NOT ALL
FOLLICULAR LYMPHOMA
IS THE SAME.
NEITHER ARE ALL
FOLLICULAR LYMPHOMA
TREATMENTS.
Indication
GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy in patients
achieving at least a partial remission, is indicated for the treatment of adult patients with
previously untreated stage II bulky, III or IV follicular lymphoma (FL).
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
Contraindications
•
GAZYVA is contraindicated in patients with known hypersensitivity reactions (e.g. anaphylaxis)
to obinutuzumab or to any of the excipients, or serum sickness with prior obinutuzumab use
Additional Warnings and Precautions
• Infusion Reactions: Premedicate patients with glucocorticoid, acetaminophen, and
anti-histamine. Monitor patients closely during infusions. Interrupt or discontinue infusion
for reactions
• Hypersensitivity Reactions Including Serum Sickness: Discontinue GAZYVA permanently
Please see the following pages for additional Important Safety Information and the
brief summary of the full Prescribing Information, including BOXED WARNINGS.