ASH Clinical News ACN_4.1_FULL_ISSUE_DIGITAL | Page 13

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 rituximabcontaining 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

RITUXAN HYCELA ® 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 rituximabcontaining 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