Generic Name and Formulations:
Mycophenolic acid 180mg, 360mg; delayed-release tabs.
Novartis Pharmaceuticals Corp
Indications for MYFORTIC:
Organ rejection prophylaxis in allogeneic renal transplant patients, in combination with cyclosporine and corticosteroids.
Swallow whole. Take on empty stomach. 720mg twice daily.
<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.
Embryo-fetal toxicity. Malignancies. Serious infections.
Embryofetal toxicity; rule out pregnancy with serum or urine pregnancy test immediately before starting therapy, 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], cytomegalovirus [CMV]); 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 GI disease or renal impairment (monitor). Hypoxanthine-guanine phosphoribosyl transferase deficiency; avoid. Pregnancy (Cat.D); avoid; counsel patients 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. Nursing mothers: not recommended; avoid breastfeeding within 6 weeks after discontinuation.
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.
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), serious GI complications (eg, bleeding, perforation, ulcers).
Renal (primarily), fecal.
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