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|Valcyte

Valcyte

Valcyte is used for:

Treating cytomegalovirus (CMV) infection of the eye in patients with AIDS. It is used to prevent CMV disease in high risk kidney, heart, and kidney-pancreas transplant patients. It may also be used for other conditions as determined by your doctor.

Valcyte is an antiviral agent. It works by stopping the growth and reproduction of the virus.

Do NOT use Valcyte if:

• you are allergic to any ingredient in Valcyte or to ganciclovir
• you have very low blood cell or platelet levels
• you are on dialysis

Contact your doctor or health care provider right away if any of these apply to you.

Before using Valcyte :

Some medical conditions may interact with Valcyte . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have kidney problems, blood cell or platelet problems, or a history of bone marrow problems
• if you have a history of chemotherapy or radiation treatment, or you have taken other medicines that may cause bone marrow problems. Ask your doctor if you are unsure if any of your medicines may cause bone marrow problems.

Some MEDICINES MAY INTERACT with Valcyte . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Didanosine because risk of severe side effects, such as toxicity, may be increased by Valcyte
• Probenecid because the risk of toxic effects of Valcyte may be increased
• Zidovudine because the risk of toxic effects, such as severe or life-threatening blood problems, may be increased
• Mycophenolate mofetil because it may increase Valcyte "s risk of side effects in patients with kidney problems

This may not be a complete list of all interactions that may occur. Ask your health care provider if Valcyte may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Valcyte :

Use Valcyte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An additional patient leaflet is available with Valcyte . Talk to your pharmacist if you have questions about this information.
• Take Valcyte with food.
• Swallow Valcyte whole. Do not break, crush, or chew before swallowing.
• Do not get broken or crushed tablets on your skin or in your eyes, nose, or mouth. If contact occurs, wash the skin thoroughly with soap and water and rinse eyes with plenty of clear water.
• Any broken or leftover medicine should be placed in a plastic bag and disposed of as instructed by your doctor or pharmacist.
• Continue to take Valcyte even if you feel well. Do not miss any doses.
• If you miss a dose of Valcyte , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Valcyte .

Important safety information:

• Valcyte may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Valcyte . Using Valcyte alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Valcyte is not a cure for CMV infection. Remain under the care of your doctor.
• Valcyte may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Do not substitute Valcyte for ganciclovir because an overdose may occur. Check with your doctor or pharmacist if you have any questions about the brand or dose of your medicine.
• Valcyte may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Use of Valcyte may increase your risk of developing cancer. Discuss any questions or concerns with your doctor.
• When your medicine supply begins to run low, get more from your doctor or pharmacist as soon as possible. The virus may develop resistance to Valcyte and become more difficult to treat if you stop taking it, even for a short period of time.
• Valcyte may cause decreased sperm production and decreased fertility.
• During sexual intercourse with a woman who may become pregnant, men taking Valcyte should use a condom during treatment with Valcyte and for 90 days after it is stopped.
• Lab tests, including eye exams, complete blood cell and platelet counts, and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Valcyte with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Valcyte with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Valcyte may cause harm to the fetus. Avoid becoming pregnant while taking Valcyte . Use effective contraception to prevent pregnancy while you are taking Valcyte . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Valcyte during pregnancy. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking Valcyte .

Possible side effects of Valcyte :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; constipation; diarrhea; dizziness; drowsiness; headache; nausea; stomach pain; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; confusion; cough; decreased urination; depression; fever; hallucinations; loss of coordination; numbness or tingling of the skin, hands, or feet; seizures; sore throat; swelling of the legs; tremors; unsteady movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; seizure; severe stomach pain, diarrhea, or vomiting; yellowing of the skin or eyes.

Store Valcyte at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Keep Valcyte out of the reach of children and away from pets.

General information:

• If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
• Valcyte is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Valcyte . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.