Prevention of organ rejection in kidney transplant: Mycophenolic acid is used to prevent organ rejection in adult patients undergoing kidney transplantation. It is also indicated for children aged 5 years and older who are at least 6 months post–kidney transplant.

Limitations of use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets or capsules should not be used interchangeably without medical supervision, as their absorption rates are not the same.

Mycophenolic acid delayed-release tablets are enteric-coated forms of mycophenolate sodium that release the active compound, mycophenolic acid. It acts as an immunosuppressive agent. It works by reversibly and noncompetitively inhibiting the enzyme inosine monophosphate dehydrogenase (IMPDH). This blocks the de novo synthesis of guanosine nucleotides without being incorporated into DNA. Mycophenolic acid has a cytostatic effect on lymphocytes. It helps prevent acute rejection in kidney and heart transplants and reduces antibody production.

Dosage in adult kidney transplant patients: The recommended dose of Mycophenolic acid is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in pediatric kidney transplant patients: The recommended dose of Mycophenolic acid in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three Mycophenolic acid 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of >1.58 m2 may be dosed either with four Mycophenolic acid 180 mg tablets, or two Mycophenolic acid 360 mg tablets twice daily (1440 mg daily dose).

Mycophenolic acid tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake. Tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

Use caution when Mycophenolic acid is taken together with antacids, azathioprine, cyclosporine, rifampin, sevelamer, cholestyramine, acyclovir, metronidazole, and hormonal contraceptives. These medications may reduce the concentration of Mycophenolic acid in the body.

Mycophenolic acid delayed-release tablets and mycophenolate mofetil formulations (tablets or capsules) should not be substituted for each other without medical supervision, as their absorption rates differ.

Common side effects (occurring in ≥20% of patients) include anemia, leukopenia, constipation, diarrhea, vomiting, indigestion, urinary tract infections, cytomegalovirus (CMV) infection, insomnia, and postoperative pain.

Pregnancy Category D: This drug may cause harm to the fetus. Either discontinue the medication or stop breastfeeding during treatment and for at least 6 weeks after stopping therapy. The benefits of treatment for the mother should be carefully considered.

Use Mycophenolic acid with caution as it may:

• Cause harm to the developing fetus
• Increase the risk of new or reactivated viral infections
• Lead to blood disorders, including pure red cell aplasia
• Cause serious gastrointestinal problems such as bleeding, ulcers, or perforation
• Increase the risk of lymphomas and other cancers, especially skin cancer
• Reduce the effectiveness of live vaccines (avoid use during treatment)

There is no available data regarding overdose.

Immunosuppressant

Store at 25°C and keep out of reach of children.