REMS
Mycophenolate mofetil
Mycophenolic acid
Absorption: Following oral and IV administration, mycophenolate mofetil is rapidly hydrolyzed to mycophenolic acid (MPA), the active metabolite. Absorption of enteric-coated mycophenolic acid (Myfortic) is delayed compared with mycophenolate mofetil (CellCept).
Distribution: Cross the placenta and enter breast milk.
Protein Binding: MPA: 97%.
Half-Life: MPA: 8–18 hr.
(blood levels of MPA)
| ROUTE | ONSET | PEAK | DURATION |
|---|---|---|---|
| mycophenolate mofetil-PO | rapid | 0.25–1.25 hr | N/A |
| mycophenolic acid | rapid | 1.5–2.75 hr | N/A |
Contraindicated in:
Use Cautiously in:
CV: edema, hypertension, hypotension, tachycardia
Derm: rash
Endo: hyperglycemia
F and E: hyperkalemia, hypocalcemia, hypokalemia, hypomagnesemia
GI: anorexia, constipation, diarrhea, nausea, vomiting, abdominal pain, GI BLEEDING
GU: renal impairment
Hemat: leukocytosis, leukopenia, thrombocytopenia, anemia, pure red cell aplasia
Neuro: anxiety, confusion, dizziness, headache, insomnia, paresthesia, sedation, tremor, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)
Misc: fever, infection (including activation of latent viral infections such as Polyomavirus-associated nephropathy or Hepatitis B/C), acute inflammatory syndrome, MALIGNANCY
Drug-drug:
Mycophenolate Mofetil
Renal Impairment
Mycophenolic Acid
Mycophenolate Mofetil
Mycophenolic Acid
(Generic available)Lab Test Considerations:
Mycophenolate is administered under REMS requirements. Prescribers are encouraged to complete Prescriber Training program and patients are encouraged to complete the Information for Patients to mitigate the risk of embryofetal toxicity associated with the use of mycophenolate during pregnancy.
IV Administration:
Explain REMS program to patient.
NDC Code