drugs

Myfenax - mycophenolate mofetil

What is Myfenax?

Myfenax is a medicine that contains the active substance mycophenolate mofetil. It is available as capsules (250 mg) and tablets (500 mg).

Myfenax is a "generic medicine", which means that it is similar to a "reference medicine" already authorized in the European Union (EU) called CellCept. For more information on generic medicines, see the questions and answers by clicking here.

What is Myfenax used for?

Myfenax is used to prevent the rejection of a kidney, heart or liver transplant by the body. it is used with ciclosporin and corticosteroids (other medicines used to prevent organ rejection).

The medicine can only be obtained with a prescription.

How is Myfenax used?

Treatment with Myfenax should be started and continued by appropriately qualified transplant specialists.

The way in which Myfenax should be administered and the dose depend on the type of organ transplanted, as well as the age and build of the patient.

For kidney transplants, the recommended dose in adults is 1.0 g twice a day within the first 72 hours after transplantation. In children and adolescents aged 2 to 18 years, the dose of Myfenax is calculated according to height and weight.

For transplants, the recommended dose in adults is 1.5 g twice a day, starting within the first five days after the transplant.

For liver transplants in adults, mycophenolate mofetil should be administered intravenously (drip into a vein) for the first four days after transplantation, then switched to 1.5 g of Myfenax twice a day when it can be tolerated. The use of Myfenax is not recommended in children and adolescents after a cardiac or hepatic transplant, due to the lack of information on its effects on this group of patients.

In patients with kidney or liver disease it may be necessary to adjust the dose. For more information, see the summary of product characteristics, also included with the EPAR.

How does Myfenax work?

The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine. In the body it is transformed into mycophenolic acid which inhibits an enzyme called "inosine monophosphate dehydrogenase". This enzyme is important for the formation of DNA in cells, particularly in lymphocytes (a type of white blood cell that contributes to the rejection of transplanted organs). By inhibiting the production of new DNA, Myfenax reduces the speed of replication of the lymphocytes, therefore the effectiveness of the latter in recognizing and attacking the transplanted organ, with consequent lower risk of rejection of the same.

How has Myfenax been studied?

Since Myfenax is a generic medicine, the studies have limited itself to demonstrating that the drug is bioequivalent to the reference drug (they produce the same amounts of active substance in the body).

What are the risks and benefits associated with Myfenax?

Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are assumed to be the same as the latter.

Why has Myfenax been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the requirements in the EU, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept. The CHMP is therefore of the opinion that, as in the case of CellCept, the benefits outweigh the identified risks. The committee recommended the granting of the marketing authorization for Myfenax.

More information on Myfenax:

The European Commission granted a marketing authorization valid throughout the European Union for Myfenax to Teva Pharma BV on 21 February 2008.

The full EPAR for Myfenax can be found here.

The full EPAR of the reference drug can also be consulted on the EMEA website.

Last update of this summary: 01-2008.