Myfortic

Prophylaxis of organ rejection in kidney transplant: Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. It is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Mycophenolic acid delayed-release tablets are enteric coated formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid. It is an immunosuppressive agent. It is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). Therefore, it inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation to DNA. Mycophenolic acid has cytostatic effects on lymphocytes. It has been shown to prevent the occurrence of acute rejection of kidney and heart allotransplantation. It also decreases antibody production.

Caution should be exercised with concomitant administration of Antacids, Azathioprine, Cyclosporin, Rifampin, Sevelamer, Cholestyramine, Acyclovir, Metronidazole, Hormonal contraceptives as these medicines may decrease Mycophenolic acid concentration.

The most common adverse reactions (≥20%) associated with the administration of Mycophenolic acid are anemia, leukopenia, constipation, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.

Pregnancy Category D. Can cause fetal harm.

Lactation: Discontinue Mycophenolic acid or discontinue nursing while on treatment or within 6 weeks after stopping therapy. Take into consideration the importance of the drug to the mother.

Mycophenolic acid tablets are used with caution because it-

• Can cause embryofetal toxicity
• Can increase new or reactive viral infections
• Can cause blood dyscrasias including pure red cell aplasia
• Can cause serious GI tract complications (gastrointestinal bleeding, perforations and ulcers)
• May increase the risk of developing lymphomas and other malignancies, particularly of the skin
• Use of live vaccine should be avoided during treatment with Mycophenolic acid

Immunosuppressant

No data are available with regard to overdose.

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