Precautions and safety tips for taking mirikizumab

While patients are using Mirikizumab to treat ulcerative colitis (UC) and Crohn's disease, they need to focus on the four major safety risks of infection, tuberculosis, hepatotoxicity, and immunization. The specific precautions are as follows:

1. Infection risk control

Milizumab has the potential to increase the risk of infection. The patient's infection status must be strictly checked before medication. Patients with clinically important active infections must wait until the infection subsides or is fully treated before medication can be started. For patients with chronic infections or patients with a history of recurrent infections, the risks and benefits of medication must be fully weighed before prescribing.

During treatment, patients need to be instructed to pay close attention to their own status. If signs and symptoms related to acute or chronic infection occur, they should seek medical treatment in time. If a patient develops a serious infection, or if the infection does not improve significantly after standard treatment, the patient needs to be closely monitored and use of Militizumab should be suspended until the infection completely resolves. Milizumab.

2. Tuberculosis screening and intervention

The patient's tuberculosis infection status must be assessed before taking the drug. Patients with active tuberculosis infection are strictly prohibited from using this drug. For patients with latent tuberculosis, anti-tuberculosis treatment must be completed before initiating militizumab treatment; patients with a history of latent or active tuberculosis and who cannot be confirmed to have completed the standard course of treatment should also consider anti-tuberculosis treatment before starting treatment.

Patients need to be continuously monitored for signs and symptoms of active tuberculosis during and after treatment. In relevant clinical trials, subjects with evidence of active tuberculosis, previous history of active tuberculosis, or confirmed latent tuberculosis at screening were excluded.

3. Hepatotoxicity monitoring and treatment

There was a case of drug-induced liver injury in a clinical trial. The subject used an induction regimen that exceeded the recommended duration. After treatment, alanine aminotransferase (ALT) rose to 18 times the upper limit of normal (ULN), aspartate aminotransferase (AST) rose to 10 times ULN, and total bilirubin rose to 2.4 times. ULN was accompanied by symptoms of pruritus, and the patient's liver test indicators eventually returned to baseline levels after drug withdrawal.

The medication must be taken during the baseline period and at leastDuring the 24-week treatment period, the patient's liver enzyme and bilirubin levels will be measured regularly. After 24 weeks, monitoring can be carried out in conjunction with routine patient management needs. For patients with evidence of cirrhosis, consider other treatment options. If a patient experiences elevated liver enzymes, the cause needs to be investigated immediately to confirm whether it is drug-induced liver injury; if drug-induced liver injury is highly suspected, treatment needs to be suspended until the diagnosis is ruled out. In addition, patients need to be instructed to seek medical attention immediately if symptoms related to abnormal liver function occur.

4. Immunization related requirements

Patients receiving militizumab should avoid receiving live vaccines because these drugs, which act on the immune system, may increase the risk of infection after receiving live vaccines. Before initiating treatment with militizumab, complete all age-appropriate vaccinations according to current immunization guidelines. Currently, there are no data supporting the immune response to live or non-live vaccines in patients receiving militizumab.

Keyword tags: Militizumab medication safety, infection risk, tuberculosis screening, hepatotoxicity monitoring, immunization, live vaccine contraindications, drug-induced liver injury, ALT, AST, bilirubin

Reference materials:https://www.ema.europa.eu/en/medicines/human/EPAR/omvoh