Mirikizumab-mrkz is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation and affects the differentiation, expansion, and survival of T cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that pharmacologic inhibition of IL-23p19 can ameliorate intestinal inflammation. Mirikizumab-mrkz inhibits the release of pro-inflammatory cytokines and chemokines.

OMVOHTM is an interleukin-23 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Prior to Treatment Initiation:
• Evaluate patients for tuberculosis (TB) infection.
• Obtain liver enzymes and bilirubin levels.
• Complete all age-appropriate vaccinations according to current immunization guidelines.

Recommended Dosage: 
• The recommended induction dosage is 300 mg administered by intravenous infusion over at least 30 minutes at Weeks 0, 4, and 8.
• The recommended maintenance dosage is 200 mg administered by subcutaneous injection (given as two consecutive injections of 100 mg each) at Week 12, and every 4 weeks thereafter.

Preparation and Administration:

• See the full prescribing information for preparation, administration and storage information for intravenous infusion and subcutaneous injection.

Most common adverse reactions (≥2%) are:
• Induction: upper respiratory tract infections and arthralgia.
• Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

History of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

• Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment.
• Infections: OMVOH may increase the risk of infection. Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves.
• Tuberculosis: Do not administer OMVOH to patients with active TB infection. Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. See package insert for complete information.