Storage requirements and storage methods of mirikizumab

Milikizumab (Mirikizumab), as an injectable biological preparation, has strict requirements on storage conditions to ensure drug stability and efficacy. According to the drug instructions, this product should be stored refrigerated at 2°C to 8°C (36°F to 46°F) to avoid frostbite and high temperature environments. If you need to carry it or use it for a short period of time, prefilled injection pens can be stored at room temperature not exceeding 30°C, but they need to be protected from light and can only be stored for a maximum of 2 weeks. It is particularly important to note that once placed in a room temperature environment, it must not be returned to the refrigerator again, otherwise it must be discarded to prevent the drug from decreasing in efficacy or denaturing the protein structure.

There are also strict time and temperature requirements for the diluted milizumab solution. The medicinal solution should be used immediately after dilution. If it cannot be used immediately, it can be refrigerated at 2°C to 8°C. However, the diluted medicinal solution can be stored for up to 48 hours from the time when the cork of the medicine bottle is pierced, of which no more than 5 hours at room temperature of no more than 25°C, and it needs to be stored in the dark. During storage, direct sunlight, high temperatures and severe vibrations should be avoided to reduce the risk of protein degradation or precipitation.

During clinical operations, nursing staff must strictly abide by the above storage specifications. Special cold chain equipment should be used when transporting drugs to ensure stable transportation temperatures. In the patient's home self-injection scenario, medicines should be kept in the original packaging and the number of times they are taken out should be minimized. Before use, carefully check whether the medicinal solution is turbid, precipitated or has abnormal color. If there is any abnormality, discard it.

The stable storage of militizumab is not only related to efficacy, but also closely related to patient safety. The protein structure of biological agents is sensitive to temperature and light. Excessive temperature or repeated freezing and thawing may cause drug degradation, thereby affecting clinical effects. Proper storage management can not only extend the shelf life of drugs, but also ensure that patients receive the best therapeutic effect with each injection, thereby achieving the purpose of long-term control of ulcerative colitis.

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