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CELLCEPT® (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants.
CELLCEPT Intravenous is recommend for patients unable to take oral CELLCEPT. CELLCEPT Intravenous should be administered within 24 hours following transplant. CELLCEPT Intravenous can be administered for up to 14 days; however patients should be switched to oral CELLCEPT as soon as they can tolerate oral medication.
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS
CELLCEPT is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. CELLCEPT Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
WARNINGS AND PRECAUTIONS
Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available.
Lymphoma and Other Malignancies
Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. These infections may lead to serious outcomes, including hospitalizations and death.
Serious viral infections reported include:
Consider reducing immunosuppression in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.
PVAN, especially due to BK virus infection, is associated with serious outcomes, including deteriorating renal function and renal graft loss. Patient monitoring may help detect patients at risk for PVAN.
PML, which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms.
The risk of CMV viremia and CMV disease is highest among transplant recipients seronegative for CMV at time of transplant who receive a graft from a CMV seropositive donor. Therapeutic approaches to limiting CMV disease exist and should be routinely provided. Patient monitoring may help detect patients at risk for CMV disease.
Viral reactivation has been reported in patients infected with HBV or HCV. Monitoring infected patients for clinical and laboratory signs of active HBV or HCV infection is recommended.
Blood Dyscrasias: Neutropenia and Pure Red Cell Aplasia (PRCA)
Monitor patients for neutropenia that has been observed most frequently in the period of 31 to 180 days post-transplant. If neutropenia develops [absolute neutrophil count (ANC)
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CELLCEPT in combination with other immunosuppressive agents. In some cases, PRCA was found to be reversible with dose reduction or cessation of CELLCEPT. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Gastrointestinal bleeding requiring hospitalization, ulceration and perforations were observed in clinical trials.
Patients with Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency (HGPRT)
CELLCEPT should be avoided in patients with hereditary deficiencies of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndromes because it may cause an exacerbation of disease symptoms characterized by the overproduction and accumulation of uric acid leading to symptoms associated with gout such as acute arthritis, tophi, nephrolithiasis or urolithiasis and renal disease including renal failure.
During treatment with CELLCEPT, the use of live attenuated vaccines should be avoided and patients should be advised that vaccinations may be less effective.
Local Reactions with Rapid Intravenous Administration
CELLCEPT Intravenous solution must not be administered by rapid or bolus intravenous injection as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis.
Risks in Patients with Phenylketonuria
CELLCEPT Oral Suspension contains aspartame, a source of phenylalanine which can be harmful to patients with phenylketonuria (PKU).
Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of CELLCEPT because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman.
Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation of CELLCEPT.
USE IN SPECIFIC POPULATIONS
Females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
CELLCEPT may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
The most common adverse reactions in clinical trials (20% or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections eg, opportunistic infection. The adverse event profile associated with the administration of CELLCEPT Intravenous has been shown to be similar to that observed after administration of oral dosage forms of CELLCEPT. Phlebitis and thrombosis have been reported with intravenous administration. Please refer to the full Prescribing Information for additional Adverse Reactions.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide, for additional Important Safety Information.