Gazyva

Obinutuzumab

In combination w/ chlorambucil for previously untreated chronic lymphocytic leukemia (CLL) w/ comorbidities. In combination w/ chemotherapy, followed by maintenance therapy in patients achieving 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.

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. 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 of each cycle. 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 of each cycle. Maintenance: 1,000 mg once every 2 mth until disease progression or for up to 2 yr. Patient at risk for tumour lysis syndrome (>25 x 10⁹/L circulating lymphocyte count) &/or renal impairment (CrCl <70 mL/min) Patient should receive prophylaxis consisting of adequate hydration & uricostatics eg, allopurinol or suitable alternative eg, urate oxidase prior to start of Gazyva infusion. Premed Cycle 1: CLL (days 1 & 2) & FL (day 1) Administer IV corticosteroid completed at least 1 hr prior to Gazyva infusion, oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to infusion. All subsequent infusion: CLL & FL Patient w/ no IRR during previous infusion Administer oral analgesic/antipyretic at least 30 min prior to Gazyva infusion. Patient w/ IRR (Grade 1 or 2) w/ previous infusion Administer oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to Gazyva 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 Gazyva infusion, oral analgesic/antipyretic & antihistaminic drug at least 30 min prior to Gazyva infusion.

Hypersensitivity.

Not to be administered as IV push or bolus. Discontinue use if hypersensitivity reactions eg, anaphylaxis, serum sickness occurs; progressive multifocal leukoencephalopathy is confirmed. Infusion-related reactions (IRRs). Not to be used in active hepatitis B disease; presence of active infection. Tumor lysis syndrome, neutropenia, thrombocytopenia, disseminated intravascular coagulation, worsening of preexisting cardiac conditions, history of recurring or chronic infection, hepatitis B reactivation. Perform HBV screening in all patients before initiation of treatment. Not recommended w/ live virus vaccines during treatment & until B-cell recovery. May affect ability to drive & use machines. Renal (CrCl ≤30 mL/min) & hepatic impairment. Postpone vaccination w/ live vaccines for infants born to mothers exposed to Gazyva during pregnancy until infants' B-cell levels are w/in normal ranges. Women of childbearing potential should use effective contraception during & for 8 mth following treatment. Avoid use during pregnancy. Not to be used during lactation & for 18 mth after last dose. Childn <18 yr.

IRRs; neutropenia, thrombocytopenia, anaemia, leukopenia; URTI, sinusitis, herpes zoster, pneumonia, UTI, nasopharyngitis; pyrexia, asthenia, fatigue; cough; arthralgia, back pain, pain in extremity; insomnia; constipation, diarrhoea; alopecia, pruritus; headache.

Targeted Cancer Therapy

L01FA03 - obinutuzumab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.

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