SATRALIZUMAB-MWGE INJ,SOLN
Clinical Criteria Summary
Exclusion Criteria
- Untreated active hepatitis B infection
- Untreated latent or active tuberculosis infection
- Active, clinically significant infection
- Active hepatic disease or hepatic impairment
- Baseline ALT and/or AST > 1.5 times the upper limit of normal (ULN)
- Concomitant therapy with another biologic therapy for neuromyelitis optica spectrum disorder (NMOSD)
- Concomitant chronic therapy with intravenous immunoglobulin or plasma exchange (use in exacerbations is reasonable)
- Pregnancy
Inclusion Criteria
- Care provided by VA or VA Community Care neurology provider or locally designated expert
- Diagnosis of aquaporin-4 antibody positive NMOSD
- Completed hepatitis B screening (HBsAg, total anti-HBc and anti-HBs) with consult referral for hepatitis B management if either HBsAg or total anti-HBc positive
- All guideline recommended eligible immunizations administered at least 4 weeks prior to treatment start for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior for inactivated vaccines
- Contraindication, intolerance, or lack of therapeutic response to rituximab OR patient not a candidate for IV rituximab due to inability to access an infusion center or poor venous access
Additional Inclusion Criteria
- For patients who can become pregnant: Counseling provided on potential risks vs benefits of treatment and to inform provider of a known or suspected pregnancy