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Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA).
Rituxan is not recommended for treatment of patients with severe active infections.
IMPORTANT SAFETY INFORMATION
Rituxan administration can result in serious, including fatal, adverse reactions. These include:
- infusion reactions
- tumor lysis syndrome (TLS)
- severe mucocutaneous reactions
- progressive multifocal leukoencephalopathy (PML)
Warnings and Precautions
Rituxan administration can also result in additional serious, including fatal, adverse reactions including:
- hepatitis B reactivation
- other infections including bacterial, fungal, new or reactivated viral infections
- cardiovascular events
Use of concomitant immunosuppressants other than corticosteroids has not been studied in GPA or MPA patients exhibiting peripheral B-cell depletion following treatment with Rituxan.
Observe patients closely for signs of infection if immunosuppressants other than corticosteroids are used concomitantly.
Common adverse reactions include infections, nausea, diarrhea, headache, muscle spasms, anemia and peripheral edema.