Mirikizumab drug package insert overview

1. Drug name

Mirikizumab (Mirikizumab), trade name: Omvoh.

2. Indications

Milizumab is suitable for the treatment of adult patients with moderate to severe activity .

3. Usage and dosage

1. Preparation before use: Before starting to use Omvoh, it is necessary to assess the patient's tuberculosis (TB) infection status and check liver enzyme and bilirubin levels. At the same time, ensure that all patients of appropriate age complete necessary vaccinations according to current immunization guidelines.

2. Recommended dosage regimen:

Induction dose: The first recommended dose is300mg, which should be infused intravenously in three times at week 0, week 4 and week 8. The infusion time should be no less than 30 minutes.

Maintenance dose: The maintenance dose is200mg, scheduled for subcutaneous injection in the 12th week, divided into two divided doses (100mg each time), and then once every 4 weeks.

3. Administration management: Milizumab is mainly administered intravenously and is administered by professional medical personnel using aseptic techniques. Each vial is for single use only, two prefilled pens or two prefilled syringes are required for a complete maintenance dose. Injection sites can be chosen on the abdomen, thighs and back of the upper arms. Instruct patients to inject in different locations and avoid repeated injections at the same site, especially in areas with soft tissue injury, congestion, erythema, or induration. Injections into the back of the upper arm should be done with assistance.

4. Treatment of missed doses: If you miss a dose of militizumab, you should take it as soon as possible, and then resume the dosing frequency once every 4 weeks.

4. Adverse reactions

In clinical trials of milizumab, common adverse reactions during the induction phase included upper respiratory tract infection and joint pain; while during the maintenance phase, common adverse reactions included upper respiratory tract infection, injection site reactions, joint pain, rash, headache, and herpes virus infection.

5. Supply and storage

Milizumab injection is a sterile, preservative-free, clear, milky white solution suitable for intravenous or subcutaneous administration. Should be stored refrigerated at2°C to 8°C (36°F to 46°F) and do not freeze. Do not use if frozen. At the same time, avoid shaking before use and keep it in the original carton to prevent it from being affected by light.

If stored at room temperature (max30°C/86°F), prefilled pens or prefilled syringes can be kept in the original packaging for up to 2 weeks but cannot be re-refrigerated. If the above conditions are exceeded, the medicine should be discarded according to relevant regulations.

6. Mechanism of action

Milizumab is a humanizedIgG4 monoclonal antibody that can specifically bind to the p19 subunit of human IL-23 cytokine, thereby inhibiting its binding to the IL-23 receptor. IL-23 plays an important role in mucosal inflammation, affecting the differentiation, proliferation and survival of T cell subsets and innate immune cell subsets. These cells are the source of pro-inflammatory cytokines. Studies have shown that inhibiting IL-23 can improve intestinal inflammation, and militizumab can effectively reduce the release of pro-inflammatory cytokines and chemokines, thereby achieving a therapeutic effect.

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