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RCVP-Cyclophosphamide-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-PREDNISOLONE-RITUXIMAB-VINCRISTINE (RCVP) Regimen Lymphoma – RCVP-Cyclophosphamide-Prednis
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RCVP-Cyclophosphamide-Prednisolone-Rituximab-Vincristine-Ver-1.2.pdf

RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-ETOPOSIDE-PREDNISOLONE-RITUXIMAB-VINCRISTINE Regimen (RCEOP) Lymphoma – RCEOP-Cyclophospha
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RCEOP-Cyclophosphamide-Etoposide-Prednisolone-Rituximab-Vincristine-Ver-1.2.pdf

Lenvatinib(60kg or greater)

Description: Chemotherapy Protocol HEPATOCELLULAR CANCER LENVATINIB (60kg or greater) Regimen • Hepatocellular – Lenvatinib Indication • Lenvatinib is
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Hepatobiliary/Lenvatinib-60kg-or-greater-Ver1.pdf

Lenvatinib(59kg or less)

Description: Chemotherapy Protocol HEPATOCELLULAR CANCER LENVATINIB (59kg or less) Regimen • Hepatocellular – Lenvatinib Indication • Lenvatinib is indicated where either; - the patient has a confirmed histological diagnosis of hepatocellular carcinoma (HCC) - or a biopsy is deemed to be very high risk or technically not feasible and the criteria below are also all met; a. the decision not to biopsy has been made and documented by a specialist HCC multidisciplinary team meeting. b. the tumour meets the non-invasive diagnostic criteria of HCC* c. data is submitted as part of the ongoing 'Systemic Therapy Audit, previously known as the Sorafenib Audit 2’. It is expected that this second option will only apply in exceptional circumstances and it should be noted that audit of non-biopsy rates will be reviewed regularly. *EASL-EORTC Clinical Practice Guidelines: Management, Journal of Hepatology (2012); 56:908-943. Noninvasive criteria can only be applied to cirrhotic patients and are based on imaging techniques obtained by 4-phase multidetector CT scan or dynamic contrast-enhanced MRI. Diagnosis should be based on the identification of the typical hallmark of HCC hypervascular in the arterial phase with washout in the portal venous or delayed phases). While one imaging technique is required for nodules beyond 1cm in diameter, a more conservative approach with 2 techniques is recommended in suboptimal settings. • the patient has either metastatic disease or locally advanced disease that is ineligible for or failed surgical or loco-regional therapies • the patient has not received any previous systemic therapy for hepatocellular carcinoma or the patient has had to discontinue sorafenib within three months of starting sorafenib and solely because of toxicity (i.e. there was sorafenib toxicity which could not be managed by dose delay or dose modification) and there has been no disease progression whilst on sorafenib • the patient had Child Pugh function class A • lenvantinib will be prescribed as monotherapy • a formal medical review as to whether treatment with lenvatinib should continue or not will be scheduled to occur at least by the end of the first 8 weeks of treatment • lenvatinib will be continued until loss of efficacy, unacceptable toxicity of the patient chooses to stop treatment Version 1 (April 2020) Page 1 of 8 Hepatocellular-Lenvatinib (59kg or less) • WHO Performance status 0, 1 • Palliative intent Toxicity Drug Lenvatinib Adverse Effect Hypertension, renal failure, hepatotoxicity, cardiac impairment, QT interval prolongation, posterior reversible encephalopathy syndrome, haemorrhage, GI perforation or fistula, thyroid abnormalities The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC, U&Es and LFTs every 28 days • Blood glucose levels at baseline and after 28 days of treatment. Thereafter every 4-8 weeks • Triglycerides at baseline then every 8 weeks • Proteinuria less than 1g/24 hours, with proteinuria measured prior to each cycle • Thyroid function every 28 days • Blood pressure should be monitored at baseline, after one week of lenvatinib then every two weeks for the first two months and then every 28 days thereafter. • ECG as clinically indicated Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. The toxicities below should be read in conjunction with the relevant Summary of Product Characteristics (www.medicines.org.uk). 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 SACT that if a third dose reduction is necessary treatment should be stopped. Dose adjustments are based only on toxicities observed and not on body weight changes during treatment. The daily dose is to be modified, as needed, according to the dose/toxicity management plan. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Version 1 (April 2020) Page 2 of 8 Hepatocellular-Lenvatinib (59kg or less) 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 50x109/L HCC patients may have longstanding thrombocytopenia which is likely attributed to hypersplenism secondary to portal hypertension rather than being treatment-related. Review of the platelet trend over a period of time is therefore recommended to fully assess regorafenib toxicity. Hepatic Impairment Child Pugh Lenvatinib Dose Class A No dose adjustment B Use with caution, may be more susceptible to toxicity C Not recommended Liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase, increases in aspartate aminotransferase, and increases in blood bilirubin. Hepatic failure and acute hepatitis (less than 1%) have been reported in patients treated with lenvatinib. The hepatic failure cases were generally reported in patients with progressive liver metastases. Liver function tests should be monitored before initiation of treatment, then every 2 weeks for the first 2 months and monthly thereafter during treatment. In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary. If patients have severe hepatic impairment, the initial dose of lenvatinib should be adjusted Renal Impairment No dose adjustments are required for patients with mild or moderate renal impairment. The manufacturer does not provide advice on dose modifications for severe renal impairment due to lack of data therefore is not recommended. Further dose reductions may be required based on tolerability. Renal impairment and renal failure have been reported in patients treated with lenvatinib. The primary risk factor identified was dehydration and/or hypovolemia due to gastrointestinal toxicity. Gastrointestinal toxicity should be actively managed in order to reduce the risk of development of renal impairment or renal failure. Dose interruptions, adjustments, or Version 1 (April 2020) Page 3 of 8 Hepatocellular-Lenvatinib (59kg or less) discontinuation may be necessary. If patients have severe renal impairment, the initial dose of lenvatinib should be adjusted. 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 of lenvatinib is adjusted as in the table below Adverse Reaction First occurrence Second occurrence (same or new reaction) Third occurrence (same or new reaction) Modification Interrupt until resolved to NCI-CTC grade 0-1 Interrupt until resolved to NCI-CTC grade 0-1 Interrupt until resolved to NCI-CTC grade 0-1 Adjusted Dose (59kg or below) 4mg once a day 4mg on alternate days Discontinue Adjusted Dose (60kg or above) 8mg once a day 4mg once a day 4mg on alternate days Cardiac Hypertension is commonly reported in association with lenvatinib and may be severe. Blood pressure should be well controlled prior to starting treatment. Early detection and management of hypertension are important during treatment. Hypertension tends to develop early in treatment. Blood pressure should be monitored at baseline, one week later and then every two weeks for the first eight weeks of treatment and four weekly thereafter. Blood Pressure Recommended Action (lenvatinib) Systolic blood pressure greater than or equal to140mmHg and up to 160mmHg or diastolic blood pressure greater than or equal to 90mmHg up to 100mmHg Continue lenvatinib and initiate antihypertensive therapy, if not already receiving or continue lenvatinib and increase the dose of the current antihypertensive therapy or initiate additional antihypertensive therapy Systolic BP ≥160 mmHg or diastolic Withhold lenvatinib until the systolic blood pressure is blood pressure greater than or equal less than or equal to150mmHg and diastolic blood to100 mmHg despite optimal antihypertensive therapy pressure is les than or equal to 95mmHg and the patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose level Life-threatening consequences Urgent intervention is indicated. Discontinue lenvatinib (malignant hypertension, and institute appropriate medical management neurological deficit, or hypertensive crisis) Decreases in left ventricular ejection fraction (LVEF) were seen in10% of RCC patients receiving combination treatment. Patients should be monitored for signs and symptoms as dose modification may be required. Arterial thromboembolic events were reported as well, Version 1 (April 2020) Page 4 of 8 Hepatocellular-Lenvatinib (59kg or less) including fatal cases. Lenvatinib should be discontinued if such an arterial thromboembolic event occurs. Use lenvatinib with caution in patients who are at increased risk of cardiac events. QT prolongation has been reported and may lead to severe ventricular arrhythmias, including Torsades de pointes. Lenvatinib is not recommended in patients with congenital long QT syndrome or those with risk factors for prolonged QT. Lenvatinib should be stopped when the QT interval is longer than 500ms. Treatment may be resumed at a reduced dose level when the interval is 480ms or less. Electrolyte abnormalities should be corrected prior to starting treatment. Endocrine Lenvatinib impairs exogenous thyroid suppression. Thyroid stimulating hormone (TSH) levels should be monitored on a regular basis and thyroid hormone administration should be adjusted to reach appropriate TSH levels, according to the patient’s therapeutic target. Proteinuria Proteinuria usually develops early in treatment. If proteinuria occurs at a level greater than or equal to 2+ or 2g/24 hours interrupt treatment, obtain a 24 hour urine protein, until it is less than this, then dose reduce down a level and resume treatment. Lenvatinib should be stopped if nephrotic syndrome occurs. Regimen 28 day cycle continued as long as clinical benefit is observed or until unacceptable toxicity occurs (6 cycles will be set in Aria) Drug Lenvatinib Dose 8mg once a day Days 1-28 incl. Administration Oral Dose Information • Lenvatinib is available as 10mg and 4mg hard capsules. Administration Information • Lenvatinib should be taken at the same time of day each day consistently with or without food. Capsules should be swallowed whole. If a dose is missed and cannot be taken within twelve hours then it should be missed and the next dose taken at the appropriate time. Additional Therapy • Routine anti-emetics are not required. • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1 (April 2020) Page 5 of 8 Hepatocellular-Lenvatinib (59kg or less) Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to lenvantinib. • It must be made clear to all staff, including those in the community, that lenvantinib should only be prescribed under the supervision of an oncologist. • Lenvatinib interact with many other agents. Always check for drug interactions. • There are several brands of lenvatinib. Please dispense the correct brand. References 1. Kudo M, Finn RS, Qin S et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial (REFLECT trial). Lancet (2018); 391: 1163-1173 Version 1 (April 2020) Page 6 of 8 Hepatocellular-Lenvatinib (59kg or less) REGIMEN SUMMARY Lenvatinib (59kg or less) Day 1 Take Home Medicines 1. Warning – Check Dose and Weight Administration Instructions The starting dose of lenvatinib varies depending on the body weight. The dose does not need to be changed in relation to weight changes during treatment. Dose changes should only occur in relation to toxicity. 2. Lenvatinib 8mg once a day oral Administration Instructions Oral chemotherapy. Please supply an original pack per 28 day cycle. There are several brands of lenvatinib. Please ensure the product you dispense is appropriate for the indication (hepatocellular carcinoma) Version 1 (April 2020) Page 7 of 8 Hepatocellular-Lenvatinib (59kg or less) DOCUMENT CONTROL Version Date 1 April 2020 Amendment None Written By Dr Deborah Wright Pharmacist Approved By Dr Alaaeldin Shablak 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 Hospitals 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 (April 2020) Page 8 of 8 Hepatocellular-Lenvatinib (59kg or less)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Hepatobiliary/Lenvatinib-59kg-or-less-.pdf

Acalabrutinib

Description: Chemotherapy Protocol Chronic Lymphocytic Leukaemia Regimen Acalabrutinib • CLL – Acalabrutinib Indication • First-line treatment of chronic lymphocytic leukaemia (CLL) prior to EU licence and NICE reimbursement through the Early Access Programme (EAP) provided by AstraZeneca. Patient should meet ALL the inclusion criteria and NONE of the exclusion criteria in order to be eligible for this programme. • Inclusion criteria: - Patients has untreated CLL and is either: a. 65 years of age or greater, OR b. greater than 18 and less than 65 years of age provided that at least one of the following criteria is met: i. Creatinine clearance more than or equal to 30 mL/min using the CockcroftGault equation ii. A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric (CIRS-G) - WHO performance status 0, 1, 2 - diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek, et al. CLL 2008) as listed below: a. monoclonal B cells (either kappa or lambda light chain restricted) that are clonally co-expressing 1 or more B-cell marker (CD19, CD20, or CD23) and CD5 b. prolymphocytes may comprise 55% or less of blood lymphocytes c. presence of greater than or equal to 5x109B lymphocytes/L (5000/μL) in the peripheral blood (at any point since diagnosis) - active disease meeting 1 or greater of the following IWCLL 2008 criteria for requiring treatment • Exclusion criteria: - any previous systemic treatment for CLL (note: prior localized radiotherapy is allowed) - known central nervous system (CNS) lymphoma or leukaemia - known prolymphocytic leukaemia or history of, or suspected, Richter’s syndrome - confirmed 17p del and/or TP53 mutations, with eligibility for currently reimbursed novel inhibitor treatment ibrutinib, idelalisib + rituximab or venetoclax in the NHS. Please note: If ibrutinib was received by a patient but discontinued due to intolerance and not due to disease progression, the patient may be eligible to receive acalabrutinib - uncontrolled autoimmune haemolytic anaemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), defined as declining haemoglobin or platelet count secondary to autoimmune destruction currently or requirement for high doses of steroids (of more than 20mg daily of prednisone daily or equivalent) - corticosteroid use of more than 20mg within 1 week before first dose of acalabrutinib, except as indicated for other medical conditions such as inhaled Version 1.0 (Aug 2020) Page 1 of 8 CLL-Acalabrutinib steroid for asthma, topical steroid use, or as premedication for administration of acalabrutinib or contrast. - major surgery within 4 weeks before first dose of acalabrutinib - history of prior malignancy except for the following: a. malignancy treated with curative intent and with no evidence of active disease present for more than 3-years before the Early Access Programme application date and felt to be at low risk for recurrence by treating physician. b. adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer. c. adequately treated cervical carcinoma in situ without current evidence of disease. - significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of this application, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc > 480msec - unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction - uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) or ongoing intravenous anti-infective treatment - known history of infection with human immunodeficiency virus (HIV) - planned vaccination with live, attenuated vaccines within 4 weeks of first dose of acalabrutinib - serologic status reflecting active hepatitis B or C infection. Patients with hepatitis B core antibody positive who are surface antigen negative or who are hepatitis C antibody positive will need to have a negative polymerase chain reaction (PCR) result before access is provided. Patients who are hepatitis B surface antigen positive or hepatitis B PCR positive and those who are hepatitis C PCR positive cannot be provided access. - history of stroke or intracranial haemorrhage within 6-months of this early access programme application - history of a bleeding diathesis (e.g., haemophilia, von Willebrand disease) - requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of acalabrutinib - requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) - breast feeding or pregnant - current life-threatening illness, medical conditions, or organ system dysfunction which, in your opinion, could compromise the patient’s safety - concurrent participation in another therapeutic clinical trial - requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor/inducer - presence of a gastrointestinal ulcer diagnosed by endoscopy within 3-months of the Early Access Programme application date Version 1.0 (Aug 2020) Page 2 of 8 CLL-Acalabrutinib Toxicity Drug Acalabrutinib Adverse Effect Diarrhoea, headache, bruising, fatigue, upper respiratory tract infection, nausea, cough, musculoskeletal pain, pyrexia, neutropenia, anaemia, thrombocytopenia, hypertension, rash and atrial fibrillation. The adverse effects listed are not exhaustive. Please refer to the relevant investigator brochure for full details. Monitoring • FBC, U&Es and LFTs prior to starting treatment and then every twenty-eight days for the first twelve weeks of treatment. Thereafter if counts are stable monitoring may take place every twelve weeks. • Hepatitis B and C status prior to starting treatment as re-activation is a known adverse effect of treatment • Ensure adequate cardiac function before and at regular intervals during treatment. Consider a baseline ECG for all patients and an echocardiogram should be conducted in patients with a history of cardiac problems or in the elderly prior to starting treatment. • Pregnancy testing in women of childbearing potential. A negative pregnancy test must be obtained before starting the 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. 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. Consider blood transfusion or the use of erythropoietin according to NICE TA323 if the patient is symptomatic of anaemia or where the haemoglobin is less than 8g/dL. Prior to prescribing cycle 1 the following criteria must be met: Criteria Neutrophils Platelets Non-haematological toxicity Eligible Level Greater than or equal to 0.75x109/L or greater than or equal to 0.5x109/L in patients with bone marrow involvement Greater than or equal to 50x109/L or greater than or equal to 30x109/L in patients with bone marrow involvement NCI-CTC grade 1 or below Version 1.0 (Aug 2020) Page 3 of 8 CLL-Acalabrutinib For subsequent cycles, dose delay if neutrophils are less than 0.5x109/L or the platelets are less than 50x109/L with bleeding or platelets are less than 25x109/L. Restart treatment once the toxicity has resolved to grade 1 using the dosing table below. Toxicity Occurrence First and Second Third Fourth Dose modification after recovery Hold acalabrutinib until recovery to Grade 1 or below or baseline; may restart at original dose level Hold acalabrutinib until recovery to Grade 1 or below or baseline; restart at one dose level reduction (100mg OD) Discontinue Hepatic Impairment Liver Function Child Pugh A (mild hepatic impairment) Child Pugh B (moderate hepatic impairment) Child Pugh C (severe hepatic impairment) Ibrutinib Dose Modifications No dose adjustment required No dose adjustment required Not recommended Renal Impairment No dose adjustments are required for patients with mild or moderate renal impairment (eGFR ≥ 30ml/min/1.73m2, as estimated by the MDRD equation). There are no data in patients with severe renal impairment (eGFR less than 29ml/min/1.73m2, MDRD) or patients on dialysis. In this latter instance prescribed only if the benefit outweighs the risk, monitor patients carefully for signs of toxicity. Other 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. Acalabrutinib may be resumed using the dosing table shown above. Dose modification for Use with CYP3A Inhibitors or Inducers CYP3A Inhibition Induction Co-administered Drug Strong CYP3A inhibitor Moderate CYP3A inhibitor Strong CYP3A inducer Recommended acalabrutinib use Avoid concomitant use. If these inhibitors will be used short-term (such as antibiotics for up to seven days), interrupt acalabrutinib. 100mg once daily Avoid concomitant use. If these inducers cannot be avoided, increase acalabrutinib dose to 200mg twice daily. Regimen 28 day cycle until disease progression or intolerance (12 cycles will be set in Aria) Drug Acalabrutinib Dose 100mg twice a day Days 1- 28 (inclusive) Administration Oral Version 1.0 (Aug 2020) Page 4 of 8 CLL-Acalabrutinib Dose Information • Acalabrutinib is available as 100mg capsules. Administration Information • Acalabrutinib capsules should be swallowed whole with water at approximately 12 hours apart. • Acalabrutinib may be taken with or without food. • If a dose of acalabrutinib is missed by more than 3 hours, it should be skipped, and the next dose should be taken at its regularly scheduled time. Extra capsules of acalabrutinib should not be taken to make up for a missed dose. Additional Therapy • Allopurinol 300mg once a day oral for 7 days for the first cycle only. • Anti-infective prophylaxis with; - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to acalabrutinib. • It must be made clear to all staff, including those in the community, that acalabrutinib is should only be prescribed under the supervision of a consultant haematologist or oncologist. • There are many drug interactions associated with acalabrutinib. Caution is advised when concurrently prescribing agents that affect coagulation or platelet function or that influence the hepatic enzyme system CYP3A. • Co-administration of acalabrutinib with a proton pump inhibitor, H2-receptor antagonist, or antacid may decrease acalabrutinib plasma concentrations. If treatment with a gastric acid reducing agent is required, consider using a H2receptor antagonist or an antacid with a two hour gap between doses of acalabrutinib and the gastric protection. Avoid co-administration with proton pump inhibitors. • Acalabrutinib should be withheld for at least 3 to 7 days pre- and post-surgery, depending upon the type of surgery and the risk of bleeding. • Grapefruit and grapefruit juice, and Seville oranges, should be avoided while on acalabrutinib. • Acalbrutinib may increase sensitivity to the sun, wear sun protection. Version 1.0 (Aug 2020) Page 5 of 8 CLL-Acalabrutinib References 1. Jeff P. Sharman, Versha Banerji, Laura Maria Fogliatto et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naïve Chronic Lymphocytic Leukemia (CLL). Blood 2019; 134 (Supplement_1):31. https://doi.org/10.1182/blood-2019128404. 2. Michael Hallek, Bruce D. Cheson, Daniel Catovsky, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukaemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008; 111(12):5446-5456. https://doi.org/10.1182/blood-2007-06-093906). Version 1.0 (Aug 2020) Page 6 of 8 CLL-Acalabrutinib REGIMEN SUMMARY Acalabrutinib Cycle 1 Day 1-28 inclusive 1. Acalabrutinib 100mg twice a day oral Administration Information Oral Chemotherapy Acalabrutinib should be swallowed whole with water at approximately 12 hours apart. Avoid grapefruit and grapefruit juice, and Seville oranges while on acalabrutinib. Always check for drug interactions. 2. Aciclovir 400mg twice a day oral 3. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday 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 4. Allopurinol 300mg once a day oral for 7 days Cycle 2 onwards Day 1-28 inclusive 5. Acalabrutinib 100mg twice a day oral Administration Information Oral Chemotherapy Acalabrutinib should be swallowed whole with water at approximately 12 hours apart. Avoid grapefruit and grapefruit juice, and Seville oranges while on acalabrutinib. Always check for drug interactions. 6. Aciclovir 400mg twice a day oral 7. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral Administration Instructions Co-trimoxazole 960mg once a day on Mondays, Wednesdays and Fridays. Please supply 28 days. This may be dispensed as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice Version 1.0 (Aug 2020) Page 7 of 8 CLL-Acalabrutinib DOCUMENT CONTROL Version Date Amendment Written By Approved By 1 Aug 2020 None Siow Chin Phua Pharmacist Dr Andrew Duncombe 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. Version 1.0 (Aug 2020) Page 8 of 8 CLL-Acalabrutinib
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CLL/Acalabrutinib.pdf

Carboplatin and Vinorelbine (intravenous)

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) CARBOPLATIN-VINORELBINE (Intravenous) Regimen • NSCLC – Carboplatin-Vinorelbine (intravenous) Indication • First line therapy of stage III or IV NSCLC • WHO Performance status 0, 1, 2 • Palliative intent Toxicity Drug Carboplatin Vinorelbine Adverse Effect Neuropathy, thrombocytopenia Neuropathy, stomatitis, transient elevation of LFTs, pain, constipation 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 • EDTA or calculated creatinine clearance before the first cycle • 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. Version 1.3 (February 2023) Page 1 of 7 NSCLC – Carboplatin -Vinorelbine (IV) 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. Haematology Prior to prescribing cycle one the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level Greater than or equal to 1.5x109/L (unless due to bone marrow impairment) Greater than or equal to 100x109/L (unless due to bone marrow impairment Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Consider blood transfusion if patient symptomatic of anaemia or haemoglobin symbols written out Renal and hepatic function tabulated. Vinorelbine information updated from SPC Carboplatin paragraph amended under regimen Regimen tabulated Vinorelbine changed to intravenous bolus over 10minutes Twice daily now twice a day Bolus removed from injection Regimen name added to summary Metoclopramide dose changed to 10mg Starting on day two of the cycle added to dexamethasone Summary re-numbered Document control tabulated Hospital representation and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright Donna Kimber 2010 Header altered to include Pharmacist Pharmacy Technician “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to Version 1.3 (February 2023) Page 6 of 7 NSCLC – Carboplatin -Vinorelbine (IV) introduction in dose modifications Dose modifications format (not information) changed Dose information added to reflect super user agreements Granisetron removed 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 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 1.3 (February 2023) Page 7 of 7 NSCLC – Carboplatin -Vinorelbine (IV)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/CarboplatinandVinorelbineintravenous.pdf

RPMitCEBO-Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Ver 1.4

Description: Chemotherapy Protocol LYMPHOMA BLEOMYCIN-CYCLOPHOSPHAMIDE-ETOPOSIDE-MITOXANTRONE-PREDNISOLONERITUXIMAB-VINCRISTINE (RPMitCEBO) Regimen  Lymphoma – RPMitCEBO-Bleomycin-Cyclophosphamide-Etoposide-MitoxantronePrednisolone-Rituximab-Vincristine Indication  CD20 Positive Non Hodgkin’s Lymphoma Toxicity Drug Bleomycin Adverse Effect Pulmonary toxicity, rigors, skin pigmentation, nail changes Cyclophosphamide Dysuria, haemorrragic cystitis (rare), taste disturbances Etoposide Hypotension on rapid infusion, alopecia, hyperbilirubinaemia Mitoxantrone Prednisolone Rituxumab Vincristine Cardiac toxicity, urinary discolouration Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Peripheral neuropathy, constipation, jaw pain The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1.4 (Sept 2017) Page 1 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Monitoring Drugs  FBC, LFTs (including albumin) and U&Es prior to day one and fifteen  Regular blood glucose monitoring  Check hepatitis B status before starting treatment with rituximab  Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems, cardiac risk factors or in the elderly. Discontinue mitoxantrone if cardiac failure develops.  Consider performing pulmonary function tests before starting therapy. These should be repeated if respiratory symptoms develop during treatment, particularly a drop in oxygen saturation on exercise. Bleomycin should be stopped until the results of such investigations are known. Dose Modifications The dose modifications listed are for haematological, liver and renal function and some 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. Version 1.4 (Sept 2017) Page 2 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Dose modifications based on haematological parameters apply to cyclophosphamide, etoposide and mitoxantrone on day one and fifteen only. Day eight and twenty two of treatment is given irrespective of the haematological counts. If day one / fifteen is delayed, delay day eight / twenty two accordingly. Neutrophils (x109/L) 1 or above 0.5-0.9 less than 0.5 or febrile neutropenia Platelets (x109/L) 100% Dose Modifications (cyclophosphamide, etoposide, mitoxantrone) 1st Occurrence If the intent is curative, the patient has a WHO performance status of 2 or below and has not previously received growth factor prophylaxis administer 100% of the dose with prophylactic growth factors An alternative approach is to delay treatment until the neutrophils are 1x109/L or above and then prescribe 75% of the original dose with prophylactic growth factors 2nd Occurrence Delay until the neutrophils are 1x109/L or above and then reduce the dose by a further 25% of the original dose with prophylactic growth factors 1st Occurrence Delay until the neutrophils are 1x109/L or above and then give 75% of the original dose with prophylactic growth factors 2nd Occurrence Delay until the neutrophils are 1x109/L or above and give 50% of the original dose with prophylactic growth factors Dose Modifications 75 or above 50–74 less than 50 or bleeding 100% 1st Occurrence Give 75% of the original dose 2nd Occurrence Give 50% of the original dose 1st Occurrence Delay until the platelets are 75x109/L or above then give 75% of the original dose 2nd Occurrence Delay until the platelets are 75x109/L or above then give 50% of the original dose Version 1.4 (Sept 2017) Page 3 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bleomycin Bilirubin μmol/L AST/ALT units/L Dose (% of original dose) Clinical decision Cyclophosphamide Etoposide *30-51 or more than 51 or 60-180 more than180 Evidence suggests dose reduction not necessary consider dose reduction to 50% clinical decision Mitoxantrone more than 60 clinical decision Rituximab N/A N/A No dose adjustment needed Vincristine *30-51 or more than 51 and more than 51 and 60-180 normal more than180 *Limits reflect local practice and may vary from published sources 50% 50% omit Version 1.4 (Sept 2017) Page 4 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Renal Impairment Drug Bleomycin Cyclophosphamide Etoposide Creatinine Clearance (ml/min) more than 50 10-50 less than10 more than 20 10-20 less than10 more than 50 15-50 less than15 Dose (% of original dose) 100% 75% 50% 100% 75% 50% 100% 75% 50% Mitoxantrone N/A No dose adjustment needed Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed 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. Bleomycin The risk of bleomycin induced pneumonitis is greater in those individuals who are older than forty years of age, have a history of smoking, those with underlying lung disease, previous mediastinal radiotherapy, poor renal function or who require growth factors. If pulmonary symptoms develop stop the bleomycin until they can be investigated fully and a diagnosis made. Etoposide Where significant reductions in albumin levels occur consider reducing the dose of etoposide. Mitoxantrone Discontinue mitoxantrone if cardiac failure develops. Version 1.4 (Sept 2017) Page 5 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine 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. 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 prior to treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flulike symptoms prior to treatment Vincristine Reduce the vincristine dose to 1mg if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Version 1.4 (Sept 2017) Page 6 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Regimen 28 day cycle for 3 cycles Drug Dose Cyclophosphamide 300mg/m2 Etoposide 150mg/m2 Mitoxantrone 7mg/m2 Rituximab 375mg/m2 Prednisolone Prednisolone Bleomycin Vincristine 50mg 50mg alternate days 10 000 International Units /m2 1.4mg/m2 (max 2mg) Days Administration 1, 15 Intravenous bolus over 10 minutes 1, 15 1, 15 1, 15 1-28 incl Intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Intravenous infusion in 500ml sodium chloride 0.9% Oral 29-end Oral 8, 22 Intravenous bolus over 10 minutes 8, 22 Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Dose Information  Bleomycin will be dose rounded to the nearest 1000 International Units (up if halfway)  The maximum cumulative dose of bleomycin is 500 000 International Units in people less than 60 years of age. Refer to SPC for further information in older patients.  Cyclophosphamide will be dose banded according to the CSCCN agreed bands  Etoposide will be dose banded according to the CSCCN agreed bands  Mitoxantrone dose will be rounded to the nearest 1mg (up if halfway)  The cardiac toxicity of mitoxantrone is more likely to occur at cumulative doses in excess of 160mg/m2 or 100mg/m2 after previous anthracycline therapy.  Rituximab will be dose rounded to the nearest 100mg (up if halfway)  Vincristine dose will be rounded to the nearest 0.1mg (up if halfway)  The maximum dose of vincristine is 2mg Version 1.4 (Sept 2017) Page 7 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Administration Information Extravasation  Bleomycin - neutral  Cyclophosphamide – neutral  Etoposide – irritant  Mitoxantrone – vesicant  Rituximab - neutral  Vincristine - vesicant Other  Prednisolone should be taken in the morning with or after food.  The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy  Antiemetics 15-30 minutes prior to chemotherapy on day 1 and 15 - ondansetron 8mg oral or intravenous As take home medication on day 1 and 15 - metoclopramide 10mg oral three times a day when required - ondansetron 8mg oral twice a day for 3 days  Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - paracetamol 1000mg oral On the morning of treatment - prednisolone 50mg oral to be self administered by the patient on the morning of treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication) Version 1.4 (Sept 2017) Page 8 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine  Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids.  Allopurinol 300mg once a day oral for the first cycle only  Anti-infective prophylaxis as follows: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only  Hydrocortisone 100mg intravenous when required for the prevention or treatment of bleomycin related reactions  Mouthwashes according to local or national policy on the treatment of mucositis  Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information  The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids.  In order to avoid unnecessary pulmonary toxicity, it is recommended that any GCSF dose scheduled for the day of bleomycin administration is omitted. Coding (OPCS 4.6)  Procurement – X71.4  Delivery – X72.1 day 1 and 15, X72.4 day 8 and 22 References 1.Burton C, Linch D, Hoskin P et al. A phase III trial comparing CHOP to PMitCEBO with or without G-CSF in patients aged sixty plus with aggressive Non-Hodgkins Lymphoma. Br J Cancer 2006; 94 (6): 806-813. 2.Mainwaring PN, Cunningham D, Gregory W et al. Mitoxantrone is superior to doxorubicin in a multi-agent weekly regimen for patients older than 60 with high grade lymphoma: results of a BNLI randomised trial of PAdriaCEBO versus PMitCEBO. Blood 2001; 97 (10): 2991-2997. 3.Pfreundschuh M, Ho A, Wolf M et al. Treatment results of CHOP-21, CHOEP-21, MAC-OPB and PMitCEBO with and without rituximab in young good-prognosis patients with aggressive lymphomas: rituximab as an “equalizer” in the mint (Mabthera international trial group) study. JCO 2005; ASCO Annual Meeting Proceedings. Vol 23, No. 16S, Part I of II (June 1 Supplement), 2005: 6529 Version 1.4 (Sept 2017) Page 9 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine REGIMEN SUMMARY RPMitCEBO-Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-PrednisoloneRituximab-Vincristine Cycle 1 Day 1 1. Warning – Check patient has taken prednisolone dose Administration Instructions Please check the patient has taken prednisolone 50mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 50mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Mitoxantrone 7mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 300mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 50mg once a day oral for 28 days 12. Aciclovir 400mg twice a day oral for 28 days 13. Allopurinol 300mg once a day oral for 28 days 14. Co-trimoxazole 960mg once a day oral on Mondays, Wednesdays and Fridays for 28 days 15. Metoclopramide 10mg three times a day oral when required 16. Ondansetron 8mg twice a day oral for 3 days starting on the evening of the day of treatment Version 1.4 (Sept 2017) Page 10 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine Cycle 1 Day 8 1. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 2. Bleomycin 10 000 International Units/m2 intravenous bolus over 10 minutes 3. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions Cycle 1 Day 15 1. Warning – Check patient has taken prednisolone dose Administration Instructions Please check the patient has taken prednisolone 50mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 50mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Mitoxantrone 7mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 300mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Metoclopramide 10mg three times a day oral when required 12. Ondansetron 8mg twice a day oral for 3 days starting on the evening of the day of treatment Cycle 1 Day 22 1. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 2. Bleomycin 10 000 International Units/m2 intravenous bolus over 10 minutes Version 1.4 (Sept 2017) Page 11 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine 3. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions Cycles 2 & 3 Day One 1. Warning – Check patient has taken prednisolone dose Administration Instructions Please check the patient has taken prednisolone 50mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 50mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Mitoxantrone 7mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 300mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 50mg on alternate days oral for 28 days 12. Aciclovir 400mg twice a day oral for 28 days 13. Co-trimoxazole 960mg once a day oral on Mondays, Wednesdays and Fridays for 28 days 14. Metoclopramide 10mg three times a day oral when required 15. Ondansetron 8mg twice a day oral for 3 days starting on the evening of the day of treatment Cycles 2 & 3 Day 8 1. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 2. Bleomycin 10 000 International Units /m2 intravenous bolus over 10 minutes Version 1.4 (Sept 2017) Page 12 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine 3. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions Cycles 2 & 3 Day 15 1. Warning – Check patient has taken prednisolone dose Administration Instructions Please check the patient has taken prednisolone 50mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 50mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Mitoxantrone 7mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Etoposide 150mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes 8. Cyclophosphamide 300mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Metoclopramide 10mg three times a day oral when required 12. Ondansetron 8mg twice a day oral for 3 days starting on the evening of the day of treatment Cycles 2 & 3 Day 22 1. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 2. Bleomycin 10 000 International Units /m2 intravenous bolus over 10 minutes 3. Hydrocortisone 100mg intravenous when required for the relief of infusion related reactions Version 1.4 (Sept 2017) Page 13 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.4 February 2017 Mitoxantrone changed to vesicant as per EONS guidelines Donna Kimber Pharmacy Technician Dr Deborah Wright Pharmacist Header changed Toxicities removed Hepatic and renal impairment updated Metoclopramide dose changed 1.3 January 2015 to 10mg Bolus removed from intravenous bolus throughout Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist text Mucositis recommendation changed Ondansetron TTO clarified Disclaimer added “and for four days after 1.2 Sept 2012 rituximab treatment” removed from prednisolone statement in the rituximab premedication Rebecca Wills Pharmacist Donna Kimber Pharmacy Technician section. Hydrocortisone administration 1.1 Sept 2012 changed in the summary to the “relief of infusion related Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician reactions” Dr Andrew Davies Rebecca Wills Consultant Medical Pharmacist Oncologist 1 July 2012 None Dr Deborah Wright Dr Alison Milne Pharmacist Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.4 (Sept 2017) Page 14 of 14 Lymphoma-RPMitCEBO–Bleomycin-Cyclophosphamide-Etoposide-Mitoxantrone-Prednisolone-Rituximab-Vincristine
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RPACEBOM - Bleomycin-Cyclophosphamide-Doxorubicin-Etoposide-Methotrexate-Prednisolone-Rituximab-Vincristine

Description: Chemotherapy Protocol LYMPHOMA BLEOMYCIN-CYCLOPHOSPHAMIDE-DOXORUBICIN-ETOPOSIDE-METHOTREXATEPREDNISOLONE-RITUXIMAB-VINCRISTINE Regimen (RP
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Chlorambucil_2_Obinutuzumab

Description: Chemotherapy Protocol Chronic Lymphocytic Leukaemia Chlorambucil (2 day)-Obinutuzumab (6 cycles) Regimen • CLL – Chlorambucil (2 day)-Obinutuzumab I
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Chlorambucil_14_Obinutuzumab

Description: Chemotherapy Protocol Chronic Lymphocytic Leukaemia Chlorambucil (14 day)-Obinutuzumab (6 cycles) Regimen • CLL – Chlorambucil (14 day)-Obinutuzumab Indication • The first line treatment of CLL in those with co-morbidities making them unsuitable for full dose fludarabine therapy or bendamustine treatment. • Palliative intent Toxicity Drug Chlorambucil Obinutuzumab Adverse Effect Neutropenia, thrombocytopenia, anaemia, nausea, vomiting, diarrhoea, mouth ulceration, rash Infusion related reactions, Progressive multifocal leukoencephalopathy (PML), cardiac toxicity, thrombocytopenia, neutropenia, tumour lysis syndrome The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC on day one, optional on days eight and fifteen of the cycle • U&E and LFT prior to day one and optionally fifteen of the cycle • Hepatitis B status prior to starting treatment. Patients with positive hepatitis B serology should consult a liver disease expert before the start of treatment and should be monitored and managed following local medical standards to prevent hepatitis re-activation • Consider uric acid and bone profile prior to cycle one in those considered at risk of tumour lysis syndrome 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. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Version 1.1 (October 2017) Page 1 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) 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 the patient is symptomatic of anaemia or where the haemoglobin is less than 8g/dL. At the start of each cycle the neutrophil count should be equal to or greater that 1x109/L and the platelets equal to or greater than 100x109/L. Toxicity Obinutuzumab Dose Grade 3 or 4 haematological toxicity, febrile neutropenia or Hold until the above thrombocytopenic bleeding parameters are met then that delays treatment by less restart at usual dose. than 4 weeks Chlorambucil Dose (% of previous dose) Hold until the above parameters are met. 1st episode: upon recovery restart at 75% 2nd episode: upon recovery restart at 50% Grade 3 or 4 haematological toxicity that delays treatment Discontinue by more than 4 weeks 3rd episode: discontinue Discontinue Hepatic Impairment Patients with hepatic impairment should be closely monitored for signs and symptoms of toxicity. Since chlorambucil is primarily metabolized in the liver, dose reduction should be considered in patients with severe hepatic impairment. However, there are insufficient data in patients with hepatic impairment to provide a specific dosing recommendation. The safety and efficacy of obinutuzumab in patients with impaired hepatic function has not been established. Renal Impairment Dose adjustment is not considered necessary for either chlorambucil or obinutuzumab in those with mild to moderate renal impairment. Patients with evidence of impaired renal function should be carefully monitored as they are prone to additional myelosuppression. Version 1.1 (October 2017) Page 2 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) Other Toxicity Obinutuzumab Chlorambucil dose dose (% previous dose) Grade 2 or 3 related organ/non- haematological toxicity Hold until less than or equal to grade 1 Hold until less than or equal to grade 1 Grade 2 non haematological toxicity that delays treatment by more than 4 weeks Discontinue Discontinue Grade 4 related organ/non- haematological toxicity, severe haemorrhage, severe skin reaction, pneumonitis, severe arrhythmias or Discontinue Discontinue other severe cardiovascular events Viral hepatitis or other serious infections; reactivation of hepatitis B Discontinue Discontinue Obinutuzumab Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with obinutuzumab. The diagnosis of PML should be considered in any patient presenting with new-onset or changes to pre- existing neurologic manifestations. The patient should be referred to a neurologist for the evaluation and treatment of PML. Infusion Reactions Obinutuzumab administration is associated with infusion related reactions, particularly during the first cycle. Most frequently reported symptoms associated with an infusion related reaction were nausea, chills, hypotension, pyrexia, vomiting, dyspnoea, flushing, hypertension, headache, tachycardia, and diarrhoea. Respiratory and cardiac symptoms such as bronchospasm, larynx and throat irritation, wheezing, laryngeal oedema and atrial fibrillation have also been reported. Anaphylaxis has been reported during administration of obinutuzumab. If a hypersensitivity reaction is suspected during infusion (e.g. symptoms typically occurring after previous exposure and very rarely with the first infusion), the infusion must be stopped and treatment permanently discontinued. Appropriate pre-medication must be administered before each infusion to reduce the risk of infusion related reactions. Infusion related reactions should be treated as described in the table below. Version 1.1 (October 2017) Page 3 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) Toxicity Grade Obinutuzumab Chlorambucil Dose (% of previous dose) Reduce the infusion rate by half and treat symptoms. Restart the infusion once 1-2 symptoms have resolved. Escalate infusion rate No change as tolerated at increments appropriate for treatment Hold infusion and treat the symptoms. Restart the 1episode of grade 3 infusion once the symptoms have resolved at no more than half the previous rate. Escalate the infusion rate as tolerated at increments appropriate for the treatment dose (see below) The day 1 (cycle 1) infusion rate may be increased back up to 25mg/hr after 60 minutes, but not increased further No change 2nd episode of grade 3 (during same or subsequent Infusion must be stopped and permanently discontinued therapy must be infusion) Discontinue Grade 4 or acute life threatening respiratory Infusion must be stopped and therapy must be permanently discontinued Discontinue reactions Tumour Lysis Syndrome (TLS) Tumour lysis syndrome (TLS) has been reported with obinutuzumab. Patients who are considered to be at risk of TLS (e.g. patients with a high tumour burden and/or a high circulating lymphocyte count (greater than 25x109/L) and/or renal impairment (CrCl less than 70 ml/min) should receive prophylaxis. Prophylaxis should consist of adequate hydration and administration of allopurinol or a suitable alternative such as rasburicase starting 12-24 hours prior to the infusion. All patients considered at risk should be carefully monitored during the initial days of treatment with a special focus on renal function, potassium, and uric acid values. Any additional guidelines according to standard practice should be followed. For example the BTS guidelines. For treatment of TLS, correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated. Regimen 28 day cycle for 6 cycles for treatment and 12 cycles for maintenance (6 cycles will be set in ARIA) Please note that if you add additional cycles to this regimen using the pen icon you must do this as starting from the last cycle of treatment (eg cycle 6). If you choose start from cycle one then the first cycle with the different doses of obintuzumab will be added. Version 1.1 (October 2017) Page 4 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) Cycle 1 Drug Chlorambucil Obinutuzumab Dose 10mg 100mg Obinutuzumab 900mg Obinutuzumab 1000mg Days 1 – 14 inclusive 1 2 8, 15 Administration Oral Intravenous infusion in 100ml sodium chloride 0.9% at a rate of 25mg/hour (over 240 minutes)* Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 50mg/hour* Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 100mg/hour* Cycle 2, 3, 4, 5, 6 Drug Chlorambucil Obinutuzumab Dose 10mg 1000mg Days 1 – 14 inclusive 1 Administration Oral Intravenous infusion in 250ml sodium chloride 0.9% at a rate of 100mg/hour* *Please see administration information below for infusion rates Dose Information • Chlorambucil is available as 2mg film-coated tablets. Administration Information • Chlorambucil should be swallowed whole on an empty stomach either one hour before meals or three hours after. • The daily dose may be divided into three (morning, noon and night) or the full dose given at night if nausea or vomiting is problematic. • The film-coated chlorambucil tablets should not be crushed or dissolved prior to administration. • Obinutuzumab standard infusion rates, in the absence of reactions are as follows; Version 1.1 (October 2017) Page 5 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) Cycle Day of Treatment Rate of Infusion 1 Day 1 Administer at 25mg/hour (over 240 minutes). Do not (100mg in 100ml) increase the rate 1 Day 2 (or day 1 continued) (900mg in 250ml) Start the administration at 50mg/hour The rate of the infusion can be escalated in increments 50 mg/hour every 30 minutes to a maximum rate of 400mg/hour of Day 8, 15 Infusions can be started at a rate of 100mg/hour and 1 increased by 100 mg/hour increments every 30 minutes to (1000mg in 250ml) a maximum of 400mg/hour 2 onwards All days (1000mg in 250ml) Infusions can be started at a rate of 100mg/hour and increased by 100mg/hour increments every 30 minutes to a maximum of 400mg/hour The recommended dose of obinutuzumab is 1000 mg administered over day 1 and day 2, and on day 8 and day 15 of the first treatment cycle. Two infusion bags should be prepared for the infusion on days 1 and 2 (100 mg for day 1 and 900 mg for day 2). If the first infusion (100mg) is completed without modifications of the infusion rate or interruptions, the second bag may be administered on the same day (no dose delay necessary, no repetition of premedication), provided that appropriate time, conditions and medical supervision are available throughout the infusion. If there are any modifications of the infusion rate or interruptions during the first 100 mg the second infusion (900mg) must be administered the following day. Additional Treatment • Antiemetics 15-30 minutes prior to chemotherapy - metoclopramide 10mg three times a day when required • Premedication for obinutuzumab infusion reactions - sodium chloride 0.9% 500ml intravenous infusion over 60 minutes then as follows; Version 1.1 (October 2017) Page 6 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) Cycle 1 days 1 and 2 Cycle 1 days 8 and 15 and Cycles 2, 3, 4, 5, 6 Pre-medication (60 minutes prior to obinutuzumab) All Patients Patients without infusion related reactions Methylprednisolone sodium succinate √ 80mg intravenous Chlorphenamine √ 10mg intravenous Paracetamol 1000mg oral √ √ Patients with grades 1-2 infusion related reactions Patients with a grade 3 infusion related reactions or with a lymphocyte count greater than 25x109/L √ √ √ √ √ On an as required basis; - chlorphenamine 10mg intravenous for infusion reactions - lorazepam 1mg oral for rigors - methylprednisolone sodium succinate 80mg intravenous for infusion reactions - paracetamol 1000mg oral for pyrexia - pethidine 25mg intravenous in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors following a verbal confirmation to administer from a doctor • Allopurinol 300mg oral starting two days prior to day one cycle one for 7 days (not included in ARIA). Patients with a high risk of TLS may require rasburicase. • Anti-infective prophylaxis as follows; - consider aciclovir 400mg twice a day oral (consultants discretion, not included on ARIA) • Mouthwashes as per local formulary Additional Information • The National Patient Safety Alert on oral chemotherapy (NPSA/2008/RRR001) must be followed in relation to chlorambucil. • It must be made clear to all staff, including those in the community, that chlorambucil is given as a short course that is repeated and should only be Version 1.1 (October 2017) Page 7 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) prescribed under the supervision of a consultant haematologist. • Hypotension may occur during obinutuzumab intravenous infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each obinutuzumab infusion and for the first hour after administration. Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their anti-hypertensive medicine Coding • Procurement – X71.5 • Delivery – X72.1, X72.4 References 1. Goede V, Fisher K, Busch et al. Obinutuzumab plus chlorambucil in patients with chronic lymphocytic leukemia and coexisting conditions. N Engl J Med 2014; 370 (12): 1101-1110. 2. Dawson K, Moran M, Guindon K et al. Managing infusion related reactions for patients with chronic lymphocytic leukemia receiving obinutuzumab . Clin J Oncol Nursing 2016; 20 (2): 41-48 Version 1.1 (October 2017) Page 8 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) REGIMEN SUMMARY Chlorambucil (14 day)-Obinutuzumab (6 cycles) Cycle 1 Day 1 1. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 2. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 3. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 4. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account Administer 60 minutes prior to obinutuzumab 5. Obinutuzumab 100mg intravenous infusion in 100ml sodium chloride 0.9% over 240 minutes Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 6. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 7. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 8. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 9. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 10. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Day 2 11. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 12. Chlorphenamine 10mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab Version 1.1 (October 2017) Page 9 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) 13. Methylprednisolone sodium succinate 80mg intravenous Administration Instructions Administer 60 minutes prior to obinutuzumab 14. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account Administer 60 minutes prior to obinutuzumab 15. Obinutuzumab 900mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 16. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions. 17. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 18. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 19. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 20. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Day 8 21. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 22. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or when the lymphocyte count is greater than 25x109/L. 23. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction 24. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 25. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. Version 1.1 (October 2017) Page 10 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) 26. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 27. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 28. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 29. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 30. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Day 15 31. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 32. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or when the lymphocyte count is greater than 25x109/L. 33. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction 34. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 35. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride over 240 minutes Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 36. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 37. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors 38. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions Version 1.1 (October 2017) Page 11 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) 39. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 40. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Take Home Medicines (day one only) 41. Chlorambucil 10mg for 14 days starting on day 1 of the chemotherapy cycle oral Administration Information Oral chemotherapy. Start on day 1 of the chemotherapy cycle. Swallow whole, do not crush or chew. Take on an empty stomach either one hour before food or three hours after. The daily dose may be divided into three (morning, noon and night) or the full dose given at night if adverse effects such as nausea and vomiting occur. 42. Metoclopramide 10mg three times a day when required for the relief of nausea Administration Instructions Please supply 28 tablets or nearest original pack size Cycle 2, 3, 4, 5, 6 Day 1 43. Sodium chloride 0.9% 500ml intravenous infusion over 60 minutes 44. Chlorphenamine 10mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 1 or above infusion related reaction or when the lymphocyte count is greater than 25x109/L. 45. Methylprednisolone sodium succinate 80mg intravenous when required for infusion related reactions Administration Instructions Please refer to the protocol. Administer 60 minutes prior to obinutuzumab if there has been a grade 3 or above infusion related reaction 46. Paracetamol 1000mg oral Administration Instructions Please check if the patient takes regular paracetamol for pain control and take dose into account. Administer 60 minutes prior to obinutuzumab 47. Obinutuzumab 1000mg intravenous infusion in 250ml sodium chloride 0.9% Administration Instructions Please refer to the protocol for information regarding infusion rates and infusion related reactions. These may be increased according to tolerance as per the protocol. 48. Chlorphenamine 10mg when required for infusion related reactions Administration Instructions For the relief of infusion related reactions 49. Lorazepam 1mg oral when required for rigors Administration Instructions For the relief of rigors Version 1.1 (October 2017) Page 12 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) 50. Methylprednisolone sodium succinate 80mg intravenous bolus when required for the relief of infusion related reactions Administration Instructions For the relief of infusion related reactions 51. Paracetamol 1000mg oral when required for pyrexia Administration Instructions For the relief of pyrexia. Please check if the patient takes regular paracetamol for pain control and take dose into account 52. Pethidine 25mg intravenous bolus in 10ml sodium chloride 0.9% over 5 minutes for the relief of rigors Administration Instructions For the relief of rigors following a verbal confirmation to administer from a doctor Take Home Medicines (day one only) 53. Chlorambucil 10mg for 14 days starting on day 1 of the chemotherapy cycle oral Administration Information Oral chemotherapy. Start on day 1 of the chemotherapy cycle Swallow whole, do not crush or chew. Take on an empty stomach either one hour before food or three hours after. The daily dose may be divided into three (morning, noon and night) or the full dose given at night if adverse effects such as nausea and vomiting occur. 55. Metoclopramide 10mg three times a day when required for the relief of nausea Administration Instructions Please supply 28 tablets or nearest original pack size Version 1.1 (October 2017) Page 13 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles) DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.1 October 2017 Hepatitis B information extended. Tumour lysis information added. Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician 1 February 2017 None Dr Deborah Wright Pharmacist Dr Helen Dignum Consultant Haematologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. Version 1.1 (October 2017) Page 14 of 14 CLL-Chlorambucil (14 day)-Obinutuzumab (6 cycles)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CLL/Chlorambucil-14-Obinutuzumab.pdf

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