Target ANCA-associated vasculitis
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Now FDA Approved!

Rituxan is a treatment for ANCA-associated vasculitis proven to induce remission in newly diagnosed and relapsing patients.

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INDICATION

Rituxan (rituximab), in combination with glucocorticoids, is indicated for the treatment of adult patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

Rituxan is not recommended for treatment of patients with severe active infections.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Fatal Infusion Reactions: Rituxan administration can result in serious, including fatal infusion reactions. Deaths within 24 hours of Rituxan infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Carefully monitor patients during infusions. Discontinue Rituxan infusion and provide medical treatment for Grade 3 or 4 infusion reactions.

Tumor Lysis Syndrome (TLS): Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of TLS following treatment of non-Hodgkin's lymphoma (NHL) patients with Rituxan.

Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions, can occur in patients receiving Rituxan.

Progressive Multifocal Leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients treated with Rituxan.

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 WG 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.

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Reference
1.
Data on file, Genentech USA/Biogen Idec.