Valcyte

Valcyte is a prescription medication used to treat cytomegalovirus (CMV) retinitis, an eye infection caused by a virus that can lead to blindness, in adults who have acquired immunodeficiency syndrome (AIDS). Valcyte is also used to prevent CMV disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a high risk for getting CMV disease.

Valcyte belongs to a group of drugs called antivirals which work by stopping the virus from multiplying.

This medication comes in tablet and liquid forms. Valcyte is taken with food.

Common side effects of Valcyte include diarrhea, nausea, vomiting, and fever.

Valcyte is a prescription medication used in adults:

• to treat cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS). 
• to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a high risk for getting CMV disease.

In children (4 months to 16 years of age) Valcyte tablets and oral solution are used:

• to prevent cytomegalovirus (CMV) disease in children who have received a heart or kidney transplant and have a high risk for getting CMV disease.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

See "Drug Precautions" for important information about serious side effects of Valcyte.

Common side effects of Valcyte in adults and children include:

• diarrhea
• nausea, vomiting
• fever
• shaky movements (tremors)
• low white cell, red cell and platelet cell counts in blood tests
• rejection of the transplanted organ (graft)

Other common side effects in children include:

• constipation
• high blood pressure
• 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.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Valcyte and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you take:

• didanosine (Videx)
• zidovudine (Retrovir, Trizivir, Combivir)
• probenecid (Col-Probenecid, Probenecid and Colchicine)
• mycophenolate mofetil (CellCept)

This is not a complete list of Valcyte drug interactions. Ask your doctor or pharmacist for more information.

• Valcyte can affect your blood cells and bone marrow causing serious and life-threatening problems. Valcyte can lower the amount of your white blood cells, red blood cells, and platelets. Your doctor may do regular blood tests to check your blood cells while you are taking Valcyte . Based on these tests, your doctor may change your dose or tell you to stop taking Valcyte.
• Valcyte may cause cancer. Valcyte causes cancer in animals. It is not known if Valcyte causes cancer in people.
• Valcyte may cause birth defects. Valcyte causes birth defects in animals. It is not known if Valcyte causes birth defects in people. If you are pregnant, talk to your doctor before taking Valcyte.
  • Tell your doctor right away if you become pregnant while taking Valcyte .
  • If you are a female who can become pregnant, you should use effective birth control during treatment with Valcyte and for at least 30 days after treatment.
  • Men should use a condom during treatment with Valcyte , and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your doctor if you have questions about birth control.
• Valcyte may lower the amount of sperm in a man's body and cause fertility problems.
• Valcyte can affect your kidney, 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.
• Valcyte changes into the medicine ganciclovir once it is in your body. Ganciclovir is also the active ingredient in Cytovene-IV and ganciclovir capsules. Do not take ganciclovir capsules or Cytovene-IV if you are taking Valcyte. The dose of medicine in Valcyte tablets and ganciclovir capsules is different. One tablet of Valcyte has more medicine than one capsule of ganciclovir. This means that one Valcyte tablet cannot be substituted for one ganciclovir capsule. You could overdose and become very sick if Valcyte is taken with ganciclovir capsules or Cytovene-IV. Talk to your doctor or pharmacist if you have questions about your medicine.

Do not take Valcyte tablets if you are:

• receiving hemodialysis. The use of ganciclovir capsules rather than Valcyte tablets is recommended.
• allergic to any of its ingredients or if you have ever had a serious allergic reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte may include: sudden trouble breathing, wheezing, hives all over your body, swelling around your mouth, or feeling anxious.

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Valcyte there are no specific foods that you must exclude from your diet when receiving Valcyte.

Before taking Valcyte, tell your doctor if you:

• have kidney problems. Your doctor may give you a lower dose of Valcyte, or check you more often if you are taking Valcyte.
• have blood cell problems
• are having radiation treatment
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Valcyte causes birth defects in an unborn baby. Tell your doctor right away if you become pregnant while taking Valcyte.
• are breast-feeding or plan to breast-feed. It is not known if Valcyte passes into your milk and if it may harm your baby. You should not breast-feed if you are HIV-positive because of the chance of passing the HIV virus to your baby through your milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. Valcyte should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Valcyte is excreted in human breast milk or if it will harm your nursing baby. The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking transmission of HIV.

• Take Valcyte exactly as your doctor prescribes it. Your dose of Valcyte will depend on your medical condition.
• Adults should only take Valcyte tablets. Children may take either Valcyte tablets or oral solution.
• Take Valcyte with food.
• Do not break or crush Valcyte tablets. Avoid contact with your skin or eyes. If you come in contact with the contents of the tablet or oral solution, wash your skin well with soap and water or rinse your eyes well with plain water.
• If your child is prescribed Valcyte for oral solution, your pharmacist will give you dosing dispensers to measure your dose of Valcyte for oral solution.
• To be sure you receive the prescribed dose, it is important to use the dispenser provided to you. Be sure to read, and that you understand, and follow the instructions below on how to take Valcyte for oral solution and how to use the dispenser. Ask your pharmacist if you have any questions. If you lose or damage your dispensers and cannot use them, contact your pharmacist.
• If you miss a dose of Valcyte , take the missed dose as soon as you remember. Then, take the next dose at the usual scheduled time. However, if it is almost time for your next dose, do not take the missed dose.
• Do not let your Valcyte run out. The amount of virus in your blood may increase if your medicine is stopped, even for a short time.
• If you take too much Valcyte, call your local poison control center or emergency room right away. You may need treatment in a hospital.
• Do not substitute Valcyte tablets for ganciclovir capsules. Talk to your doctor, nurse or pharmacist if you have questions about your medicine.

Take Valcyte exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Valcyte tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Store Valcyte for oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C), for no longer than 49 days. Do not freeze.
• Do not keep medicine that is out of date or that you no longer need.
• Keep Valcyte and all medicines out of the reach of children.

WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

• Clinical toxicity of Valcyte , which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia
• In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis