Product image of Mepact (Mifamurtide) supplied by GNH India

Mepact

Active Ingredient:
Mifamurtide
Origin:
EU

Mepact (Mifamurtide)

Mifamurtide, the active ingredient in Mepact, is an immunostimulant presented as a 1 mg lyophilized powder for intravenous use. It is indicated for high‑grade non‑metastatic osteosarcoma after complete surgical resection in pediatric and young adult patients.

GNH India supplies Mepact as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Takeda France Sas

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Indications & Clinical Uses

Mepact is used as part of the postoperative treatment regimen for high‑grade osteosarcoma, targeting the disease’s immune‑mediated pathways.

  • High‑grade non‑metastatic osteosarcoma: improves event‑free survival when added to standard postoperative chemotherapy after complete surgical resection.
  • Adjunctive chemotherapy: administered alongside multi‑agent chemotherapy to enhance immune‑mediated tumor control.
  • Pediatric and young adult patients: approved for use in patients up to 30 years of age following surgery.

How It Works

  • Mifamurtide binds to the intracellular NOD2 receptor on monocytes and macrophages, triggering a signaling cascade that activates NF‑κB and MAPK pathways. This leads to the release of pro‑inflammatory cytokines and chemokines, promoting macrophage activation and enhancing innate immune recognition and destruction of residual tumor cells after surgical resection.

Side Effects

Mepact may cause a range of adverse reactions, most of which are related to immune activation and infusion.

Common Side Effects

  • Fever or chills
  • Nausea and vomiting
  • Fatigue or malaise
  • Headache
  • Hypotension during infusion
  • Injection‑site pain or erythema

Serious or Rare Side Effects

  • Severe hypersensitivity or anaphylaxis
  • Cytokine release syndrome
  • Hepatic enzyme elevation
  • Acute respiratory distress
  • Severe hypotension requiring intervention
  • Thromboembolic events

Precautions & Warnings

Mepact requires careful monitoring due to its immunostimulatory properties.

  • Monitor vital signs: observe blood pressure, temperature, and heart rate during and after infusion.
  • Assess for hypersensitivity: discontinue infusion if severe allergic reactions occur.
  • Evaluate liver function: check hepatic enzymes before each treatment cycle.
  • Use with caution in immunocompromised patients: increased infection risk.
  • Avoid in patients with active uncontrolled infections.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Mepact can interact with other agents that modify immune function or hemodynamics.

Major Interactions (Avoid)

  • Live vaccines: concurrent use may alter vaccine efficacy or increase adverse events.
  • Potent immunosuppressants (e.g., high‑dose steroids, calcineurin inhibitors): may diminish therapeutic effect.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: cytokine release may affect coagulation parameters.
  • Other immunostimulants: additive risk of cytokine‑related toxicity.
  • Drugs affecting hepatic metabolism: monitor liver enzymes as Mepact may influence hepatic function.

Frequently Asked Questions

Mepact is an intravenous immunostimulant indicated as an adjunct to postoperative chemotherapy for patients with high‑grade non‑metastatic osteosarcoma who have undergone complete surgical resection. It is approved for use in pediatric and young adult patients to improve event‑free survival.

Mifamurtide activates the intracellular NOD2 receptor on macrophages, initiating a signaling cascade that releases cytokines and chemokines. This activation enhances the innate immune response, enabling macrophages to recognize and destroy residual tumor cells after surgery.

The specific dose and infusion schedule of Mepact are determined by the prescribing oncologist based on the patient’s age, weight, and treatment protocol. The product is supplied as a 1 mg lyophilized powder for reconstitution and intravenous administration.

The safety of Mepact in pregnancy and lactation has not been established. It is classified as pregnancy category unknown, and use is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant.

To order Mepact, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain logistics), and necessary import documentation.

Mepact differs from conventional chemotherapy by targeting the immune system rather than directly killing tumor cells. While standard agents such as methotrexate, doxorubicin, and cisplatin act cytotoxically, Mepact stimulates macrophage activity via NOD2, offering a complementary mechanism that can improve survival when combined with standard regimens.

Mepact should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. The lyophilized powder remains stable in its original vial until reconstitution for intravenous infusion.

Mepact is supplied as a lyophilized powder that is reconstituted with a suitable diluent and administered by intravenous infusion over a prescribed period, typically under clinical supervision with monitoring of vital signs.

Serious risks include severe hypersensitivity reactions such as anaphylaxis, cytokine release syndrome, significant hypotension, hepatic enzyme elevation, and rare thromboembolic events. Patients should be closely monitored during and after infusion for any signs of these reactions.

Mepact is contraindicated in patients with known hypersensitivity to Mifamurtide or any component of the formulation, and it should be avoided in individuals with active uncontrolled infections or severe immunodeficiency where immune activation could be harmful.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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