Mycophenolate Mofetil acts by blocking purine synthesis in human lymphocytes through the reversible inhibition of inosine monophosphate dehydrogenase. It also inhibits the proliferation of both T and B lymphocytes. The mean absolute bioavailability of oral Mycophenolate Mofetil relative to intravenous administration is 94%. Orally administered radiolabeled Mycophenolate Mofetil resulted in complete recovery of the administered dose, with 93% excreted in urine and 6% in feces.
Mycophenolate Mofetil is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It should be used concomitantly with other immunosuppressants.
Renal Transplantation: In adults, a dose of 1 g orally twice a day (daily dose of 2 g) is recommended, starting within 72 hours of transplantation. Although a 1.5 g dose twice daily (daily dose of 3 g) was used in clinical trials and found to be safe and effective.
Cardiac Transplantation: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for adult cardiac transplant patients.
Hepatic Transplantation: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for adult hepatic transplant patients.
In renal transplant patients with severe chronic renal impairment (GFR < 25 mL/min/1.73 m²), doses greater than 1 g twice daily should be avoided. These patients should be carefully observed. No dosage adjustments are needed for renal transplant patients experiencing delayed graft function postoperatively.
Mycophenolate Mofetil is contraindicated in patients with hypersensitivity to Mycophenolate Mofetil, mycophenolic acid, or any component of the drug product.
Patients receiving immunosuppressive regimens involving combinations of drugs, including Mycophenolate Mofetil, are at an increased risk of developing lymphomas and other malignancies, particularly skin cancer. Over-suppression of the immune system can also increase susceptibility to opportunistic infections, fatal infections, and sepsis.
In pediatric patients, no malignancies other than lymphoproliferative disorders have been observed.
The principal adverse reactions associated with Mycophenolate Mofetil include diarrhea, leukopenia, anemia, abdominal pain, headache, sepsis, and vomiting. There is also evidence of a higher frequency of certain types of infections, such as opportunistic infections.
The use of Mycophenolate Mofetil during pregnancy is associated with an increased risk of first-trimester pregnancy loss and an increased risk of congenital malformations. It is unknown whether this drug is excreted in human milk.
For pediatric patients after renal transplantation, the recommended dose of Mycophenolate Mofetil is 600 mg/m² twice daily. Safety and effectiveness in pediatric patients receiving allogeneic cardiac or hepatic transplants have not been established.
In geriatric patients, dose selection should be cautious, considering the greater frequency of decreased hepatic, renal, or cardiac function and the likelihood of concomitant drug therapy. Elderly patients may be at an increased risk of adverse reactions compared to younger individuals.
Increased plasma concentration when co-administered with acyclovir and ganciclovir.
Reduced absorption when taken with antacids and cholestyramine.
Experience with Mycophenolate Mofetil overdose in humans is limited. The highest dose administered to renal transplant patients in clinical trials was 4 g/day. At this dose, there was a higher incidence of nausea, vomiting, and/or diarrhea.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
