Description
Omvoh (mirikizumab-mrkz) is a humanized IgG4 monoclonal antibody that selectively targets the p19 subunit of interleukin-23 (IL-23), a cytokine involved in the inflammatory cascade associated with ulcerative colitis and other autoimmune conditions. By inhibiting IL-23 signaling, Omvoh reduces chronic intestinal inflammation. It is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults who have had an inadequate response, lost response, or were intolerant to conventional therapy or a biologic agent. Omvoh is the first FDA-approved IL-23 inhibitor specifically for ulcerative colitis.
Directions
Omvoh is administered via intravenous (IV) infusion for induction, followed by subcutaneous (SC) injections for maintenance:
- Induction: 300 mg IV at Weeks 0, 4, and 8
- Maintenance: 200 mg SC every 4 weeks starting at Week 12
IV infusions should be given over at least 30 minutes. The first SC injection should be administered under healthcare supervision; subsequent doses may be self-administered by the patient or caregiver after training. Treatment should be continued as long as clinical benefit is observed.
Ingredients
Each vial or prefilled syringe of Omvoh contains:
- Mirikizumab-mrkz (300 mg/15 mL for IV or 200 mg/1 mL for SC)
The product is preservative-free and latex-free.
Contraindications
Omvoh is contraindicated in patients with:
- Known hypersensitivity to mirikizumab or any component of the formulation
- Active serious infections, including tuberculosis
Cautions
Evaluate patients for latent or active tuberculosis before initiating therapy. Monitor for signs of infection, and interrupt treatment if a serious infection develops. Use caution in patients with a history of chronic or recurrent infections. Omvoh may increase the risk of hypersensitivity reactions, including anaphylaxis and angioedema. Live vaccines should not be administered during treatment. The safety of Omvoh during pregnancy and lactation has not been established; use only if clearly needed.
Side Effects
Common side effects of Omvoh include:
- Upper respiratory tract infections
Serious adverse effects may include:
- Serious infections (e.g., pneumonia, cellulitis)
- Hypersensitivity reactions
- Tuberculosis reactivation
Patients should be monitored throughout therapy for infections and hypersensitivity, and periodic laboratory assessments may be recommended based on clinical status.
IMPORTANT NOTE:
The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.
Product Code : 14597
Prescription Required