Cellcept Tablets Generic Name & Formulations
Mycophenolate mofetil 500mg.
Caps, Tabs—100, 500; Susp—225mL (w. bottle adapter and 2 oral dispensers); Vials (20mL)—4
Cellcept Tablets Indications
Organ rejection prophylaxis in allogeneic kidney, heart, or liver transplant patients, in combination with other immunosuppressants.
Cellcept Tablets Dosage and Administration
Give as soon as possible after transplantation on empty stomach. Swallow caps or tabs whole. Oral susp can also be given via NG tube. Kidney: 1g twice daily (2g/day). Heart or liver: 1.5g twice daily (3g/day). Renal impairment, neutropenia: see full labeling.
<3mos: not established. Give as soon as possible after transplantation on empty stomach. Swallow caps or tabs whole. Oral susp can also be given via NG tube. Kidney (≥3mos): Oral susp: 600mg/m2 twice daily (max 2g/10mL per day). If BSA (1.25–<1.5m2): 750mg caps twice daily (1.5g/day); (≥1.5m2): 1g caps or tabs twice daily (2g/day). Heart or liver (≥3mos): Oral susp: initially 600mg/m2 twice daily; if tolerated, may increase to maintenance dose of 900mg/m2 twice daily (max 3g/15mL per day). If BSA (1.25–<1.5m2): initially 750mg caps twice daily (1.5g/day); (≥1.5m2): initially 1g caps or tabs twice daily (2g/day). Both max maintenance (heart or liver): 3g/day. Renal impairment, neutropenia: see full labeling.
Cellcept Tablets Contraindications
Hypersensitivity to other forms of mycophenolate. IV: polysorbate 80 allergy.
Cellcept Tablets Boxed Warnings
Embryo-fetal toxicity. Malignancies. Serious infections.
Cellcept Tablets Warnings/Precautions
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 dose reduction or discontinuation 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, interrupt or reduce dose. Active GI disease or renal impairment (monitor). Hypoxanthine-guanine phosphoribosyl transferase deficiency; avoid. Monitor for acute inflammatory syndrome at initiation or when increasing dose; discontinue and consider alternatives. Phenylketonuria (oral susp). Monitor MPA levels before and after any changes in immunosuppressants or concomitant drugs. 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.
Cellcept Tablets Pharmacokinetics
Cellcept Tablets Interactions
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.
Cellcept Tablets Adverse Reactions
Diarrhea, leukopenia, anemia, infection, vomiting, nausea, constipation, hypertension; serious viral infections (eg, polyomavirus-associated nephropathy, progressive multifocal leukoencephalopathy, CMV, HBV, HCV), neutropenia (monitor), pure red cell aplasia (w. concomitant immunosuppressants), malignancies, acute inflammatory syndrome; rare: GI bleeding, ulceration, perforation. IV: phlebitis, thrombosis.
Cellcept Tablets Clinical Trials
Cellcept Tablets Note
Encourage pregnant patients to enroll in the Mycophenolate Pregnancy Registry by calling (800) 617-8191.
Cellcept Tablets Patient Counseling