Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Indication

Adult Patients:

VALCYTE (valganciclovir hydrochloride) is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

VALCYTE is indicated for the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]).

Pediatric Patients:

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 Including Boxed WARNINGS

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

CONTRAINDICATION

VALCYTE is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction 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
  • VALCYTE should be avoided if the absolute neutrophil count is
  • Use with caution in patients with pre-existing cytopenias, or who have received or who are receiving myelosuppressive drugs or irradiation
  • 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
    • Patients receiving potential nephrotoxic drugs
    • Patients without adequate hydration

ADVERSE REACTIONS

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.

Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information, including Boxed WARNING, for additional Important Safety Information at www.valcyte.com.