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Rituxan is a treatment for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), proven to induce remission1

Historical standard of care

Cyclophosphamide (CYC), in combination with steroids, has been a commonly prescribed treatment regimen for patients with Granulomatosis with Polyangiitis and Microscopic Polyangiitis.2 Current survival outcomes suggest:

  • 5-year survival for Microscopic Polyangiitis (MPA) is 45%-76%3
  • 5-year survival for Granulomatosis with Polyangiitis (GPA) is 69%-91%3
  • Approximately 50% of patients will suffer a relapse2

Concomitant use with immunosuppressants other than corticosteroids in GPA and MPA

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.

References
1.
Data on file, Genentech USA/Biogen Idec.
2.
Turnbull J, Harper L. Adverse effects of therapy for ANCA-associated vasculitis. Best Pract Res Clin Rheumatol. 2009;23(3):391-401.
3.
Mukhtyar C, Flossmann O, Hellmich B, et al. Outcomes from studies of antineutrophil cytoplasm antibody associated vasculitis: a systematic review by the European League Against Rheumatism systemic vasculitis task force. Ann Rheum Dis. 2008;67(7):1004-1010.

INDICATION

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

BOXED WARNINGS

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.

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