Generic Name: valganciclovir (VAL-gan-SYE-kloe-vir)
Brand Name: Valcyte
Severe and sometimes life-threatening blood and bone marrow side effects (eg, low platelet levels, low white blood cell counts, anemia) have happened with Valcyte. Contact your doctor right away if you develop unusual tiredness or weakness, easy bruising or bleeding, or symptoms of an infection (eg, fever, chills, persistent sore throat).
Valcyte has caused cancer, fertility problems in males and females that could be permanent, and birth defects in animals. Valcyte may have the same effects in humans. Discuss any questions or concerns with your doctor.
Valcyte is used for:
Treating cytomegalovirus (CMV) infection of the eye in patients with acquired immunodeficiency syndrome (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 levels of red blood cells, certain white blood cells (eg, neutrophils), or platelets
- you are on dialysis
- you are taking ganciclovir
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 have allergies to medicines, foods, or other substances
- if you are dehydrated or have kidney problems
- if you have congenital CMV disease, blood cell or platelet problems, or a history of bone marrow problems
- if you have had a transplant other than a kidney, heart, or kidney-pancreas transplant
- if you have recently received or are receiving chemotherapy or radiation treatment
- if you have taken other medicines that may cause bone marrow problems or weaken your immune system. Ask your doctor if you are unsure if any of your medicines may cause bone marrow problems or weaken your immune system
Some MEDICINES MAY INTERACT with Valcyte. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Zidovudine because the risk of low white blood cell levels or anemia may be increased
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney problems may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Mycophenolate mofetil, mycophenolic acid, or probenecid because they may increase the risk of Valcyte's side effects
- Didanosine because the risk of its side effects may be increased by Valcyte
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 extra patient leaflet is available with Valcyte. Talk to your pharmacist if you have questions about this information.
- Take Valcyte by mouth 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 your skin thoroughly with soap and water and rinse your eyes with plenty of clear water.
- Check with your pharmacist about how you should dispose of any unused medicine.
- Take Valcyte on a regular schedule to get the most benefit from it.
- 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:
- Tell your doctor or dentist that you take Valcyte before you receive any medical or dental care, emergency care, or surgery.
- Valcyte may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Valcyte with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Valcyte is not a cure for CMV infection. Remain under the care of your doctor.
- If you are switching from ganciclovir to Valcyte: 1 tablet of Valcyte contains more medicine than 1 capsule of ganciclovir. Be sure you know how many tablets of Valcyte your doctor wants you to take. Do NOT take more than the recommended dose; you may experience serious side effects or overdose.
- You should be careful not to become dehydrated while you are taking Valcyte. The risk of kidney problems may be increased. Check with your doctor about whether you should drink extra fluids while you are taking Valcyte.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Valcyte may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Valcyte may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Valcyte, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
- Some patients have had rejection of their transplanted organ while taking Valcyte. Discuss any questions or concerns with your doctor.
- Men who take Valcyte should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Valcyte and for at least 90 days after you stop taking it.
- Women who take Valcyte and who may become pregnant should always use effective birth control during sex. Do this for as long as you take Valcyte and for at least 30 days after you stop taking it.
- A pregnancy test will be done to show that you are not pregnant before starting Valcyte. Discuss any questions or concerns with your doctor.
- Have an eye exam as you have been told by your doctor.
- Lab tests may be performed while you use Valcyte. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Valcyte with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems.
- Caution is advised when using Valcyte in CHILDREN; they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: Valcyte may cause harm to the fetus. Do not become pregnant while you are using it. Use effective contraception to prevent pregnancy while you are taking Valcyte. If you think you may be pregnant, contact your doctor right away. It is not known if this medicine is found 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; 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); confusion; dark urine; decreased coordination; hallucinations; irregular heartbeat; mental or mood changes (eg, depression); muscle weakness; numbness or tingling of the skin, hands, or feet; pale skin; seizures; severe or persistent headache, dizziness, or drowsiness; swelling of the arms or legs; symptoms of bleeding (eg, vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; unusual vaginal bleeding; bruises without a reason or that get bigger; any bleeding that is severe or that you cannot stop); symptoms of infection (eg, fever, chills, sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, painful urination, mouth sores, wound that will not heal); symptoms of kidney problems (eg, not able to pass urine, change in how much urine is passed, blood in the urine, a big weight gain); tremors, unsteady movements; unusual tiredness or weakness; vision changes; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Valcyte:
Store Valcyte at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not store in the bathroom. Keep Valcyte out of the reach of children and away from pets.
- If you have any questions about Valcyte, 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Valcyte or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Valcyte. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Valcyte. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Valcyte.
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- Drug class: purine nucleosides