Gazyva 1000 mg/ 40ml Concentrate for Solution for Infusion

Manufacturer
ROCHE DIAGNOSTICS GMBH
 
Contents
Obinutuzumab
 
Indication
In combination w/ chemotherapy, followed by maintenance therapy in patients achieving a response for previously untreated advanced follicular lymphoma (FL). In combination w/ bendamustine, followed by maintenance therapy for FL who did not respond or who progressed during or up to 6 mth after treatment w/ rituximab or rituximab-containing regimen. In combination w/ chlorambucil for previously untreated chronic lymphocytic leukemia (CLL) w/ comorbidities.
 
Instruction
Previously untreated FL Cycle 1: Administer 1,000 mg in combination w/ chemotherapy on days 1, 8 & 15 of 21- or 28-day treatment cycle. Cycle 2-8 (w/ CHOP & CVP) or cycle 2-6 (w/ bendamustine): Administer 1,000 mg each on day 1. Maintenance: 1,000 mg once every 2 mth until disease progression or for up to 2 yr. Patient w/ FL who did not respond or who progressed during or up to 6 mth after treatment w/ rituximab or rituximab-containing regimen Cycle 1: Administer 1,000 mg in combination w/ bendamustine on days 1, 8 & 15 of 28-day treatment cycle. Cycle 2-6 (w/ bendamustine): Administer 1,000 mg each on day 1. Maintenance: 1,000 mg once every 2 mth until disease progression or for up to 2 yr. CLL Cycle 1: Administer 1,000 mg in combination w/ chlorambucil on days 1-2 (100 mg to be given 1st on day 1, followed by the remaining 900 mg on day 1 or 2), days 8 & 15 of 28-day treatment cycle. Cycles 2-6: Administer 1,000 mg each on day 1. Patient at risk for tumour lysis syndrome (>25 x 10⁹/L) &/or renal impairment (CrCl <70 mL/min) Patient should receive prophylaxis consisting of adequate hydration & uricostatics eg, allopurinol prior to start of infusion. Prophylactic measures for infusion-related reactions (IRRs) include adequate glucocorticoid, oral analgesic/antihistamine, omission of antihypertensives 12 hr prior to & throughout each infusion & for 1st hr after administration & split dosing of cycle 1 over 2 days. Premed Cycle 1: CLL (days 1 & 2) & FL (day 1) Administer IV corticosteroid completed at least 1 hr prior to infusion, oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to infusion. All subsequents infusion: CLL & FL Patient w/ no IRR during previous infusion Administer oral analgesic/antipyretic at least 30 min prior to infusion. Patient w/ IRR (Grade 1 or 2) w/ previous infusion Administer oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to infusion. Patient w/ Grade 3 IRR w/ previous infusion or w/ lymphocyte counts >25 x 10⁹/L prior to next treatment Administer IV corticosteroid completed at least 1 hr prior to infusion, oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to infusion.
 
Drug interaction
May increase risk of hypotension with antihypertensive agents. May increase risk of haemorrhage with anticoagulants, platelet inhibitors.
Potentially Fatal: May enhance the adverse effects and diminish the therapeutic effects of live vaccines.