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CELLCEPT TABLETS
Organ rejection prophylaxis
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Drug Name:

CELLCEPT TABLETS Rx

Generic Name and Formulations:
Mycophenolate mofetil 500mg.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for CELLCEPT TABLETS:

Organ rejection prophylaxis in allogeneic renal, cardiac, or hepatic transplant patients, in combination with cyclosporine and corticosteroids.

Adult:

Give as soon as possible after transplantation on empty stomach. Renal: 1g twice daily (2g/day). Cardiac or hepatic: 1.5g twice daily (3g/day). Severe renal impairment: see full labeling.

Children:

<3 months, or in allogeneic cardiac or hepatic transplant: not established. Give as soon as possible after transplantation on empty stomach. Renal: 3 months–18yrs: 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.

Contraindications:

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

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 infections, lymphomas and other malignancies (eg, skin). Avoid sun, UV light. Monitor CBCs weekly for 1 month, twice monthly for 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. Oral susp: phenylketonuria. Elderly. Pregnancy (Cat.D); avoid. 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. Nursing mothers: not recommended.

Interactions:

Concomitant azathioprine, live vaccines, rifampin, cholestyramine, drugs that interfere with enterohepatic recirculation, or the combination of norfloxacin and metronidazole: not recommended. Antagonized by antacids (separate dosing), PPIs (use with caution), drugs that alter GI flora, telmisartan. May antagonize oral contraceptives; use additional birth control methods. May potentiate or be potentiated by acyclovir, ganciclovir, probenecid. Antagonized by sevelamer and other calcium-free phosphate binders; may give 2hrs after mycophenolate mofetil. Caution when concomitant cyclosporine A and then switching to other immunosuppressants (eg, tacrolimus, belatacept).

See Also:

CELLCEPT CAPSULES

CELLCEPT ORAL SUSPENSION

CELLCEPT INTRAVENOUS

Pharmacological Class:

Immunosuppressant.

Adverse Reactions:

Blood dyscrasias, constipation, diarrhea, vomiting, peripheral edema, hypertension, new or reactivated infections (eg, UTI, cytomegalovirus, sepsis, herpes), progressive multifocal leukoencephalopathy, pure red cell aplasia (w. concomitant immunosuppressants), malignancies (eg, lymphomas, skin), insomnia; 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:

Caps, tabs (YES); inj, susp (NO)

How Supplied:

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

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