Mifamurtide injection--Mepact recommended usage and dosage

Mifamurtide injection (Mifamurtide) is an immunomodulatory drug mainly used for the adjuvant treatment of high-grade, resectable, non-metastatic osteosarcoma in children, adolescents and young adults (under 30 years old). The drug needs to be used in combination with multi-agent chemotherapy after complete surgical resection of the tumor to improve the treatment effect and reduce the risk of recurrence. Its indications are based on clinical research data, and its safety and effectiveness have been verified in patients aged 2 years old to 30 years old.

In terms of usage and dosage, mivamutide is administered intravenously. The recommended dose is 2 mg/m² body surface area. Each infusion should last 1 hour. The treatment is divided into two phases: the first phase (the first 12 weeks) is administered 2 times a week, with an interval of at least 3 days between the two administrations; the second phase (following 24 weeks) is changed to weekly 1 times. The entire treatment course lasted 36 weeks, and the total number of administrations was 48 times. This phased dosing schedule is designed to balance efficacy and safety and ensure that the drug continues to exert its immunomodulatory effects during long-term treatment.

During use, special attention should be paid to the patient's individual condition. For patients with asthma or chronic obstructive pulmonary disease, prophylactic use of bronchodilators is recommended to reduce the risk of respiratory distress. Since this drug may cause neutropenia, especially when combined with chemotherapy, the patient's blood picture needs to be closely monitored and alert for signs of fever or infection. In addition, mivamutide may induce inflammatory reactions such as pericarditis or pleurisy and should be used with caution in patients with autoimmune diseases. Patients with cardiovascular disease also need to be closely monitored to prevent complications such as thrombosis or vasculitis. Allergic reactions, although uncommon, require vigilance, especially during the first dose.

In addition, mivamutide is not recommended for use in 2 children under the age of 2, pregnant women, and lactating women because its safety has not been fully evaluated. Patients of childbearing age should take effective contraceptive measures during treatment. The medicine needs to be refrigerated at 2℃~8℃ to avoid freezing and light. The reconstituted medicine should be used within 6 hours.

In general, the use of mivamutide injection must strictly follow the recommended dosage and administration regimen, and the patient's response must be closely monitored during treatment to ensure maximum safety and efficacy. Physicians should adjust treatment strategies based on the patient's specific circumstances to optimize clinical benefit.

Reference link: https://www.ema.europa.eu/en/documents/product-information/mepact-epar-product-information_en.pdf