Myfortic

— THERAPEUTIC CATEGORIES —
  • Organ rejection prophylaxis

Myfortic Generic Name & Formulations

General Description

Mycophenolic acid 180mg, 360mg; delayed-release tabs.

Pharmacological Class

Immunosuppressant.

How Supplied

Tabs—120

Generic Availability

YES

Myfortic Indications

Indications

Organ rejection prophylaxis in allogeneic renal transplant patients, in combination with cyclosporine and corticosteroids.

Myfortic Dosage and Administration

Adult

Swallow whole. Take on empty stomach. 720mg twice daily.

Children

<5yrs or BSA<1.19m2: not established. Swallow whole. Take on empty stomach. ≥5yrs (≥6mos post-transplant): BSA: 1.19–1.58m2: 540mg twice daily; >1.58m2: 720mg twice daily.

Myfortic Contraindications

Not Applicable

Myfortic Boxed Warnings

Boxed Warning

Embryo-fetal toxicity. Malignancies. Serious infections.

Myfortic Warnings/Precautions

Warnings/Precautions

Embryo-fetal toxicity; rule out pregnancy with serum or urine pregnancy test immediately before starting therapy, and then another test 8–10 days later. Repeat pregnancy tests during routine follow-up visits. Increased risk of infections (eg, bacterial, viral, fungal, protozoal), lymphomas and other malignancies (eg, skin). New or reactivated viral infections (eg, polyomavirus associated nephropathy [PVAN], progressive multifocal leukoencephalopathy [PML], CMV, SARS-CoV-2); consider dose reduction if develops. Monitor for active HBV/HCV infection. Not interchangeable with other forms of mycophenolate. Avoid sun, UV light. Monitor CBCs weekly for first month, then twice monthly for the 2nd and 3rd months, then monthly during first year. If neutropenia or anemia occur, interrupt or reduce dose. Active serious digestive system disease, acute inflammatory syndrome, or renal impairment; monitor. Avoid in those with hypoxanthine-guanine phosphoribosyl transferase deficiency. Avoid blood donation during and for at least 6 weeks after discontinuation. Elderly. Pregnancy: avoid if safer treatment options are available. Counsel females of reproductive potential to use 2 forms of contraception (or 1 form if using IUDs, tubal sterilization, or if partner has had vasectomy) during therapy, and for 6 weeks after discontinuation unless patient chooses abstinence. Advise males (w. female partners) to use effective contraception and should not donate sperm during and for at least 90 days after discontinuation. Nursing mothers.

REMS

YES

Myfortic Pharmacokinetics

See Literature

Myfortic Interactions

Interactions

Concomitant live vaccines, azathioprine, cholestyramine, drugs that interfere with enterohepatic recirculation, drugs that may bind bile acids (eg, bile acid sequestrates, activated charcoal), norfloxacin plus metronidazole, rifampin or other forms of mycophenolate: not recommended. Antagonized by antacids, sevelamer, cyclosporine, drugs that alter GI flora (eg, ciprofloxacin, amoxicillin/clavulanate). Antagonizes oral contraceptives; use additional birth control methods. May potentiate or potentiated by acyclovir, ganciclovir.

Myfortic Adverse Reactions

Adverse Reactions

Blood dyscrasias (eg, anemia, leukopenia), constipation, nausea, diarrhea, vomiting, dyspepsia, UTI, CMV infection, insomnia, post-op pain; new or reactivated infections, pure red cell aplasia (w. concomitant immunosuppressants), malignancies (eg, lymphomas, skin), GI complications (eg, bleeding, perforation, ulcers).

Myfortic Clinical Trials

See Literature

Myfortic Note

Not Applicable

Myfortic Patient Counseling

See Literature