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

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

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

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

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

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.

Valganciclovir comes as a tablet and as an oral solution (liquid) to take by mouth. It is usually taken with food once or twice a day. To help you remember to take valganciclovir, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valganciclovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Children may take the tablets or the oral solution; however, adults should only take the tablets.

The oral solution will be prepared by your pharmacist and they will also give you a device to measure your dose. Only use the measuring device provided to you to measure your solution.

Shake the oral solution well before each use.

Swallow the tablets whole; do not split, chew, break, or crush them.

Be careful when handling valganciclovir tablets or oral solution. Do not allow your skin, eyes, mouth, or nose to come into contact with broken or crushed valganciclovir tablets or oral solution. If such contact occurs, wash your skin well with soap and water or rinse your eyes well with plain water.

Valganciclovir helps to control CMV but does not cure it. Do not stop taking valganciclovir without talking to your doctor. Stopping to take valganciclovir too soon may cause the amount of CMV in your blood to increase or the virus to become resistant to this medication.

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

Take valganciclovir with food.

Valganciclovir tablets are for adults or children, but valganciclovir 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 valganciclovir 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 valganciclovir, you may need frequent blood tests.

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

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

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

Store valganciclovir 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 valganciclovir.

Using valganciclovir 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.

Valganciclovir 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 valganciclovir 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 valganciclovir.

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 valganciclovir 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the oral solution in the refrigerator for up to 49 days at 2–8°C; do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Drink plenty of fluids while you are taking valganciclovir.

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 valganciclovir 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 valganciclovir. 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 valganciclovir 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.

Valganciclovir 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 valganciclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Do not let anyone else take your medication. Do not let your valganciclovir supply run out. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.