Valganciclovir (By mouth)

Introduction

Valganciclovir (val-gan-SYE-kloe-vir)

Treats cytomegalovirus (CMV) retinitis (eye infection) in patients who have AIDS. Also prevents CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).

Brand Name(s)

Valcyte

How to Use This Medicine

Powder for Solution, Liquid, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• If you took Cytovene® (ganciclovir) before switching to Valcyte®, the dose of your medicine may change. Although these medicines both treat the same problem, they are absorbed differently by your body. Make sure you understand the new directions for Valcyte® so you do not take too many tablets.
• It is best to take this medicine with food or milk.
• Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Be careful not to handle crushed or broken tablets. If you have contact with broken or crushed tablets, wash your skin with soap and clear water. If the medicine gets into your eyes, rinse them with clear water.
• When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the mixed oral liquid in the refrigerator. Do not freeze.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. Throw away any unused medicine after 49 days through community take-back programs when available.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using didanosine (ddI, Videx®), mycophenolate mofetil (Cellcept®), probenecid (Benemid®), zidovudine (AZT, Retrovir®), or medicines that weaken the immune system (such as steroids, cancer medicines, or radiation treatment).

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. The medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If a pregnancy occurs while you are using this medicine, tell your doctor right away. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for at least 1 month after stopping it. Also, men should use a condom during treatment with this medicine and for at least 90 days after treatment has been completed.
• Make sure your doctor knows if you have kidney disease, blood or bone marrow problems, or brain or nerve problems.
• If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
• You should not breast feed if you have HIV or AIDS, because you may give the infection to your baby through your breast milk.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests and eye examinations may be needed to check for unwanted effects.
• This medicine may make you confused, dizzy, or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate.
• Eye pain or trouble seeing.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Problems with coordination or muscle control.
• Unexplained fever, chills, sore throat, or painful sores.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, or stomach pain.
• Headache.
• Trouble sleeping.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

When This Medicine Should Not Be Used