There are different paths to the patient services and programs offered by Genentech® Transplant Access Services (GTAS).
Indications and Important Safety Information
VALCYTE® (valganciclovir hydrochloride) is indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).
VALCYTE is indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Adult patients should use VALCYTE tablets, not VALCYTE for oral solution.
IMPORTANT SAFETY INFORMATION
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY, FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
- Hematologic Toxicity: Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia and aplastic anemia have been reported in patients treated with VALCYTE
- Impairment of Fertility: Based on animal data, VALCYTE may cause temporary or permanent inhibition of spermatogenesis
- Fetal Toxicity: Based on animal data, VALCYTE has the potential to cause birth defects in humans
- Mutagenesis and Carcinogenesis: Based on animal data, VALCYTE has the potential to cause cancers in humans
VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the formulation.
WARNINGS AND PRECAUTIONS
- Severe leukopenia, neutropenia, anemia, thrombocytopenia, pancytopenia, bone marrow aplasia, and aplastic anemia have been observed in patients treated with VALCYTE or ganciclovir
- VALCYTE should be avoided if the absolute neutrophil count is <500 cells/μL, the platelet count is <25,000/μL, or the hemoglobin is <8 g/dL
- Use with caution in patients with pre-existing cytopenias, or who have received or who are receiving myelosuppressive drugs or irradiation. Cytopenia may occur at any time during treatment and may worsen with continued dosing. Cell counts usually begin to recover within 3 to 7 days after discontinuing drug
- Pregnancy should be avoided in female patients taking VALCYTE and in females with male partners taking VALCYTE. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 30 days following treatment with VALCYTE. Similarly, males should be advised to practice barrier contraception during and for at least 90 days following treatment with VALCYTE
- Animal data indicate that ganciclovir is mutagenic and carcinogenic. VALCYTE should therefore be considered a potential carcinogen in humans
- Acute renal failure may occur in:
- Elderly patients with or without reduced renal function. Caution should be exercised when administering VALCYTE to geriatric patients and dosage reduction is recommended for those with impaired renal function
- Patients receiving potential nephrotoxic drugs. Caution should be exercised when administering VALCYTE to patients receiving potential nephrotoxic drugs
- Patients without adequate hydration. Adequate hydration should be maintained for all patients
Adult Patients: The most common adverse events and laboratory abnormalities reported in at least one indication by ≥20% of patients are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.
Pediatric Patients: The most common adverse events and laboratory abnormalities reported in ≥20% of pediatric solid organ transplant recipients are diarrhea, pyrexia, hypertension, upper respiratory tract infection, urinary tract infection, vomiting, neutropenia, leukopenia, and headache.
Please click here for Valcyte full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.
Indication and Important Safety Information
CellCept® (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets, and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; 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. Females of reproductive potential (FRP) must be counseled regarding pregnancy prevention and planning.
Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac, or hepatic transplant patients should prescribe CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. CellCept Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
- Pregnancy category D: Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant female. 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 the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.
- Patients receiving immunosuppressive regimens involving combinations of drugs, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin.
- CellCept has been administered in combination with the following agents in clinical trials: antithymocyte globulin, OKT3, cyclosporine, and corticosteroids. The efficacy and safety in combination with other immunosuppressive agents have not been determined.
- 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, including fatal outcomes. Because of the danger of oversuppression of the immune system which can increase susceptibility to infection, combination immunosuppressant therapy should be used with caution.
- Polyomavirus associated nephropathy (PVAN), JC virus associated progressive multifocal leukoencephalopathy (PML), cytomegalovirus (CMV) infections, reactivation of hepatitis B (HBV) or hepatitis C (HCV) have been reported in patients treated with immunosuppressants, including CellCept. Reduction in immunosuppression should be considered for patients who develop evidence of new or reactivated viral infections. Physicians should also consider 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. Risk factors for PML include treatment with immunosuppressant therapies and impairment of immune function. In immunosuppressed patients, physicians should consider PML in the differential diagnosis in patients reporting neurological symptoms and consultation with a neurologist should be considered as clinically indicated.
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.
- Monitor patients for neutropenia that has been observed most frequently in the period of 31 to 180 days posttransplant. 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. Severe neutropenia (ANC <0.5 x 10³/µL) 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 3g 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. The mechanism for CellCept induced PRCA and the relative contribution of other immunosuppressants and their combinations in an immunosuppression regimen are unknown. 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.
- CAUTION: CELLCEPT INTRAVENOUS SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
- Females of reproductive potential (including pubertal girls and perimenopausal women) 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 Testing: 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, females should be counseled with regard to whether the maternal benefits of mycophenolate treatment may outweigh the risks to the fetus in certain situations, please report the pregnancy to Mycophenolate Pregnancy Registry (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).
- CellCept may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.
- In cardiac transplant patients, the overall incidence of opportunistic infections was approximately 10% higher in patients treated with CellCept than in those receiving azathioprine therapy.
- CellCept should not be administered concomitantly with azathioprine and used with caution when used in the concomitant administration with drugs that interfere with enterohepatic recirculation.
- CellCept should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT), such as Lesch-Nyhan or Kelley-Seegmiller syndrome.
- Gastrointestinal bleeding (requiring hospitalization) has been observed.
- During treatment with CellCept, avoid the use of live attenuated vaccines and advise patients that vaccinations may be less effective.
- Care should be taken if CellCept Oral Suspension is administered to patients with phenylketonuria.
- The principal adverse reactions associated with the administration of CellCept include diarrhea, leukopenia, sepsis, vomiting, and there is evidence of a higher frequency of certain types of infections, eg, opportunistic infections (see WARNINGS in full Prescribing Information). 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 click here for CellCept full Prescribing Information, including Boxed WARNINGS and Medication Guide, for additional Important Safety Information.
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