Indication

GAZYVA^TM(obinutuzumab), in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

Important Safety Information

Boxed WARNINGS: HEPATITIS B VIRUS REACTIVATION AND PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

• Hepatitis B Virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients receiving CD20-directed cytolytic antibodies, including GAZYVA. Screen all patients for HBV infection before treatment initiation. Monitor HBV positive patients during and after treatment with GAZYVA. Discontinue GAZYVA and concomitant medications in the event of HBV reactivation.
• Progressive Multifocal Leukoencephalopathy (PML) including fatal PML, can occur in patients receiving GAZYVA.

Additional Warnings and Precautions

• Infusion Reactions: GAZYVA can cause severe and life-threatening infusion reactions. For patients with Grade 4 infusion reactions, including but not limited to anaphylaxis, acute life-threatening respiratory symptoms, or other life-threatening infusion reaction, stop and permanently discontinue GAZYVA therapy. Premedicate patients with acetaminophen, antihistamine, and a glucocorticoid. Closely monitor patients during the entire infusion. Infusion reactions within 24 hours of receiving GAZYVA have occurred. For Grades 1, 2, or 3 infusion reactions, interrupt or discontinue infusion for reactions.
• Tumor Lysis Syndrome (TLS): TLS can occur within 12-24 hours after the first infusion. Patients with high tumor burden and/or high circulating lymphocyte count (>25 x 10⁹/L) are at greater risk for TLS and should receive appropriate tumor lysis prophylaxis with anti-hyperuricemics and hydration beginning 12-24 hours prior to the infusion of GAZYVA.
• Infections: Serious bacterial, fungal, and new or reactivated viral infections can occur during and following GAZYVA therapy. Do not administer GAZYVA to patients with an active infection.
• Neutropenia: Severe neutropenia can occur. Monitor patients with Grade 3 to 4 neutropenia frequently with regular laboratory tests until resolution. Neutropenia can also be of late onset and/or prolonged.
• Thrombocytopenia: Severe thrombocytopenia can occur. Monitor patients with Grade 3 or 4 thrombocytopenia for platelet counts and bleeding frequently until resolution. Management of hemorrhage may require blood product support.