mycophenolate (Cellcept, Myfortic)
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Introduction
Mycophenolate mofetil. Antibiotic substance produced by Penicillium brevi-compactum, P. stoloniferum & related species.
Medication Guide to be distributed to every patient who fills a CellCept prescription.[7]
Indications
- maintenance of immunosuppression after organ transplantation & for treatment of refractory rejection
- used in conjunction with corticosteroids & cyclosporine
- use in suppressing need for azathioprine
- treatment of systemic lupus erythematosus, especially lupus nephritis[11]
- polymyositis, dermatomyositis, vasculitis
Contraindications
- pregnancy, pregnancy category: D[1][4][6]
- women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within one week prior to beginning therapy
- women of childbearing potential taking mycophenolate must
- receive contraceptive counseling
- use effective contraception
- begin using 2 chosen methods of contraception 4 weeks prior to starting mycophenolate therapy, unless abstinence is the chosen method
- contraceptives should be used during & for 6 weeks after stopping mycophenolate
Dosage
- 1 g PO BID
- take on an empty stomach
- do not crush or chew capsules
- dose should be decreased or stopped in patients with neutropenia < 1300/mm3
Tabs: 250 mg. Myfortic: enteric coated
Storage
- must be protected from light
- product labeling for U.S. products does not instruct to dispense in original container[13] Dosage adjustment with renal failure:
- doses > 2 g/day are not recommended
Monitor
- baseline CBC, LFTs, serum creatinine
- thereafter CBC, LFTs, serum creatinine every 3 months[1]
Adverse effects
- commmon > 10%
- general
- abdominal pain, fever, headache, infection from immunosuppression, asthenia, chest pain, back pain, hypertension
- central nervous system
- dermatology
- gastrointestinal
- hematologic
- metabolic
- respiratory
- urogenital
- general
- progressive multifocal leukoencephalopathy ?[5]
- congenital anomalies following exposure to mycophenolate mofetil during pregnancy, including microtia, cleft lip & cleft palate[6]
- BK virus-associated nephropathy in renal transplant patients[8]
Caution:
- avoid inhalation or direct contact with skin or mucous membranes of powder in capsules; wash with soap & water if occurs
- capsules should not be opened or crushed
- teratogenic[6]
Drug interactions
- antacids decrease absorption
- cholestyramine decreases absorption
- mycophenolate may increase levels of
- iron supplements may increase mycophenolate levels
- probenecid may increase mycophenolate levels
- salicylates may increase free fraction of mycophenolate
- drug interaction(s) of methotrexate with biological response modifier
- drug interaction(s) of antibiotics with warfarin
Mechanism of action
- immunosuppressive agent
- inhibits purine metabolism
- inhibits inosine monophosphate dehydrogenase
- antiproliferative
More general terms
- immunosuppressive agent
- carboxylate
- phenol
- alkene; olefin
- ester
- other antibiotic
- antineoplastic agent (chemotherapeutic agent)
- disease-modifying antirheumatic agent (DMARD)
- IMP dehydrogenase inhibitor
References
- ↑ 1.0 1.1 1.2 1.3 Medical Knowledge Self Assessment Program (MKSAP) 11, 17. American College of Physicians, Philadelphia 1998, 2015
- ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
- ↑ Department of Veterans Affairs, VA National Formulary
- ↑ 4.0 4.1 Prescriber's Letter 14(12): 2007 Pregnancy Category Change for Mycophenolate Motefil (CellCept) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=231208&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate
- ↑ 6.0 6.1 6.2 6.3 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#MMF
- ↑ 7.0 7.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept
- ↑ 8.0 8.1 FDA Medwatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm
- ↑ 9.0 9.1 FDA Medwatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm
- ↑ 10.0 10.1 FDA MedWatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm
- ↑ 11.0 11.1 Kamanamool N, McEvoy M, Attia J et al Efficacy and adverse events of mycophenolate mofetil versus cyclophosphamide for induction therapy of lupus nephritis: systematic review and meta-analysis. Medicine (Baltimore). 2010 Jul;89(4):227-35. PMID: https://www.ncbi.nlm.nih.gov/pubmed/20616662
- ↑ 12.0 12.1 Deprecated Reference
- ↑ 13.0 13.1 Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=300622&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ Myfortic: Novartis at (888) 669-6682
Database
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?sid=31839
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?sid=5281078
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?sid=4272
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=4271
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=198011
- PubChem: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=162230