Information for Healthcare Providers / Patients

Valcyte® (valganciclovir hydrochloride)

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.

What it Treats

Adult patients:
Valcyte® (valganciclovir hydrochloride) is prescribed to patients with acquired immunodeficiency syndrome (AIDS) for the treatment of cytomegalovirus (CMV) retinitis. When CMV virus infects the eyes, it is called CMV retinitis.

Valcyte tablets are an antiviral prescription medication given to patients who have a high chance of developing CMV disease after receiving a heart, kidney, or kidney-pancreas transplant. Valcyte helps prevent CMV disease in these patients.

Pediatric patients
Valcyte tablets or oral solution is prescribed for the prevention of CMV disease in patients that are 4 months to 16 years of age who have received a kidney or heart transplant and have a high chance of developing CMV disease.

Valcyte should not be used in adults or children who have received a liver transplant.

It is not known if Valcyte works or is safe to use in:

  • Solid organ transplants other than those stated above
  • Patients younger than 4 months of age
  • Prevention of CMV disease that was present at birth
  • Patients aged 65 and older

Important Safety Information and Most Serious Side Effect

Valcyte can affect blood cells and bone marrow causing serious and life-threatening problems. Patients’ doctors may do regular blood tests to check blood cells and may change the dose or tell patients to stop taking Valcyte. Patients must tell their doctor right away if they have any unexpected bruising or bleeding, unusual tiredness, fever, lack of energy, dizziness, or fainting.

Valcyte may cause cancer. Valcyte causes cancer in animals. It is not known if Valcyte causes cancer in people.

Valcyte may cause birth defects. Pregnant women who take Valcyte have a higher chance of having a baby with birth defects. Valcyte should not be used during pregnancy.

Women who can get pregnant must use a reliable method of birth control during treatment with Valcyte and continue birth control for at least 30 days after they stop taking Valcyte. Women must tell their doctor right away if they get pregnant or plan to become pregnant while taking Valcyte.

Men must use a condom during treatment with Valcyte, and for at least 90 days after treatment, if their partner can get pregnant. Patients should talk to their doctor if they have questions about birth control.

Valcyte may lower the amount of sperm in a man’s body and cause fertility problems.

Valcyte tablets cannot be substituted for the same number of ganciclovir capsules. Patients could overdose and become very sick if Valcyte is taken with ganciclovir capsules or Cytovene-IV. Patients should talk to their doctor or pharmacist if they have questions about their medicine.

Patients should not receive Valcyte if they are allergic to any of its ingredients or if they have ever had a serious reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte may include cold, sudden trouble breathing, wheezing, hives all over the body, swelling around the mouth, or feeling anxious.

Valcyte can affect the kidneys, including serious problems such as kidney failure. The patient’s doctor may do regular blood tests to check kidney function while patients are taking Valcyte. The doctor may adjust the dose based on these tests.

Patients must not take Valcyte tablets if they are receiving hemodialysis. Patients should talk to their doctor if they are receiving hemodialysis.

Before stating Valcyte, patients should tell their doctor if they:

  • are pregnant or plan to become pregnant. It is not known if Valcyte causes birth defects in an unborn baby.
  • are breast feeding, or plan to breast feed
  • have kidney problems or any other medical condition
  • have problems with their blood cells
  • are taking any prescription or non-prescription medicines, vitamins, and herbal supplements
  • are having radiation treatment

Valcyte can cause seizures, sleepiness, dizziness, unsteady movements, and confusion. Patients should not drive a car or operate other dangerous machinery until they know how Valcyte affects them.

Patients must take Valcyte exactly as their doctor prescribes it. Adult patients should use Valcyte tablets, not Valcyte for oral solution. Valcyte must be taken with food. Do not break or crush tablets.

Common side effects of Valcyte in adults and children include: diarrhea, nausea, vomiting, fever, shaky movements (tremors), low blood cell counts in a blood test, and rejection of the transplanted organ (graft).

Other common side effects in children include: constipation, high blood pressure, and cough and colds.

Patients should tell their doctor if they have any side effect that bothers them or that does not go away.

Patients should call their doctor for medical advice about side effects. Consumers may report side effects to the FDA at 1-800-FDA-1088 or to Genentech at 1-888-835-2555.

For Valcyte full prescribing information, including Boxed WARNINGS, Medication Guide and additional important safety information, please visit www.valcyte.com.

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