Organ rejection prophylaxis:

Indications for: MYFORTIC

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

Adult Dosage:

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

Children Dosage:

<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.

Boxed Warning:

Embryo-fetal toxicity. Malignancies. Serious infections.

MYFORTIC 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.

MYFORTIC Classification:


MYFORTIC 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.

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).



Generic Drug Availability:


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