For Healthcare Professionals

Important Safety Information

Efficacy for Pediatric Patients: Demonstrated Cytomegalovirus (CMV) Disease Prevention1

Tested in 3 pediatric clinical trials

In 3 clinical trials, the efficacy and safety of Valcyte for oral solution and Valcyte tablets were evaluated in high-risk pediatric kidney or heart transplant patients. Valcyte for oral solution received FDA approval based on the results of the 3 trials: WP16296,* WP16303,* and WV16726.†1,2

  • Valcyte has been studied in 109 pediatric kidney or heart transplant patients who were at high risk for developing CMV disease
  • Valcyte has demonstrated proven efficacy in high-risk (D+/R-) pediatric kidney or heart transplant patients aged 4 months to 16 years3

Percentage (No.) of Patients Developing CMV Disease (N=63)1

CMV disease 0%
CMV syndrome 0%
CMV viremia 11% (n=7)
  • Overall safety profile was similar to that of adults
    • However, the rates of certain AEs and laboratory abnormalities, such as upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia, were reported more frequently in pediatric patients than in adults

* WP16296 and WP16303 have been published as Pescovitz et al. Transpl Infect Dis. 2010;12:195-203.
† WV16726 has been published as Vaudry et al. Am J Transplant. 2009;9(3):636-643.

INDICATIONS

ADULT PATIENTS

Valcyte® (valganciclovir hydrochloride) tablets are indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

PEDIATRIC PATIENTS

Valcyte (valganciclovir hydrochloride) for oral solution and tablets are indicated for the prevention of CMV disease in kidney or heart transplant patients (4 months to 16 years of age) at high risk.

LIMITATIONS OF USE

  • Valcyte is not indicated for use in either adult or pediatric liver transplant patients
  • The safety and efficacy of Valcyte have not been established for:
    • Prevention of CMV disease in solid organ transplants other than those indicated
    • Prevention of CMV disease in pediatric solid organ transplant patients <4 months of age
    • Treatment of congenital CMV disease

IMPORTANT DOSING INFORMATION

  • Adult patients should use Valcyte tablets, not Valcyte for oral solution
  • Valcyte should be taken with food
  • The bioavailability of ganciclovir from Valcyte is significantly higher than from ganciclovir capsules. Therefore, Valcyte tablets cannot be substituted for ganciclovir capsules on a one-to-one basis
  • Valcyte tablets should not be broken or crushed
  • Valcyte for oral solution must be prepared by the pharmacist prior to dispensing to patient

IMPORTANT SAFETY INFORMATION

WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

  • Clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia
  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis

CONTRAINDICATION

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
  • Do not administer 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
  • Advise women of childbearing potential to use effective contraception during treatment and for at least 30 days following treatment with Valcyte. Advise men to practice barrier contraception during and for at least 90 days following treatment with Valcyte
  • 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

ADVERSE REACTIONS

Adult Patients: The most common adverse events and laboratory abnormalities reported in at least one indication by ≥ 20% of patients treated with Valcyte tablets are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.

Pediatric Patients: The most common adverse events and laboratory abnormalities reported in >10% of solid organ transplant recipients treated with Valcyte for oral solution or tablets are diarrhea, pyrexia, hypertension, upper respiratory tract infection, vomiting, anemia, neutropenia, constipation, nausea, and cough.

Please see full Prescribing Information, including Boxed WARNING, for additional Important Safety Information.

References:
1.
Vaudry W, Ettenger R, Jara P, et al; on behalf of the Valcyte WV16726 Study Group. Valganciclovir dosing according to body surface area and renal function in pediatric solid organ transplant recipients. Am J Transplant. 2009;9(3):636-643.
2.
Pescovitz MD, Ettenger RB, Strife CF, et al. Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients. Transpl Infect Dis. 2010;12:195-203.
3.
Valcyte® [package insert]. South San Francisco, CA: Genentech USA, Inc.; 2010.

Important Safety Informationclose

INDICATIONS

ADULT PATIENTS

Valcyte® (valganciclovir hydrochloride) tablets are indicated for the prevention of cytomegalovirus (CMV) disease in kidney, heart, or kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

PEDIATRIC PATIENTS

Valcyte (valganciclovir hydrochloride) for oral solution and tablets are indicated for the prevention of CMV disease in kidney or heart transplant patients (4 months to 16 years of age) at high risk.

LIMITATIONS OF USE

  • Valcyte is not indicated for use in either adult or pediatric liver transplant patients
  • The safety and efficacy of Valcyte have not been established for:
    • Prevention of CMV disease in solid organ transplants other than those indicated
    • Prevention of CMV disease in pediatric solid organ transplant patients <4 months of age
    • Treatment of congenital CMV disease

IMPORTANT DOSING INFORMATION

  • Adult patients should use Valcyte tablets, not Valcyte for oral solution
  • Valcyte should be taken with food
  • The bioavailability of ganciclovir from Valcyte is significantly higher than from ganciclovir capsules. Therefore, Valcyte tablets cannot be substituted for ganciclovir capsules on a one-to-one basis
  • Valcyte tablets should not be broken or crushed
  • Valcyte for oral solution must be prepared by the pharmacist prior to dispensing to patient

IMPORTANT SAFETY INFORMATION

WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

  • Clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia
  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis

CONTRAINDICATION

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
  • Do not administer 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
  • Advise women of childbearing potential to use effective contraception during treatment and for at least 30 days following treatment with Valcyte. Advise men to practice barrier contraception during and for at least 90 days following treatment with Valcyte
  • 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

ADVERSE REACTIONS

Adult Patients: The most common adverse events and laboratory abnormalities reported in at least one indication by ≥ 20% of patients treated with Valcyte tablets are diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, thrombocytopenia, and vomiting.

Pediatric Patients: The most common adverse events and laboratory abnormalities reported in >10% of solid organ transplant recipients treated with Valcyte for oral solution or tablets are diarrhea, pyrexia, hypertension, upper respiratory tract infection, vomiting, anemia, neutropenia, constipation, nausea, and cough.

Please see full Prescribing Information, including Boxed WARNING, for additional Important Safety Information.