxicity. The starting dose may vary depending on factors such as renal and hepatic function or performance status. The lenalidomide dose should not drop below 5mg. Version 1 (May 2018) Page 2 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Dose Level Starting Dose -1 -2 -3 Ixazomib Dose 4mg 3mg 2.3mg discontinue Lenalidomide Dose 25mg 15mg 10mg 5mg 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 the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or where the haemoglobin is less than 8g/dL (80g/L). Consider growth factor support as an alternative to the options below, particularly where there is evidence of bone marrow suppression. Prior to starting a cycle of treatment the platelet count must be equal to or higher than 75x109/L and the neutrophil count must be equal to or higher than higher than 1x109/L. The dose of dexamethasone does not require adjustment for haematological toxicity. Toxicity Action First Occurrence Hold until platelets are greater than or equal to 30x109/L AND Platelet count less than the neutrophil count is greater 30x109/L or neutrophils than or equal to 0.5x109/L and less than 0.5x109/L consider adding G-CSF Second Occurrence Hold until platelets are greater than or equal to 30x109/L AND Platelet count less than the neutrophil count is greater 30x109/L or neutrophils than or equal to 0.5x109/L and less than 0.5x109/L consider adding G-CSF Ixazomib dose when restarting Lenalidomide dose when restarting No change Decrease by 1 dose level Decrease by 1 dose level No change Hepatic Impairment Hepatic impairment Ixazomib dose Mild (total bilirubin less than or equal to ULN and greater than ULN OR the total bilirubin 1- AST No doseage adjustment required 1.5xULN and any AST) Moderate or severe 3 mg (total bilirubin greater than 1.5xULN) Lenalidomide dose No dose adjustment required No data Version 1 (May 2018) Page 3 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Renal Impairment Creatinine Clearance (ml/min) Ixazomib dose Greater than or equal to 60 No dose adjustment 30 – 59 No dose adjustment Less than 30 (not requiring dialysis) Less than 30 (requiring dialysis) 3 mg 3 mg Lenalidomide dose No dose adjustment 10 mg once a day (may be escalated to 15 mg once a day after 2 cycles if patient is not responding to treatment and is tolerating the drug) 15 mg every other day 5 mg once a day. On dialysis days, the dose should be administered following dialysis Other Toxicity Action Ixazomib dose when Lenalidomide dose when restarting restarting Resume with 1 dose level NCICTC grade 2 Rash or 3 Hold both until less than or equal to NCI-CTC grade 1 Continue at same dose. If it reduction recurs, hold until recovery and then resume with 1 dose Discontinue if greater than level reduction or equal to NCI-CTC grade 2 exfoliative skin toxicity NCI- CTC Discontinue Discontinue Discontinue grade 4 Version 1 (May 2018) Page 4 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Toxicity Action Ixazomib dose Lenalidomide dose when when restarting restarting NCI-CTC Hold ixazomib until grade 1 with pain or grade less than or equal to NCI-CTC grade 1 without pain or Resume at same dose Continue at same dose 2 patient’s baseline Peripheral Neuropathy Grade 2 with pain or grade 3 Hold both until less than or equal to NCICTC grade 1 without pain or patient’s 1 dose level reduction baseline Consider 1 dose level reduction if NCI-CTC grade 3 Grade 4 Discontinue Discontinue Discontinue Other NCI-CTC grade 3 or 4 nonhaematological toxicities Hold both until recovery to baseline or less than or equal to NCI-CTC grade 1 If toxicity due to ixazomib, resume at 1 dose level reduction once recovered or discontinue If toxicity due to lenalidomide, resume at 1 dose level reduction once recovered or discontinue. If pneumonitis investigate and discontinue if confirmed Lenalidomide Pregnancy As lenalidomide is structurally related to thalidomide a teratogenic effect is expected, therefore, it must not be taken during pregnancy. All women of child bearing potential (even if they have amenorrhoea) must use one effective method of pregnancy prevention at least 4 weeks before therapy, during therapy and even in the case of dose interruptions, and for at least a further 4 weeks after stopping therapy. Additionally a negative pregnancy test is required prior to commencing each cycle of therapy. Men are required to undertake to use a barrier method of contraception. The conditions of the Celgene Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential. Patients should not donate blood or semen while taking lenalidomide and for eight weeks after stopping therapy to prevent foetal exposure via blood transfusion of pregnant women. Venous Thromboembolism (VTE) Patients receiving lenalidomide in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident). Appropriate VTE prophylaxis is recommended. All patients should be initially prescribed a low molecular weight heparin at the appropriate prophylactic dose. Aspirin 75mg each morning is an alternative in very low risk patients once a response has been obtained. The duration of thromboprophylaxis remains unclear but guided by risk factors such as active disease (e.g. for the first 4 to 6 months of treatment until disease control achieved) and de-escalated or discontinued unless there are ongoing significant risk factors. If patients are treated with a low molecular weight heparin consider switching patients to aspirin after six cycles of therapy or after maximum response is achieved. Version 1 (May 2018) Page 5 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide A high index of suspicion for venous thromboembolism should always be maintained. If a venous thrombosis or embolism NCI-CTC grade 3 or above occurs then stop treatment and start full anticoagulation. Lenalidomide may be restarted at the clinician’s discretion, once the patient is fully anti-coagulated. Modifiable risk factors for thromboembolic events should be managed wherever possible to reduce the risk of VTE (e.g. smoking cessation; control of hypertension and hyperlipidaemia). Medicines that may increase the risk of thromboembolism, such as oestrogens and erythropoietic agents, should be used with caution during lenalidomide treatment. For all other NCI-CTCAE grade 3 or 4 adverse reactions, judged to be related to lenalidomide, stop treatment. Restart treatment when the adverse reaction has resolved to NCI-CTC grade 2 or below at one dose level below the previous dose, or at the consultant’s discretion. Dexamethasone Dose Level 3 (starting) 2 1 Dose 40mg 20mg 10mg If recovery from toxicities is prolonged beyond 14 days, then the dose of dexamethasone will be decreased by one dose level. Toxicity Dyspepsia Oedema Confusion or mood alteration Muscle weakness Hyperglycaemia Acute pancreatitis Other Grade (NCI-CTC) 1-2 3 or above 3 or above 2 or above 2 or above 3 or above 3 or above Dose modification Maintain dose and treat with histamine (H2) antagonist or proton pump inhibitor. Decrease by one dose level if symptoms persist. Interrupt dose until symptoms are controlled. Add H2 blocker or proton pump inhibitor and decrease one dose level when dose restarted. Use diuretics as needed and decrease dose by one dose level. Interrupt dose until symptoms resolve. When dose restarted decrease dose by one dose level. Interrupt dose until the muscle weakness is grade 1 or below. Restart with dose decreased by one level. Decrease dose by one dose level. Treat with insulin or oral hypoglycaemic agents as needed Discontinue patient from dexamethasone treatment regimen. Stop dexamethasone dosing until adverse event resolves to grade 2 or below. Resume with dose reduced by one level. Version 1 (May 2018) Page 6 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Regimen 28 day cycle until disease progression or intolerance or the patient chooses to stop treatment (12 cycles will be set in Aria) Drug Dexamethasone Ixazomib Lenalidomide Dose 40mg once a day 4mg once a day 25mg once a day Days 1, 8, 15 and 22 1, 8, 15 1-21 inclusive Administration Oral Oral Oral Dose Information • Dexamethasone is available as 500microgram, 2mg and 4mg tablets and as a 2mg/5ml oral liquid. • Ixazomib is available as 2.3mg, 3mg and 4mg capsules • Lenalidomide is available as 5mg, 10mg, 15mg and 25mg capsules Administration Information • Dexamethasone should be taken in the morning with or immediately after food. • Ixazomib should be taken once a week on the same day and at approximately the same time for the first 21 days of a 28 day cycle. • The ixazomib capsule should be swallowed whole with water, on an empty stomach (at least one hour before or at least two hours after food). • The ixazomib capsule should not be crushed, chewed, or opened. Direct contact with capsule contents should be avoided as inhalation, ingestion, or skin absorption may be harmful. • If a dose of ixazomib is missed, it should be taken only if the next scheduled dose is greater than or equal to 72 hours away. A double dose should not be taken to make up for a missed dose. • If a patient vomits after taking a dose of ixazomib, the patient should not repeat the dose; resume dosing at the time of the next scheduled dose. • If a dose of lenalidomide is missed, it may be taken up to 12 hours after the time it is normally taken. Otherwise, skip this and take the next dose on the following day at its usual scheduled time. • All prescriptions for lenalidomide must be accompanied by a prescription authorisation form (PAF). Version 1 (May 2018) Page 7 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Additional therapy • No antiemetics are required. • Thromboprophylaxis, the choice depending on risk factors and duration of therapy. • Consider allopurinol 300mg oral once a day for seven days for the first cycle only • Consider anti-infective prophylaxis including; - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday 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. Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to ixazomib and lenalidomide. • It must be made clear to all staff, including those in the community, that ixazomib and lenalidomide should only be prescribed under the supervision of a consultant haematologist. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. • For all patients taking lenalidomide; the patient, prescriber and supplying pharmacy must comply with the Celgene pregnancy prevention programme (PPP). Coding • Procurement – X71.5 • Delivery – X73.1 References 1.Moreau P, Masszi T, Grzasko N, et al. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2016; 374:1621-1634. 2.National Institute for Health and Clinical Excellence. Technology Appraisal 505. Ixazomib with lenalidomide and dexamethsone for treating relapsed or refractory multiple myeloma. February 2018. NICE:DOH Version 1 (May 2018) Page 8 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide REGIMEN SUMMARY Cycle 1 IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide Take home medicines 1. Dexamethasone 40mg on days 1, 8, 15 and 22 oral Administration Information Please supply four doses of dexamethasone on day 1 of the cycle, ONE dose to be taken on days 1, 8, 15 and 22 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. 2. Ixazomib 4mg once a day on days 1, 8, 15 Administration Instructions Please supply all three doses on day 1 of the cycle, ONE dose to be taken on days 1, 8 and 15. Oral chemotherapy 3. Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 4. Lenalidomide 25mg once a day on days 1-21 oral Administration Information Oral chemotherapy. Pregnancy prevention programme Take at the same time each day. Swallow the capsules whole, preferably with water, with or without food. 5. Allopurinol 300mg once a day for 7 days, oral Administration information Take in the morning with food and plenty of water. This should be supplied for the first cycle. 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 only 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. 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 supply 28 days or the nearest original pack size. Version 1 (May 2018) Page 9 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide 9. Thromboprophylaxis according to risk factors Administration Instructions The choice of thromboprophylaxis is dependent on local formulary 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 Aspirin 75mg each morning may be considered once a maximum response has been achieved or afer six cycles Please supply 28 days or nearest original pack size. Cycle 2 onwards Take home medicines 10. Dexamethasone 40mg on days 1, 8, 15 and 22, oral Administration Information Please supply four doses of dexamethasone on day 1 of the cycle, ONE dose to be taken on days 1, 8, 15 and 22 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. 11. Ixazomib 4mg once a day on days 1, 8, 15 Administration Instructions Please supply all three doses on day 1 of the cycle, ONE dose to be taken on days 1, 8 and 15 Oral chemotherapy 12. Warning – Pregnancy Prevention Programme Administration Instructions Lenalidomide is associated with a pregnancy prevention programme. Please ensure this is completed for all patients. 13. Lenalidomide 25mg once a day on days 1-21 oral Administration Information Oral chemotherapy. Pregnancy prevention programme Take at the same time each day. Swallow the capsules whole, preferably with water, with or without food. 14. Aciclovir 400mg twice a day for 28 days oral Administration Instructions Please supply 28 days or an original pack if appropriate. 15. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only 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. 16. 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 supply 28 days or the nearest original pack size. Version 1 (May 2018) Page 10 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide 17. Thromboprophylaxis according to risk factors Administration Instructions The choice of thromboprophylaxis is dependent on local formulary 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 Aspirin 75mg each morning may be considered once a maximum response has been achieved or afer six cycles Please supply 28 days or nearest original pack size. Version 1 (May 2018) Page 11 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 June 2018 None Dr Deborah Wright Pharmacist Dr Srinivasan Narayanan 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 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. These protocols are only one source of information. They should be read in conjunction with the latest Summary of Product Characteristics and published information. Version 1 (May 2018) Page 12 of 12 Myeloma – IRD (40)-Dexamethasone (40)-Ixazomib-Lenalidomide
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