N
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W
AP
PR
OV
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D
R ITUXAN HYC E LA ™
for
SUBCUTANEOUS INJECTION
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IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY
ê Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients
receiving rituximab-containing products, including RITUXAN HYCELA
ê Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab-
containing products, including RITUXAN HYCELA, in some cases resulting in fulminant hepatitis, hepatic
failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients
during and after treatment with RITUXAN HYCELA. Discontinue RITUXAN HYCELA and concomitant
medications in the event of HBV reactivation
ê Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving
rituximab-containing products, including RITUXAN HYCELA