GAZYVA

*Chronic Lymphocytic Leukemia (CLL) in combination with Chlorambucil:* BY IV INF: Adult: To be administered during six 28-day treatment cycles as follows: Cycle 1 (loading doses): Day 1: 100 mg, Day 2: 900 mg, Day 8: 1000 mg, Day 15: 1000 mg. Cycles 2-6: Day 1: 1000 mg. *Follicular Lymphoma (FL), in combination with Bendamustine followed monotherapy:* BY IV INF: Adult: To be Administered during Six 28-Day treatment cycles as follows: Cycle 2 (loading doses): Day 1: 1000 mg, Day 2: 1000 mg, Day 8: 1000 mg, Day 15: 1000 mg. Cycles 2-6 or 2-8: Day 1: 1000 mg. Followed by Monotherapy: 1000 mg every 2 months for up to two years.

Administer only as an IV infusion through a dedicated line. Do not administer as an IV push or bolus. Dilute into a 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag. Do not use other diluents such as dextrose (5%). Preparation of solution for infusion of day 1 (100 mg) and day 2 (900 mg) of Cycle 1: Withdraw 40 ml of Obinutuzumab solution from the vial. Dilute 4 ml (100 mg) of Obinutuzumab into a 100 ml 0.9% sodium chloride infusion bag for immediate administration. Dilute the remaining 36 ml (900 mg) into a 250 ml 0.9% sodium chloride infusion bag at the same time for use on day 2 and store at 2C (36F to 46F) for up to 24 hours. After allowing the diluted bag to come to room temperature, use immediately. Preparation of solution for infusion of 1000 mg dose: Withdraw 40 ml of Obinutuzumab solution from the vial. Dilute 40 ml (1000 mg) into a 250 ml 0.9% sodium chloride infusion bag. Mix diluted solution by gentle inversion. Do not shake or freeze.The product can be administered at a final concentration of 0.4 mg/ml to 4 mg/ml

Hypersensitivity to the drug, serum sickness with prior obinutuzumab use.

Pre-medicate before each infusion. Provide prophylactic hydration and anti-hyperuricemics to patients at high risk of tumor lysis syndrome. Monitor blood counts at regular intervals. Risk of hepatitis B infection and reactivation; patients with positive hepatitis B serology should be referred to a liver specialist for monitoring and initiation of antiviral therapy before treatment initiation. Patients should be closely monitored for signs of active hepatitis B infection during treatment and for up to a year following the last infusion risk of immunogenicity.

lrinotecan

Anemia, neutropenia, thrombocytopenia, leucopenia, pyrexia, diarrhea, constipation, nasopharyngitis, urinary tract infection, infusion related reaction, hypocalcemia, hypokalaemia, hyponatremia, increased AST/SGOT, increased ALT/SGPT, hypoalbuminaemia, tumourlysis syndrome, nausea and vomiting, dyspepsia, pyrexia, asthenia, sinusitis, arthralgia, pain in extremity, cough, nasal congestion, pruritus, immunogenicity.