Mepact
Active
Substance: mifamurtide
Common Name: mifamurtide
ATC Code: L03AX15
Marketing Authorisation Holder: Takeda France SAS
Active Substance: mifamurtide
Status: Authorised
Authorisation Date: 2009-03-06
Therapeutic Area: Osteosarcoma
Pharmacotherapeutic Group: Immunostimulants
Therapeutic
Indication
Mepact is
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 postoperative
multi-agent chemotherapy. Safety and efficacy have been assessed in studies of
patients two to 30 years of age at initial diagnosis.
What is Mepact?
Mepact is a
powder that is made up into a suspension for infusion (drip into a vein). It
contains the active substance mifamurtide.
What is Mepact
used for?
Mepact is used
to treat high-grade non-metastatic osteosarcoma (a type of bone cancer) in
patients aged between two and 30 years. ‘High-grade’ means that the cancer is
of a severe type, and ‘non-metastatic’ means that it is at an early stage and
has not spread far within the body. Mepact is used with other anticancer
medicines after the cancer has been removed by surgery.
Because the
number of patients with osteosarcoma is low, the disease is considered ‘rare’,
and Mepact was designated an ‘orphan medicine’ (a medicine used in rare
diseases) on 21 June 2004.
The medicine can
only be obtained with a prescription.
How is Mepact
used?
Mepact treatment
should be started and supervised by a specialised doctor who has experience in
diagnosing and treating osteosarcoma.
The dose of
Mepact depends on the patient’s height and weight. It should be given twice a
week for 12 weeks, and then once a week for 24 weeks. Mepact is given as a slow
infusion lasting an hour. It must not be given as a bolus injection (all at
once).
How does Mepact
work?
The active
substance in Mepact, mifamurtide, is an immunomodulator. It works by activating
macrophages and monocytes (types of white blood cell that form part of the
immune system). The precise way that mifamurtide works in osteosarcoma is not
fully understood, but it is thought to cause the white blood cells to release
chemicals that kill the cancerous cells.
How has Mepact
been studied?
Mepact has been
studied in one main study involving 678 patients aged between one and 31 years
with high-grade non-metastatic osteosarcoma. After surgery to remove the
cancer, all of the patients were given various combinations of anticancer
medicines. Half of the patients were also given Mepact. The study compared
patients who were given Mepact with those who were not. The main measure of
effectiveness was the number of patients who survived without the disease
coming back. The patients were followed up for up to 10 years.
What benefit has
Mepact shown during the studies?
Mepact, used
with other anticancer medicines, increased how long patients survived without
their disease coming back: 68% of the patients receiving Mepact (231 out of
338) survived without the disease coming back, compared with 61% of the
patients who did not receive it (207 out of 340). The risk of dying was also
reduced by 28% in patients receiving Mepact.
What is the risk
associated with Mepact?
The most common
side effects with Mepact (seen in more than 1 patient in 10) are anaemia (low
red-blood-cell counts), loss of appetite, headache, dizziness, tachycardia
(rapid heartbeat), hypertension (high blood pressure), hypotension (low blood
pressure), dyspnoea (difficulty breathing), tachypnoea (rapid breathing),
cough, vomiting, diarrhoea, constipation, abdominal pain (stomach ache),
nausea, hyperhidrosis (excessive sweating), myalgia (muscle pain), arthralgia
(joint pain), back pain, pain in extremity (the arms and legs), fever, chills,
fatigue (tiredness), hypothermia (low body temperature), general pain, malaise (feeling
unwell), asthenia (weakness) and chest pain. For the full list of all side
effects reported with Mepact, see the package leaflet.
Mepact should
not be used in people who may be hypersensitive (allergic) to mifamurtide or
any of the other ingredients. It must not be used at the same time as
ciclosporin or other calcineurin inhibitors (medicines that reduce the activity
of the immune system), or high doses of non-steroidal anti-inflammatory drugs
(NSAIDs; used to treat pain and inflammation).
Why has Mepact
been approved?
The CHMP decided
that Mepact’s benefits are greater than its risks when used with other
anticancer medicines and recommended that it be given marketing authorisation.
Other
information about Mepact
The European
Commission granted a marketing authorisation valid throughout the European
Union for Mepact on 6 March 2009. The marketing authorisation is valid for five
years, after which it can be renewed.
For more
information about treatment with Mepact, read the package leaflet (also part of
the EPAR) or contact your doctor or pharmacist.
Source: European
Medicines Agency
