Valcyte

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 plain 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 Valcyte 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.

Tablet

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

Oral solution

Each bottle contains 5.5 g valganciclovir hydrochloride (corresponding to 5 g valganciclovir), in 12 g powder for oral solution. Following reconstitution, 1 mL solution contains 55 mg valganciclovir hydrochloride corresponding to 50 mg 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.

Do not take valganciclovir if you:

• are allergic to valganciclovir, Ganciclovir, or any ingredients of the medication
• are allergic to acyclovir or Valacyclovir

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

• didanosine
• imipenem - cilastatin
• Mycophenolate Mofetil
• tenofovir
• 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 Valcyte. 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.

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 Valcyte.

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 Valcyte. Your doctor will monitor you closely while you are taking Valcyte 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: People with reduced kidney function may need a lower dose of Valcyte. Valganciclovir may also cause kidney problems. Your doctor will monitor you while you are on Valcyte.

Fertility and pregnancy: Valganciclovir may decrease fertility in both men and women, and these effects may last for some time after the medication has been stopped. Valcyte should not be used during pregnancy because it can harm the developing child. 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). Effective birth control should be practiced for at least 90 days after stopping the medication.

Breast-feeding: It is not known if valganciclovir passes into breast milk. It is recommended that women taking Valcyte should not breast-feed.

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

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