IMPORTANT SAFETY INFORMATION ( cont ’ d ) Cardiovascular Adverse Reactions
• Cardiac adverse reactions , including ventricular fibrillation , myocardial infarction , and cardiogenic shock , may occur in patients receiving rituximab products . Discontinue infusions for serious or life-threatening cardiac arrhythmias . Perform cardiac monitoring during and after all infusions of RUXIENCE for patients who develop clinically significant arrhythmias , or who have a history of arrhythmia or angina
Renal Toxicity
• Severe , including fatal , renal toxicity can occur after rituximab product administration in patients with NHL . Renal toxicity has occurred in patients who experience TLS and in patients with NHL administered concomitant cisplatin therapy during clinical trials . The combination of cisplatin and RUXIENCE is not an approved treatment regimen . Monitor closely for signs of renal failure and discontinue RUXIENCE in patients with a rising serum creatinine or oliguria
Bowel Obstruction and Perforation
• Abdominal pain , bowel obstruction , and perforation , in some cases leading to death , can occur in patients receiving rituximab products in combination with chemotherapy . In postmarketing reports , the mean time to documented gastrointestinal perforation was 6 ( range 1 – 77 ) days in patients with NHL . Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur
Immunization
• The safety of immunization with live viral vaccines following rituximab product therapy has not been studied , and vaccination with live virus vaccines is not recommended before or during treatment
• For patients treated with RUXIENCE , physicians should review the patient ’ s vaccination status and patients should , if possible , be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating RUXIENCE ; administer nonlive vaccines at least 4 weeks prior to a course of RUXIENCE
Embryo-Fetal Toxicity
• Based on human data , rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed in utero . Advise pregnant women of the potential risk to a fetus . Advise females of reproductive potential to use effective contraception during treatment with RUXIENCE and for at least 12 months after the last dose
Adverse Reactions
• The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and chronic lymphocytic leukemia ( CLL ) were infusion-related reactions , neutropenia , leukopenia , anemia , thrombocytopenia , and infections . Additionally , lymphopenia and lung disorder were seen in NHL trials ; and febrile neutropenia , pancytopenia , hypotension , and hepatitis B were seen in CLL trials
• The most common adverse reactions ( incidence ≥25 %) in clinical trials of NHL and CLL were infusion-related reactions . Additionally , fever , lymphopenia , chills , infection , and asthenia were seen in NHL trials ; and neutropenia was seen in CLL trials Nursing Mothers
• There are no data on the presence of rituximab products in human milk , the effect on the breastfed child , or the effect on milk production . However , rituximab is detected in the milk of lactating cynomolgus monkeys and IgG is present in human milk . Because of the potential of serious adverse reactions in the breastfed child , advise women not to breastfeed during treatment with RUXIENCE and for at least 6 months after the last dose
References : 1 . Pfizer Inc . Hematology : Pfizer Oncology . https :// pfe-pfizercom-d8-prod . s3 . amazonaws . com / news / asco / Hematology-Franchise-Fact-Sheet-6JUNE2018 . pdf . Updated June 6 , 2018 . Accessed August 6 , 2020 . 2 . RUXIENCE [ prescribing information ]. New York , NY : Pfizer Inc .; May 2020 . 3 . Rituxan [ prescribing information ]. San Francisco , CA : Genentech , Inc .; March 2020 . 4 . IMS Institute for Healthcare Informatics . Delivering on the Potential of Biosimilar Medicines : The Role of Functioning Competitive Markets . Parsippany , NJ : IMS ; March 2016 .
Please see the Brief Summary of Prescribing Information , including BOXED WARNINGS , on the following pages .
Rituxan is a registered trademark of Biogen , Inc . PI Revised : 5 / 2020
PP-RIT-USA-0175 © 2020 Pfizer Inc . All rights reserved . September 2020