CellCept

CellCept 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.

The CHMP decided that CellCept’s benefits are greater than its risks and recommended that it be given marketing authorisation.

The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer. The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick). For the full list of side effects reported with CellCept, see the package leaflet.

It has been shown that there is a significant risk of harm to a developing baby and of miscarriage if CellCept is used in pregnancy. Therefore, CellCept must not be used during pregnancy unless there is no suitable alternative to prevent rejection of the transplant. Women able to have children should be tested before starting treatment to ensure that they are not pregnant. Both men and women must use highly effective contraception before, during and for a suitable period after CellCept treatment. Women must not breastfeed while using CellCept and patients should not donate blood or sperm during treatment or for a period afterwards. For full details of the restrictions with CellCept, see the package leaflet.

CellCept is a medicine containing the active substance mycophenolate mofetil. It is available as capsules (250 mg), tablets (500 mg), a powder to be made up into an oral suspension (1 g / 5 ml) and a powder to be made up into a solution for infusion (drip) into a vein (500 mg).

CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant. CellCept was compared with azathioprine (another anti-rejection medicine) in all studies except for one of the kidney transplant studies, in which it was compared with placebo (a dummy treatment). A further study looked at the effect of CellCept oral suspension in 100 children following a kidney transplant. In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.

Further studies showed that the solution for infusion and the oral suspension produced similar levels of the active substance in the blood as the capsules.

CellCept can only be obtained with a prescription. Treatment should be started and supervised by a doctor specialised in organ transplants.

CellCept is available as capsules, tablets or a powder to be made up into a liquid to be taken by mouth; in adults it can also be given by injection (drip) into a vein. How CellCept is given depends on the type of organ transplant. In children and adolescents, CellCept is only taken by mouth.

For more information about using CellCept, see the package leaflet or contact your doctor or pharmacist.

The active substance in CellCept, mycophenolate mofetil, is an immunosuppressant (a medicine that reduces the activity of the immune system). It is converted in the body into mycophenolic acid, which blocks 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 involved in the rejection of organ transplants). By preventing the production of new DNA, CellCept 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.

Treatment with CellCept was shown to be effective at preventing the rejection of a newly transplanted kidney, heart or liver in adults and children from 1 year of age.

In all studies, CellCept was given with ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ was rejected within six months of receiving the transplant. In most studies, CellCept was compared with azathioprine (another medicine to prevent transplant rejection) or placebo (a dummy treatment).

Kidney transplant

Three main studies involved a total of 1,493 adults who had received a kidney transplant. CellCept was as effective as azathioprine and more effective than placebo in preventing rejection of the new kidney in the first 6 months after transplantation.

A fourth study looked at the effects of CellCept in 100 children who had received a kidney transplant. This study did not compare CellCept with any other medicine or placebo. The proportion of children whose new kidney was rejected was similar to that seen in adults and lower than that seen in other studies of children who underwent a kidney transplant but did not receive CellCept.

Heart transplant

A main study involved 650 adults who had undergone a heart transplant. In the first 6 months after the transplant, the new heart was rejected in 37% of patients taking CellCept, compared with 38% of patients taking azathioprine.

Liver transplant

A main study involved 565 adults who had undergone a liver transplant. In the first 6 months after the transplant, the new liver was rejected in around 38% of patients taking CellCept, compared with around 48% of patients taking azathioprine. The proportion of patients whose new liver was lost after one year was similar in the two groups, at around 4%.

Use in children

The company provided data showing that CellCept behaves in the body in the same way across all age groups from 1 to 18 years of age. It is therefore expected to be effective in preventing rejection following a kidney, heart or liver transplant in these children. This is supported by data from the medical literature on the use of CellCept in children and adolescents.

The company that markets CellCept will provide educational materials for patients and healthcare professionals, explaining the risk of serious harm to a developing baby, the precautions to be taken to avoid pregnancy during treatment and the course of action if a woman becomes pregnant during treatment. The materials will also inform patients not to donate blood during treatment or for at least 6 weeks after, and men not to donate semen during, or for at least 3 months after, treatment.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of CellCept have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of CellCept are continuously monitored. Suspected side effects reported with CellCept are carefully evaluated and any necessary action taken to protect patients.

CellCept received a marketing authorisation valid throughout the EU on 14 February 1996.

For the full list of side effects and restrictions with CellCept, see the package leaflet.

The most common side effects with CellCept combined with ciclosporin (which may affect more than 1 in 10 people) include diarrhoea, leucopenia, bacterial infections and vomiting.

Using CellCept during pregnancy can cause miscarriage and serious harm to a developing baby. Therefore, CellCept must not be used by women who are pregnant unless no other suitable treatment option is available to prevent rejection of the transplant. Women able to have children must take a pregnancy test before starting treatment to confirm that they are not pregnant. Both women and men should use an effective form of contraception before and during treatment with CellCept and for at least 6 weeks after. CellCept must not be used by women who are breastfeeding.

Treatment with CellCept in combination with ciclosporin and corticosteroids is effective at preventing the rejection of a newly transplanted kidney, heart or liver in adults and children from 1 year of age.

The most serious risks with CellCept are the possible development of cancer (particularly lymphoma and skin cancer), infections (including serious infections), and serious harm to a developing baby. Considering the measures in place to minimise these risks and what the medicine is used for, the safety profile of CellCept is considered acceptable.

The European Medicines Agency therefore decided that CellCept’s benefits are greater than its risks and it can be authorised for use in the EU.