CellCept

by William Berquist, MD

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What is CellCept?

One of the new drugs approved by the FDA in 1995 was CellCept (Roche Laboratories), also known as mycophenolate mofetil. CellCept is an oral agent used for the prevention of organ rejection in patients receiving kidney transplants. It prevents rejection by interfering with the production of certain white blood cells which cause rejection. Multi-center studies have shown CellCept to be more effective than azathioprine (Imuran) when used with cyclosporine in kidney transplant patients (Lancet, 345:1321, May 25, 1995).

There are other studies in animals and in humans which demonstrate that CellCept prevents rejection in other organ transplants, including pancreas, heart, and liver. There was an adult series that demonstrated a decrease in initial liver transplant rejection on CellCept and cyclosporine or tacrolimus (Prograf) when prednisone is discontinued within two weeks after transplantation. Comparison control patients were on cyclosporine and prednisone (Stegall MD, et al, 1995-1996 ASTS Meetings). I did not find any information on CellCept in children other than studies on the drug levels and treatment of rejection in kidney transplant children.

CellCept may be taken with food and is broken down in the liver to a chemical form which is excreted in the urine. The capsules come in 250 mg size and the usual dose for adults is 1-1.5 g (4-6 capsules) twice a day. The dose for children is 15 mg/kg/day. The cost for a pharmacist is $450 for a month’s supply for an adult, compared to $100 for Imuran.

Adverse effects of CellCept compared to Imuran are a slight increase in reported episodes of diarrhea and lowered white blood cell counts. There are also more reported tissue-invasive infections of cytomegalovirus and an increased incidence of lymphoma (1%) in patients receiving CellCept.

Drugs which can affect the levels of active CellCept are antacids and cholestyramine (Questran).

In summary, CellCept appears to be a useful drug for preventing rejection without causing many bad side effects; however, there have not enough liver transplant patients treated with CellCept to make any firm conclusions. More clinical trials are needed in children and adult liver transplant recipients. In our liver transplant program, at Lucile Salter Packard Children's Hospital, less than 5% of children receive CellCept. We have generally used it to treat rejection when management with standard drug combinations has failed. In other words, since we don’t really know everything we would like to know about CellCept, we only use it when we feel the child has very little to lose.

Dr. Berquist is Chief, Gastroenterology and Liver Transplantation at Lucile Salter Packard Children's Hospital at Stanford University and Chairman of the C.L.A.S.S. Scientific Advisory Committee.

References used for this topic include the drug insert and The Medical Letter, Volume 37 (Issue 958) September 29, 1995.