IMPORTANT SAFETY INFORMATION ( CONT ’ D )
ADDITIONAL WARNINGS AND PRECAUTIONS Hypersensitivity and Other Administration Reactions Systemic Reactions
ê Patients must receive at least one full dose of RITUXAN before receiving RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion . Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping the intravenous infusion
ê Rituximab-containing products , including RITUXAN HYCELA , are associated with hypersensitivity and other administration reactions . This set of reactions includes syndrome of cytokine release , tumor lysis syndrome , and anaphylactic and hypersensitivity reactions . They are not specifically related to the route of administration of a rituximab-containing product
ê Severe infusion-related reactions with fatal outcome have been reported with the use of RITUXAN , with an onset of 30 minutes to 2 hours after starting the first infusion . Anaphylactic and other hypersensitivity reactions can also occur . In contrast to cytokine release syndrome , true hypersensitivity reactions typically occur within minutes after starting infusion
ê Cytokine release syndrome may occur within 1-2 hours of initiating the infusion . Patients with a history of pulmonary insufficiency or those with pulmonary tumor infiltration may be at a greater risk of poor outcome . Rituximab product administration should be interrupted immediately and aggressive symptomatic treatment initiated
ê Interrupt RITUXAN HYCELA administration immediately when observing signs of a severe reaction and initiate aggressive symptomatic treatment . Closely monitor : those with pre-existing cardiac or pulmonary conditions , those who experienced prior cardiopulmonary adverse reactions , and those with high numbers of circulating malignant cells ( ≥25,000 / mm 3 )
ê Premedicate patients with an antihistamine and acetaminophen and consider glucocorticoids prior to each administration of RITUXAN HYCELA . Observe patients for at least 15 minutes following RITUXAN HYCELA . A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions
Local Cutaneous Reactions ê Local cutaneous reactions , including injection site reactions , have been reported in patients receiving RITUXAN HYCELA Tumor Lysis Syndrome ( TLS )
ê TLS can occur within 12-24 hours after administration of a rituximab-containing product , including RITUXAN HYCELA . Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS . Correct electrolyte abnormalities , monitor renal function and fluid balance , and administer supportive care , including dialysis , as indicated
Infections
ê Serious , including fatal , bacterial , fungal , and new or reactivated viral infections can occur during and following the completion of therapy with rituximab-containing products , including RITUXAN HYCELA . Discontinue RITUXAN HYCELA for serious infections and institute appropriate antiinfective therapy
Cardiovascular Adverse Reactions
ê Cardiac adverse reactions , including ventricular fibrillation , myocardial infarction , and cardiogenic shock , may occur with rituximab-containing products , including RITUXAN HYCELA . Discontinue RITUXAN HYCELA for serious or life-threatening cardiac arrhythmias . Perform cardiac monitoring during and after all administrations of RITUXAN HYCELA for patients who develop clinically significant arrhythmias , or who have a history of arrhythmia or angina
Renal Toxicity
ê Severe , including fatal , renal toxicity can occur after administration of rituximab-containing products , including RITUXAN HYCELA . Monitor closely for signs of renal failure and discontinue RITUXAN HYCELA in patients with a rising serum creatinine or oliguria
Bowel Obstruction and Perforation
ê Abdominal pain , bowel obstruction , and perforation , in some cases leading to death , can occur in patients receiving rituximab-containing products , including RITUXAN HYCELA , in combination with chemotherapy
Immunization
ê The safety of immunization with live viral vaccines following rituximab-containing products , including RITUXAN HYCELA , has not been studied and vaccination with live virus vaccines is not recommended before or during treatment
Embryo-Fetal Toxicity
ê Based on human data , rituximab-containing products can cause fetal harm . Advise pregnant women of the risk to a fetus . Females of childbearing potential should use effective contraception while receiving RITUXAN HYCELA and for 12 months following the last dose of rituximab-containing products , including RITUXAN HYCELA
ADVERSE REACTIONS
ê The most common adverse reactions ( ≥20 %) of RITUXAN HYCELA observed in patients with FL in SABRINA were : infections , neutropenia , nausea , constipation , cough , and fatigue
ê The most common adverse reactions ( ≥20 %) of RITUXAN HYCELA observed in patients with DLBCL in MabEASE were : infections , neutropenia , alopecia , nausea , and anemia
ê The most common adverse reactions ( ≥20 %) of RITUXAN HYCELA observed in patients with CLL in part 2 of SAWYER were : infections , neutropenia , nausea , thrombocytopenia , pyrexia , vomiting , and injection site erythema
Please see the following pages for the brief summary of the full Prescribing Information , including BOXED WARNINGS , for additional Important Safety Information .
Attention Healthcare Provider : Provide Medication Guide to patient prior to RITUXAN HYCELA treatment . You may report side effects to the FDA at ( 800 ) FDA-1088 or www . fda . gov / medwatch . You may also report side effects to Genentech at ( 888 ) 835-2555 .
To learn more , visit RITUXANHYCELA . com / hcp
© 2017 Genentech USA , Inc . and Biogen . All rights reserved . RSC / 051217 / 0037 ( 2 ) a Printed in USA . December 2017 Jointly Marketed by : Biogen and Genentech USA , Inc . RITUXAN ® and RITUXAN HYCELA ® are registered trademarks of Biogen .