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 (antineoplastic) presented as a 1 mg per vial lyophilized powder for intravenous infusion use. It is indicated for high‑grade, non‑metastatic osteosarcoma after complete surgical resection, where it is administered as part of adjuvant therapy to improve disease‑free survival.

GNH India supplies Mepact as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, providing reliable sourcing for clinical oncology programs, including academic and private institutions, and supporting regulatory compliance for cross‑border distribution.

Manufacturer / TM Owner

Takeda France Sas

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Indications & Clinical Uses

Mepact (mifamurtide) is used as an immunotherapy for osteosarcoma, acting through innate immune activation.

  • High‑grade, non‑metastatic osteosarcoma (adjuvant setting): improves disease‑free survival after complete surgical resection.

How It Works

  • Mifamurtide binds to the intracellular pattern‑recognition receptor NOD2 in macrophages and dendritic cells, triggering a signaling cascade that releases pro‑inflammatory cytokines and chemokines. This activation enhances the innate immune response, promoting tumor‑associated antigen presentation and cytotoxic activity against residual osteosarcoma cells following surgery.

Side Effects

Mepact may cause a range of adverse reactions during and after infusion.

Common Side Effects

  • Fever: transient elevation of body temperature during infusion.
  • Chills: shaking or shivering episodes.
  • Nausea: mild to moderate upset stomach.
  • Vomiting: occasional emesis post‑infusion.
  • Fatigue: generalized tiredness.
  • Hypotension: temporary drop in blood pressure.

Serious or Rare Side Effects

  • Anaphylaxis: severe allergic reaction requiring immediate medical attention.
  • Hepatotoxicity: elevated liver enzymes indicating liver stress.
  • Cytokine release syndrome: systemic inflammatory response.
  • Severe hypotension requiring vasopressors.
  • Acute respiratory distress: difficulty breathing during infusion.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient suitability and monitor for potential complications.

  • Infusion reactions: monitor vital signs during and after administration.
  • Hepatic function: assess liver enzymes prior to each cycle.
  • Infection risk: defer treatment in patients with active severe infections.
  • Pediatric use: adjust monitoring as children may experience heightened cytokine responses.
  • Pregnancy and lactation: safety unknown; avoid use unless benefits outweigh risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Mepact may interact with other agents that affect immune function or hemodynamics.

Major Interactions (Avoid)

  • Live vaccines: concurrent administration may cause uncontrolled immune activation.
  • Known hypersensitivity to excipients: avoid to prevent severe allergic reactions.
  • Other immunostimulants: may amplify cytokine release syndrome.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: monitor coagulation parameters due to potential platelet activation.
  • Nephrotoxic drugs: assess renal function as cytokine surge can affect kidney perfusion.
  • Concurrent antineoplastic agents: watch for overlapping toxicities, especially hepatic and hematologic effects.

Frequently Asked Questions

Mepact contains the immunostimulant mifamurtide and is approved for the adjuvant treatment of high‑grade, non‑metastatic osteosarcoma after complete surgical resection. It is given intravenously to help reduce the risk of disease recurrence.

Mifamurtide activates the intracellular NOD2 receptor in macrophages and dendritic cells, leading to the release of cytokines that boost innate immune activity. This enhanced immune response promotes the recognition and destruction of residual osteosarcoma cells following surgery.

The specific dose and schedule of Mepact are determined by the prescribing oncologist based on the patient’s weight, clinical status, and treatment protocol. The product is supplied as a 1 mg lyophilized vial that is reconstituted for intravenous infusion.

Safety of mifamurtide in pregnancy and lactation has not been established. It is generally avoided unless the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To request Mepact, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

Mepact is unique in that it is an immunostimulant rather than a conventional cytotoxic chemotherapy. It is used alongside standard multi‑agent regimens and specifically targets the innate immune system, whereas other agents such as methotrexate, doxorubicin or cisplatin act directly on tumor cell proliferation.

Mepact vials must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. Prior to use, the lyophilized powder is reconstituted with the appropriate diluent under aseptic conditions.

Mepact is given as an intravenous infusion. After reconstitution, the solution is infused over a specified period, typically 30‑60 minutes, under close clinical monitoring for infusion‑related reactions.

Serious adverse events include anaphylaxis, severe hypotension, cytokine release syndrome, and significant liver enzyme elevations. Prompt recognition and management of these reactions are essential, and patients should be observed closely during and after the infusion.

Mepact is contraindicated in patients with known hypersensitivity to mifamurtide or any excipients, those receiving live vaccines, and individuals with active severe infections. Caution is also advised for patients with uncontrolled cardiovascular disease or severe hepatic impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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