mirikizumab-mrkz (Omvoh)

^[1]^[2]^[3]^[4]

Indications

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

humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine & inhibits its interaction with the IL-23 receptor

↑ Brooks M FDA Approves Mirikizumab for Ulcerative Colitis. Medscape. October 27, 2023 https://www.medscape.com/viewarticle/997822
↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/37379135 Clinical Trial. https://www.nejm.org/doi/full/10.1056/NEJMoa2207940
↑ ^3.0 ^3.1 Haelle T Mirikizumab Effective in Crohn's Disease After Initial Standard Therapy Failure. Study also showed the monoclonal antibody was noninferior to ustekinumab. MedPage Today November 29, 2024 https://www.medpagetoday.com/gastroenterology/inflammatoryboweldisease/113125
Ferrante M, D'Haens G, Jairath V et al Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo- controlled and active-controlled, treat-through study. Lancet. 2024 Nov 21:S0140-6736(24)01762-8. PMID: https://www.ncbi.nlm.nih.gov/pubmed/39581202
↑ HIGHLIGHTS OF PRESCRIBING INFORMATION OMVOH (mirikizumab-mrkz) injection, for intravenous or subcutaneous use https://pi.lilly.com/us/omvoh-uspi.pdf