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Radiotherapy to the skin - patient information

Description
This factsheet explains what to expect during and after radiotherapy treatment to the skin.
Url
/Media/UHS-website-2019/Patientinformation/Cancercare/Radiotherapy-to-the-skin-1327-PIL.pdf

Cyclophosphamide and Etoposide

Description
Chemotherapy Protocol LUNG CANCER – SMALL CELL (SCLC) CYCLOPHOSPHAMIDE and ETOPOSIDE Regimen SCLC - Cyclophosphamide and Etoposide Indication First or second line therapy of SCLC WHO performance status 0, 1, 2, 3 Palliative intent Toxicity Drug Cyclophosphamide Etoposide Adverse Effect Haemorrhagic cystitis, taste disturbances, gastritis Alopecia, hyperbilirubinaemia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen FBC, LFTs and U&Es prior to each cycle A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated 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 1.2 (December 2013) Page 1 of 7 SCLC – Cyclophosphamide-Etoposide PO 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 is a general guide only. Haematology Prior to prescribing on day one of cycle one 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 Consider blood transfusion if patient symptomatic of anaemia or haemoglobin less than 8g/dL Subsequently if the neutrophils are less than 1x109/L then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Kidney / Liver Impairment Hepatic Impairment Drug Cyclophosphamide Etoposide Bilirubin AST/ALT Dose µmol/L units (%of original dose) Consider dose adjustments if the bilirubin is greater than ULN or the ALP/AST/ALT is greater than 2xULN If the bilirubin is 26-51umol/L or the AST 60-180units/L give 50% of the dose. Above these levels avoid if possible. Renal Impairment Drug Cyclophosphamide (consider mesna) Etoposide Creatinine Clearance (ml/min) 10-20 less than 10 15-50 Less than 15 Dose (% of original dose) 75 50 75 50 Version 1.2 (December 2013) Page 2 of 7 SCLC – Cyclophosphamide-Etoposide PO Regimen Etoposide is available as 50mg and 100mg capsules. Cyclophosphamide is available as a 50mg tablet. Doses must be rounded to the nearest 50mg or an alternate day dosing schedule used to facilitate the administration of the correct dose. It must be made clear to all staff, including those in the community, that this is a short course of therapy that must not be continued. It should be prescribed from secondary care only. 28 day cycle for 6 cycles Drug Dose Cyclophosphamide 50mg twice a day Etoposide 50mg twice a day Days 1 – 14 incl. 1 – 14 incl. Administration Oral Oral 21 day cycle for 6 cycles Drug Dose Cyclophosphamide 200mg once a day Etoposide 200mg once a day Days 1 – 5 incl. 1 – 5 incl. Administration Oral Oral Administration Information Cyclophosphamide should be taken an hour before food or on an empty stomach and swallowed whole, not chewed, with plenty of water Etoposide should be taken an hour before food or on an empty stomach Additional Therapy SCLC can be very sensitive to chemotherapy. This may lead to the development of tumour lysis syndrome at the start of therapy. For those at risk individuals’ allopurinol should be prescribed. This should begin the day before chemotherapy treatment and continue for as long as a significant chemosensitive tumour bulk remains. Normally one cycle suffices. Metoclopramide 10mg three times a day when required oral 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 adhered to in relation to oral chemotherapy. Coding (OPCS 4.5 version 2) Procurement – X70.1 Delivery – X73.1 Version 1.2 (December 2013) Page 3 of 7 SCLC – Cyclophosphamide-Etoposide PO References 1. Grunberg SM, Crowley J, Hande KR et al. Treatment of poor prognosis extensive disease small cell lung cancer with an all oral regimen of etoposide and cyclophosphamide – a Southwest Oncology Group clinical and pharmacokinetic study. Cancer Chemother Pharmacol 1999; 44 (6): 461-468. Version 1.2 (December 2013) Page 4 of 7 SCLC – Cyclophosphamide-Etoposide PO REGIMEN SUMMARY Cyclophosphamide-Etoposide PO (14 day) Day One 1. Cyclophosphamide 50mg twice a day for 14 days oral 2. Etoposide 50mg twice a day for 14 days oral 3. Metoclopramide 10mg three times a day when required oral Cyclophosphamide-Etoposide PO (5 day) Day One 1. Cyclophosphamide 200mg once a day for 5 days oral 2. Etoposide 200mg once a day for 5 days oral 3. Metoclopramide 10mg three times a day when required oral Version 1.2 (December 2013) Page 5 of 7 SCLC – Cyclophosphamide-Etoposide PO DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.2 December CSCCN removed from header Dr Deborah Wright Donna Kimber 2013 Toxicities removed Pharmacist Pharmacy Technician Tables used throughout Renal and hepatic function updated removed and words used Metoclopramide dose changed to 10mg TDS OPCS updated Name changed added to top of summary page Once daily and twice daily changed to once a day and twice a day Hospitals and disclaimer added 1.1 Sept 2010 Font changed to Arial Dr Deborah Wright Donna Kimber Header altered to include Pharmacist Pharmacy Technician “Strength through Partnership” Drug names given capitals in regimen Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Coding added Summary page added Document control added 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 Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust Version 1.2 (December 2013) Page 6 of 7 SCLC – Cyclophosphamide-Etoposide PO 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 1.2 (December 2013) Page 7 of 7 SCLC – Cyclophosphamide-Etoposide PO
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-small-cellSCLC/CyclophosphamideandEtoposide.pdf

Rucaparib

Description
A document based on Rucarib, an ovarian cancer condition.
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Ovarian-cancer/Rucaparib.pdf

Leg amputation - patient information

Description
Information about leg amputation surgery, performed as an absolute last resort for poor blood flow to your leg, or a serious
Url
/Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Leg-amputation-1661-PIL.pdf

Femoral endarterectomy - patient information

Description
information about having a femoral endarterectomy to improve the circulation to the legs
Url
/Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Femoral-endarterectomy-1658-PIL.pdf

Abdominal aortic aneurysm repair - patient information

Description
Information about abdominal aortic aneurysm repair
Url
/Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Abdominal-aortic-aneurysm-repair-1654-PIL.pdf

Eat, drink, move - patient information

Description
We've written this leaflet to help you eat, drink and move as you recover.
Url
/Media/UHS-website-2019/Patientinformation/Visitinghospital/Eat-drink-move-1901-PIL.pdf

Craniotomy for brain tumour removal - patient information

Description
A craniotomy is an operation where a disc of bone is removed from the skull using special tools to allow access to the underlying brain.
Url
/Media/UHS-website-2019/Patientinformation/Brain-and-spine/Craniotomy-for-brain-tumour-removal-1192-PIL.pdf

Brigatinib

Description
Chemotherapy Protocol Lung Cancer Regimen Brigatinib • NSCLC – Brigatinib Indication • Brigatinib is indicated as monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib; - where the patient has progressed on is 1st line crizotinib or 2nd line crizotinib after 1st line chemotherapy and that the patient has not been treated with either 1st line alectinib or 1st line ceritinib. - where the patient has not been treated with 2nd line ceritinib after 1st line crizotinib unless the ceritinib had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression. - where the patient has not been previously treated with brigatinib unless brigatinib has been received as part of any compassionate use scheme and the patient meets all the other criteria set out here - where brigatinib will be used only as monotherapy - where the patient either has no brain metastases or, if the patient has brain metastases, the patient is symptomatically stable prior to starting brigatinib - where the patient will be treated with brigatinib until loss of clinical benefit or excessive toxicity or patient choice to discontinue treatment, whichever is the sooner. - where treatment breaks of up to 6 weeks are allowed but solely to allow toxicities to settle - where the ECOG performance status is 0, 1 or 2 Version 1 (Sept 2020) Page 1 of 10 NSCLC – Brigatinib Toxicity Drug Brigatinib Adverse Effect Pneumonia, upper respiratory tract infections, pneumonitis, haematological toxicity, electrolyte disturbances, hyperglycaemia, headache, peripheral neuropathy, dizziness, insomnia, visual disturbance, hypertension, cough, dyspnoea, GI disturbances, increased LFTs, blood CPK increased, myalgia, arthralgia, musculoskeletal chest pain, blood creatinine increase, fatigue, oedema, pyrexia, nausea, rash, bradycardia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC, U&Es, LFTs at baseline, then LFTs every 2 weeks during the first 3 months of treatment then prior to each cycle or as clinically indicated. • Fasting serum glucose at baseline then prior to each cycle or as clinically indicated. • Lipase and amylase at baseline then prior to each cycle or as clinically indicated. • Heart rate and blood pressure at baseline then prior to each cycle or as clinically indicated. Heart rate should be monitored more frequently in patients if concomitant use of a medicinal product known to cause bradycardia cannot be avoided. • CPK levels at baseline then prior to each cycle or as clinically indicated. Dose Modifications The dose modifications listed are for haematological, liver and renal function and certain drug specific toxicities. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated 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 is a general guide only. Version 1 (Sept 2020) Page 2 of 10 NSCLC – Brigatinib Brigatinib Dose Reduction levels Dose Level 0 -1 -2 -3 Brigatinib Dose (mg/day) Days 1-7 Day 8+ 90 180 60 120 Permanently Discontinue 90 N/A 60 Brigatinib should be permanently discontinued if the patient is unable to tolerate 60mg once a day. If brigatinib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose. 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. Consider blood transfusion or the use of erythropoietin according to NICE TA323 if patient symptomatic of anaemia or has haemoglobin of less than 8g/dL (80g/L) Prior to prescribing cycle 1 the following criteria must be met; Criteria Neutrophils Platelets Eligible Level Equal to or more than 1x109/L Equal to or more than 100x109/L For subsequent cycles; Haematological toxicity (x109/L) Grade 3 Neutrophils less than 1 or Lymphocytes less than 0.5 or Platelets less than 50 Grade 4 Neutrophils less than 0.5 or Lymphocytes less than 0.2 or Platelets less than 25 Dose Modifications First occurrence - withhold brigatinib until recovery to baseline, then resume at same dose. Recurrence - withhold brigatinib until recovery to baseline then resume at the next lower dose level or permanently discontinue brigatinib. For other Grade 4 adverse reactions First occurrence - withhold brigatinib until recovery to baseline, then resume at the next lower dose level. Recurrence - withhold brigatinib until recovery to baseline then resume at the next lower dose level or permanently discontinue brigatinib. Version 1 (Sept 2020) Page 3 of 10 NSCLC – Brigatinib Hepatic Impairment No dose adjustment of brigatinib is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B). A reduced starting dose of 60 mg once daily for the first 7 days, then 120 mg once daily is recommended for patients with severe hepatic impairment (Child-Pugh class C) AST/ALT (units/L) Grade 3 or above and Grade 2 or above and Renal Impairment Bilirubin (μmol/L) 2xULN or less Greater than 2x ULN in the absence of cholestasis or haemolysis Brigatinib dose adjustment Withhold until recovery to baseline or less than or equal to 3×ULN (AST/ALT) then resume at next lower dose. Permanently discontinue brigatinib. GFR / eGFR Greater than or equal to 30ml/min Less than 30ml/min Brigatinib dose adjustment No dose adjustment required Reduce starting dose to 60 mg once daily for the first 7 days, then increase to 90 mg once daily Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc) particularly in the first week. Version 1 (Sept 2020) Page 4 of 10 NSCLC – Brigatinib Other Interstitial lung disease (ILD)/pneumonitis Grade Grade 1 Grade 2 Occurrence During the first 7 days of treatment After the first 7 days of treatment Recurrence During the first 7 days of treatment After the first 7 days of treatment Recurrence Dose Modification Withhold until recovery to baseline, then resumed at same dose level. Do NOT escalate to 180 mg once daily Withhold until recovery to baseline, then resumed at same dose level. Permanently discontinue brigatinib. Withhold until recovery to baseline, then resume at next lower dose level. Do NOT escalate to 180 mg once daily Withhold until recovery to baseline, then resume at next lower dose level. Permanently discontinue brigatinib. Grade 3 or 4 Any Permanently discontinue brigatinib. Hypertension For NCI-CTC grade 3 hypertension withhold brigatinib until hypertension has recovered to NCI-CTC grade 1 or below (SBP less than 140 mmHg and DBP less than 90 mmHg), then resumed at same dose. If NCI-CTC grade 3 hypertension recurs, withhold brigatinib until hypertension has recovered to NCI-CTC grade 1 or below then resume at the next lower dose level or permanently discontinue. For NCI-CTC grade 4 hypertension withhold brigatinib until hypertension has recovered to NCI-CTC grade 1 or below (SBP less than 140mmHg and DBP less than 90mmHg), then resumed at the next lower dose level or permanently discontinue. If NCI-CTC grade 4 hypertension recurs permanently discontinue brigatinib. Bradycardia (heart rate less than 60 bpm) For symptomatic bradycardia withhold brigatinib until recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above. If a concomitant medicinal product known to cause bradycardia is identified and discontinued, or its dose is adjusted, resume brigatinib at the same dose upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above. If no concomitant medicinal product known to cause bradycardia is identified, or if contributing concomitant medications are not discontinued or dose modified, resume brigatinib at the next lower dose upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above. For bradycardia with life-threatening consequences / urgent intervention indicated. Version 1 (Sept 2020) Page 5 of 10 NSCLC – Brigatinib If contributing concomitant medicinal product is identified and discontinued, or its dose is adjusted, resume brigatinib at the next lower dose level upon recovery to asymptomatic bradycardia or to a resting heart rate of 60 bpm or above, with frequent monitoring as clinically indicated. If no contributing concomitant medicinal product is identified, or in the case of recurrence, permanently discontinue brigatinib. CPK Elevation For Grade 3 elevation of CPK; 1. First occurrence - withhold until recovery to NCI-CTC grade 1 or below or to baseline, then resume at the same dose. 2. Recurrence - withhold until recovery toNCI-CTC grade 1 or below or to baseline, then resumed at the next lower dose level. For Grade 4 elevation of CPK; Withhold until recovery to NCI-CTC grade 1 or below or to baseline, then resume at the next lower dose. Elevation of lipase or amylase For NCI-CTC grade 3 elevation of lipase or amylase; 1. First occurrence - withhold brigatinib until recovery to NCI-CTC grade1 or below or to baseline, then resume at same dose. 2. Recurrence - withhold brigatinib until recovery to NCI-CTC grade 1 or below or to baseline, then resume at the next lower dose level. For NCI-CTC grade 4 elevation of lipase or amylase then withhold brigatinib until recovery to NCI-CTC grade 1 or below, then resume at the next lower dose level. Hyperglycaemia For NCI-CTC grade 3 or greater, if adequate hyperglycaemic control cannot be achieved with optimal medical management, withhold brigatinib until adequate hyperglycaemic control is achieved. Upon recovery, either resume at the next lower dose or permanently discontinue. Visual Disturbance For NCI-CTC grade 2 or 3 visual disturbance withhold brigatinib until recovery to NCI-CTC grade 1 or baseline, then resumed at the next lower dose level. For NCI-CTC grade 4 visual disturbance permanently discontinue brigatinib. Other adverse reactions not listed above For other NCI-CTC grade 3 adverse reactions; 1. First occurrence - withhold brigatinib until recovery to baseline, then resume at same dose. Version 1 (Sept 2020) Page 6 of 10 NSCLC – Brigatinib 2. Recurrence - withhold brigatinib until recovery to baseline then resume at the next lower dose level or permanently discontinue brigatinib. For other NCI-CTC grade 4 adverse reactions; 1. First occurrence - withhold brigatinib until recovery to baseline, then resume at the next lower dose level. 2. Recurrence - withhold brigatinib until recovery to baseline then resume at the next lower dose level or permanently discontinue brigatinib. Regimen 28 day cycle continued as long as benefit is observed or until unacceptable toxicity occurs (twelve cycles will be set in ARIA) Cycle 1 Drug Brigatinib Brigatinib Dose 90mg once a day 180mg once a day Days 1-7 8-28 Route Oral Oral Cycle 2 onwards Drug Brigatinib Dose 180mg once a day Days 1-28 Route Oral Dose Information • Brigatinib is available as 30mg, 90mg and 180mg tablets • If brigatinib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose. • If concomitant use of strong CYP3A inhibitors cannot be avoided, the dose of brigatinib should be reduced from 180mg to 90mg or from 90mg to 60mg. After discontinuation of a strong CYP3A inhibitor, brigatinib should be resumed at the dose that was tolerated prior to the initiation of the strong CYP3A inhibitor. Administration Information • Brigatinib tablets should be swallowed whole and with water. Brigatinib may be taken with or without food. • Grapefruit or grapefruit juice may increase plasma concentrations of brigatinib and should be avoided. • The concomitant use of brigatinib with strong and moderate CYP3A inducers should be avoided. Version 1 (Sept 2020) Page 7 of 10 NSCLC – Brigatinib • If a dose is missed or vomiting occurs after taking a dose, an additional dose should not be administered and the next dose should be taken at the scheduled time. • If possible a 7 day interval should occur between discontinuation of crizotinib and start of brigatinib. Supportive Treatments As take home medication (cycle 1 only) • Metoclopramide 10mg oral up to three times a day when required for the relief of nausea and vomiting • Loperamide 4mg after the first loose stool and 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours. Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to brigatinib. • It must be made clear to all staff, including those in the community, that brigatinib should only be prescribed under the supervision of a consultant oncologist • Brigatinib interacts with many other agents. Always check for drug interactions. References 1. Brigatinib in Patients with Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. Kim DW, Tiseo M, Ahn M et al; J Clin Oncol, 2017; 35 (22): 2490 – 2498. 2. Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib. NICE TA571 20/03/2019 Version 1 (Sept 2020) Page 8 of 10 NSCLC – Brigatinib REGIMEN SUMMARY Brigatinib Cycle 1 only Day One 1. Brigatinib 90mg once a day for 7 days oral Administration Instructions Oral SACT. This supply together with the 180mg supply for this cycle may be dispensed as treatment starter pack. This is a 28 day cycle. Take 90mg once a day for 7 days then increase to 180mg once a day days 8-28. 2. Brigatinib 180mg once a day for 21 days oral Administration Instructions Oral SACT. This supply together with the 90mg supply for days 1-7 may be dispensed as treatment starter pack. This is a 28 day cycle. Take 90mg once a day for 7 days then increase to 180mg once a day days 8-28. 3. Metoclopramide 10mg three times a day when required Administration Instructions Take 10mg up to three times a day when required for the relief of nausea and vomiting. Please supply 28x10mg tablets or nearest equivalent original pack size. 4. Loperamide as directed Administration instructions Loperamide 4mg after the first loose stool and 2mg after each subsequent loose stool to a maximum of 16mg in 24 hours Cycle 2 onwards Day One 5. Brigatinib 180mg once a day for 28 days oral Administration Instructions Oral SACT. Version 1 (Sept 2020) Page 9 of 10 NSCLC – Brigatinib DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Sept 2020 None Rebecca Wills Pharmacist Dr Luke Nolan 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 which occur as a result of following these guidelines. Version 1 (Sept 2020) Page 10 of 10 NSCLC – Brigatinib
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Brigatinib.pdf

Everolimus-Lenvatinib

Description
Chemotherapy Protocol RENAL CELL EVEROLIMUS and LENVATINIB Regimen • Renal Cell – Everolimus-Lenvatinib Indication • Confirmed histological di
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Renal-cell/Everolimus-Lenvatinib.pdf
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