What are the precautions when using Milizumab? What details do patients need to pay special attention to?

Mirikizumab (Mirikizumab) is a new type of humanized IgG4 monoclonal antibody that mainly targets interleukin -23 (IL-23)p19 subunit, used to treat moderate to severe ulcerative colitis (UC) and other chronic inflammatory diseases. As a biological agent targeting specific immune pathways, militizumab has significant clinical efficacy during treatment, but there are also certain medication precautions. Patients should pay special attention to many aspects before, during and after using this drug to ensure that the treatment is safe and effective.

First, patients need to undergo a comprehensive health assessment before starting militizumab. In particular, potential serious infections such as active tuberculosis, hepatitis B, hepatitis C and other chronic infectious diseases should be excluded. This is because IL-23 plays a role in immune defense, and inhibiting this pathway may increase the risk of infection. For patients with a past history of tuberculosis, a tuberculin test or IGRA test should be performed, and if necessary, anti-tuberculosis pretreatment should be performed. Physicians will also evaluate whether there are immune dysfunction, a history of malignant tumors, or other diseases that affect immune system function, which may affect the safety of militizumab.

Secondly, during the treatment process, patients need to pay close attention to their physical condition and regularly review blood routine, liver and kidney function, and inflammatory indicators (such asCRP, ESR, etc.). Although militizumab has a relatively high safety profile and a low incidence of serious adverse reactions, mild to moderate side effects may still occur, such as injection site reactions (redness, swelling, pain), upper respiratory tract infection, headache, fatigue, etc. If persistent high fever, severe diarrhea, persistent abdominal pain, rash or other systemic symptoms occur, patients should contact their doctor in time to rule out the possibility of infection or abnormal immune response.

Third, patients must strictly follow the doctor's instructions in terms of medication methods and dosages. Militizumab is usually administered as a subcutaneous injection or intravenous infusion. The initial treatment phase is usually administered intravenously by a medical professional, and can subsequently be switched to monthly subcutaneous injections for maintenance treatment. Patients should never change the dosage or stop taking the medicine on their own, as stopping the medicine at will may lead to a recurrence of the disease or a return of symptoms. In addition, some patients may experience allergic reactions or delayed reactions at the injection site. They should read the drug instructions carefully before use and observe for a period of time after the first injection to ensure that there is no allergic reaction before considering self-injection.

Fourth, caution is also required when used in combination with other immunosuppressants or biological agents. Milizumab is used as an intervention drug in immune pathways. If combined with other biological agents (such as anti-TNFAlpha drugs) or strong immunosuppressants (such as cyclosporine, methotrexate) may increase the risk of infection or immune-related adverse reactions. Therefore, when formulating a treatment plan, doctors will take into account the patient's previous medication history and condition characteristics to try to avoid cross-risks between drugs. If biological agents need to be replaced, an appropriate drug “washout period” must be set to avoid interactions caused by drug residues.

In addition, female patients should use militizumab with caution during pregnancy and lactation. Although there is currently no sufficient evidence from human studies to show that this drug has obvious harm to the fetus or infant, as an IgG antibody, it may theoretically be transmitted through the placenta or breast milk. Therefore, it is recommended that women of childbearing potential undergo pregnancy evaluation before treatment and use effective contraceptive measures during treatment. If the patient is planning to become pregnant or is already pregnant, the doctor should be informed, and the doctor will decide whether to continue taking the medication after assessing the risks and benefits.

In general, militizumab, as an IL-23 inhibitor, has significant advantages in the treatment of autoimmune diseases such as moderate to severe ulcerative colitis, but it also requires patients to closely cooperate with the medical team, complete necessary examinations and assessments before treatment, monitor and follow up during treatment, and strictly follow the medication plan. Only by comprehensively understanding the characteristics of drugs and mastering the precautions for medication can we better ensure the therapeutic effect and reduce the risk of adverse reactions, thereby achieving long-term disease control and improvement of quality of life.

Reference materials:https://omvoh.lilly.com/