For Healthcare Professionals

Important Safety Information

Logo | Valcyte InCharge Patient Program

Enroll Your Patients Now

Your Valcyte® (valganciclovir hydrochloride) patients may partner with you to manage their life after transplant with the VIP Program.

This program encourages your patients to be their own advocates as they embark on their journey to post-transplant recovery.

It was designed to help guide your patients through their transplant journey and provides education, resources, and savings to preserve the choice for branded Valcyte.

Your patients enrolled in this program will receive their very own VIP ORGANizer, which may help your patients keep track of every step of their recovery. The VIP ORGANizer includes the following materials:

Education

  • Educational brochures that cover topics such as cytomegalovirus (CMV) disease and the role of Valcyte

  • Guidance to help them learn how to preserve the choice of branded Valcyte that they've made with you and to know what to ask at the pharmacy

Resources

  • Trackers and tools to help them stay organized, including forms and checklists so they can record information about their medicines and doctor visits

Savings

  • Important information about services that may help them understand their Valcyte out-of-pocket-costs, as well as programs and services for patients who may require support

The VIP ORGANizer may also include a Valcyte Co-pay Card, placed inside by the transplant team if they determined that the patient is eligible for the program.

Upon enrollment in the VIP Program, your patients will receive the following items:

Free Sun Protection Kit

Since transplant patients are at increased risk for skin cancer, we are providing patients with a free sun protection kit that includes lip balm and sunscreen

Ongoing Educational Communications

Members of the VIP Program will receive ongoing educational communications that will inform and remind them of the necessary steps to help guide them through their transplant journey

Please see Important Safety Information and complete Prescribing Information below.

This program is open to residents of the United States and Puerto Rico 18 years of age or older.

Help your patients manage their life after transplant.

Enroll Your Patients Now

If you have already enrolled patients and need to order more VIP ORGANizers, click here to order directly from , the Valcyte Materials Ordering System.

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.
Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function–Study Design, Data Analysis, and Impact on Dosing and Labeling. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). 2010; Clinical Pharmacology: Revision 1.
2.
Limaye AP, Blumberg E, Mu Y, et al. Evaluation of the modification of diet in renal disease (MDRD) equation versus the Cockcroft-Gault (CG) equation as a measure of renal function for valganciclover dose calculations. Poster presented at 2011 American Transplant Congress-11th Joint Annual Meeting of the American Society of Transplant Surgeons and the American Society of Transplantation; April 30–May 4, 2011; Philadelphia, PA.
3.
Data on file 156-013 (IMS National Prescription Audit, October 2010), Genentech USA, Inc., South San Francisco, CA.

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.