Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Mepact; Bulgaria: Mepact; Czech Republic: Mepact; Estonia: Mepact; Germany: Mepact; Greece: Mepact; Ireland: Mepact; Latvia: Mepact; Lithuania: Mepact; Luxembourg: Mepact; Malta: Mepact; Netherlands: Mepact; Portugal: Mepact; Romania: Mepact; Slovakia: Mepact; Slovenia: Mepact; Sweden: Mepact; UK: Mepact.

Drug combinations


Mifamurtide: C~59~H~109~N~6~O~19~P. Mw: 1237.50 (1) Muramyl tripeptide phosphatidylethanolamine (MTP-PE); (2) [(2R)-3-[2-[[(2S)-2-[[(4R)-4-[[(2S)-2-[[(2R)-2-[(2R,3R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxypropanoyl]amino]propanoyl]amino]-5-amino-5-oxopentanoyl]amino]propanoyl]amino]ethoxy-hydroxyphosphoryl]oxy-2-hexadecanoyloxypropyl] hexadecanoate. CAS-83461-56-7.

Pharmacologic Category

Other Miscellaneous Therapeutic Agents. Other Cytokines and Immunomodulators; Synthetic Derivative of Muramyl Dipeptide (MDP). (ATC-Code: L03AX15).

Mechanism of action

MTP-PE is a specific ligand of NOD~2~, a receptor found primarily on monocytes, dendritic cells and macrophages. MTP-PE is a potent activator of monocytes and macrophages. Activation of human macrophages by MTP-PE is associated with production of cytokines, including tumor necrosis factor (TNF~α~), interleukin-1 (IL-1~β~), IL-6, IL-8, and IL-12 and adhesion molecules, including lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). In vitro-treated human monocytes killed allogeneic and autologous tumor cells (including melanoma, ovarian, colon, and renal carcinoma), but had no toxicity towards normal cells. In vivo administration of MTP-PE resulted in the inhibition of tumor growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma. Significant enhancement of disease-free survival was also demonstrated in the treatment of dog osteosarcoma and hemangiosarcoma with MTP-PE as adjuvant therapy. The exact mechanism by which MTP-PE activation of monocytes and macrophages leads to antitumor activity in animals and humans is not yet known.

Therapeutic use

Indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with post-operative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.

Pregnancy and lactiation implications

Should not be used during pregnancy or in women not using effective contraception. Not recommended during lactation.

Unlabeled use


Hypersensitivity to the active substance or to any of the excipients. Concurrent use with cyclosporine or other calcineurin inhibitors. Concurrent use with high-dose non-steroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase inhibitors.

Warnings and precautions

Mild-to-moderate respiratory distress associated with the treatment has been reported in two patients with pre-existing asthma (if a severe respiratory reaction occurs, treatment should be discontinued and appropriate treatment initiated). Commonly associated with transient neutropenia, usually when used in conjunction with chemotherapy (episodes of neutropenic fever should be monitored and managed appropriately). Caution in patients with history of autoimmune, inflammatory or other collagen diseases (patients should be monitored for unusual signs or symptoms, such as arthritis or synovitis, suggestive of uncontrolled inflammatory reactions). Patients with history of venous thrombosis, vasculitis or unstable cardiovascular disorders should be closely monitored during mifamurtide administration (if symptoms are persistent and worsening, administration should be delayed or discontinued). Occasional allergic reactions have occurred. Nausea, vomiting and loss of appetite are very common adverse reactions.



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