Methotrexate Injection (generic methotrexate 50mg/2mL PF, Otrexup, Rasuvo)

SELF ADMINISTERED

FDA Approved Indications:

  • Magagement of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy
  • Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy

Approved Indications and Usage Guidelines:

  • Generic Methotrexate Injection
    • 1. Diagnosis of severe, active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or severe, recalcitrant, disabling psoriasis.
  • Otrexup or Rasuvo (methotrexate) Injection:
    • 1. Diagnosis of severe, active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis or severe, recalcitrant, disabling psoriasis, AND
    • 2.  Failure or clinically significant adverse effects to generic methotrexate injection, OR medical justification why generic cannot be considered (e.g. inability to use syringe and vial due to severe disfiguring/disabling condition) supported by chart note documentation

Coverage is Not Authorized For:

  • Non-FDA approved indications, which are not listed in the Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

  • Otrexup and Rasuvo are not indicated for the treatment of neoplastic diseases

Recommended Dosing Regimen and Authorization Limit:

  • Recommended starting doses:
    • Otrexup, Rasuvo:
      • RA: 7.5 mg once weekly
      • pJIA: 10 mg/m2 once weekly
      • Psoriasis: 10-25 mg once weekly

Availability:

  • Otrexup: Autoinjector that administers a single 0.4 mL dose: 10 mg/0.4mL methotrexate, 15 mg/0.4mL methotrexate, 20 mg/0.4mL methotrexate, 25 mg/0.4mL methotrexate
  • Rasuvo: Preservative-free sterile solution for a single subcutaneous injection: 7.5 mg/0.15 mL, 10 mg/0.20 mL, 12.5 mg/0.25 mL, 15 mg/0.30 mL, 17.5 mg/0.35 mL, 20 mg/0.40 mL, 22.5 mg/0.45 mL, 25 mg/0.5 mL, 27.5 mg/0.55 mL, 30 mg/0.60 mL

Approval:

  • 1 year