Cycopin Mycophenolate Mofetil Dispersible 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.
Treatment of Refractory Rejection: Treatment of refractory rejection in renal, cardiac, or hepatic transplantation.
2. Dosage and Administration
Standard Regimen: The recommended adult dose for renal transplantation is 1 g administered orally twice daily. For refractory rejection, the recommended dose is 1.5 g administered orally twice daily.
Administration: The dispersible tablets can be swallowed whole or dispersed in water (typically 2-5 mL) before administration. They can be taken with or without food, although fasting is generally recommended for stable absorption.
Dose Adjustments: If neutropenia occurs (absolute neutrophil count < 1.3 × 10³/µL), therapy should be interrupted or the dose reduced. Dose adjustments may also be necessary in patients with severe renal impairment (GFR < 25 mL/min/1.73 m²).
3. Mechanism of Action
Prodrug Conversion: Mycophenolate mofetil 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 efficacy in refractory rejection.
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.
Cholestyramine: Can decrease the bioavailability of MPA.
7. Pharmaceutical Information
Active Ingredient: Mycophenolate Mofetil.
Appearance: White or off-white tablets.
Storage: Store at room temperature in a tight container to protect from moisture.