Mycophenolate sodium is an enteric-coated formulation of mycophenolic acid (MPA), a potent, selective, non-competitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). It is an immunosuppressive agent used primarily to prevent acute organ rejection in adult patients receiving allogeneic renal, cardiac, or hepatic transplants. The 360mg enteric-coated tablet is bioequivalent to 500mg of mycophenolate mofetil (MMF), offering a gastro-resistant formulation designed to reduce upper gastrointestinal side effects.
Adult: Renal Transplant: 720 mg (two 360 mg tablets) twice daily (1440 mg/day). Cardiac Transplant: 720 mg twice daily (1440 mg/day). Hepatic Transplant: 720 mg twice daily (1440 mg/day). Should be initiated within 24 hours post-transplantation. Must be taken on an empty stomach, 1 hour before or 2 hours after food.
Note: Swallow tablets whole with a glass of water. Do NOT crush, chew, or break the enteric-coated tablet. Must be taken on an empty stomach (at least 1 hour before or 2 hours after food) to ensure consistent absorption. If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose. Do NOT double the dose.
Mycophenolate sodium is a prodrug that is rapidly hydrolyzed in the gastrointestinal tract to release the active moiety, mycophenolic acid (MPA). MPA is a potent, selective, non-competitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), specifically the type II isoform which is upregulated in activated lymphocytes. This inhibition blocks the de novo pathway of guanosine nucleotide synthesis, a critical step for DNA and RNA synthesis in T- and B-lymphocytes. Unlike other cell types, lymphocytes are highly dependent on this pathway, leading to a cytostatic effect on lymphocyte proliferation, suppression of antibody formation, and inhibition of cell-mediated immune responses.
Pregnancy: Pregnancy Category D. Mycophenolate is a potent human teratogen associated with a high risk of miscarriage (45-49%) and a specific pattern of congenital malformations (external ear, facial, cardiovascular, CNS, and limb abnormalities). Women of childbearing potential MUST use two reliable forms of contraception before, during, and for 6 weeks after stopping therapy. A negative pregnancy test is required before initiation.
Driving: May cause dizziness, somnolence, or blurred vision. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
| Acyclovir / Valacyclovir / Ganciclovir | Competition for renal tubular secretion may increase plasma levels of both MPA and the antiviral drug, potentially increasing toxicity (myelosuppression, neurotoxicity). | Major |
| Antacids containing Aluminium/Magnesium | Decrease absorption of MPA, leading to reduced bioavailability and efficacy. Administer mycophenolate sodium at least 2 hours apart. | Moderate |
| Cholestyramine / Sevelamer | Interrupt enterohepatic recirculation of MPA, significantly reducing systemic exposure (AUC) by up to 40%. Administer at least 2 hours apart. | Major |
| Proton Pump Inhibitors (e.g., Omeprazole) | May potentially alter the dissolution of the enteric coating, though data is conflicting. Monitor for efficacy. | Moderate |
| Rifampicin / Rifabutin | Induce UGT enzymes and possibly P-glycoprotein, decreasing MPA plasma concentrations and potentially reducing efficacy. | Major |
| Salicylic Acid (high dose) | May displace MPA from plasma protein binding, increasing free fraction and potential toxicity. | Moderate |
| Live Attenuated Vaccines (e.g., MMR, Varicella, Yellow Fever) | Risk of disseminated vaccine-induced infection. Contraindicated. | Major |
| Azathioprine | Concomitant use is not recommended due to overlapping mechanisms and potentiation of myelosuppression. | Major |
Same composition (Mycophenolate sodium (360mg)), different brands: