Mycophenolate mofetil is used together with corticosteroids and either ciclosporin or tacrolimus for:

• Prevention of acute organ rejection and treatment of initial or resistant rejection in patients undergoing kidney (renal) transplantation from another donor.
• Prevention of acute organ rejection in patients receiving heart transplants.
• Prevention of acute organ rejection in patients receiving liver transplants.
• It is also indicated for both induction and maintenance treatment of patients with Class III–V lupus nephritis, as classified by the International Society of Nephrology/Renal Pathology Society.

Mycophenolate mofetil is an immunosuppressive medication. It works as a reversible inhibitor of the enzyme inosine monophosphate dehydrogenase (IMPDH). By doing so, it blocks the formation of guanosine nucleotides through the de novo pathway without being incorporated into DNA. Its active form, mycophenolic acid, slows down the growth of lymphocytes, helps prevent organ rejection (especially in kidney and heart transplants), and reduces antibody production.

Mechanism of Action: Mycophenolate mofetil is converted in the body to mycophenolic acid (MPA), which inhibits IMPDH in a selective and reversible way. This enzyme is essential for producing guanosine nucleotides needed for DNA and RNA synthesis. MPA blocks a key step in this process by interfering with the conversion of inosine monophosphate (IMP) to xanthose monophosphate. It mainly affects T and B lymphocytes, which depend heavily on this pathway, while other cells can use alternative pathways.

Pharmacodynamics:  Mycophenolic acid reduces the production of guanosine nucleotides required for DNA and RNA formation by inhibiting IMPDH. T and B lymphocytes rely on this pathway for growth, so their activity is suppressed. Laboratory studies show that it: Inhibits lymphocyte proliferation, Reduces immune responses, Lowers intracellular levels of GTP and dGTP in immune cells, However, it does not significantly affect neutrophils.

Transplant patients:

Standard dosage for prophylaxis of renal rejection

• Adults: A dose of 1 g administered orally twice a day (daily dose of 2 g) is recommended for use in renal transplant patients.
• Children (aged 3 months to 18 years): Patients with a body surface area of 1.25 to 1.5 m² may be prescribed Mycophenolate Mofetil Tablets at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area >1.5 m² may be prescribed Mycophenolate Mofetil tablets at a dose of 1 g twice daily (2 g daily dose).

Standard dosage for prophylaxis of cardiac rejection

• Adults: A dose of 1.5 g administered orally (over not less than 2 hour) twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
• Children: no data are available for pediatric cardiac transplant patients.

Standard dosage for prophylaxis of hepatic rejection

• Adults: A dose of 1.5 g orally twice a day (daily dose of 3 g) is recommended for use in hepatic transplant patients.
• Children: no data are available for pediatric hepatic transplant patients.

Standard dosage for treatment of first or refractory renal rejection

• Adults: A dose of 1.5 g administered orally twice a day (daily dose of 3 g) is recommended for management of first or refractory rejection.
• Children: no data are available for the treatment of first or refractory renal rejection in pediatric renal transplant patients.

Lupus nephritis patients:

Standard Dosage for Induction Therapy

• Adults: A dose of 750 mg–1.5 g administered orally twice a day (daily dose of up to 3 g) is recommended.
• Children: A dose of 600 mg/m² administered orally twice a day (up to a maximum of 2 g daily) is recommended.

Standard Dosage for Maintenance Therapy

• Adults: A dose of 500 mg–1 g administered orally twice a day is recommended.
• Children: A dose of 300 mg/m² administered orally twice a day is recommended.

Mycophenolate Mofetil should be used in combination with corticosteroids. Doses should be introduced gradually and adjusted according to clinical response. Therapeutic drug monitoring could help prevent sub-therapeutic exposure (Cmin ≥3.0 mg/L or inter-dose AUC ≥35 h·mg/L).

Caution is advised when Mycophenolate Mofetil is used together with drugs such as antacids, azathioprine, cyclosporin, rifampin, sevelamer, cholestyramine, acyclovir, metronidazole, and hormonal contraceptives, as these may reduce the concentration of mycophenolic acid in the body.

Mycophenolic acid should not be used in: Patients with known hypersensitivity to mycophenolic acid or any of its components. Pregnant women, due to the risk of birth defects and genetic damage. Breastfeeding mothers.

Common side effects of Mycophenolate Mofetil include: Diarrhea, Low white blood cell count (leukopenia), Sepsis, Gastrointestinal fungal infection (candidiasis), Urinary tract infection, Herpes simplex infection, Vomiting. There is also an increased risk of certain infections, especially opportunistic infections.

Mycophenolate Mofetil is contraindicated during pregnancy and breastfeeding. Its safety during labor and delivery has not been established.

Use Mycophenolic acid with caution as it may:

• Increase the risk of viral infections or reactivation (e.g., hepatitis B, hepatitis C, polyomavirus)
• Cause blood disorders such as pure red cell aplasia (PRCA)
• Lead to serious gastrointestinal complications (bleeding, ulcers, perforation)
• Increase the risk of cancers, especially lymphoma and skin cancer

Additional precautions:

• Avoid live vaccines during treatment
• Patients should not donate blood while on therapy.

Elderly (Geriatric patients): Older patients may have a higher risk of adverse effects such as infections (e.g., cytomegalovirus), gastrointestinal bleeding, and pulmonary edema compared to younger patients.

In many overdose cases, no serious adverse effects are reported. However, excessive doses may: Suppress the immune system, Increase infection risk, Cause bone marrow suppression. If neutropenia occurs, the dose should be reduced or discontinued.

Immunosuppressant (Immunological Chemotherapy)

Store below 30°C in a cool, dry place, protected from light. Keep out of reach of children.