TM Owner Esteve
Mepact 4mg Powder for Suspension for Infusion
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Indications & Clinical Uses
- Mepact (mifamurtide) 4 mg per vial is an immunostimulant, made by Esteve (Spain), used in combination with post-operative multi-agent chemotherapy to treat high-grade resectable non-metastatic osteosarcoma (a type of bone cancer) after surgical removal of the primary tumour, in patients aged 2 to 30 years at initial diagnosis.
- It is authorised in the European Union and is not approved in the United States.
- Mepact is a specialist hospital-only medicine, prepared and given exclusively by, or under the supervision of, a healthcare provider experienced in treating osteosarcoma.
- The dose is calculated by body surface area and given twice weekly for 12 weeks, then once weekly for a further 24 weeks, alongside the chemotherapy regimen; it has not been studied as a treatment on its own.
Side Effects
- Mepact does not carry an EU boxed warning, but infusion-related reactions are very common: more than 1 in 10 patients experience chills or rigors, fever, fatigue, headache, nausea, vomiting, tachycardia, high or low blood pressure, breathlessness, and pain in muscles, joints, back or limbs, typically during or shortly after the infusion.
- Anaemia and loss of appetite are also very common.
- These reactions usually respond to supportive treatment such as antipyretics.
- Seek urgent medical attention for severe breathing difficulty, chest pain, marked swelling, or signs of a severe allergic reaction.
- Because most reactions cluster around the infusion, patients are monitored closely by hospital staff throughout each dose and for a period afterward.
Precautions & Warnings
- Mepact must not be used in patients with known hypersensitivity to mifamurtide or its components, and it must be given only as a slow intravenous infusion over about one hour, never as a bolus injection or by any other route.
- It should not be used together with ciclosporin, other calcineurin inhibitors, or high-dose non-steroidal anti-inflammatory drugs, because of a theoretical risk of reducing the drug's effect on macrophages.
- Caution is advised in patients with a history of autoimmune, chronic inflammatory, or thromboembolic/vasculitic disease, and in those with impaired cardiac or respiratory function, since infusion-related reactions can affect these systems.
- There is limited data in pregnancy and breastfeeding, so Mepact should be used in these situations only if clearly needed, and effective contraception is advised during treatment.
Avoid Interactions
- Tell the treating team about all other medicines being used, because Mepact must not be given together with ciclosporin or other calcineurin inhibitors, or with high-dose NSAIDs, as these may blunt the macrophage-activating effect that makes Mepact work.
- Because chemotherapy is given alongside Mepact as part of the treatment protocol, the hospital team sequences doses carefully and monitors for combined toxicity, particularly effects on blood counts, kidney and liver function.
- No formal interaction studies have been performed with other agents, so any new medicine, including over-the-counter painkillers, should be checked with the oncology team before use.
- There are no specific food or alcohol restrictions described in the label, but patients should follow all instructions given by the treating hospital.
References
Frequently Asked Questions
Mepact (mifamurtide) treats high-grade osteosarcoma, a type of bone cancer, after surgery to remove the tumour. It is given alongside chemotherapy in patients aged 2 to 30 years at diagnosis. Mepact is authorised in the European Union as part of this combined treatment plan, not as a standalone medicine.
A hospital team gives Mepact as a slow intravenous infusion lasting about one hour, never as a fast injection. The dose is based on body surface area, given twice a week for 12 weeks, then once a week for another 24 weeks, alongside chemotherapy.
Very common effects, in more than 1 in 10 patients, include chills, fever, fatigue, headache, nausea, fast heartbeat, low or high blood pressure, breathlessness and joint or muscle pain, usually around the time of infusion. Seek urgent help for severe breathing difficulty or chest pain.
Do not take ciclosporin, other calcineurin inhibitors, or high-dose NSAID painkillers during Mepact treatment, as these may blunt its effect on the immune cells that fight the cancer. Tell the oncology team about every medicine you use, including over-the-counter painkillers and supplements, before each infusion cycle.
Each Mepact dose is infused slowly into a vein over about one hour in hospital. Fever, chills and flu-like symptoms are common during or shortly after the infusion and usually settle with supportive treatment. Staff monitor your temperature, heart rate and breathing throughout and afterward.
No. Mepact must always be given as a slow intravenous infusion over about one hour; it must never be given as a bolus (fast push) injection. It is also only used together with chemotherapy after osteosarcoma surgery, not as a treatment on its own.
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