GNH USA

Europe — EMA

Mepact

GNH USA supplies Mepact (Mifamurtide), an immunomodulator for high‑grade resectable non‑metastatic osteosarcoma in patients aged 2 years and older.

Mifamurtide

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What is Mifamurtide?

Mifamurtide, the active ingredient in Mepact, is an immunomodulator presented as an intravenous solution for intravenous use. It is indicated for the treatment of high‑grade resectable non‑metastatic osteosarcoma in patients aged two years and older, acting as part of a multimodal therapy regimen.

GNH USA supplies Mepact as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide, ensuring quality‑controlled shipments and regulatory compliance across multiple jurisdictions, and our distribution network includes major cancer treatment facilities in Europe, Asia and the Americas.

What is Mifamurtide used for?

Mepact (mifamurtide) is used in the management of bone‑derived malignancies, specifically high‑grade osteosarcoma. High‑grade resectable non‑metastatic osteosarcoma: improves event‑free survival when combined with standard chemotherapy in patients ≥2 years. Localized osteosarcoma after complete surgical resection: provides immunostimulatory support to reduce recurrence risk. Adjuvant therapy for osteosarcoma in pediatric and adolescent patients: integrates with multi‑agent regimens to target microscopic disease.

What are the side effects of Mifamurtide?

Mepact may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects: - Fever: transient elevation of body temperature often occurring shortly after infusion. - Nausea: mild to moderate feeling of queasiness. - Vomiting: occasional episodes post‑infusion. - Fatigue: generalized tiredness during treatment course.

Serious or Rare Side Effects: - Hypotension: sudden drop in blood pressure requiring medical attention. - Anaphylaxis: severe allergic reaction with respiratory distress and urticaria. - Hepatotoxicity: elevated liver enzymes indicating potential liver injury.

What precautions apply to Mifamurtide?

When using Mepact, clinicians should observe several precautionary measures to ensure patient safety and product integrity. - Monitoring: Perform regular assessment of vital signs, especially during and after infusion. - Liver Function: Check hepatic enzymes before each cycle and adjust therapy if significant elevation occurs. - Cardiovascular: Observe for signs of hypotension or arrhythmia during administration. - Concomitant Therapy: Evaluate potential interactions with other immunomodulatory or cytotoxic agents. - Pregnancy and Lactation: Use only if potential benefit justifies potential risk; data are limited. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Mifamurtide interact with?

Mepact can interact with other medicines, influencing its efficacy or safety profile.

Major Interactions (Avoid): - Live Vaccines: concurrent use may increase risk of severe infection due to immune modulation. - High‑dose Corticosteroids: may blunt the immunostimulatory effect of mifamurtide. - Anticoagulants: increased bleeding risk if infusion causes thrombocytopenia.

Moderate Interactions (Monitor Closely): - Other Immunotherapies: combined immune activation may raise incidence of cytokine‑release symptoms. - Hepatotoxic Drugs: concurrent use may exacerbate liver enzyme elevations. - NSAIDs: may mask fever, a key indicator of infusion reaction.

Frequently asked questions

What is Mepact used for?+
Mepact, whose active ingredient is mifamurtide, is indicated for the treatment of high‑grade resectable non‑metastatic osteosarcoma in patients aged two years and older. It is used as an adjuvant to standard chemotherapy to improve event‑free survival and reduce the risk of disease recurrence.
How does Mifamurtide work?+
Mifamurtide activates the intracellular NOD2 receptor on monocytes and macrophages, triggering NF‑κB signaling. This leads to the release of pro‑inflammatory cytokines and chemokines, enhancing innate immune activity, promoting tumor‑cell phagocytosis, and supporting adaptive immune responses against osteosarcoma cells.
What is the usual dose of Mepact?+
The dosing regimen for Mepact is individualized and set by the treating oncologist based on patient age, weight, and the overall chemotherapy protocol. Clinicians determine the infusion volume, rate, and schedule according to the approved label and clinical guidelines.
Is Mepact safe in pregnancy or breastfeeding?+
Safety data for Mepact during pregnancy and lactation are limited. The product should be used only if the potential therapeutic benefit justifies any potential risk to the fetus or infant. Clinicians are advised to discuss risks with the patient and consider alternative therapies when possible.
How do I order Mepact from GNH USA?+
To order Mepact, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain handling if needed), and import documentation.
How does Mepact compare with other osteosarcoma treatments?+
Mepact is the only approved immunomodulator that targets the innate immune system via NOD2 activation, whereas standard osteosarcoma therapy relies on multi‑agent chemotherapy and surgery. Compared with chemotherapy alone, adding Mepact has shown improved event‑free survival in clinical trials, but it does not replace conventional agents.
What are the storage and handling requirements for Mepact?+
Mepact must be stored refrigerated at 2‑8 °C. Keep the vials in the original packaging, protect them from light, and avoid freezing or shaking. If the product is to be transported, maintain the cold‑chain throughout to preserve stability and efficacy.
How is Mepact administered?+
Mepact is given as an intravenous infusion. The infusion is typically administered over a defined period, often once weekly or as specified in the treatment protocol, and is performed in a clinical setting where vital signs can be monitored before, during, and after the infusion.
What are the most serious risks associated with Mepact?+
The most serious adverse reactions to watch for include hypotension, which may require immediate medical intervention; anaphylaxis, a severe allergic response with respiratory compromise; and hepatotoxicity, indicated by marked elevations in liver enzymes. Prompt recognition and management are essential.
Who should not use Mepact?+
Mepact should be avoided in patients with known hypersensitivity to mifamurtide or any component of the formulation. Caution is also advised for individuals with uncontrolled cardiovascular disease, severe hepatic impairment, or those receiving live vaccines concurrently, as these conditions may increase the risk of serious adverse events.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Mifamurtide
Route
Intravenous Use
Manufacturer
Takeda France Sas
Origin
EU

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