• Non-metastatic, high-grade osteosarcoma following surgical resection
  • Used in combination with postoperative multi-agent chemotherapy

Dosage:

  • 2 mg/m² intravenously, twice weekly for the first 12 weeks, then once weekly for an additional 24 weeks
  • Total duration: 36 weeks (48 doses)

Dosage is based on body surface area (BSA)

  • Lyophilized powder for IV infusion
    • Each vial contains 4 mg of mifamurtide
  • Administered via IV infusion over 1 hour
  • Infusion should be started immediately after preparation
  • Premedication with acetaminophen or NSAIDs may be considered to reduce fever and chills
  • Class: Immunomodulator / Macrophage activator
  • Mechanism of Action:
    Mifamurtide activates monocytes and macrophages, stimulating production of cytokines (e.g., TNF-α, interleukins) that help destroy tumor cells, particularly osteosarcoma cells.
  • Half-life: ~2 hours
  • Metabolism: Not well characterized; rapidly cleared from plasma
  • Excretion: Likely via hepatic and renal mechanisms
  • Fever, chills
  • Fatigue
  • Nausea, vomiting
  • Headache
  • Tachycardia
  • Back or joint pain
  • Hypersensitivity to mifamurtide or any component of the formulation
  • Concurrent use with cyclosporine or other immunosuppressants
  • Not to be used in patients with autoimmune disease or those receiving high-dose corticosteroids
  • Immunosuppressants (e.g., cyclosporine, tacrolimus): ↓ efficacy of mifamurtide
  • Corticosteroids: may interfere with immune activation; avoid concurrent high-dose use
  • No known CYP450 interactions

                                   Drug Status

Availability
Pregnancy
Breastfeeding
Schedule
BRAND NAME STRENGTH FORMULATION PACK SIZE MANUFACTURER DISTRIBUTOR
Mepact 4mg Injection 1’s Takeda France Phillips Therapeutics