WHO IS VALCYTE FOR?

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.

Limitations of use:

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

HOW SHOULD I TAKE VALCYTE?

• Take Valcyte exactly as your doctor prescribes it
• Adult patients should use Valcyte tablets, not Valcyte for oral solution
• Take Valcyte with food
• Do not break or crush tablets

IMPORTANT SAFETY INFORMATION

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT VALCYTE?

• Valcyte can affect your blood cells and bone marrow, causing serious and life-threatening problems. Your doctor may do regular blood tests to check your blood cells and may change your dose or tell you to stop taking Valcyte

Tell your doctor right away if you 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

If you are a woman who can get pregnant, you must use a reliable method of birth control during treatment with Valcyte and continue birth control for at least 30 days after you stop taking Valcyte. Tell your doctor right away if you 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 following treatment if their partner can get pregnant.

Talk to your doctor if you have any questions on 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

WHO SHOULD NOT RECEIVE VALCYTE?

• You should not receive Valcyte if you are allergic to any of its ingredients or if you 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 your body, swelling around your mouth, or feeling anxious
• Valcyte can affect your kidneys, including serious problems such as kidney failure. Your doctor may do regular blood tests to check your kidney function while you are taking Valcyte. Your doctor may adjust your dose based on these tests
• You must not take Valcyte tablets if you are receiving hemodialysis. You should talk to your doctor if you are receiving hemodialysis

WHAT SHOULD I TELL MY DOCTOR BEFORE STARTING VALCYTE?

Tell your doctor if:

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

WHAT SHOULD I AVOID WHILE TAKING VALCYTE?

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

WHAT ARE THE MOST COMMON SIDE EFFECTS FROM VALCYTE?

• 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

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Valcyte. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at
1-800-FDA-1088 or to Genentech at 1-888-835-2555.

Talk to your doctor if you have any questions about your medication.

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