OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Mycophenolate Mofetil – Generic, CellCept®

DRUG CLASS

Transplant Agents

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Mycophenolate Mofetil	128794-94-5	C23-H31-N-O7

ANNOTATED BIBLIOGRAPHY

• References updated: 12 February 2020.
• Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.

  (Expert review of hepatotoxicity published in 1999 does not mention or discuss mycophenolate).
• Reuben A. Hepatotoxicity of immunosuppressive drugs. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier, 2013, pp. 569-92.

  (Review of hepatotoxicity of immunosuppressive agents mentions that reports of hepatotoxicity of cyclosporine have decreased since the 1980s, perhaps because of monitoring of serum levels and lower doses used; liver injury from tacrolimus, sirolimus and mycophenolate is rare and usually rapidly reversible).
• Krensky AM, Azzi JR, Hafler DA. Immnosuppressants and tolerogens. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman's the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 637-54.

  (Textbook of pharmacology and therapeutics).
• Simmons WD, Rayhill SC, Sollinger HW. Preliminary risk-benefit assessment of mycophenolate mofetil in transplant rejection. Drug Saf. 1997;17:75–92. [PubMed: 9285199]

  (Review of mechanism of action, pharmacology, clinical efficacy and toxicity of mycophenolate for transplant rejection; gastrointestinal intolerance was the most common side effect; no mention of effect on ALT levels or hepatotoxicity).
• Basara N, Fauser AA. Safety profile of mycophenolate mofetil. Bone Marrow Transplant. 2000;26:1362–3. [PubMed: 11223981]

  (Letter stressing the good safety profile of mycophenolate and that severe liver injury after bone marrow transplantation is more likely due to graft-vs-host disease than drug induced liver injury).
• Corrieri-Baizeau C, Dumortier J, Scoazec JY, Poncet G, Choucair A, Vial T, Boillot O. Gastroenterol Clin Biol. 2002;26:300–1. [Mycophenolate mofetil induced acute hepatitis] French. [PubMed: 11981480]

  (36 year old liver transplant recipient developed ALT elevations 5 times ULN 2 weeks after starting mycophenolate [bilirubin normal, Alk P 1.5 times ULN], biopsy not showing rejection and tests returning to normal 6 weeks after stopping mycophenolate).
• Sen HN, Suhler EB, Al-Khatib SQ, Djalilian AR, Nussenblatt RB, Buggage RR. Mycophenolate mofetil for the treatment of scleritis. Ophthalmology. 2003;110:1750–5. [PubMed: 13129873]

  (One of 8 patients with scleritis treated with mycophenolate developed liver test abnormalities, but patient was also receiving methotrexate).
• Russo MW, Galanko JA, Shrestha R, Fried MW, Watkins P. Liver transplantation for acute liver failure from drug-induced liver injury in the United States. Liver Transpl. 2004;10:1018–23. [PubMed: 15390328]

  (Among ~50,000 liver transplants reported to UNOS between 1990 and 2002, 270 [0.5%] were done for drug induced acute liver failure, 124 for acetaminophen and 137 for other drugs or toxins, but none for agents used to prevent transplant rejection).
• Balal M, Demir E, Paydas S, Sertdemir Y, Erken U. Uncommon side effect of MMF in renal transplant recipients. Ren Fail. 2005;27:591–4. [PubMed: 16152998]

  (Among 79 renal transplant recipients receiving mycophenolate, 11 had serum ALT elevations [51-508 U/L] 4-70 days after transplant and resolving with lowering dose or stopping mycophenolate).
• Loupy A, Anglicheau D, Mamzer-Bruneel MF, Martinez F, Thervet E, Legendre C, Serpaggi J, et al. Mycophenolate sodium-induced hepatotoxicity: first report. Transplantation. 2006;82:581. [PubMed: 16926609]

  (42 year old renal transplant recipient with chronic hepatitis C developed rash and jaundice 17 days after switching from sirolimus to mycophenolate [bilirubin 11.1 mg/dL, ALT 140 U/L], with no change in HCV RNA levels and resolution upon stopping mycophenolate).
• Jakab SS, West AB, Meighan DM, Brown RS Jr, Hale WB. Mycophenolate mofetil for drug-induced vanishing bile duct syndrome. World J Gastroenterol. 2007;13:6087–9. [PMC free article: PMC4250896] [PubMed: 18023105]

  (69 year old man developed jaundice followed by vanishing bile duct syndrome 3 weeks after a course of amoxicillin/clavulanate, which appeared to improve upon corticosteroid and then mycophenolate therapy).
• Dourakis SP, Boki K, Soultati A, Cherouvim E, Delladetsima I. Acute hepatitis following mycophenolate mofetil administration for ANCA-positive vasculitis. Scand J Rheumatol. 2007;36:237–9. [PubMed: 17657683]

  (73 year old man with systemic vasculitis developed abnormal liver tests 5 months after starting mycophenolate [bilirubin 1 mg/dL, ALT 750 U/L, Alk P 500 U/L], resolving 12 weeks after stopping).
• Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J., Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008;135:1924–34. [PMC free article: PMC3654244] [PubMed: 18955056]

  (Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, none were attributed to cyclosporine, tacrolimus, sirolimus or mycophenolate).
• Reuben A, Koch DG, Lee WM., Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52:2065–76. [PMC free article: PMC3992250] [PubMed: 20949552]

  (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, but none to an agent used to prevent transplant rejection).
• Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013;144:1419–25. [PubMed: 23419359]

  (In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, none of which were attributed to an anti-rejection agent used in transplantation).
• Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A, Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America: an analysis of published reports. Ann Hepatol. 2014;13:231–9. [PubMed: 24552865]

  (Among 176 reports of drug induced liver injury from Latin America published between 1996 and 2012, one was attributed to mycophenolate but none to cyclosporine, sirolimus or tacrolimus).
• Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52. e7. [PMC free article: PMC4446235] [PubMed: 25754159]

  (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, one case was attributed to cyclosporine, but none to tacrolimus, sirolimus or mycophenolate mofetil).