Pronunciation:

val-gan-SYE-kloe-veer

Brand Names:

• Valcyte

Dosage Forms:

• Tablet

Warnings:

The clinical toxicity of valganciclovir hydrochloride, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis .

The clinical toxicity of valganciclovir, which is metabolized to ganciclovir, includes granulocytopenia, anemia and thrombocytopenia. In animal studies ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Viral DNA Polymerase Inhibitor

Chemical—

Guanosine Nucleoside Analog

Uses of This Medicine:

Valganciclovir 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.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

It is also very important that your ophthalmologist (eye doctor) check your eyes every 4 to 6 weeks since it is still possible that you may have some loss of eyesight during valganciclovir treatment.

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:

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.