CELLCEPT TABLETS Rx
Generic Name and Formulations:
Mycophenolate mofetil 500mg.
Indications for CELLCEPT TABLETS:
Organ rejection prophylaxis in allogeneic kidney, heart, or liver transplant patients, in combination with other immunosuppressants.
Give as soon as possible after transplantation on empty stomach. Swallow caps or tabs whole. May give oral susp via NG tube. Kidney: 1g twice daily (2g/day). Heart or liver: 1.5g twice daily (3g/day). Severe renal impairment: see full labeling.
<3mos, or in allogeneic heart or liver transplant: not established. Give as soon as possible after transplantation on empty stomach. Swallow caps or tabs whole. Kidney (≥3mos): Oral susp: 600mg/m2 twice daily (max 2g/10mL per day); also, may give via NG tube. BSA 1.25–<1.5m2: 750mg twice daily (1.5g/day), may give in caps; if ≥1.5m2: 1g twice daily (2g/day), may give in caps or tabs. Severe renal impairment: see full labeling.
Hypersensitivity to other forms of mycophenolate. IV: polysorbate 80 allergy.
Embryo-fetal toxicity. Malignancies. Serious infections.
Embryo-fetal 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 lymphomas and other malignancies (eg, skin). Avoid sun, UV light. Increased susceptibility to infections (eg, bacterial, fungal, protozoal, new or reactivated viral, opportunistic); monitor and consider reducing immunosuppression if new infections or reactivate viral infections develop. Monitor CBCs weekly for 1 month, twice monthly for next 2 months, then monthly during first year. If ANC <1300/µL, discontinue or reduce dose. Active GI disease or renal impairment (monitor). Hypoxanthine-guanine phosphoribosyl transferase deficiency; avoid. Phenylketonuria (oral susp). Advise patients to avoid blood donation during and for ≥6 weeks after cessation. Elderly. Pregnancy: avoid (esp. 1st trimester). Females of reproductive potential must be counseled on using 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. Males: use effective contraception and avoid semen donation during and for ≥90 days after discontinuation. Nursing mothers.
Avoid concomitant live vaccines. May antagonize oral contraceptives (eg, levonorgestrel); use additional barrier methods. May potentiate acyclovir, ganciclovir, probenecid, valacyclovir, valganciclovir; monitor. Antagonized by PPIs, drugs that interfere with enterohepatic recirculation (eg, cholestyramine, rifampin, trimethoprim/sulfamethoxazole, other antibiotics), or drugs that induce glucuronidation (eg, telmisartan); monitor. May be potentiated by drugs that inhibit glucuronidation (eg, isavuconazole). Antagonized by calcium-free phosphate binders (eg, sevelamer), magnesium- or aluminum-containing antacids; may give ≥2hrs after mycophenolate mofetil.
Diarrhea, leukopenia, anemia, infection, vomiting, nausea, constipation, hypertension, peripheral edema; serious viral infections (eg, polyomavirus-associated nephropathy, progressive multifocal leukoencephalopathy, CMV, HBV, HCV), neutropenia (monitor), pure red cell aplasia (w. concomitant immunosuppressants), malignancies; rare: GI bleeding, ulceration, perforation. IV: phlebitis, thrombosis.
Encourage pregnant patients to enroll in the Mycophenolate Pregnancy Registry by calling (800) 617-8191.
Renal (major), fecal.
Caps, Tabs—100, 500; Susp—225mL (w. bottle adapter and 2 oral dispensers); Vials (20mL)—4