Eligibility Criteria for Exceptional Access Program Funding for Rituximab for GPA or MPA

Patients who meet all of the following criteria may apply through EAP:

• The patient must have severe active disease that is life- or organ-threatening. At least one supporting laboratory and/or imaging report must be provided. The organ(s) and how the organ(s) is (are) threatened must be specified.
• There is a positive serum assays for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided.
• Cyclophosphamide cannot be used for the patient for at least ONE of the following reasons:
  • The patient has failed a minimum of 6 IV pulses of cyclophosphamide; OR
  • The patient has failed 3 months of oral cyclophosphamide therapy; OR
  • The patient has a severe intolerance or an allergy to cyclophosphamide; OR
  • Cyclophosphamide is contraindicated; OR
  • The patient has received a cumulative lifetime dose of at least 25 g of cyclophosphamide; OR
  • The patient wishes to preserve ovarian/testicular function for fertility.

Other Requirements

• The initial treatment would be a once weekly infusion dosed at 375 mg/m² x 4 weeks.
• The physician must confirm that the treatment would not be a maintenance infusion as maintenance infusions will not be funded.

Renewals will be considered provided that the patient meets the same criteria for initial approval and the request for retreatment is made no less than 6 months after the last dose of the patient’s last treatment cycle with rituximab.