What is CellCept?
CellCept is a drug containing the active substance mycophenolate mofetil. It is available as capsules (250 mg), tablets (500 mg), powder for oral suspension (1 g / 5 ml) and powder for solution for infusion (drip into a vein: 500 mg).
What is CellCept used for?
CellCept is used to prevent the rejection of a kidney, heart or liver transplanted by the body. It is given in combination with ciclosporin and corticosteroids (other drugs indicated for the prevention of organ rejection).
The medicine can only be obtained with a prescription.
How is CellCept used?
Treatment with CellCept should be started and continued by a suitably qualified transplant specialist.
The method of administration and the dose of CellCept depend on the type of organ transplanted and on the age, height and weight of the patient.
In the case of a renal transplant, the recommended dose in adults is 1.0 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 after the transplant. CellCept can also be administered as an infusion over two hours, within 24 hours after the operation and for a period not exceeding 14 days. In children and adolescents aged 2 to 18 years, the dose of CellCept is calculated based on height and weight and should be administered orally.
In the case of a heart transplant, the recommended dose in adults is 1.5 g twice a day by mouth, given within five days of transplantation.
Finally, in the case of hepatic transplantation in adults, CellCept should be administered as an infusion of 1.0 g twice a day for the first four days after transplantation. Subsequently, as soon as it can be tolerated, it is passed to the oral administration of 1.5 g twice a day. The use of CellCept is not recommended in children after a heart or liver transplant, because there is no information on the effects of the product in this group of patients.
In patients with liver or kidney problems it may be necessary to adjust the dose. For more information, see the summary of product characteristics, also included with the EPAR.
How does CellCept work?
The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive drug. In the body, CellCept is transformed into mycophenolic acid, which blocks an enzyme called "inosine-monophosphate-dehydrogenase". This enzyme is important for the formation of DNA in cells, especially 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 speed of lymphocyte proliferation. In this way the drug limits the ability of these cells to recognize and attack the transplanted organ and decreases the risk of organ rejection.
What studies have been carried out on CellCept?
CellCept capsules and tablets were examined in three studies involving a total of 1 493 adults undergoing kidney transplantation, a study conducted on 650 adults after a heart transplant and a study carried out on 565 transplanted adults of liver. The efficacy of CellCept was compared with that of azathioprine (another anti-rejection drug) in all studies, except for one renal transplant study, in which it was compared with placebo (a dummy treatment). Another study examined the efficacy of CellCept oral suspension in 100 children undergoing kidney transplantation. Cyclosporin and corticosteroids were also administered to all patients during all the studies performed; the main measure of effectiveness was the percentage of patients in whom, after six months, the transplanted organ had been rejected.
Further studies have shown that the infusion solution and oral suspension produce similar concentrations of the active ingredient in the blood compared to the capsules.
What benefit has CellCept shown during the studies?
CellCept was as effective as azathioprine and more effective than placebo in preventing rejection of kidney transplants six months after surgery. In children undergoing kidney transplantation the observed rejection rates were similar to those recorded in adults treated with CellCept and lower than those found in other studies carried out on children who had not received CellCept.
In the heart transplantation study, approximately 38% of patients treated with CellCept and those treated with azathioprine had rejection after six months. After liver transplantation, the new organ was rejected at six months, 38% of patients treated with CellCept compared to 48% of subjects treated with azathioprine, while the percentage of patients who had lost their new liver one year after transplantation it was similar in both groups (about 4%).
What is the risk associated with CellCept?
The most serious risk associated with CellCept is the possible development of cancer, especially lymphomas and skin cancers. The most common adverse events observed with CellCept administered in combination with ciclosporin and corticosteroids (seen in more than 1 in 10 patients) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or intestines), infection of urinary tract (infection of the structures responsible for the passage of urine), herpes simplex (a viral infection producing sores or vesicles), herpes zoster (an infection with the virus responsible for chickenpox and shingles), leukopenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets), anemia (reduction in the number of red blood cells), vomiting, abdominal pain, diarrhea and nausea. For the complete list of side effects reported with CellCept, see the package leaflet.
CellCept should not be used in people who may be hypersensitive (allergic) to mycophenolate mofetil or mycophenolic acid. The medicine should not be used during breast-feeding. CellCept therapy is contraindicated in pregnant women. Before starting treatment, make sure that the pregnancy test is negative. In addition, effective contraception should be used prior to the start of therapy, for its entire duration and for six weeks after discontinuation.
Why has CellCept been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of CellCept outweigh its risks in combination with ciclosporin and corticosteroids for the prophylaxis of acute rejection in patients receiving renal, cardiac or hepatic allograft. The Committee therefore recommended that CellCept be given marketing authorization.
More information on CellCept
On 14 February 1996, the European Commission granted a marketing authorization valid for CellCept, valid throughout the European Union, to Roche Registration Limited. The marketing authorization was renewed on February 14, 2001 and February 14, 2006.
For the complete evaluation (EPAR) of CellCept, click here.
Last update of this summary: 02-2008.
