Rapamune

What is it?

An immunosuppressant preparation available as film-coated, triangular, white tablets containing 1mg of sirolimus marked with strength and name. Also, RAPAMUNE ORAL SOLUTION, containing 1mg of sirolimus per ml.

Medical Uses

Prevention of organ rejection in patients who have received a kidney transplant. For use with corticosteroids and cyclosporin microemulsion for 2 to 3 months. Then, if cyclosporin can be gradually discontinued, maintenance can proceed with corticosteroids alone.

Dosage

Adults, 6mg as loading dose as soon as possible after transplant then 2mg once each day for 2 to 3 months. Individual treatment is worked out according to blood levels and to optimise corticosteroids and cyclosporin microemulsion. Maintenance according to response; withdraw if cyclosporin cannot be stopped.

Special Care

Black patients, elderly persons, liver disorders, risk of skin cancer and elevated blood lipid levels. For specialist use only. Patients require blood monitoring and checks on kidney function. Women must use effec tive contraception during treatment and for 3 months afterwards.

Avoid Use

Children, pregnancy, breastfeeding, patients at high immunological risk.

Possible Drug and Food Interactions

Drugs affecting kidney function, live vaccines, inducers and inhibitors of CYP3A4, multidrug efflux pump P-glycoprotein. Grapefruit juice.

Known Side Effects

Infections, blood changes, gastrointestinal upset, skin reactions, fluid retention, effects on bones, joint pains, abnormal healing, rapid heartbeat, lymphocele, urinary tract infections, metabolic and nutritional disorders, liver toxicity, nosebleeds, pancytopenia (abnormal decline in all blood cells), increased risk of malignancies such as lymphoma. Any adverse side effects must be reported to the Committee on the Safety of Medicines (CSM).