Myfenax

mycophenolate mofetil

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Myfenax?

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

Myfenax is a ‘generic medicine’. This means that Myfenax is similar to a ‘reference medicine’ already authorised in the European Union (EU) called CellCept.

What is Myfenax used for?

Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver. 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?

Myfenax treatment should be initiated and maintained by a qualified transplant specialist.

The way that Myfenax should be given and the dose depend on the type of organ transplant and the patient’s age and size.

For kidney transplants, the recommended dose in adults is 1.0 g twice a day starting within 72 hours after the transplant. In children aged between two and 18 years, the dose of Myfenax is calculated depending on height and weight.

For heart transplants, the recommended adult dose is 1.5 g twice a day, starting within five days following the transplant.

For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated. Myfenax is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.

The dose may need to be adjusted in patients with liver or kidney disease. For more information, see the summary of product characteristics (also part of the EPAR).

How does Myfenax work?

The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine. In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase’. This enzyme is important for the formation of DNA in cells, particularly in the lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants). By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply. This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.

How has Myfenax been studied?

Because Myfenax is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (they produce the same levels of the active substance in the body).

What are the benefit and risk of Myfenax?

Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.

Why has Myfenax been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept. Therefore, the CHMP’s view was that, as for CellCept, the benefit outweighs the identified risk. The Committee recommended that Myfenax be given marketing authorisation.

Other information about Myfenax

The European Commission granted a marketing authorisation valid throughout the EU for Myfenax to Teva Pharma B.V. on 21 February 2008.

This EPAR was last updated on 17/04/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

16/03/2012  Myfenax -EMEA/H/C/000884 -IAIN/0014

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Immunosuppressants

Therapeutic indication

Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents