For Healthcare Professionals

Important Safety Information

Tools and Interactive Calculators1

The following tools are provided here to assist transplant professionals with patient management:

The creatinine clearance calculator is an easy way to determine Valcyte adult dosing.

Dosing for pediatric patients may be calculated with the pediatric dosing tool.

Creatinine clearance calculator (adult)1

To use our online Creatinine Clearance Calculator, fill in the details and press Calculate to display the creatinine clearance and renal function.

This calculator is for informational purposes only. Calculations performed with this software should be verified and should not be solely relied upon when making treatment decisions. Please refer to the Valcyte Prescribing Information for the Cockcroft-Gault formula used in pivotal trials for renally adjusted dosing of this medication. Healthcare professionals who use this calculator should exercise their own clinical judgement as to the result.

Cockcroft-Gault Creatinine Clearance Calculator
Fill in the details required in the boxes and indicate the patient’s sex.
Press Calculate to display the correct dosage.
Weight
Age Years
Plasma creatinine concentration (mg/dL)
Sex
 
Reset

Valcyte Dosage Corresponding to the Patient’s Cockcroft-Gault Creatinine Clearance (CrCl)1

Crcl (mL/min) Maintenance/Prevention Dosage
≥60 900 mg once daily
40-59 450 mg once daily
25-39 450 mg every 2 days
10-24 450 mg twice weekly
<10
(on hemodialysis)		 Not recommended
  • Modified Cockcroft-Gault formula: (140 – age [years]) x (body weight [kg])/(72) x (serum creatinine [mg/dL])
  • For females = 0.85 x male value

For more information, please see Adult Dosing.

Pediatric Dosing Calculator

Prevention of CMV disease1

For pediatric patients 4 months to 16 years of age who have received a kidney or heart transplant, the recommended daily dose of Valcyte starting within 10 days of transplantation until 100 days posttransplantation is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula.

This dosage may be quickly determined using the calculator below.

Pediatric Dosing Calculator
Fill in the details required in the boxes and indicate the patient’s sex.
Press Calculate to display the correct dosage.
Height
Weight
Age Years
(1-16)
Sex
 
Serum Creatinine (mg/dL)
Reset
  • If the calculated Schwartz creatinine clearance exceeds 150 mL/min/1.73 m2, then a maximum creatinine clearance value of 150 mL/min/1.73 m2 should be used in the equation

For more information, please see Pediatric Dosing.

Valcyte Dosing for Pediatric Patients*1

Chart: Valcyte Dosing for pediatric patients
* Where k = 0.45 for patients aged <1 year, 0.45 for patients aged 1 year to <2 years, 0.55 for boys aged 2 years to <13 years and girls aged 2 years to 16 years, and 0.7 for boys aged 13 years to 16 years.
† Valcyte tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg).

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.

Reference:
1.
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.