Valcyte SolutionGeneric Name: Valganciclovir
Valcyte Solution is changed into another medicine, ganciclovir, in the body. It may cause severe blood side effects (eg, low platelets, low white blood cell counts, anemia). Contact your doctor right away if you develop unusual fatigue, easy bruising or bleeding, or signs of an infection (eg, fever, chills, persistent sore throat).
Valcyte Solution has caused cancer, birth defects, and a lack of sperm production in animals. Discuss any questions or concerns with your doctor.
Valcyte Solution is used for:
Treating cytomegalovirus (CMV) infection of the eye in patients 4 months to 16 years old 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 Solution is an antiviral agent. It works by stopping the growth and reproduction of the virus.
Do NOT use Valcyte Solution if:
- you are allergic to any ingredient in Valcyte Solution or to ganciclovir
- you have very low blood cell or platelet levels
- you are on dialysis
- you are an adult. Adult patients should use the tablet form of Valcyte Solution
- you are taking ganciclovir
Contact your doctor or health care provider right away if any of these apply to you.
Before using Valcyte Solution:
Some medical conditions may interact with Valcyte Solution. 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 are dehydrated or have kidney problems
- if you have 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 Solution. 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 Solution's side effects
- Didanosine because the risk of its side effects may be increased by Valcyte Solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Valcyte Solution 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 Solution:
Use Valcyte Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Valcyte Solution. Talk to your pharmacist if you have questions about this information.
- Take Valcyte Solution by mouth with food.
- Shake well for about 5 seconds before each use.
- Use the measuring device that comes with Valcyte Solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Do not get Valcyte Solution on your skin or in your eyes or nose. If contact occurs, wash the skin thoroughly with soap and water and rinse eyes with plenty of clear water.
- Check with your pharmacist about how you should dispose of any unused medicine.
- Take Valcyte Solution on a regular schedule to get the most benefit from it.
- Continue to take Valcyte Solution even if you feel well. Do not miss any doses.
- If you miss a dose of Valcyte Solution, 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 Solution.
Important safety information:
- Valcyte Solution 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 Solution. Using Valcyte Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Valcyte Solution is not a cure for CMV infection. Remain under the care of your doctor.
- Do NOT take more than the recommended dose without checking with your doctor.
- You should be careful not to become dehydrated while you are taking Valcyte Solution. The risk of kidney problems may be increased. Check with your doctor about whether you should drink extra fluids while you are taking Valcyte Solution.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Valcyte Solution 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.
- Valcyte Solution 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 the stools, or dark, tarry stools to your doctor.
- Use of Valcyte Solution 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 Solution and become more difficult to treat if you stop taking it, even for a short period of time.
- Valcyte Solution may cause decreased sperm production. This may be temporary or permanent. Discuss any questions or concerns with your doctor.
- Valcyte Solution may cause decreased fertility in women. Discuss any questions or concerns with your doctor.
- Men who take Valcyte Solution should always use a condom when having sex with a woman who may become pregnant. Do this for as long as you take Valcyte Solution and for at least 90 days after you stop taking it.
- Women who take Valcyte Solution and who may become pregnant should always use effective birth control during sex. Do this for as long as you take Valcyte Solution and for at least 30 days after you stop taking it.
- 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 Solution with caution in the ELDERLY; they may be more sensitive to its effects, especially kidney problems.
- Caution is advised when using Valcyte Solution in CHILDREN; they may be more sensitive to its effects, especially fever, upper respiratory tract infection, anemia, and low white blood cell levels.
- Use Valcyte Solution with extreme caution in CHILDREN younger than 4 months old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Valcyte Solution may cause harm to the fetus. Avoid becoming pregnant while taking Valcyte Solution. Use effective contraception to prevent pregnancy while you are taking Valcyte Solution. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Valcyte Solution while you are pregnant. It is not known if Valcyte Solution is found in breast milk. Do not breast-feed while taking Valcyte Solution.
Possible side effects of Valcyte Solution:
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; cough; diarrhea; dizziness; drowsiness; headache; nausea; stomach pain; trouble sleeping; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; 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; seizures; severe or persistent headache or dizziness; swelling of the arms or legs; symptoms of infection (eg, fever, chills, sore throat); tremors; unsteady movements; unusual bruising or bleeding; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include blood in the urine; change in the amount of urine produced; dark urine; fever, chills, or sore throat; seizures; severe or persistent diarrhea, vomiting, or stomach pain; tremors; unusual bruising or bleeding; yellowing of the skin or eyes.Proper storage of Valcyte Solution:
Store Valcyte Solution in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep the container tightly closed. Throw away any unused medicine after 49 days. Keep Valcyte Solution out of the reach of children and away from pets.
- If you have any questions about Valcyte Solution, please talk with your doctor, pharmacist, or other health care provider.
- Valcyte Solution 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 Solution. 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.
- Valcyte Prescribing Information (FDA)
- Valcyte Advanced Consumer (Micromedex) - Includes Dosage Information
- Valcyte Detailed Consumer Information (PDR)
- Valcyte Concise Consumer Information (Cerner Multum)
- Valganciclovir Professional Patient Advice (Wolters Kluwer)