mycophenolate (Cellcept, Myfortic)

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^[1]^[2]^[3]^[4]^[5]^[6]^[7]^[8]^[9]^[10]^[11]^[12]^[13]^[14]

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
- renal graft rejection
- liver transplantation^[12]
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

pregnancy category = x

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]

monitor with immunosuppressive agents

Adverse effects

commmon > 10%
- general
  - abdominal pain, fever, headache, infection from immunosuppression, asthenia, chest pain, back pain, hypertension
- central nervous system
  - tremor, insomnia, dizziness
- dermatology
  - acne, rash
- gastrointestinal
  - diarrhea, constipation, dyspepsia, nausea/vomiting
- hematologic
  - hypochromic anemia, leukopenia, thrombocytopenia, leukocytosis
  - pure red cell aplasia^[9]^[10]
- metabolic
  - peripheral edema, hypercholesterolemia, hypophosphatemia, edema, hypokalemia, hyperkalemia, hyperglycemia
- respiratory
  - dyspnea, cough, pharyngitis, bronchitis, pneumonia
- urogenital
  - UTI, hematuria, renal tubular necrosis
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 adverse effects of immunosuppressive agents

Drug interactions

antacids decrease absorption
cholestyramine decreases absorption
mycophenolate may increase levels of
- acyclovir
- ganciclovir
iron supplements may increase mycophenolate levels
probenecid may increase mycophenolate levels
salicylates may increase free fraction of mycophenolate

Mechanism of action

immunosuppressive agent
inhibits purine metabolism
- inhibits inosine monophosphate dehydrogenase
- antiproliferative
  - preferentially inhibits T-cells & B-cells^[1]

More general terms

References

↑ ^{Jump up to: 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
↑ ^{Jump up to: 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
↑ ^{Jump up to: 5.0} ^5.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate
↑ ^{Jump up to: 6.0} ^6.1 ^6.2 ^6.3 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#MMF
↑ ^{Jump up to: 7.0} ^7.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept
↑ ^{Jump up to: 8.0} ^8.1 FDA Medwatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm171828.htm
↑ ^{Jump up to: 9.0} ^9.1 FDA Medwatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm177397.htm
↑ ^{Jump up to: 10.0} ^10.1 FDA MedWatch http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm
↑ ^{Jump up to: 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
↑ ^{Jump up to: 12.0} ^12.1 Deprecated Reference
↑ ^{Jump up to: 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

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