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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 is used in adults to prevent infection with cytomegalovirus (CMV) that may occur after an organ transplant (heart, kidney, or pancreas). Valganciclovir is also used to treat CMV infection of the eye in adults with acquired immunodeficiency syndrome (AIDS).

Valganciclovir is used in children at least 4 months old to prevent CMV infection after a kidney transplant. Valganciclovir is also used in children at least 1 month old to prevent CMV disease after a heart transplant.

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.

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

Valganciclovir has caused birth defects in animal studies. Do not use valganciclovir without telling your doctor if you are pregnant.

Use birth control to prevent pregnancy, whether you are a man or a woman. Valganciclovir use by either parent may cause birth defects. A man taking valganciclovir should use a condom during treatment, and for at least 90 days after treatment ends.

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Serious infections may occur during treatment with valganciclovir. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, weakness, cold or flu symptoms, painful mouth sores, pale skin, easy bruising or bleeding, dry cough, weight loss, or trouble breathing.

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

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

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

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

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.

To make sure valganciclovir is safe for you, tell your doctor if you have:

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

  • 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).

Valganciclovir can cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant. You may need to have a negative pregnancy test before taking valganciclovir. Use effective birth control while you are taking valganciclovir and for at least 30 days after your treatment ends.

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

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?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

Take valganciclovir with food.

Drink plenty of liquids while you are taking valganciclovir.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush or break a valganciclovir tablet. 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.

While using valganciclovir, you may need frequent blood tests.

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.

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

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.

Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected sex or share 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 signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious infections may occur during treatment with valganciclovir. Call your doctor right away if you have signs of infection such as:

  • sudden weakness or ill feeling, fever, chills, sore throat, cold or flu symptoms;

  • painful mouth sores, pain when swallowing, red or swollen gums;

  • pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum); or

  • feeling light-headed or short of breath, chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

  • a seizure (convulsions);

  • pain or burning when you urinate;

  • pain or swelling near your transplanted organ; or

  • kidney problems--little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.

Kidney problems may be more likely in older adults.

Common side effects may include:

  • fever or other signs of infection;

  • nausea, vomiting, diarrhea;

  • headache;

  • tremors, loss of balance or coordination;

  • cold symptoms such as stuffy nose, sneezing, sore throat; or

  • high blood pressure--severe headache, blurred vision, pounding in your neck or ears, confusion, severe chest pain, irregular heartbeats.

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

Comments:
-The tablet formulation should be used, not the oral solution.
-The maintenance dose should be used after the induction dose or in patients with inactive CMV retinitis.

Use: For the treatment of CMV retinitis in patients with AIDS

Usual Adult Dose for CMV Prophylaxis:

900 mg orally once a day

Duration of therapy:
-Heart or kidney-pancreas transplant patients: Until 100 days posttransplantation.
-Kidney transplant patients: Until 200 days posttransplantation.

Comments:
-The tablet formulation should be used, not the oral solution.
-Therapy should be started within 10 days of transplantation.

Use: For the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative)

Usual Pediatric Dose for CMV Prophylaxis:

1 month to 16 years (heart transplant recipients) or 4 months to 16 years (kidney transplant recipients):
The recommended once-daily oral dose is based on BSA and 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)

k values:
-Infants less than 1 year of age with low birth weight for gestational age: 0.33
-Infants less than 1 year of age with birth weight appropriate for gestational age: 0.45
-Children aged 1 to less than 2 years: 0.45
-Boys aged 2 to less than 13 years and girls aged 2 to less than 16 years: 0.55
-Boys aged 13 to 16 years: 0.7

Maximum dose: 900 mg orally once a day

Older than 16 years: 900 mg orally once a day

Duration of therapy:
-Heart transplant patients (1 month or older): Until 100 days posttransplantation.
-Kidney transplant patients (4 months or older): Until 200 days posttransplantation.
-Kidney-pancreas transplant patients (older than 16 years): Until 100 days posttransplantation.

Comments:
-The recommended once-daily dose should be started within 10 days of transplantation.
-The k values provided are based on the Jaffe method of measuring serum creatinine; correction may be necessary when enzymatic methods are used.
-During prophylaxis, the calculated dose should be adjusted as appropriate; serum creatinine levels should be monitored regularly and changes in height and body weight should be considered.
-All calculated doses should be rounded to the nearest 10 mg increment for actual deliverable dose, up to maximum dose of 900 mg.
-The oral solution is the preferred formulation for patients 1 month to 16 years; it provides the ability to administer a dose calculated according to the formula above. The 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 used for calculated doses between 405 mg and 495 mg.
-The oral solution should be used for patients 1 month to 16 years unable to reliably swallow a tablet.
-Patients older than 16 years should use the tablet formulation, not the oral solution.

Uses: For the prevention of CMV disease:
-In heart transplant recipients (1 month or older) at high risk
-In kidney transplant recipients (4 months or older) at high risk
-In kidney-pancreas transplant recipients (older than 16 years) at high risk

Usual Pediatric Dose for CMV Retinitis:

Older than 16 years:
Induction dose: 900 mg orally twice a day for 21 days
Maintenance dose: 900 mg orally once a day

Comments:
-The tablet formulation should be used, not the oral solution.
-The maintenance dose should be used after the induction dose or in patients with inactive CMV retinitis.

Use: For the treatment of CMV retinitis in patients with AIDS

What other drugs will affect valganciclovir?

Valganciclovir can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with valganciclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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: 6.01. Revision Date: 2015-06-11, 5:07:20 PM.

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