Gazyva

Gazyva

obinutuzumab

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Obinutuzumab
Indications/Uses
Chronic lymphocytic leukemia (CLL) in combination w/ chlorambucil. Follicular lymphoma (FL) in combination w/ chemotherapy followed by Gazyva maintenance for previously untreated patients & w/ bendamustine followed by Gazyva maintenance for FL that progressed or did not respond during or after treatment w/ rituximab or rituximab-containing regimen.
Dosage/Direction for Use
IV infusion Prophylaxis & premedication for tumour lysis syndrome: Adequate hydration & administration of uricostatics (eg, allopurinol) or alternative eg, urate oxidase (eg, rasburicase) prior to start of infusion. Prophylaxis & premedication for infusion-related reactions: Corticosteroid premedication is recommended in FL patients & mandatory for CLL patients for 1st infusion. CLL in combination w/ chlorambucil 1,000 mg over Days 1-2, & on Days 8 & 15 of the 1st 28-day treatment cycle followed by 1,000 mg on Day 1 only for each 28-day cycle for cycles 2-6. Duration of treatment: 6 cycles, each of 28-day duration. Cycle 1: Day 1: 100 mg infused at 25 mg/hr over 4 hr. Cycle 1: Day 2 or Day 1 (continued): 900 mg infused at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr. If infusion-related reactions (IRR) occur during previous infusion, administer at 25 mg/hr, may be increased in increments of up to 50 mg/hr every 30 min to max rate of 400 mg/hr. Cycle 1: Day 8 & 15: 1,000 mg infused at 100 mg/hr, increased by 100 mg/hr increments every 30 min to max of 400 mg/hr. If IRR occur during previous infusion, administer at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr. Cycles 2-6: Day 1: 1,000 mg infused at 100 mg/hr increased by 100 mg/hr increments every 30 min to a max of 400 mg/hr. If IRR occur during previous infusion, administer at 50 mg/hr, may be increased in increments of 50 mg/hr every 30 min to max rate of 400 mg/hr. FL Cycle 1: Day 1: 1,000 mg IV at 50 mg/hr, may be increased in 50 mg/hr increments every 30 min to max of 400 mg/hr. Cycle 1: Day 8 & 15, & Cycles 2-6 or 2-8: Day 1: 1,000 mg starting at 100 mg/hr & increased by 100 mg/hr increments every 30 min to a max of 400 mg/hr, if no IRR or Grade 1 IRR occurs. If ≥Grade 2 IRR occurs, administer at 50 mg/hr, may be increased in 50 mg/hr increments every 30 min to a max of 400 mg/hr. Maintenance: 1,000 mg every 2 mth until progression or up to 2 yr. Previously untreated FL Administered w/ chemotherapy six 28-day cycles in combination w/ bendamustine or six 21-day cycles in combination w/ CHOP, followed by 2 additional cycles of Gazyva alone, or eight 21-day cycles in combination w/ CVP. Patients who achieve complete or partial response to Gazyva + chemotherapy should continue to receive Gazyva (1,000 mg) alone as maintenance therapy once every 2 mth until disease progression or for up to 2 yr. Relapsed/refractory FL patients Administered in six 28-day cycles in combination w/ bendamustine. Patients who achieve complete or partial response or have stable disease should continue to receive Gazyva 1,000 mg alone as maintenance therapy once every 2 mth until disease progression or for up to 2 yr.
Contraindications
Special Precautions
Do not administer as IV push or bolus. Stop & permanently discontinue if Grade 4 IRR & hypersensitivity occurs. Temporarily interrupt & administer appropriate medication if Grade 3 IRR occurs. Discontinue in patients w/ acute life-threatening resp symptoms or 2nd occurrence of Grade 3 IRR. Carefully monitor patients w/ preexisting cardiac or pulmonary conditions; renal function, K & uric acid values. Consider withholding antihypertensive therapy for 12 hr prior to & throughout each infusion & for 1st hr after administration. Administer prophylaxis (consists of adequate hydration & uricostatics eg, allopurinol or alternative eg, urate oxidate eg, rasburicase) to patients at risk of tumor lysis syndrome eg, patients w/ high tumor burden &/or high circulating lymphocyte count (>25 x 109/L) &/or renal impairment (CrCl <70 mL/min). Closely monitor patients experiencing neutropenia; thrombocytopenia especially during 1st cycle; history of cardiac disease (hydrated w/ caution to prevent potential fluid overload). History of recurring or chronic infections. Perform HBV screening before initiation of therapy. Should not be used in patients w/ active hepatitis B disease. Permanently discontinue if progressive multifocal leukoencephalopathy occurs. Concomitant use w/ live virus vaccines is not recommended during treatment & until B-cell recovery. Consider postponing vaccination of live vaccines to infants born to mothers exposed to Gazyva during pregnancy until B cell levels are normal. Hepatic impairment. Patients experiencing IRR should not drive & use machines. Women of childbearing potential should use effective contraception during therapy & for 18 mth following treatment. Pregnancy & lactation (discontinue during therapy & for 18 mth after Gazyva last dose). Childn <18 yr. Elderly.
Adverse Reactions
IRR; neutropenia, thrombocytopenia, anaemia, leukopenia; upper resp tract infection, sinusitis, herpes zoster, pneumonia, UTI, nasopharyngitis; pyrexia, asthenia, fatigue; cough; arthralgia, back pain, pain in extremity; insomnia; constipation, diarrhoea; alopecia, pruritus; headache. Febrile neutropenia; rhinitis, pharyngitis oral herpes, flu, lung infection; chest pain; oropharyngeal pain, nasal congestion, rhinorrhea; hypokalemia, tumor lysis syndrome, hyperuricemia; bone pain, musculoskeletal chest pain; anxiety, depression; dysuria, urinary incontinence; HTN; decreased neutrophil count, increased wt, decreased WBC; atrial fibrillation; squamous cell carcinoma of skin, basal cell carcinoma; dyspepsia, haemorrhoids; eczema.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XC15 - obinutuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Gazyva soln for infusion 1000 mg/40 mL
Packing/Price
1's
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