Organ rejection prophylaxis:

Indications for: CELLCEPT CAPSULES

Organ rejection prophylaxis in allogeneic kidney, heart, or liver transplant patients, in combination with other immunosuppressants.

Adult Dosage:

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.

Children Dosage:

<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 CAPSULES Contraindications:

Hypersensitivity to other forms of mycophenolate. IV: polysorbate 80 allergy.

Boxed Warning:

Embryo-fetal toxicity. Malignancies. Serious infections.

CELLCEPT CAPSULES 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.




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.

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.


Encourage pregnant patients to enroll in the Mycophenolate Pregnancy Registry by calling (800) 617-8191.



Generic Drug Availability:


How Supplied:

Caps, Tabs—100, 500; Susp—225mL (w. bottle adapter and 2 oral dispensers); Vials (20mL)—4