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CELLCEPT ORAL SUSPENSION
Organ rejection prophylaxis
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Drug Name:

CELLCEPT ORAL SUSPENSION Rx

Generic Name and Formulations:
Mycophenolate mofetil 200mg/mL; pwd for oral susp after reconstitution; mixed fruit flavor; contains phenylalanine.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for CELLCEPT ORAL SUSPENSION:

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

Adult:

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.

Children:

<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.

Contraindications:

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

Boxed Warning:

Embryo-fetal toxicity. Malignancies. Serious infections.

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 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.

See Also:

CELLCEPT CAPSULES

CELLCEPT TABLETS

CELLCEPT INTRAVENOUS

Pharmacological Class:

Immunosuppressant.

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.

Adverse Reactions:

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.

Note:

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

Metabolism:

Hepatic.

Elimination:

Renal (major), fecal.

REMS:

YES

Generic Availability:

YES

How Supplied:

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

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