REMS
Contraindicated in:
Pregnancy
.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, MALIGNANCYDrug-drug:
Mycophenolate Mofetil
Mycophenolic Acid
Mycophenolate Mofetil
Renal Impairment
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: Widely distributed to tissues.
Protein Binding: MPA: 97%.
Half-Life: MPA: 8–18 hr.
(MPA plasma concentrations)
| 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 |
Instruct patient to notify health care provider immediately if signs and symptoms of infection (temperature ≥100.5°F; cold symptoms [runny nose, sore throat]; flu symptoms [upset stomach, stomach pain, vomiting, diarrhea]; earache or headache; pain during urination; frequent urination; white patches in mouth or throat; unexpected bruising or bleeding; cuts, scrapes, or incisions that are red, warm, and oozing pus) or PML occur. Advise patient to avoid contact with persons with contagious diseases.
Inform patient of the ↑ risk of lymphoma and other malignancies. Advise patient to use sunscreen and wear protective clothing to ↓ risk of skin cancer.
Inform women of reproductive potential of potential for pregnancy loss and fetal harm. Discuss importance of simultaneously using two reliable nonhormonal forms of contraception or abstinence prior to beginning, during, and for 6 wk following discontinuation of therapy and to avoid breastfeeding. Discuss acceptable forms of contraception with health care provider. Mycophenolate may ↓ effectiveness of hormonal contraceptives. Encourage patients who become pregnant during or within 6 wk after therapy to enroll in the pregnancy registry by calling 1-800-617-8191 or www.mycophenolateREMS.com to monitor outcomes in women exposed to mycophenolate during pregnancy. Instruct male patients with female partners of reproductive potential to use effective contraception during and for ≥90 days after discontinuing therapy. Advise male patients to avoid semen donation during and for ≥90 days after discontinuing therapy.
NDC Code