Valcyte

Brand Name

Valcyte

Common Name

valganciclovir

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Valganciclovir belongs to a group of medications known as antivirals. It is used to treat a viral eye infection called cytomegalovirus (CMV) retinitis for people with acquired immunodeficiency syndrome (AIDS). It can also be used to prevent CMV disease for people who have received a solid organ transplant and are at risk of the condition. It works by slowing the growth of the CMV virus that causes the infection.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

For people with active CMV retinitis, the usual dose is 900 mg twice a day with food for 21 days. After 21 days of treatment, or for people with inactive CMV retinitis, the dose is 900 mg once a day with food.

For people who have received a solid organ transplant, the recommended dose is 900 mg once daily with food starting within 10 days of transplantation and continued for 100 days after the transplantation.

If you have reduced kidney function, you may require a lower dose of valganciclovir, as recommended by your doctor.

If you are using the tablets, do not break or crush them. If you are using the oral solution, use the measuring device provided for accurate dosing. Shake the bottle well for about 5 seconds before each use.

If you accidentally get broken tablets or solution on your skin, wash the area thoroughly with soap and water. If you accidentally get broken tablets or solution in your eyes, rinse your eyes thoroughly with sterile or regular water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. The amount of virus in your blood may increase even if you stop your medication for a short time. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the tablets at room temperature, protect them from moisture, and keep them out of the reach of children.

Store the oral solution in the refrigerator and keep it out of the reach of children. Discard any solution that is not used within 49 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Tablet

Each pink, convex, oval, film-coated tablet with "VGC" on one side and "450" on the other side contains 496.3 mg of valganciclovir HCl (corresponding to 450 mg of valganciclovir). Nonmedicinal ingredients: crospovidone, microcrystalline cellulose, povidone K-30, and stearic acid powder; Opadry pink film-coating: hydroxypropyl methylcellulose, polyethylene glycol 400/macrogol, polysorbate 80, synthetic red iron oxide, and titanium dioxide.

Oral solution

Each bottle contains 5.5 g of valganciclovir hydrochloride (corresponding to 5 g of valganciclovir), in 12 g of powder for oral solution. Following reconstitution, 1 mL of solution contains 55 mg of valganciclovir hydrochloride (corresponding to 50 mg of valganciclovir free base). Nonmedicinal ingredients: fumaric acid, mannitol, povidone K30, sodium benzoate, sodium saccharin, tutti-frutti flavour (maltodextrins [maize], propylene glycol, arabic gum, and natural identical flavouring substances mainly consisting of banana, pineapples, and peach flavour). Before mixing, the powder is white-to-slightly-yellow.

Who should NOT take this medication?

Do not take valganciclovir if you:

• are allergic to valganciclovir, ganciclovir, or any ingredients of the medication
• are allergic to acyclovir or valacyclovir

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• constipation
• diarrhea
• dizziness
• fever
• headache
• joint pain
• nausea or vomiting
• trembling
• trouble sleeping
• unsteadiness or clumsiness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention

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

• confusion
• high blood pressure
• infertility
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of an infection (e.g., cough, chills, mouth sores, redness on any area of your body, nasal congestion, sore throat, runny nose, night sweats, pain or burning when urinating)
• signs of graft rejection (transplanted organ not functioning properly; e.g., feeling ill or uncomfortable, fever)
• signs of kidney problems (e.g., swelling of the legs, decreased urine amount, lower back pain)
• symptoms of anemia (e.g., feeling tired, shortness of breath, paleness, rapid heartbeat)
• symptoms of depression (e.g., lack of motivation or energy, feelings of worthlessness or guilt, difficulty concentrating)
• symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
• white patches on the mouth, tongue, or throat

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• signs of a serious allergic reaction (e.g., swelling of the face or throat, hives, or difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood disorders: Valganciclovir can cause a reduction in certain blood cells, which can lead to serious problems. People with certain severe blood disorders (e.g., anemia, neutropenia, thrombocytopenia) may not be able to use this medication, as valganciclovir may make the number of blood cells in the body dangerously low for these people. Your doctor will monitor you closely while you are taking this medication for any signs of blood cell problems.

Cancer: Although it has not been clearly demonstrated in humans, there is the possibility that valganciclovir might cause certain types of cancer. If you have concerns, discuss this with your doctor.

Drowsiness/reduced alertness: Valganciclovir may reduce alertness. Avoid activities such as driving or operating machinery until you know whether the medication affects you in this way.

Kidney disease: Decreased kidney function or kidney disease may cause this medication to build up in the body, causing side effects. People with reduced kidney function may need a lower dose of this medication. Valganciclovir may also cause kidney problems. Your doctor will monitor you while you are on this medication.

Fertility and pregnancy: Valganciclovir may decrease fertility for both men and women, and these effects may last for some time after the medication has been stopped. This medication should not be used during pregnancy because it can harm the developing child and cause birth defects. Men and women who are taking valganciclovir should ensure their partners are aware of the risks and practice effective birth control, which includes barrier protection (e.g., condoms) and one additional form of contraception (e.g., birth control pills, intrauterine device). Women taking valganciclovir should use effective birth control during treatment and for 30 days after stopping. Men taking valganciclovir should use effective birth control during treatment and for at least 90 days after stopping the medication.

Breast-feeding: It is not known if valganciclovir passes into breast milk. If you are taking this medication, it is recommended that you do not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: Seniors may require lower doses of this medication due to age-related decreases in kidney function.

What other drugs could interact with this medication?

There may be an interaction between valganciclovir and any of the following:

• amphotericin B
• certain cancer medications (e.g., cladribine, doxorubicin, vincristine, vinblastine)
• cyclosporine
• dapsone
• didanosine
• imipenem - cilastatin
• mycophenolate mofetil
• tacrolimus
• tenofovir
• trimethoprim
• zidovudine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Valcyte