Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Infusion-related 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) ] Most common adverse reactions in clinical trials were: NHL (greater than or equal to 25%): infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia ( 6.1 ).
CLL (greater than or equal to 25%): infusion-related reactions and neutropenia ( 6.1 ).
RA (greater than or equal to 10%): upper respiratory tract infection, nasopharyngitis, urinary tract infection, and bronchitis (other important adverse reactions include infusion-related reactions, serious infections, and cardiovascular events) ( 6.1 ).
GPA and MPA (greater than or equal to 15 %): infections, nausea, diarrhea, headache, muscle spasms, anemia, peripheral edema, infusion-related reactions ( 6.1 ).
PV (greater than or equal to 15%): infusion-related reactions, depression, upper respiratory tract infection/nasopharyngitis, headache (other important adverse reactions include infections) ( 6.1 ).
To report SUSPECTED ADVERSE REACTIONS, contact TEVA Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience in Lymphoid Malignancies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
B-Cell Malignancies The data described below reflect exposure to rituximab in 3,092 patients, with exposures ranging from a single infusion up to 2 years.
Rituximab was studied in both single-arm and controlled trials (n=356 and n=2,427).
The population included 1180 patients with low grade or follicular lymphoma, 927 patients with DLBCL, 676 patients with CLL, and 309 patients with another indication.
5 WARNINGS AND PRECAUTIONS Tumor lysis syndrome: Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function ( 5.5 ).
Infections: Withhold TRUXIMA and institute appropriate anti-infective therapy ( 5.6 ).
Cardiac adverse reactions: Discontinue infusions in case of serious or life-threatening events ( 5.7 ).
Renal toxicity: Discontinue in patients with rising serum creatinine or oliguria ( 5.8 ).
Bowel obstruction and perforation: Consider and evaluate for abdominal pain, vomiting, or related symptoms ( 5.9 ).
Like all medications, Truxima can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: