Valcyte contains the active ingredient valganciclovir hydrochloride, which is a hydrochloride salt form of the L-valyl ester of ganciclovir. It is a synthetic guanine derivative known for its activity against cytomegalovirus (CMV). Valcyte is available as a 450 mg tablet intended for oral administration, with key inactive ingredients including crospovidone, microcrystalline cellulose, and stearic acid.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take all of this medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Handling this medication may be harmful. Wash skin with soap and water if the solution touches your skin.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

After the medication is mixed by your pharmacist, store it in the refrigerator. Do not freeze. Get rid of any unused medication after 49 days.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Aplastic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, increased bleeding or bruising
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Fatigue
• Fever
• Headache
• Nausea
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Low blood counts, such as low white cell, platelet, or red cell counts
• An unusual or allergic reaction to ganciclovir, valganciclovir, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

This medication may interact with the following:

• Amphotericin B
• Certain medications for cancer, such as adriamycin, doxorubicin, vinblastine, vincristine
• Certain medications for HIV, such as didanosine, zidovudine
• Cyclosporine
• Dapsone
• Flucytosine
• Hydroxyurea
• Imipenem; cilastatin
• Mycophenolate mofetil
• Pentamidine
• Probenecid
• Sulfamethoxazole; trimethoprim
• Tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Drink 6 to 8 glasses of water or fluids daily while taking this medication to help prevent side effects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy and for 30 days after the last dose. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 30 days after the last dose. Talk to your care team about effective forms of contraception. Do not father a child while taking this medication and for 90 days after the last dose. Use a condom during sex during this time period.

Do not breast-feed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

This medication can decrease the amount of blood cells (white cells, red cells, platelets) your body makes. This increases the risk of anemia, bleeding, and infection. Your care team will check your blood cell levels during your treatment. Talk to your care team right away if you have unusual bruising or bleeding, fever, chills, cough, sore throat, pain or trouble when passing urine, or a general feeling of discomfort or being unwell.

Taking this medicine can impair your ability to have children. Talk to your healthcare provider before starting this medicine if you want to have children.

Taking this medicine can increase the risk of getting cancer.

Males who get this medicine must use a condom during sex with female partners who can get pregnant. If you get a woman pregnant during treatment, the baby could have severe birth defects or die before they are born. You may need to continue to avoid getting a female pregnant after stopping the medicine. The length of time depends on the medication. Talk to your healthcare provider about how long you should continue to wear condoms after stopping the medicine. Tell your healthcare provider right away if your partner becomes pregnant while you are taking this medicine.

This medication may cause serious birth defects if taken during pregnancy. Do not take this medication if you are pregnant.