g ventricular fibrillation, myocardial infarction, andcardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions forserious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after allinfusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who havea history of arrhythmia or angina.
5.8 Renal Toxicity
Severe, including fatal, renal toxicity can occur after rituximab product administration in patientswith NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and inpatients with NHL administered concomitant cisplatin therapy during clinical trials. Thecombination of cisplatin and a rituximab product is not an approved treatment regimen.
Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a risingserum creatinine or oliguria. [see Warnings and Precautions (5.5)].
5.9 Bowel Obstruction and Perforation
Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur inpatients receiving rituximab products in combination with chemotherapy. In postmarketingreports, the mean time to documented gastrointestinal perforation was 6 (range 1−77) days inpatients with NHL. eva luate if symptoms of obstruction such as abdominal pain or repeatedvomiting occur.
5.10 Immunization
The safety of immunization with live viral vaccines following rituximab product therapy has notbeen studied and vaccination with live virus vaccines is not recommended before or duringtreatment.
5.11 Embryo-Fetal Toxicity
Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia ininfants exposed in-utero. Advise pregnant women of the risk to a fetus.
Females of childbearingpotential should use effective contraception while receiving TRUXIMA and for 12 monthsfollowing the last dose of TRUXIMA.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the
labeling:
•Infusion reactions [see Warnings and Precautions (5.1)]
•Severe mucocutaneous reactions [see Warnings and Precautions (5.2)]
•Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions(5.3)]
•Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4)]
•Tumor lysis syndrome [see Warnings and Precautions (5.5)]
•Infections [see Warnings and Precautions (5.6)]
•Cardiovascular adverse reactions [see Warnings and Precautions (5.7)]
•Renal toxicity [see Warnings and Precautions (5.8)]
•Bowel obstruction and perforation [see Warnings and Precautions (5.9)]
6.1 Clinical Trials Experience in Lymphoid Malignancies
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinical trialsof another drug and may not reflect the rates observed in clinical practice. The data describedbelow reflect exposure to rituximab in 2783 patients, with exposures ranging from a singleinfusion up to 2 years. Rituximab was studied in both single-arm and controlled trials (n=356and n=2427). The population included 1180 patients with low grade or follicular lymphoma,and 1603 patients with other indications. Most NHL patients received rituximab as an infusion |
