CellCept (Mycophenolate Mofetil)

Warnings & Precautions

Embryofetal toxicity: use during pregnancy causes first-trimester pregnancy loss and congenital malformations. This carries a boxed warning, and pregnancy must be excluded before starting.
Increased risk of lymphoma and other malignancies, particularly of the skin. This carries a boxed warning.
Increased susceptibility to serious infection, including opportunistic infection, sepsis, and progressive multifocal leukoencephalopathy. This carries a boxed warning.
CMV reactivation, BK virus-associated nephropathy and hepatitis B or C reactivation have been reported.
Blood dyscrasias, including neutropenia and pure red cell aplasia, can occur.

Common Side Effects

The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.

Pregnancy & Lactation

Pregnancy: Contraindicated. Use causes first-trimester pregnancy loss and congenital malformations, including of the external ear, face, heart, oesophagus and kidney. Females of reproductive potential must use effective contraception before, during, and for 6 weeks after therapy.

Lactation: Unknown whether it is present in human milk; because of the potential for serious adverse reactions, advise against breastfeeding.

Pediatric Use

Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants.