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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.
Important Safety Information
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS
- Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer options are available. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
- Increased risk of development of lymphoma and other malignancies, particularly of the skin.
- Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes.
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.
To report a pregnancy or obtain information about the pregnancy exposure registry, visit www.mycophenolateREMS.com or call 1- 800-617-8191.
Lymphoma and Other Malignancies
Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving CELLCEPT (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients.
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:
- Polyomavirus-associated nephropathy (PV AN), especially due to BK virus infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
- JC virus-associated progressive multifocal leukoencephalopathy (PML), which is sometimes fatal, commonly presents with hemiparesis, apathy, confusion, cognitive deficiencies, and ataxia.
- Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.
- Viral reactivation in patients infected with hepatitis B and C.
Patient monitoring may help detect patients at risk for these infections. Consider dose reduction or discontinuation of CELLCEPT in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.
Blood Dyscrasias: Neutropenia and Pure Red Cell Aplasia (PRCA)
Monitor patients for neutropenia, which has been observed most frequently in the period of 31 to 180 days post-transplant. If neutropenia develops [absolute neutrophil count (ANC) <1.3 x 103/μL], interrupt or reduce dosing with CELLCEPT, perform appropriate diagnostic tests and manage patient appropriately. Instruct patients to report immediately any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow depression.
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.
Acute Inflammatory Syndrome Associated with Mycophenolate Products
Acute inflammatory syndrome (AIS) has been reported with the use of MMF and mycophenolate products, and some cases have resulted in hospitalization. AIS is a paradoxical pro-inflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain and elevated inflammatory markers including, C-reactive protein and erythrocyte sedimentation rate, without evidence of infection or underlying disease recurrence. Symptoms occur within weeks to months of initiation of treatment or a dose increase. After discontinuation, improvement of symptoms and inflammatory markers are usually observed within 24 to 48 hours.
Monitor patients for symptoms and laboratory parameters of AIS when starting treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider other treatment alternatives based on the risk and benefit for the patient.
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.
Effect of Concomitant Medications on Mycophenolic Acid Concentrations
A variety of drugs have potential to alter systemic MPA exposure when co-administered with CELLCEPT. Therefore, determination of MPA concentrations in plasma before and after making any changes to immunosuppressive therapy, or when adding or discontinuing concomitant medications, may be appropriate to ensure MPA concentrations remain stable.
Potential Impairment of Ability to Drive or Operate Machinery
CELLCEPT may impact the ability to drive and use machines. Patients should avoid driving or using machines if they experience somnolence, confusion, dizziness, tremor, or hypotension during treatment with CELLCEPT.
The most common adverse reactions in clinical trials (≥ 20%) 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.