Mycophenolate mofetil

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Administration

  • Type: Immunosuppressant
  • Dosage Forms: 250,500; 200mg/mL; IV
  • Routes of Administration: PO, IV
  • Common Trade Names: CellCept

Adult Dosing

Kidney transplant rejection prophylaxis

  • 1 g PO/IV bid
  • Start: IV with in 24h post transplant, continue up to 14 days, switch to PO ASAP; Info: give on empty stomach; stable patients may take with food

Heart transplant rejection prophylaxis

  • 1.5 g PO/IV bid
  • Start: IV with in 24h post transplant, continue up to 14 days, switch to PO ASAP; Info: give on empty stomach

Liver transplant rejection prophylaxis

  • 1.5 g PO bid or 1 g IV bid
  • Info: start IV with in 24h post transplant, continue up to 14 days, switch to PO ASAP; Info: give on empty stomach

Lupus nephritis

  • 1 g PO bid
  • Info: use with prednisone, consider decease dose 50% after 6mo treatment

Pediatric Dosing

Kidney transplant rejection prophylaxis

  • 3 mo-18 yo: Dose: 600mg/m^2 PO bid; Alt: 750mg PO bid for body surf. area = 1.25-1.5 m^2; 1 g PO bid for body surf. area >1.5 m^2; Max: 1 g/dose

Special Populations

Renal Dosing

  • Adult:
    • kidney transplant patients, delayed graft function immediate postop: no adjustment
    • kidney transplant patients, outside immediate post-transplant period:CrCl <25: max 1 g bid; HD/PD: no supplement
    • heart or liver transplant patients: CrCl <25: weigh risk/benefit; HD/PD: not defined
  • Pediatric:
    • kidney transplant patients, delayed graft function immediate postop: no adjustment
    • kidney transplant patients, outside immediate post-transplant period: CrCl <30: max 600mg/m^2/day; HD/PD: no supplement

Hepatic Dosing

  • Adult: renal transplant with severe hepatic parenchymal disease: no adjustment; other hepatic impairment: not defined
  • Pediatric: renal transplant with severe hepatic parenchymal disease: no adjustment; other hepatic impairment: not defined

Contraindications

  • Allergy to class/drug
  • hypersens. to polysorbate 80 (IV form)
  • Lesch-Nyhan syndrome
  • Kelly-Seegmiller syndrome
  • caution in elderly patients
  • caution if GI disorder
  • caution if renal disease, severe
  • caution if bone marrow depression
  • caution if PKU (phenylalanine-containing forms)

Adverse Reactions

Serious

  • thrombocytopenia
  • leukopenia
  • neutropenia
  • immunosuppression
  • infection, severe
  • opportunistic infection
  • viral reactivation
  • polyomavirus-assoc. nephropathy
  • PML
  • pure red cell aplasia
  • lymphoma
  • lymphoproliferative disorders
  • malignancy
  • GI bleeding
  • GI perforation/ulcer
  • colitis
  • acute renal failure
  • interstitial lung disease
  • pregnancy loss, 1st trimester
  • congenital malformations

Common

  • hypertension
  • infection
  • diarrhea
  • peripheral edema
  • anemia
  • abdominal pain
  • constipation
  • leukopenia
  • fever
  • headache
  • nausea/vomiting
  • dyspepsia
  • hypotension (rapid IV use)
  • dyspnea
  • cough
  • hypercholesterolemia
  • hypokalemia
  • tremor
  • acne
  • insomnia

Pharmacology

  • Half-life: 17.9h (PO route), 16.6h (IV route)
  • Metabolism: liver; CYP450: Info: prodrug converted to mycophenolic acid (MPA)
  • Excretion: urine 93% (<1% unchanged), feces 6%

Mechanism of Action

inhibits B- and T-lymphocyte proliferation

Comments

See Also

References

epocrates