Obinutuzumab+Bendamustine followed by Obinutuzumab Maintenance Burton in-patient Derby in-patient Burton day-case Derby day-case

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1 Obinutuzumab+Bendamustine followed by Obinutuzumab Maintenance Burton in-patient Derby in-patient Burton day-case Derby day-case Burton community Derby community Burton out-patient Derby out-patient Available for Use in Not routinely commissioned, each case requires prior documented approval before offering & commencing therapy from: a) the BLUETEQ website Indication Follicular lymphoma that did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Treatment Intent Disease modification Anti-Emetics Pre-chemotherapy 3 Post-chemotherapy C+ ondansetron 8mg twice daily for 3days Blood Products Irradiated blood products required lifelong Frequency & Duration Every 28 days for up to 6 cycles, followed in responding patients or those with stable disease with maintenance single agent once every 2 months for a maximum of 2 years or until disease progression (whichever occurs first) ALL CYCLES 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 CYCLE 1 ONLY Day 1 Dexamethasone 20mg Slow intravenous injection 60 minutes pre Ondansetron 8mg Orally as a single dose 30 mins pre Bendamustine Bendamustine 90mg/m 2 Intravenous infusion in 500ml sodium chloride 0.9% over minutes Chlorphenamine 4mg Orally as a single dose 30 minutes pre Paracetamol 1g Orally as a single dose 30 minutes pre REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 1 of 10

2 Pethidine 25mg Intravenous injection if required for severe rigors Obinutuzumab 1000mg Intravenous infusion in 250ml sodium chloride 0.9% as per rate calculator. Allopurinol 300mg Oral once daily for 7 days for 1-2 cycles or as clinically indicated (reduce to 100mg dose if CrCl<20ml/min). Omit on the bendamustine days. Aciclovir 400mg Oral twice daily for 28 days Co-trimoxazole 480mg Oral once daily for 28 days Ondansetron 8mg Oral twice daily for 3 days Metoclopramide 10mg Oral four times daily for 4 days then as required Dexamethasone 4mg Oral twice daily for 2 days Day 2 Bendamustine 90mg/m 2 Intravenous infusion in 500ml sodium chloride 0.9% over minutes Days 8 & 15 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 CYCLES 2-6 Day 1 Dexamethasone 20mg Slow intravenous injection 60 minutes pre For patients with a previous Grade 3 reaction or lymphocyte count >25x10 9 /l ONLY Ondansetron 8mg Orally as a single dose 30 mins pre Bendamustine Bendamustine 90mg/m 2 Intravenous infusion in 500ml sodium chloride 0.9% over minutes Chlorphenamine 4mg Orally as a single dose 30 minutes pre Paracetamol 1g Orally as a single dose 30 minutes pre REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 2 of 10

3 Pethidine 25mg Intravenous injection if required for severe rigors Obinutuzumab Allopurinol 1000mg 300mg Intravenous infusion in 250ml sodium chloride as per rate calculator 0.9% Oral once as per daily rate for calculator 7 days for 1-2 cycles or as clinically indicated (reduce dose in renal impairment). Omit on the bendamustine days Aciclovir 400mg Oral twice daily for 28 days Co-trimoxazole 480mg Oral once daily for 28 days Ondansetron 8mg Oral twice daily for 3 days Metoclopramide 10mg Oral four times daily for 4 days then as required Dexamethasone 4mg Oral twice daily for 2 days Day 2 Bendamustine 90mg/m 2 Intravenous infusion in 500ml sodium chloride 0.9% over minutes CYCLE 7 ONWARDS: Patients without evidence of progression may continue with maintenance therapy Obinutuzumab every 2 months for 2 years (12 doses), or until disease progression: Day 1 Dexamethasone 20mg Slow intravenous injection 60 minutes pre For patients with a previous Grade 3 reaction or 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 Obinutuzumab 1000mg Intravenous infusion in 250ml sodium chloride as per rate calculator 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 3 of 10

4 Patients who have pre-existing cardiac or pulmonary conditions should be monitored carefully throughout the infusion and the postinfusion 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 antihypertensive medicine. Investigations pre each cycle FBC, U&Es & LFTs prior to Day 1 FBC (U&Es if clinically indicated) prior to Day 8 and 15 of cycle 1 Tumour lysis bloods as clinically indicated Toxicity assessment at each visit for infusion related reactions, infection, bleeding, thromboembolism, GI, cardiac and respiratory effect Dose modifications and toxicities 1. Haematological toxicity At the start of each cycle the neutrophil count should be 1.0 x 10 9 /l and platelets 100 x 10 9 /l (unsupported) unless cytopaenias are considered to be diseaserelated. Toxicity Obinutuzumab Dose Bendamustine Dose Grade 3 or 4 neutropaenia (ANC<0.5x10 9 /l), febrile neutropenia, grade 2-4 thrombocytopaenia (platelets<75x10 9 /l) Toxicity that delays treatment by >4 weeks Hold until the above parameters are met then restart at usual dose. Consider GCSF prophylaxis for treatment related neutropaenia. Hold until the above parameters are met. 1st episode: upon recovery restart at 60mg/m 2 Subsequent episodes: Consultant decision, consider discontinuing. Consider GCSF prophylaxis to maintain doses for treatment related neutropaenia. REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 4 of 10

5 2. Non-haematological toxicity 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 Bendamustine dose (% previous dose) Hold until grade 1 Hold until grade 1 1st episode: upon recovery restart at 60mg/m 2 Subsequent episodes: Consultant decision, consider discontinuing. 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. 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. Anaphylaxis has been reported in patients. 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 5 of 10

6 Toxicity Grade 1-2 infusion 1 st episode of grade 3 infusion reaction Obinutuzumab dose 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) 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) 4. Standard infusion rate in the absence of infusion reactions or hypersensitivity ycycle Day of Treatment Rate of Infusion Cycle 1 Day 1 (1000mg in 250 ml) Cycle 1 Day 8 & 15 (1000mg in 250ml) Cycles 2-6 Maintenance Day 1 (1000mg in 250ml) See associated rate calculator to support administration Administer at 50 mg/hr. 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 If no infusion related reaction occurred during the prior infusion, 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. If no infusion related reaction occurred during the prior infusion, 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. 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 6 of 10

7 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 Patients withcrcl < 40 ml/min were excluded from the pivotal trial. Obinutuzumab Patients with CrCl<50ml/min are at more risk of serious adverse events including neutropaenia, thrombocytopaenia and infusion reactions. No dose adjustment is required in patients with mild to moderate renal impairment (CrCl ml/min). The safety and efficacy has not been established in patients with severe renal impairment (CrCl < 30 ml/min). Bendamustine No dose adjustment is necessary in patients with a creatinine clearance of > 10 ml/min. Experience in patients with severe renal impairment is limited. 6. Hepatic impairment Patients with ALT>2.5xULN and/or Bil 3xULN were excluded from the pivotal trial. Obinutuzumab The safety and efficacy of in patients with impaired hepatic function has not been established. No specific dose recommendations can be made. Bendamustine Bilirubin micromol/l Dose <20 100% % >51 No data available * 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 7 of 10

8 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. 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 8 of 10

9 References 1. NICE technology appraisal guidance [TA472]; Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab Published date: Aug Levact Summary of Product Characteristics; Last updated on emc (Accessed 26/10/17) 3. Gazyvaro Summary of Product Characteristics; Last Updated on emc (Accessed 7/8/17) 4. Obinutuzumab plus bendamustine versus bendamustine monotherapy in patients with rituximab-refractory indolent non-hodgkin lymphoma (GADOLIN): a randomised, controlled, open-label, multicentre, phase 3 trial. Lancet Oncology. g 2016 Aug; 17(8): The North London Cancer Network. Dosage Adjustments for Cytotoxics in Hepatic Impairment. November The North London Cancer Network. Dosage Adjustments for Cytotoxics in Renal Impairment. November 2003 REVIEWED BY K Graham 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 REVIEWED BY K Graham AUTHORISED BY: Dr J Addada PAGE 10 of 10

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