Mycophenolate

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Unlabeled Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names

Europe

Austria: Cellcept, Mycophenolate, Myfenax; Belgium: Cellcept; Bulgaria: Cellcept, Mycophenolate; Cyprus: Cellcept, Mycophenolate, Myfenax; Czech Republic: Cellcept, Limfocept, Mophecen, Mycofenolat, Mycophenolat, Myfenax, Myfortic, Mygref; Denmark: Cellcept, Myfortic; Estonia: Cellcept, Limfocept, Mycophenolate, Myfenax, Myfortic; Finland: Cellcept; France: Cellcept; Germany: Cellcept, Mycophenolat, Myfenax, Myfortic; Greece: Cellcept, Mycophenolate, Myfenax, Myfetil; Hungary: Cellcept, Mycophenolate, Myfenax; Ireland: Cellcept, Mycolat, Mycophenolate, Myfenax; Italy: Cellcept, Myfortic; Latvia: Cellcept, Limfocept, Mophecen, Mycophenolate, Myfenax; Lithuania: Cellcept, Limfocept, Mophecen, Mycophenolate, Myfenax; Luxembourg: Cellcept, Mycophenolate, Myfenax; Malta: Cellcept, Mycophenolate, Myfortic; Netherlands: Cellcept, Mycofenolaat; Poland: Cellcept, Mycophenolate, Myfenax, Trixin; Portugal: Cellcept, Micofenolato, Myfenax; Romania: Cellcept, Limfocept, Micofenolat, Micogal-Teva Pharma, Mophecen, Mycofenolat, Myfenax; Slovakia: Cellcept, Mycophenolate, Myfenax, Myfortic, Mykofenolat; Slovenia: Cellcept, Mofetilmikofenolat, Myfortic; Spain: Cellcept, Micofenolato, Myfortic; Sweden: Cellcept, Mycophenolate, Myfenax; UK: Cellcept, Myfortic.

North America

Canada: Cellcept, Myfortic; USA: Cellcept, Mycophenolate, Myfortic.

Latin America

Argentina: Cellcept, Imuxgén, Micofenolato, Mycoldosa, Myfortic; Brazil: Cellcept, Myfortic; Mexico: Cellcept, Lanfetil, Myfortic, Tevacept.

Asia

Japan: CellCept.

Drug combinations

Chemistry

Mycophenolate Mofetil: C~23~H~31~NO~7~. Mw: 433.49. (1) 4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, 2-(4-morpholinyl)ethyl ester, (E)-; (2) 2-Morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. CAS-115007-34-6 (1990).

Mycophenolate Sodium: C~17~H~19~NaO~6~. Mw: 342.32. 4-Hexenoic acid, 6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-, monosodium salt, (4E)-. CAS-37415-62-6 (2002).

Pharmacologic Category

Immunosuppressive Agents. (ATC-Code: L04AA06).

Mechanism of action

Exhibits cytostatic effect on T and B lymphocytes. Inhibitor of inosine monophosphate dehydrogenase which inhibits de novo guanosine nucleotide synthesis. T and B lymphocytes dependent on this pathway for proliferation.

Therapeutic use

Prophylaxis of organ rejection concomitantly with cyclosporine and corticosteroids in patients receiving allogeneic renal, cardiac, or hepatic transplants.

Pregnancy and lactiation implications

Mycophenolate associated with increased risk of congenital malformations and spontaneous abortions when used during pregnancy.

Unlabeled use

Treatment of rejection in liver transplant patients unable to tolerate tacrolimus or cyclosporine due to neurotoxicity. Mild rejection in heart transplant patients. Treatment of moderate-severe psoriasis, proliferative lupus nephritis, myasthenia gravis. Prevention and treatment of graft-vs-host disease.

Contraindications

Hypersensitivity to mycophenolate mofetil, mycophenolic acid, mycophenolate sodium, or any component of the formulation. Intravenous formulation contraindicated in patients allergic to polysorbate 80.

Warnings and precautions

Hazardous agent. Increased risk for infection. Increased risk of development of lymphoma and skin malignancy. Severe neutropenia may occur. Progressive multifocal leukoencephalopathy, a rare and potentially fatal condition affecting CNS as a result of activation of John Cunningham virus, reported. Use should be avoided in rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (such as Lesch-Nyhan or Kelley-Seegmiller syndrome). Use with caution in active peptic ulcer disease (may be associated with GI bleeding and/or perforation), and in renal impairment, as toxicity may be increased. Some dosage forms may contain phenylalanine. Mycophenolate associated with increased risk of congenital malformations and spontaneous abortions when used during pregnancy. Intravenous solution should never be administered by rapid or bolus injection.

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