CELLCEPT INTRAVENOUS Rx
Generic Name and Formulations:
Mycophenolate mofetil (as hydrochloride) 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free; contains polysorbate 80.
Indications for CELLCEPT INTRAVENOUS:
Organ rejection prophylaxis in allogeneic kidney, heart, or liver transplant patients, in combination with other immunosuppressants.
Administer within 24hrs after transplantation. Give by slow IV infusion over ≥2hrs. Kidney or liver: 1g twice daily (2g/day). Heart: 1.5g twice daily (3g/day). May treat up to 14 days. Switch to oral forms when tolerated. 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