N
O
W
AP
PR
OV
E
D
R ITUXAN HYC E LA ™
for
SUBCUTANEOUS INJECTION
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