REMS
Contraindicated in:
Pregnancy
.Use Cautiously in:
Women of reproductive potential and men with female partners of reproductive potential
;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, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), MALIGNANCY
Drug-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.
May cause fetal harm and pregnancy loss. Discuss importance of simultaneously using two reliable nonhormonal forms of contraception or abstinence prior to beginning, during, and for 6 wk following last dose and to avoid breastfeeding. Discuss acceptable forms of contraception with health care provider. Mycophenolate may ↓ effectiveness of hormonal contraceptives. Encourage pregnant patients during or within 6 wk after therapy to enroll in registry that monitors outcomes in women exposed to mycophenolate during pregnancy by calling 1-800-617-8191 or visiting www.mycophenolateREMS.com. Instruct men with female partners of reproductive potential to use effective contraception during and for ≥90 days after last dose. Advise men to avoid semen donation during and for ≥90 days after last dose.
NDC Code