CellCept Mycophenolate Mofetil Tablets

1. Indications and Usage
Prophylaxis of Organ Rejection: Treatment to prevent rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants, in combination with cyclosporine and corticosteroids.
Lupus Nephritis: Treatment of active lupus nephritis (World Health Organization classes III through V) in adults.
2. Dosage and Administration
Renal Transplantation: The recommended adult dose is 1 g administered orally twice daily.
Lupus Nephritis: The recommended adult dose is 1 g administered orally twice daily.
Administration: Should be taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
3. Mechanism of Action
Prodrug Conversion: Mycophenolate mofetil is an ester prodrug that is rapidly hydrolyzed in vivo to its active metabolite, mycophenolic acid (MPA).
IMPDH Inhibition: MPA selectively and non-competitively inhibits inosine monophosphate (IMP) dehydrogenase.
Lymphocyte Proliferation: This inhibition blocks the de novo pathway of guanosine nucleotide synthesis, thereby selectively inhibiting T and B lymphocyte proliferation.
4. Safety and Warnings
Infection and Malignancy: May increase the risk of opportunistic infections (e.g., CMV) and malignancies, including lymphoma and skin cancer.
Embryo-Fetal Toxicity: The drug is contraindicated in pregnancy due to high risks of miscarriage and congenital malformations.
Gastrointestinal Disorders: Severe diarrhea, colitis, or gastrointestinal bleeding may occur and require dose adjustment or discontinuation.
Bone Marrow Suppression: Myelosuppression, particularly leukopenia, may require dose interruption.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Gastrointestinal effects (diarrhea, nausea, vomiting), bone marrow suppression, opportunistic infections, and tumor induction.
Clinical Research: Clinical trials have demonstrated significant improvements in graft survival rates in renal transplantation and remission induction in lupus nephritis.
6. Drug Interactions
Nephrotoxic Drugs: Concomitant use with cyclosporine or tacrolimus may alter pharmacokinetics and requires careful monitoring.
Antacids: Antacids containing magnesium or aluminum may decrease the absorption of mycophenolate mofetil.
Antivirals: Drugs like acyclovir or ganciclovir may compete for renal excretion, leading to increased plasma concentrations of both drugs.
7. Pharmaceutical Information
Active Ingredient: Mycophenolate Mofetil.
Appearance: White to off-white tablets.
Storage: Store at room temperature, preferably in a tight container to protect from moisture.