Valcyte is used in adults to prevent infection with cytomegalovirus (CMV) that may occur after an organ transplant (heart, kidney, or pancreas). This medicine is also used to treat CMV infection of the eye in adults with acquired immunodeficiency syndrome (AIDS).

Valcyte is used in children who are 4 months old to 16 years old to prevent CMV infection after a kidney transplant. This medicine is also used in children who are 1 month old to 16 years old to prevent CMV disease after a heart transplant.

Valcyte will not cure CMV but it can help control the infection.

Valcyte may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Valcyte can cause birth defects. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Valcyte.

Use effective birth control to prevent pregnancy, whether you are a man or a woman. Keep using birth control for at least 30 days after your last dose of valganciclovir if you are a woman, or for at least 90 days after your last dose if you are a man.

Call your doctor right away if you have signs of infection such as: fever, chills, tiredness, flu symptoms, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding, shortness of breath, or feeling light-headed.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Valcyte with food.

Valcyte tablets are for adults or children, but this medicine liquid is only for children.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Do not crush or break a Valcyte tablet. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water.

While using Valcyte, you may need frequent blood tests.

You should have your eyes checked at least every 4 to 6 weeks while you are using Valcyte for CMV. Your doctor may want you to have eye exams more often.

Use Valcyte regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store Valcyte tablets at room temperature away from moisture and heat.

Store Valcyte liquid in the refrigerator. Do not freeze. Throw away any unused after 49 days.

You should not use this medicine if you are allergic to ganciclovir or Valcyte.

Using Valcyte may increase your risk of developing certain types of cancers. Ask your doctor about this risk.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);

• low blood cell counts; or

• radiation treatment.

Valcyte can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Valcyte if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 90 days after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Valcyte.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Valcyte can harm an unborn baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Do not give this medicine to a child without medical advice.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury.

Avoid driving or hazardous activity until you know how Valcyte will affect you. Your reactions could be impaired.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Ask your doctor how to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with Valcyte. Call your doctor right away if you have signs of infection such as:

• fever, chills, tiredness, flu-like symptoms;

• feeling light-headed or short of breath;

• mouth sores, skin sores;

• pale skin, cold hands and feet; or

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum).

Also call your doctor at once if you have:

• a seizure (convulsions);

• pain or burning when you urinate;

• pain or swelling near your transplanted organ; or

• kidney problems--little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Kidney problems may be more likely in older adults.

Common side effects of Valcyte may include:

• fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, feeling light-headed or short of breath;

• pain or burning when you urinate;

• nausea, vomiting, diarrhea;

• headache;

• tremors;

• sleep problems (insomnia); or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Valcyte can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect Valcyte, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.