valganciclovir

Generic Name: valganciclovir (val gan SYE kloe veer)
Brand Name: Valcyte

What is valganciclovir?

Valganciclovir is an antiviral drug. It works by preventing viral cells from multiplying in your body.

Valganciclovir treats cytomegalovirus (CMV) infection of the eye in adults with acquired immunodeficiency syndrome (AIDS). Valganciclovir also prevents CMV infection in adults and children who have received an organ transplant (heart, kidney, or kidney-pancreas).

Valganciclovir will not cure CMV but it can help control the infection. Valganciclovir is not for treating CMV that a baby is born with.

Valganciclovir may also be used for purposes other than those listed in this medication guide.

Your doctor may have switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte). The strength of these two medications is different. A valganciclovir tablet contains more medicine than a ganciclovir capsule. You may not need to use as many valganciclovir tablets as you did ganciclovir capsules. Take only the number of valganciclovir tablets your doctor has prescribed.

What is the most important information I should know about valganciclovir?

Valganciclovir tablets are for adults or children, but valganciclovir liquid is only for children. Adults should not use the oral solution or the dose may not be correct.

Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together. If your doctor switched you from ganciclovir (Cytovene) to valganciclovir (Valcyte), the number of pills you use each day may change. Take only the number of tablets your doctor has prescribed.

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Valganciclovir has caused birth defects in animal studies. Do not take this medication without telling your doctor if you are pregnant. Use effective birth control while you are using this medication and for at least 30 days after your treatment ends.

If a man fathers a child while taking valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir.

Do not crush or break a valganciclovir tablet. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Valganciclovir can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your treatment may be delayed based on the results of these tests. Visit your doctor regularly.

What should I discuss with my healthcare provider before taking valganciclovir?

You should not use this medication if you are allergic to valganciclovir or ganciclovir (Cytovene).

Valganciclovir (Valcyte) and ganciclovir (Cytovene) must never be taken together.

To make sure you can safely take valganciclovir, tell your doctor if you have any of these other conditions:

  • kidney disease (or if you are on dialysis);

  • liver disease;

  • a blood cell disorder (such as anemia or low levels of platelets in your blood); or

  • if you are receiving radiation treatment or drugs that weaken your immune system (such as cancer medicine or steroids).

HIV or AIDS can be passed to the baby if the mother is not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection while you are pregnant. Valganciclovir will not prevent congenital (inherited) CMV in a newborn baby.

FDA pregnancy category C. Valganciclovir has caused birth defects in animal studies. Do not take this medication without telling your doctor if you are pregnant. Use effective birth control while you are using this medication and for at least 30 days after your treatment ends.

If a man fathers a child while using valganciclovir, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 90 days after you stop using valganciclovir.

This medication can affect fertility (your ability to have children), whether you are a man or a woman.

You should not breast-feed while you are taking valganciclovir. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

How should I take valganciclovir?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take valganciclovir with food.

Valganciclovir tablets are for adults or children, but valganciclovir liquid is only for children. Adults should not use the oral solution or the dose may not be correct.

Shake valganciclovir liquid well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush or break a valganciclovir tablet. Do not use a tablet that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Use valganciclovir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Valganciclovir can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your treatment may be delayed based on the results of these tests. Visit your doctor regularly.

You should have your eyes checked at least every 4 to 6 weeks while you are using valganciclovir. Your doctor may want you to have eye exams more often.

Store valganciclovir tablets at room temperature away from moisture and heat.

Store valganciclovir liquid in the refrigerator. Do not freeze. Throw away any unused after 49 days.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include urinating less than usual or not at all, swelling, weight gain, stomach pain, nausea, vomiting, signs of infection (fever, chills, sore throat, flu symptoms), or jaundice (yellowing of the skin or eyes).

What should I avoid while taking valganciclovir?

Valganciclovir may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

If you have HIV or AIDS, taking this medication will not prevent you from passing HIV to other people. Avoid having unprotected sex or sharing razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury.

Valganciclovir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using valganciclovir and call your doctor at once if you have a serious side effect such as:

  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • urinating less than usual or not at all;

  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  • swelling, weight gain, feeling short of breath; or

  • seizure (convulsions).

Less serious side effects may include:

  • dizziness, loss of balance or coordination;

  • diarrhea, constipation;

  • tremor (shaking); or

  • cold symptoms such as stuffy nose, sneezing, sore throat, and cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Valganciclovir dosing information

Usual Adult Dose for CMV Retinitis:

Induction dose: 900 mg orally twice a day for 21 days
Maintenance dose: 900 mg orally once a day

Usual Adult Dose for CMV Prophylaxis:

900 mg orally once a day starting within 10 days of transplantation

Heart or kidney-pancreas transplant patients: Therapy should continue until 100 days posttransplantation.
Kidney transplant patients: Therapy should continue until 200 days posttransplantation.

Usual Pediatric Dose for CMV Prophylaxis:

Kidney or heart transplant patients:
4 months to 16 years: The recommended once daily oral dose of valganciclovir starting within 10 days of transplantation until 100 days posttransplantation is based on body surface area (BSA) and creatinine clearance (CrCl) derived from a modified Schwartz formula, and is calculated using the following equation:

Pediatric dose (mg) = 7 x BSA x CrCl (calculated using a modified Schwartz formula). If the calculated Schwartz CrCl exceeds 150 mL/min/1.73 m2, then a maximum value of 150 mL/min/1.73 m2 should be used in the equation.

Mosteller BSA (m2) = the square root of (height [cm] x weight [kg] divided by 3600)

Schwartz CrCl (mL/min/1.73 m2) = k x height (cm) divided by serum creatinine (mg/dL)

where k =

4 months to less than 1 year: 0.45
1 to less than 2 years: 0.45 (note: k value is 0.45 instead of the typical value of 0.55)
2 to less than 13 years (boys) and 2 to 16 years (girls): 0.55
13 to 16 years (boys): 0.7

All calculated doses should be rounded to the nearest 25 mg increment for actual deliverable dose, up to maximum dose of 900 mg. Valganciclovir oral solution is the preferred formulation since it provides the ability to administer a dose calculated according to the formula above; however, valganciclovir tablets may be used if the calculated doses are within 10% of available tablet strength (450 mg). For example, one 450 mg tablet may be taken for calculated doses between 405 mg and 495 mg.

What other drugs will affect valganciclovir?

Tell your doctor about all other medications you use, especially:

  • didanosine (Videx);

  • mycophenolate (CellCept);

  • probenecid (Benemid, Col-Probenecid); or

  • zidovudine (Combivir, Retrovir, Trizivir).

This list is not complete and other drugs may interact with valganciclovir. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?/

  • Your pharmacist can provide more information about valganciclovir.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision Date: 2011-01-25, 3:14:59 PM.

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