Valcyte (Valganciclovir)

VALCYTE has caused birth defects in animal studies. Do not use VALCYTE without telling your doctor if you are pregnant.

Use birth control to prevent pregnancy, whether you are a man or a woman. VALCYTE use by either parent may cause birth defects. A man taking VALCYTE should use a condom during treatment, and for at least 90 days after treatment ends.

Serious infections may occur during treatment with VALCYTE. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, weakness, cold or flu symptoms, painful mouth sores, pale skin, easy bruising or bleeding, dry cough, weight loss, or trouble breathing.

Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together.

You should not use this medicine if you are allergic to valganciclovir or ganciclovir (Cytovene).

Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together.

Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). The strength of these two medications is different. A VALCYTE tablet contains more medicine than a ganciclovir capsule. You may not need to use as many VALCYTE tablets as you did ganciclovir capsules. Take only the number of VALCYTE tablets your doctor has prescribed.

To make sure VALCYTE is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• a blood cell disorder (such as anemia or low levels of platelets in your blood); or
• if you are receiving radiation treatment or drugs that weaken your immune system (such as cancer medicine or steroids).

VALCYTE can cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant. You may need to have a negative pregnancy test before taking VALCYTE. Use effective birth control while you are taking VALCYTE and for at least 30 days after your treatment ends.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. VALCYTE will not prevent congenital (inherited) CMV in a newborn baby.

If a man fathers a child while using VALCYTE, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using VALCYTE.

This medication can affect fertility (your ability to have children), whether you are a man or a woman.

You should not breast-feed while you are taking VALCYTE. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

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:

• sudden weakness or ill feeling, fever, chills, sore throat, cold or flu symptoms;
• painful mouth sores, pain when swallowing, red or swollen gums;
• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum); or
• feeling light-headed or short of breath, chest discomfort, wheezing, dry cough or hack, rapid weight loss.

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 urinating; 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 may include:

• fever or other signs of infection;
• nausea, vomiting, diarrhea;
• headache;
• tremors, loss of balance or coordination;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• high blood pressure--severe headache, blurred vision, pounding in your neck or ears, confusion, severe chest pain, irregular heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

VALCYTE may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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.

VALCYTE can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with VALCYTE, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

VALCYTE tablets are for adults or children, but VALCYTE liquid is only for children. Adults should not use the oral solution or the dose may not be correct.

Take VALCYTE with food.

Drink plenty of liquids while you are taking VALCYTE.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

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. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

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. 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.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include urinating less than usual or not at all, swelling, weight gain, stomach pain, nausea, vomiting, signs of infection (fever, chills, sore throat, flu symptoms), or jaundice (yellowing of the skin or eyes).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.