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mirikizumab-mrkz (Omvoh)

Indications: - treatment of moderate to severe ulcerative colitis in adults Contraindications: - hypersentitivity reactions - avoid live virus vaccines - active tuberculosis - Dosage: - Prior to Treatment Initiation - evaluate patients for tuberculosis infection - obtain serum AST, serum ALT & serum bilirubin - complete all age-appropriate vaccinations according to guidelines - 300 mg via intravenous infusion over at least 30 minutes at Weeks 0, 4, & 8 - maintenance dosage is 200 mg via subcutaneous injection - given as 2 consecutive injections of 100 mg each at Week 12, & every 4 weeks thereafter * Intravenous Infusion: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial * Subcutaneous Injection: 100 mg/mL solution in a single-dose prefilled pen Adverse effects: - hepatotoxicity - > 2%: upper respiratory tract infections, arthralgia Mechanism of action: - humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine & inhibits its interaction with the IL-23 receptor

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

pharmaceutical monoclonal antibody

References

  1. Brooks M FDA Approves Mirikizumab for Ulcerative Colitis. Medscape. October 27, 2023 https://www.medscape.com/viewarticle/997822
  2. D'Haens G, Dubinsky M, Kobayashi T et al Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med 2023; 388:2444-2455, June 29 PMID: 37379135 Clinical Trial. https://www.nejm.org/doi/full/10.1056/NEJMoa2207940
  3. HIGHLIGHTS OF PRESCRIBING INFORMATION OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use https://pi.lilly.com/us/omvoh-uspi.pdf