Instructions for Mirikizumab

1. Name: Mirikizumab, Omvoh

2. Indications:

Mirikizumab-Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

3. Usage and dosage:

1. Before treatment: Before starting treatment with OMVOH, assess the patient's tuberculosis (TB) infection and obtain liver enzyme and bilirubin levels. Complete all age-appropriate vaccinations according to current immunization guidelines

2. Recommended dose: The recommended induction dose of militizumab is 300 mg, administered by intravenous infusion over at least 30 minutes at weeks 0, 4, and 8; the recommended maintenance dose is 200 mg, administered by subcutaneous injection at week 12 (two consecutive injections of 100 mg each), and every 4 weeks thereafter.

3. Medication management: Militizumab is mainly used for intravenous injection and is administered by doctors using aseptic techniques. Each bottle is for single use only. A complete maintenance dose requires 2 prefilled pens or 2 prefilled syringes. Injection sites include the abdomen, thighs, and back of the upper arms. Instruct the patient to inject in a different location each time. For example, if the first injection is in the abdomen, give a second injection (to complete the full dose) in another area of u200bu200bthe abdomen, upper arm, or thigh. Militizumab should only be administered to the back of the upper arm by another person. Do not inject into areas of tender skin, bruises, redness, or induration.

4. Missed dose: If you miss a dose of Milizumab, please administer it as soon as possible. Thereafter, dosing resumes every 4 weeks.

4. Adverse reactions:

In clinical studies of militizumab, the most common common adverse reactions during the induction phase included upper respiratory tract infection and arthralgia; and during the maintenance phase included upper respiratory tract infection, injection site reactions, arthralgia, rash, headache, and herpes virus infection.

5. Supply and storage:

Milizumab injection is a sterile, preservative-free, clear to milky white, colorless to slightly yellow to slightly brown solution that can be used for intravenous infusion or subcutaneous injection. Store refrigerated at2°C to 8°C (36°F to 46°F). Do not freeze. Do not use ifmilitizumab has been frozen. Don't shake. Prior to use, please store Milizumab in the original carton to protect it from light.

If desired, prefilled pens or prefilled syringes can be used up to Store in original carton for up to 2 weeks at room temperature 30°C (86°F) protected from light. After storing Milizumab at room temperature, do not return it to the refrigerator. If these conditions are exceeded, Milizumab must be discarded.

6. Mechanism of action:

Milizumab is a humanized IgG4 monoclonal antibody that selectively binds to the p19 subunit of the human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is involved in mucosal inflammation, affecting the differentiation, expansion, and survival of T cell subsets and innate immune cell subsets, which are sources of pro-inflammatory cytokines. Animal model studies have shown that pharmacological inhibition of IL-23p19 can improve intestinal inflammation. Milizumab inhibits the release of pro-inflammatory cytokines and chemokines.

Reference materials:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=472cbe04-263e-433d-9a0f-58c1b50b715a