Medication Guide — Valganciclovir

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Valganciclovir can affect the bone marrow lowering the amount of your white blood cells, red blood cells, and platelets and may cause serious and life-threatening problems.

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Kidney failure may happen in people who are elderly, people who take valganciclovir with certain other medicines, or people who are not adequately hydrated.

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Valganciclovir may lower sperm count in males and cause fertility problems. Valganciclovir may also cause fertility problems in women. Talk to your healthcare provider if this is a concern for you.

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Valganciclovir causes birth defects in animals. It is not known if valganciclovir causes birth defects in people. If you are a female who can become pregnant, you should use effective birth control during treatment with valganciclovir and for at least 30 days after treat- ment.

• Tell your healthcare provider right away if you become pregnant during treatment with valganciclovir.
• Males should use condoms during treatment with valganciclovir, and for at least 90 days after treatment, if their female sexual partner can become pregnant. Talk to your healthcare provider if you have ques- tions about birth control.

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Valganciclovir causes cancer in animals and may potentially cause cancer in people.

Valganciclovir is a prescription antiviral medicine.

• 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 not treated, it can cause blind- ness.

• to prevent CMV disease in people who have received a

transplant and who have a high risk for getting CMV disease.

You may still get retinitis or worsening of retinitis during or after treatment with valganciclovir. It is important to stay under a healthcare provider's care and have your eyes checked at least every 4 to 6 weeks during treatment with valganciclovir.

• to prevent CMV disease in children 4 months to 16 years of age who have received a

transplant and have a high risk for getting CMV disease.

• to prevent CMV disease in children 1 month to 16 years of age who have received a

transplant and have a high risk for getting CMV disease.

It is not known if valganciclovir is safe and effective in children for preven- tion of CMV disease in liver transplant, in kidney transplant in infants less than 4 months of age, in heart transplant in infants less than 1 month of age, in children with AIDS who have CMV retinitis, and in infants with con- genital CMV infection.

See the end of this leaflet for a list of the ingredients in Valganciclovir.

• have low blood cell counts

• have kidney problems

• are receiving hemodialysis

• are receiving radiation treatment

• are pregnant or plan to become pregnant.

• are breastfeeding or plan to breastfeed. It is not known if valganciclovir passes into your breast milk. You should not breastfeed if you take val- ganciclovir.

• You should not breastfeed if you have Human Immunodeficiency Virus (HIV-1) because of the risk of passing HIV-1 to your baby.

Talk to your healthcare provider about the best way to feed your baby.

including prescription and over-the-counter medicines, vitamins and herbal supple- ments. Valganciclovir and other medicines may affect each other and cause serious side effects. Keep a list of your medicines to show your healthcare provider and pharmacist.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with valganciclovir.

Your healthcare provider can tell you if it is safe to take valganciclovir with other medicines.

Take valganciclovir exactly as your healthcare provider tells you. Your dose of valganciclovir will depend on your medical condition.

Adults should only take valganciclovir tablets. Children may take either valganciclovir tablets or oral solution.

Take valganciclovir with food.

Do not break or crush valganciclovir 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 you take too much valganciclovir, call your healthcare provider or go to the nearest hospital emergency room right away.

Valganciclovir can cause seizures, dizziness, and confusion. You should not drive a car or operate machinery until you know how valganciclovir affects you.

Valganciclovir may cause serious side effects, including:

See

• diarrhea • low white cell, red cell and platelet cell counts in blood tests

• fever • headache

• fatigue • sleeplessness

• nausea • urinary tract infection

• shaky movements (tremors) • vomiting

• diarrhea • vomiting

• fever • low white blood cell counts in blood tests

• upper respiratory tract infection • headache

• urinary tract infection

These are not all the possible side effects of valganciclovir.

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

• Store valganciclovir tablets at room temperature between 59°F to 86°F (15°C to 30°C).

• Do not keep valganciclovir tablets that are out of date or that you no lon- ger need.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valganciclovir for a condition for which it was not prescribed. Do not give valganciclovir to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about valganciclovir that is written for health professionals

valganciclovir hydrochloride

colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone K-30, and stearic acid. The film-coating applied to the tablets contains polyvinyl alcohol, titanium dioxide, polyeth-ylene glycol, talc, and iron oxide red.

Manufactured for:

AvKARE

Pulaski, TN 38478

Mfg. Iss. 10/21

AV 12/23 (M)