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1 OBINUTUZUMAB+CHLORAMBUCIL Regimen RDH; Day 1 and 2 Dose to be given on Ward Available for Routine Use in Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby out-patient Indication First line treatment of CLL in patients unsuitable for full dose fludarabine and bendamustine Treatment Intent Palliative Anti-Emetics Pre-chemotherapy 1 Post-chemotherapy A Frequency & Every 28 days for up to 6 cycles Duration CYCLE 1 ONLY Day 1 Sodium chloride 500ml Intravenous infusion over 30 minutes 0.9% Dexamethasone 20mg Slow intravenous injection 60 minutes pre Chlorphenamine 4mg Orally as a single dose 30 minutes pre Paracetamol 1g Orally as a single dose 30 minutes pre Pethidine 25mg Intravenous injection if required for severe rigors Obinutuzumab 100mg Intravenous infusion in 100ml sodium chloride 0.9% over 4 hours. Do not increase the infusion rate. Chlorambucil 0.5mg/kg Orally as a single dose (Rounded to nearest 2mg) Allopurinol 300mg Oral once daily for 28 days for 1-2 cycles or as clinically indicated Aciclovir 400mg Oral twice daily for 28 days Co-trimoxazole 480mg Oral once daily for 28 days Metoclopramide 10mg Oral four times daily as required Day 2 Sodium 500ml Intravenous infusion over 30 minutes chloride0.9% Dexamethasone 20mg Slow intravenous injection 60 minutes pre Chlorphenamine 4mg Orally as a single dose 30 minutes pre Paracetamol 1g Orally as a single dose 30 minutes pre AUTHORISED BY: Dr J Addada PAGE 1 of 10
2 Days 8 & 15 Day 15 ONLY Pethidine 25mg Intravenous injection if required for severe rigors Obinutuzumab 900mg Intravenous infusion in 250ml sodium chloride 0.9% as per rate calculator Sodium chloride 500ml Intravenous infusion over 30 minutes 0.9% Dexamethasone 20mg Slow intravenous injection 60 minutes pre Obinutuzumab For patients with a previous Grade 3 reaction or lymphocyte count >25x10 9 /I ONLY Chlorphenamine 4mg Orally as a single dose 30 minutes pre Obinutuzumab Paracetamol 1g Orally as a single dose 30 minutes pre Obinutuzumab Pethidine 25mg Intravenous injection if required for severe rigors Obinutuzumab 1000mg Intravenous infusion in 250ml sodium chloride 0.9% as per rate calculator Chlorambucil 0.5mg/kg Orally as a single dose (rounded to nearest 2mg) CYCLES 2-6 Day 1 Sodium chloride 500ml Intravenous infusion over 30 minutes 0.9% Dexamethasone 20mg Slow intravenous injection 60 minutes pre For patients with a previous Grade 3 reaction or lymphocyte count >25x10 9 /l ONLY Chlorphenamine 4mg Orally as a single dose 30 minutes pre Paracetamol 1g Orally as a single dose 30 minutes pre Pethidine 25mg Intravenous injection if required for severe rigors Day 1 Obinutuzumab Chlorambucil 1000mg 0.5mg/kg Intravenous infusion in 250ml sodium chloride 0.9% Orally as per a single rate calculator dose & 15 (Rounded to nearest 2mg) Allopurinol Aciclovir 300mg 400mg Oral once daily for 28 days for 1-2 cycles or as clinically Oral twice indicated daily for 28 days Co-trimoxazole 480mg Oral once daily for 28 days AUTHORISED BY: Dr J Addada PAGE 2 of 10
3 Metoclopramide 10mg Oral four times daily as required The following rescue medicines to be prescribed/available for infusion reactions: Paracetamol 1g Oral/IV (max 4g in 24 hours) Chlorphenamine 10mg IV (max 4 doses in 24 hours) Dexamethasone 20mg IV for severe infusion reactions Notes: Baseline investigations Cardiac tests for patients with cardiac risk factors Hepatitis B serology FBC, U&Es, LFTs Consider uric acid and bone profile for patients at risk of tumour lysis Patients who have pre-existing cardiac or pulmonary conditions should be monitored carefully throughout the infusion and the post-infusion period. Hypotension may occur during intravenous infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each 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 Investigations during each cycle FBC before each dose and as clinically indicated following treatment completion U&Es & LFTs prior to Day 1 and 15 and as clinically indicated Tumour lysis bloods as clinically indicated Toxicity assessment at each visit for infusion related reactions, infection, bleeding, thromboembolism, GI, cardiac and respiratory effect AUTHORISED BY: Dr J Addada PAGE 3 of 10
4 Dose modifications and toxicities 1. Haematological toxicity Toxicity Obinutuzumab Dose Chlorambucil Dose Grade 3 or 4 haematological toxicity, febrile neutropenia or thrombocytopaenic bleeding Grade 3 or 4 haematological toxicity that delays treatment by >4 weeks Toxicity Hold until the above parameters are met then restart at usual dose AUTHORISED BY: Dr J Addada PAGE 4 of 10 (% of previous dose) Hold until the above parameters are met. 1st episode: upon recovery restart at 75% 2nd episode: upon recovery restart at 50% 3rd episode: discontinue At the start of each cycle the neutrophil count should be 1.5 x 10 9 /l and platelets 100 x 10 9 /l (unsupported) unless cytopaenias are considered to be diseaserelated. 2. Non-haematological toxicity Grade 2 or 3 related organ/nonhaematological toxicity grade 2 non haematological toxicity that delays treatment by >4 weeks Grade 4 related organ/nonhaematological toxicity, severe haemorrhage, severe skin reaction, pneumonitis, severe arrhythmias or other severe cardiovascular events Viral hepatitis or other serious infections; reactivation of hepatitis B Obinutuzumab dose Chlorambucil dose (% previous dose) Hold until grade 1 Hold until grade 1 3. Infusion related reactions (IRR) and hypersensitivity reactions Infusion related reactions occurred in the majority of patients during the first cycle in the pivotal study. Patients with a high tumour burden (i.e. high peripheral lymphocyte count > 25 x 10 9 /L) may be at increased risk of severe infusion related reactions. Owing to the risk of infusion related reactions, consideration should be given to administering cycle 1 days 1 & 2 as an inpatient stay. Most frequently reported symptoms associated with an IRR 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.
5 Anaphylaxis has been reported in patient. 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 IRRs Toxicity Obinutuzumab dose Chlorambucil Dose (% of previous dose) Grade 1-2 infusion 1 st episode of grade 3 infusion reaction Reduce infusion rate by half and treat symptoms. Restart once resolved. Escalate infusion rate as tolerated at increments appropriate for treatment Hold infusion and treat symptoms. Restart once resolved at no more than half the previous rate. Escalate 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 25 mg/hr after 1 hour, but not increased further No change No change 2nd episode of grade 3 infusion reaction (during same or subsequent infusion) Grade 4 infusion reaction or acute life threatening respiratory reactions Infusion must be stopped and therapy must be permanently discontinued Infusion must be stopped and therapy must be permanently discontinued (Refer to table1 at the end of this document for grading of reactions) AUTHORISED BY: Dr J Addada PAGE 5 of 10
6 4. Standard infusion rate in the absence of infusion reactions or hypersensitivity ycycle Day of Treatment Rate of Infusion Cycle 1 Cycle 1 Day 1 (100mg in 100ml) Day 2 (or day 1 continued) (900mg in 250 ml) Administer at 25 mg/hr over 4 hours. Do not increase the infusion Administer rate. 50 mg/hr. Cycle 1 Day 8 & 15 (1000mg in 250ml) Cycles 2-6 All days (1000mg in 250ml) The rate of the infusion can be escalated in increments of 50 mg/hr every 30 minutes to a maximum rate of 400 mg/hr Infusions can be started at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. Infusions can be started at a rate of 100 mg/hr An and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. See associated rate calculator to support administration Cycle 1 - the recommended dose of is 1000 mg administered over Day 1 and Day 2, and on Day 8 and Day 15 of the first 28 day 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. Management of IRRs may require temporary interruption, reduction in the rate of infusion, or treatment discontinuations of as outlined below (see also SPC). Grade 4 (life threatening): Infusion must be stopped and therapy must be permanently discontinued. Grade 3 (severe): Infusion must be temporarily stopped and symptoms treated. Upon resolution of symptoms, the infusion can be restarted at no more than half the previous rate (the rate being used at the time that the IRR occurred) and, if the patient does not experience any IRR symptoms, the infusion rate escalation can resume at the increments and intervals as appropriate for the treatment dose (see table above). The Day 1 (Cycle 1) infusion rate may be increased back up to 25 mg/hr after 1 hour, but not increased further. The infusion must be stopped and therapy permanently discontinued if the patient experiences a second occurrence of a Grade 3 IRR 5. Renal Impairment In the pivotal trial, patients with moderate renal impairment (CrCl < 50 ml/min) experienced more serious adverse events than those with CrCl 50 ml/min AUTHORISED BY: Dr J Addada PAGE 6 of 10
7 CrCl (ml/min) Obinutuzumab dose Chlorambucil Dose (% of previous dose) >30 but <50 No change, use with caution 75% 10 to 30 No data, omit 75% <10 No data, omit 50% 6. Hepatic impairment Safety and efficacy of have not been established in patients with hepatic impairment. For chlorambucil, dose adjustment is required with severe hepatic impairment; no details found. Modify dose according to response 7. Other adverse effects Cardiac effects Patients who have pre-existing cardiac or pulmonary conditions should be monitored carefully throughout the infusion and the post-infusion period. Hypotension may occur during infusions. Therefore, withholding of antihypertensive treatments should be considered for 12 hours prior to and throughout each infusion and for the first hour after administration. In patients with underlying cardiac disease, arrhythmias, angina pectoris, acute coronary syndrome, myocardial infarction and heart failure have occurred. Therefore patients with a history of cardiac disease should be monitored closely. Thrombocytopaenia Severe and life-threatening thrombocytopenia including acute thrombocytopenia (occurring within 24 hours after the infusion) has been observed during treatment. Patients with renal impairment (CrCl < 50 ml/min) are more at risk of thrombocytopenia. Haemorrhagic events have also been reported. Patients should be closely monitored for thrombocytopenia, especially during the first cycle. Use of antiplatelets and anticoagulants, which could possibly worsen thrombocytopenia- related events should also be taken into consideration, especially during the first cycle. AUTHORISED BY: Dr J Addada PAGE 7 of 10
8 PML Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with. The diagnosis of PML should be considered in any patient presenting with new-onset or changes to preexisting neurologic manifestations. The patient should be referred to a neurologist for the evaluation and treatment of PML. 8. Drug interactions None known. Vaccination with live virus vaccines is not recommended during treatment and until B cell recovery because of the immunosuppressive effect of Supportive care 1. Tumour lysis syndrome Patients with a high tumour burden and/or a high circulating lymphocyte count [> 25 x 10 9 /L] and/or renal impairment [CrCl <70 ml/min]) should receive prophylaxis with adequate hydration and administration of allopurinol, or rasburicase starting hours prior to the infusion. Renal function, potassium, and uric acid should be monitored carefully in the initial days after treatment 2. Anti-infective prophylaxis All patients should receive: Co-trimoxazole 480mg once daily. o In cases of allergy to cotrimoxazole consider dapsone 100mg daily. Aciclovir 400mg twice daily. Consider antifungal prophylaxis with Fluconazole 100mg daily if prolonged neutropaenia occurs until neutrophils >1x10 9 /l References 1. NICE technology appraisal guidance [TA343]; Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia; Published date: June Gazyvaro Summary of Product Characteristics; Last Updated on emc 19-Jun-2015 (Accessed 13/8/2015) 3. Cancer Care Ontario Chlo+Obin regimen monograph Jan The North London Cancer Network. Dosage Adjustments for Cytotoxics in Hepatic Impairment. November 2003 AUTHORISED BY: Dr J Addada PAGE 8 of 10
9 6. The North London Cancer Network. Dosage Adjustments for Cytotoxics in Renal Impairment. November 2003 AUTHORISED BY: Dr J Addada PAGE 9 of 10
10 Table 1. NCI-CTCAE Grading of infusion related reactions and hypersensitivity reactions Adverse event Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Allergic Anaphylaxis Death reaction/hypersensitivity Cytokine release syndrome/infusion related reaction Transient flushing or rash, fever <38 C Mild reaction; infusion interruption not indicated; intervention not indicated Rash: flushing; urticaria; dyspnoea; drug fever 38 C Requires infusion interruption but responds promptly to symptomatic treatment (e.g., antihistamines, IV fluids); prophylactic medications indicated for <=24 hrs Symptomatic bronchospasm, with or without urticaria; parenteral medications indicated; allergy related oedema/angioedema; hypotension Prolonged (e.g. not rapidly responsive to symptomatic medication and/or brief interruption of infusion) recurrence of symptoms following initial improvement; hospitalization indicated (e.g., renal impairment, pulmonary infiltrates) Life-threatening consequences; pressor or ventilatory support indicated Death PAGE 10 of AUTHORISED BY: Dr J Addada 10
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