Dose of obinutuzumab is administered during 6 treatment cycles each of 28 days duration, as an IV infusion, through a dedicated line
Do not administer as a IV push or bolus
Cycle 1
Day 1: 100 mg IV . Administer at 25 mg/hr over 4 hours. Do not increase the infusion rate
Day 2: 900 mg IV. 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
Day 8 and Day 15: 1,000 mg IV: Start infusion at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
Cycles 2-6
Day 1: 1,000 mg IV: Start infusion at a rate of 100 mg/hr and increased by 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr
Note:
Premedicate with glucocorticoid, acetaminophen and anti-histamine, before each infusion to reduce the risk of infusion reactions (Refer package insert for detail information of premedication infusion, preparation and administration procedure)
In case if dose is missed, administer the missed dose as soon as possible and adjust dosing schedule accordingly. If appropriate, patients who do not complete the Day 1 Cycle 1 dose may proceed to the Day 2 Cycle 1 dose
Should be administer only as an intravenous infusion through a dedicated line
Monitor blood counts at regular intervals
Pediatric Dosing
Safety and effectiveness have not been established in pediatric patients
Treatment of patients with previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil
Contraindications⬆⬇
Hypersensitivity to any of the ingredients of the product
Black Box Warnings⬆⬇
Hepatitis B Virus (HBV) reactivation, in rare cases leading to fulminant hepatitis, hepatic failure, and death, may occur in patients receiving obinutuzumab. Screen all patients for HBV infection before treatment initiation.
Discontinue obinutuzumab and concomitant medications in the event of HBV reactivation
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, may occur in patients receiving obinutuzumab
Dosing Adjustment⬆⬇
Renal Dose Adjustment (Based on CrCl)
>30mL/min: No dose adjustments
< 30mL/min: Dose adjustments not defined
Hepatic Dose Adjustment
Hepatic impairment: Dose adjustments not defined
Warnings/Precautions⬆⬇
Hepatitis B Virus (HBV) reactivation, in rare cases leading to fulminant hepatitis, hepatic failure, and death, may occur in patients receiving obinutuzumab. Screen all patients for HBV infection before treatment initiation. Discontinue obinutuzumab and concomitant medications in the event of HBV reactivation [US Black Box Warning]
Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, may occur in patients receiving obinutuzumab [US Black Box Warning]
Therapy may cause severe and life-threatening infusion reactions. Premedicate patients with acetaminophen, antihistamine and a glucocorticoid. Monitor patients closely during entire infusions. Interrupt or discontinue infusion for reactions
Tumor Lysis Syndrome (TLS) may occur within 12-24 hours after the first infusion and hence patient should receive appropriate tumor lysis prophylaxis with antihyperuricemics and adequate hydration especially for patients with high tumor burden and/or high circulating lymphocyte count. Correct electrolyte abnormalities, provide supportive care and monitor renal function and fluid balance
Therapy may cause neutropenia. Monitor for infection. Recommended to receive antimicrobial prophylaxis throughout the treatment period
Thrombocytopenia has been reported in patients receiving obinutuzumab with chlorambucil. Monitor platelet counts and for bleeding. Management of hemorrhage may require blood product support
Immunization with live virus vaccines is not recommended during treatment and until B-cell recovery
Monoclonal antibody; binds to CD20 antigen and mediates B-cell lysis through engagement of immune effector cells, activating intracellular death signaling pathways and complement cascade