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IMPORTANT SAFETY INFORMATION

INDICATION

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 recommended 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.

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.

CONTRAINDICATIONS

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

Embryofetal Toxicity

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.


Serious Infections

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 (PVAN), especially due to BK virus infection
  • JC virus-associated progressive multifocal leukoencephalopathy (PML)
  • 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

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) <1.3 x 103/ÁL], interrupt or reduce dosing with CellCept, perform appropriate diagnostic tests and manage patient appropriately. Severe neutropenia (ANC <0.5 x 103/ÁL) developed in up to 2.0% of renal, up to 2.8% of cardiac, and up to 3.6% of hepatic transplant patients receiving CellCept 3 g daily. 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 Complications

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.


Immunizations

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).


Blood Donation

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.


Semen Donation

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.

  • Pregnancy Planning: For patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.
  • Pregnancy Testing: All females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL immediately before starting CellCept. Another pregnancy test with the same sensitivity should be done 8 to 10 days later. Repeat pregnancy tests should be performed during routine follow-up visits. In the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. To report a pregnancy or obtain information about the pregnancy exposure registry, visit www.mycophenolateREMS.com or call 1-800-617-8191.
  • Contraception: Females of reproductive potential taking CellCept must receive contraceptive counseling and use acceptable contraception (see Table 8 of the full Prescribing Information for acceptable contraception methods). Patients must use acceptable birth control during entire CellCept therapy, and for 6 weeks after stopping CellCept, unless the patient chooses abstinence (she chooses to avoid heterosexual intercourse completely). Sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment.
CellCept may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.

ADVERSE REACTIONS

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.