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VALCYTE®
(valganciclovir hydrochloride) Tablets

VALCYTE®
(valganciclovir hydrochloride) for Oral Solution

Read the Patient Information that comes with Valcyte (valganciclovir hcl) before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor.

What is the most important information I should know about Valcyte (valganciclovir hcl) ?

• Valcyte (valganciclovir hcl) can affect your blood cells and bone marrow causing serious and life-threatening problems. Valcyte (valganciclovir hcl) can lower the amount of your white blood cells, red blood cells, and platelets. Your doctor may do regular blood tests to check your blood cells while you are taking Valcyte (valganciclovir hcl) . Based on these tests, your doctor may change your dose or tell you to stop taking Valcyte (valganciclovir hcl) .
• Valcyte (valganciclovir hcl) may cause cancer. Valcyte (valganciclovir hcl) causes cancer in animals. It is not known if Valcyte (valganciclovir hcl) causes cancer in people.
• Valcyte (valganciclovir hcl) may cause birth defects. Valcyte (valganciclovir hcl) causes birth defects in animals. It is not known if Valcyte (valganciclovir hcl) causes birth defects in people. If you are pregnant, talk to your doctor before taking Valcyte (valganciclovir hcl) .
  • Tell your doctor right away if you become pregnant while taking Valcyte (valganciclovir hcl) .
  • If you are a female who can become pregnant, you should use effective birth control during treatment with Valcyte (valganciclovir hcl) and for at least 30 days after treatment.
  • Men should use a condom during treatment with Valcyte (valganciclovir hcl) , and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your doctor if you have questions about birth control.
• Valcyte (valganciclovir hcl) may lower the amount of sperm in a man's body and cause fertility problems.
• Valcyte (valganciclovir hcl) can affect your kidney, including serious problems such as kidney failure. Your doctor may do regular blood tests to check your kidney function while you are taking Valcyte (valganciclovir hcl) . Your doctor may adjust your dose based on these tests
• Valcyte (valganciclovir hcl) changes into the medicine ganciclovir once it is in your body. Ganciclovir is also the active ingredient in Cytovene®-IV and ganciclovir capsules. Do not take ganciclovir capsules or Cytovene-IV if you are taking Valcyte (valganciclovir hcl) . The dose of medicine in Valcyte (valganciclovir hcl) tablets and ganciclovir capsules is different. One tablet of Valcyte (valganciclovir hcl) has more medicine than one capsule of ganciclovir. This means that one Valcyte (valganciclovir hcl) tablet cannot be substituted for one ganciclovir capsule. You could overdose and become very sick if Valcyte (valganciclovir hcl) is taken with ganciclovir capsules or Cytovene-IV. Talk to your doctor or pharmacist if you have questions about your medicine.

What is Valcyte (valganciclovir hcl) ?

Valcyte (valganciclovir hcl) is an “antiviral” medicine.

In adults, Valcyte (valganciclovir hcl) tablets are used:

• to treat cytomegalovirus (CMV) retinitis in people who have acquired immunodeficiency syndrome (AIDS). When CMV virus infects the eyes, it is called CMV retinitis. If CMV retinitis is left untreated, it can cause blindness.
• to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a high risk for getting CMV disease.

In children (4 months to 16 years of age) Valcyte (valganciclovir hcl) tablets or oral solution are used:

• to prevent cytomegalovirus (CMV) disease in children who have received a heart or kidney transplant and have a high risk for getting CMV disease.

Valcyte (valganciclovir hcl) is not for use in adults or children who have received a liver transplant.

It is not known if Valcyte (valganciclovir hcl) is safe and effective:

• to prevent CMV disease in people who have had other types of organ transplants such as lung or intestine.
• to prevent CMV disease in children under 4 months of age who receive an organ transplant.
• to treat CMV disease that a baby might be born with (congenital CMV disease)
• in adults older than age 65.

Valcyte (valganciclovir hcl) does not cure CMV retinitis. You may still get retinitis or worsening of retinitis during or after treatment with Valcyte (valganciclovir hcl) . It is important to stay under a doctor's care and have your eyes checked regularly.

Who should not take Valcyte (valganciclovir hcl) ?

Do not take Valcyte (valganciclovir hcl) tablets if you are receiving hemodialysis. The use of ganciclovir capsules rather than Valcyte (valganciclovir hcl) tablets is recommended.

Do not take Valcyte (valganciclovir hcl) if you are allergic to any of its ingredients or if you have ever had a serious allergic reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte (valganciclovir hcl) may include: sudden trouble breathing, wheezing, hives all over your body, swelling around your mouth, or feeling anxious. See the end of this leaflet for a list of the ingredients in Valcyte (valganciclovir hcl) .

What should I tell my doctor before taking Valcyte (valganciclovir hcl) ?

Before taking Valcyte (valganciclovir hcl) , tell your doctor if you:

• have kidney problems. Your doctor may give you a lower dose of Valcyte (valganciclovir hcl) , or check you more often if you are taking Valcyte (valganciclovir hcl) .
• have blood cell problems
• are having radiation treatment
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Valcyte (valganciclovir hcl) causes birth defects in an unborn baby. Tell your doctor right away if you become pregnant while taking Valcyte (valganciclovir hcl) . See “What is the most important information I should know about Valcyte (valganciclovir hcl) ?”
• are breast-feeding or plan to breast-feed. It is not known if Valcyte (valganciclovir hcl) passes into your milk and if it may harm your baby. You should not breast-feed if you are HIV-positive because of the chance of passing the HIV virus to your baby through your milk.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Valcyte (valganciclovir hcl) and other medicines may affect each other and cause serious side effects. Especially tell your doctor if you take:

• didanosine (Videx®)
• zidovudine (Retrovir®, Trizivir, Combivir)
• probenecid (Col-Probenecid, Probenacid and Colchicine)
• mycophenolate mofetil (CellCept®)

How should I take Valcyte (valganciclovir hcl) ?

• Take Valcyte (valganciclovir hcl) exactly as your doctor prescribes it. Your dose of Valcyte (valganciclovir hcl) will depend on your medical condition.
• Adults should only take Valcyte (valganciclovir hcl) tablets. Children may take either Valcyte (valganciclovir hcl) tablets or oral solution.
• Take Valcyte (valganciclovir hcl) with food.
• Do not break or crush Valcyte (valganciclovir hcl) tablets. Avoid contact with your skin or eyes. If you come in contact with the contents of the tablet or oral solution, wash your skin well with soap and water or rinse your eyes well with plain water.
• If your child is prescribed Valcyte (valganciclovir hcl) for oral solution, your pharmacist will give you dosing dispensers to measure your dose of Valcyte (valganciclovir hcl) for oral solution. To be sure you receive the prescribed dose, it is important to use the dispenser provided to you. Be sure to read, and that you understand, and follow the instructions below on how to take Valcyte (valganciclovir hcl) for oral solution and how to use the dispenser. Ask your pharmacist if you have any questions. If you lose or damage your dispensers and cannot use them, contact your pharmacist.
• If you miss a dose of Valcyte (valganciclovir hcl) , take the missed dose as soon as you remember. Then, take the next dose at the usual scheduled time. However, if it is almost time for your next dose, do not take the missed dose.
• Do not let your Valcyte (valganciclovir hcl) run out. The amount of virus in your blood may increase if your medicine is stopped, even for a short time.
• If you take too much Valcyte (valganciclovir hcl) , call your local poison control center or emergency room right away. You may need treatment in a hospital.
• Do not substitute Valcyte (valganciclovir hcl) tablets for ganciclovir capsules. Talk to your doctor, nurse or pharmacist if you have questions about your medicine.

What should I avoid while taking Valcyte (valganciclovir hcl) ?

• Valcyte (valganciclovir hcl) can cause seizures, sleepiness, dizziness, unsteady movements, and confusion. You should not drive a car or operate other dangerous machinery until you know how Valcyte (valganciclovir hcl) affects you.

What are the possible side effects of Valcyte (valganciclovir hcl) ?

Valcyte (valganciclovir hcl) may cause serious side effects, including:

• See “What is the most important information I should know about Valcyte (valganciclovir hcl) ?”

Common side effects of Valcyte (valganciclovir hcl) in adults and children include:

• diarrhea
• nausea, vomiting
• fever
• shaky movements (tremors)
• low white cell, red cell and platelet cell counts in blood tests
• rejection of the transplanted organ (graft)

Other common side effects in children include:

• constipation
• high blood pressure
• cough and colds

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Valcyte (valganciclovir hcl) . For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Valcyte (valganciclovir hcl) ?

• Store Valcyte (valganciclovir hcl) tablets at room temperature between 59°F to 86°F (15°C to 30°C).
• Store Valcyte (valganciclovir hcl) for oral solution in the refrigerator between 36°F to 46°F (2°C to 8°C), for no longer than 49 days. Do not freeze.
• Do not keep medicine that is out of date or that you no longer need.
• Keep Valcyte (valganciclovir hcl) and all medicines out of the reach of children.

General information about Valcyte (valganciclovir hcl)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Valcyte (valganciclovir hcl) for a condition for which it was not prescribed. Do not give Valcyte (valganciclovir hcl) to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about Valcyte (valganciclovir hcl) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Valcyte (valganciclovir hcl) that is written for health professionals.

For more information about Valcyte (valganciclovir hcl) go to www.VALCYTE (valganciclovir hcl) .com or call 1-888-835-2555.

What are the ingredients in Valcyte?

Active Ingredient: valganciclovir hydrochloride

Inactive Ingredients for Tablets: microcrystalline cellulose, povidone K-30, crospovidone, and stearic acid. The film-coating applied to the tablets contains Opadry Pink® .

Inactive Ingredients for Oral Solution: sodium benzoate, fumaric acid, povidone K-30, sodium saccharin, mannitol and tutti-frutti flavoring.

Patient Instructions for Use

How do I give Valcyte (valganciclovir hcl) for oral solution?

Your pharmacist will mix Valcyte (valganciclovir hcl) for oral solution for you.

Be sure that you read, and that you understand and follow these instructions carefully to ensure proper dosing of the oral solution. To take a dose of Valcyte (valganciclovir hcl) for oral solution, you will need the bottle of medicine and an oral dispenser. See Figure 1 below.

Figure 1

• Shake closed bottle well for about 5 seconds before each use.
• Remove the child-resistant bottle cap.
• Before inserting the tip of the oral dispenser into bottle adapter, push the plunger completely down toward the tip of the oral dispenser.
• Insert tip firmly into opening of the bottle adapter.

Turn the entire unit (bottle and oral dispenser) upside down (see Figure 2).

Figure 2

• Make sure the dosing dispenser stays connected to the bottle. Pull the plunger down slowly until the prescribed amount of medicine is withdrawn into the oral dispenser (See Figure 3).

Figure 3

• Turn the entire unit right side up and remove the oral dispenser slowly from the bottle.
• Give the dose of medicine directly into mouth and swallow. Do not mix with any liquid before giving the dose.
• Close the bottle with child-resistant bottle cap after each use.
• After taking your medicine, take apart (disassemble) the oral dispenser right away and rinse under running tap water. Then air dry before next use.

Avoid skin contact with Valcyte (valganciclovir hcl) for oral solution. If you come in contact with Valcyte (valganciclovir hcl) for oral solution, wash the area well with soap and water.

Do not use Valcyte (valganciclovir hcl) for oral solution after the expiration date on the bottle.

Call your pharmacist if your oral dispenser is lost or damaged, and they will tell you how to continue to take your medicine.

VALCYTE (valganciclovir hcl) is a registered trademark of Hoffmann-La Roche Inc.

Last reviewed on RxList: 9/8/2010
This monograph has been modified to include the generic and brand name in many instances.