Valcyte / valganciclovir

Brand Names

In the U.S.—

• Valcyte

Category

• Antiviral, systemic

Description

Valganciclovir (val-gan-SYE-kloh-veer) is an antiviral. It is used to treat infections caused by viruses.

Valganciclovir is used to treat the symptoms of cytomegalovirus (CMV) retinitis, an infection in the eyes of people with acquired immunodeficiency syndrome (AIDS). Valganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse.

This medicine may cause some serious side effects, including anemia and other blood problems. Before you begin treatment with valganciclovir, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral

• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valganciclovir, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to valganciclovir or ganciclovir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Valganciclovir has not been studied in pregnant women. However, studies in animals have shown that valganciclovir causes birth defects and other problems. Use of valganciclovir during pregnancy should be avoided whenever possible. The use of birth control is recommended during valganciclovir therapy. Men should use a condom while taking valganciclovir, and for at least 90 days following treatment.

Breast-feeding—It is not known whether valganciclovir passes into the breast milk. However, valganciclovir is not recommended during breast-feeding, because it may cause unwanted effects in nursing babies.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of valganciclovir in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of valganciclovir in the elderly with use in other age groups.

Other medicines— Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking valganciclovir, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin) or
• Zidovudine (e.g., AZT, Retrovir)—Caution should be used if these medicines and valganciclovir are used together; receiving valganciclovir while you are using these medicines may make anemia and other blood problems worse

• Didanosine (e.g., Videx) or
• Mycophenolate (e.g., CellCept) or
• Probenecid (e.g., Benemid)—Use of these medicines with valganciclovir may increase the chance of side effects

Other medical problems—The presence of other medical problems may affect the use of valganciclovir. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Valganciclovir may build up in the blood in patients with kidney disease, increasing the chance of side effects

• Low platelet count or
• Low red blood cell count or
• Low white blood cell count—Valganciclovir may make these blood diseases worse

Proper Use of This Medicine

It is important that you take valganciclovir tablets with food. This is to make sure the medicine is fully absorbed into the body and will work properly.

To get the best results, valganciclovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, valganciclovir must be taken on a regular schedule.

Dosing—

The dose of valganciclovir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of valganciclovir. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
• For treatment of CMV in the eyes:
• Adults—To start, 900 milligrams (mg) two times a day with food. As you improve the dose may be changed to 900 mg once a day with food.
• Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits

It is also very important that your ophthalmologist (eye doctor) check your eyes every 4 to 6 weeks

Valganciclovir can lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets, wash your skin with soap and clear water. If the medicine gets into your eyes, rinse them with clear water.

Side Effects of This Medicine

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools;  blood in urine or stools;  chills;  cough ;  fever;  hoarseness;  lower back or side pain;  painful or difficult urination;  pale skin;  pinpoint red spots on skin;  sore throat;  seeing flashes or sparks of light;  seeing floating spots before the eyes;  troubled breathing ;  ulcers, sores, or white spots in the mouth;  unusual bleeding or bruising;  unusual tiredness or weakness;  veil or curtain appearing across part of vision 

Less common

Changes in facial skin color;  fast or irregular breathing;  hives, itching, and skin rash ;  large, hive-like swellings on eyelids, face, lips, mouth, and/or tongue;  puffiness or swelling of the eyelids or around the eyes;  runny or stuffy nose ;  shortness of breath;  tightness in chest and/or wheezing 

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Confusion;  false beliefs;  feeling, hearing, or seeing things that are not there;  illogical thinking;  seizures 

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Abdominal pain;  diarrhea;  headache;  nausea and vomiting;  numbness, tingling, pain, or weakness of hands or feet;  sleeplessness;  tingling, burning, or prickly sensations;  trouble sleeping 

Less common

Agitation 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 06/27/2001

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