Cellcept Intravenous Generic Name & Formulations
Mycophenolate mofetil (as hydrochloride) 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free; contains polysorbate 80.
Caps, Tabs—100, 500; Susp—225mL (w. bottle adapter and 2 oral dispensers); Vials (20mL)—4
Cellcept Intravenous Indications
Organ rejection prophylaxis in allogeneic kidney, heart, or liver transplant patients, in combination with other immunosuppressants.
Cellcept Intravenous Dosage and Administration
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. Renal impairment, neutropenia: see full labeling.
Cellcept Intravenous Contraindications
Hypersensitivity to other forms of mycophenolate. IV: polysorbate 80 allergy.
Cellcept Intravenous Boxed Warnings
Embryo-fetal toxicity. Malignancies. Serious infections.
Cellcept Intravenous 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 Intravenous Pharmacokinetics
Cellcept Intravenous 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 Intravenous 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 Intravenous Clinical Trials
Cellcept Intravenous Note
Encourage pregnant patients to enroll in the Mycophenolate Pregnancy Registry by calling (800) 617-8191.
Cellcept Intravenous Patient Counseling