RUXIENCE™ ( rituximab-pvvr ): A BIOSIMILAR * IN THE HEMATOLOGY SETTING — BUILT BY PFIZER
RUXIENCE is an important offering in Pfizer ’ s hematology portfolio . It is backed by the expertise of Pfizer in the treatment of blood cancers , and by our commitment to go beyond the medicine and support the patient journey . 1
• Approved across all oncology indications of Rituxan ® ( rituximab ) 2 , 3
• Offers potential savings to the healthcare system 4 VISIT WWW . RUXIENCEHCP . COM TO LEARN MORE
INDICATIONS AND IMPORTANT SAFETY INFORMATION INDICATIONS
• Non-Hodgkin ’ s Lymphoma ( NHL )
RUXIENCE™ ( rituximab-pvvr ) is indicated for the treatment of adult patients with :
º Relapsed or refractory , low-grade or follicular , CD20-positive , B-cell NHL as a single agent
º Previously untreated follicular , CD20-positive , B-cell NHL in combination with first-line chemotherapy and , in patients
achieving a complete or partial response to a rituximab product in combination with chemotherapy , as single-agent maintenance therapy
º Non-progressing ( including stable disease ), low-grade , CD20-positive , B-cell NHL , as a single agent after
first-line cyclophosphamide , vincristine , and prednisone ( CVP ) chemotherapy
º Previously untreated diffuse large B-cell , CD20-positive NHL in combination with cyclophosphamide , doxorubicin ,
vincristine , prednisone ( CHOP ) or other anthracycline-based chemotherapy regimens
• Chronic Lymphocytic Leukemia ( CLL )
º In combination with fludarabine and cyclophosphamide ( FC ), for the treatment of adult patients with previously untreated
and previously treated CD20-positive CLL
IMPORTANT SAFETY INFORMATION BOXED WARNINGS
FATAL INFUSION-RELATED REACTIONS , SEVERE MUCOCUTANEOUS REACTIONS , HEPATITIS B VIRUS REACTIVATION , PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions : Rituximab product administration can result in serious , including fatal , infusion-related reactions . Deaths within 24 hours of rituximab infusion have occurred . Approximately 80 % of fatal infusion-related reactions occurred in association with the first infusion . Monitor patients closely . Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions
Severe Mucocutaneous Reactions : Severe , including fatal , mucocutaneous reactions can occur in patients receiving rituximab products . Discontinue RUXIENCE in patients who experience a severe mucocutaneous reaction . The safety of readministration of RUXIENCE to patients with severe mucocutaneous reactions has not been determined
Hepatitis B Virus ( HBV ) Reactivation : HBV reactivation can occur in patients treated with rituximab products , 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 RUXIENCE . Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation
Progressive Multifocal Leukoencephalopathy ( PML ), including fatal PML , can occur in patients receiving rituximab products . Discontinue RUXIENCE and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML
Please see continued Important Safety Information on next page .
* Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product , known as a reference product , and that there are no clinically meaningful differences between the biosimilar and the reference product .
Please see the Brief Summary of Prescribing Information , including BOXED WARNINGS , on the following pages .