Valganciclovir (patient information)

IMPORTANT WARNING:

Valganciclovir may lower the number of all types of cells in your blood, causing serious and life-threatening problems. Tell your doctor if you have or have ever had anemia (red blood cells do not bring enough oxygen to all parts of the body); neutropenia (less than normal number of white blood cells); thrombocytopenia (less than normal number of platelets); or other blood or bleeding problems. Tell your doctor if you have ever developed blood problems as a side effect of any medication. Tell your doctor and pharmacist if you are taking or have taken any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin); cancer chemotherapy medications; dapsone; flucytosine, (Ancobon); heparin; immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Neoral, Sandimmune) , methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf); interferons (Infergen, Intron A, PEGASYS, PEG-Intron, Roferon-A); medications to treat human immunodeficiency virus (HIV) and acquired immunodeficiency syndrome (AIDS) including didanosine (Videx) , zalcitabine (HIVID), or zidovudine (Retrovir, AZT); nonsteroidal anti-inflammatory medications to treat pain and swelling such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and others; pentamidine (NebuPent, Pentam); pyrimethamine (Daraprim, in Fansidar); steroids such as dexamethasone (Decadron), prednisone (Deltasone), or others; trimethoprim/sufamethoxazole (co-trimoxazole, Bactrim, Septra); or if you have received or are receiving radiation (X-ray) therapy. If you experience any of the following symptoms, call your doctor immediately: excessive tiredness; pale skin; headache; dizziness; confusion; fast heartbeat; difficulty falling asleep or staying asleep; weakness; shortness of breath; unusual bleeding or bruising; or sore throat, fever, chills, cough, or other signs of infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to valganciclovir.

Laboratory animals who were given valganciclovir developed birth defects. It is not known if valganciclovir causes birth defects in people. If you can become pregnant, you should use effective birth control while taking valganciclovir. If you are a man and your partner can become pregnant, you should use a condom while taking valganciclovir and for 90 days after your treatment. Talk to your doctor if you have questions about birth control. Do not take valganciclovir if you are pregnant or plan to become pregnant. If you become pregnant while taking valganciclovir, call your doctor immediately.

Laboratory animals who were given valganciclovir developed a lower sperm count (fewer male reproductive cells) and fertility problems. It is not known if valganciclovir causes lower sperm counts in men or problems with fertility in women.

Laboratory animals who were given valganciclovir developed cancer. It is not known if valganciclovir increases the risk of cancer in humans.

Talk to your doctor about the risks of taking valganciclovir.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully before you start taking this medication and each time you get a refill.

Why is this medication prescribed

Valganciclovir is used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS). Valganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have received a heart, kidney, or kidney-pancreas transplant and who have a chance of getting CMV disease. Valganciclovir is in a class of medications called antivirals. It works by preventing the spread of CMV disease or slowing the growth of CMV.

How should this medicine be used

Valganciclovir comes as a tablet to take by mouth. It is usually taken with food once or twice a day. To help you remember to take valganciclovir, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valganciclovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you used to take ganciclovir (Cytovene), your doctor may have prescribed valganciclovir for you to take instead. Valganciclovir changes into ganciclovir in your body. However, valganciclovir tablets contain a different amount of medication and are taken differently than ganciclovir capsules. Do not take the same number of valganciclovir tablets at the same times that you used to take ganciclovir capsules Take valganciclovir according to the directions you were given by your doctor. Talk to your doctor or pharmacist if you have questions about taking valganciclovir.

Swallow the tablets whole; do not split, chew, break or crush them.

Be careful when handling valganciclovir tablets. Do not allow your skin, eyes, mouth, or nose to come into contact with broken or crushed valganciclovir tablets. If such contact occurs, wash your skin well with soap and water or rinse your eyes well with plain water.

Your doctor may start you on a high dose of valganciclovir and decrease your dose after several weeks. Valganciclovir does not cure CMV retinitis. You may develop CMV retinitis or your symptoms may get worse while you are taking valganciclovir. However, valganciclovir may prevent blindness caused by CMV retinitis. It is important that you see your doctor regularly and continue to take valganciclovir for as long as your doctor tells you that you should. Do not stop taking valganciclovir without talking to your doctor and try not to miss any doses. If you stop taking valganciclovir even for a short time, your condition may become worse and may be more difficult to treat.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking valganciclovir

• tell your doctor and pharmacist if you are allergic to valganciclovir, acyclovir (Zovirax), ganciclovir (Cytovene or Cytovene-IV), or any other medications.
• do not take ganciclovir (Cytovene, Cytovene-IV) while you are taking valganciclovir.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: aminoglycoside antibiotics such as amikacin (Amikin), gentamicin (Garamycin), neomycin (Neo-Rx, Neo-Fradin), netilmycin (Netromycin), streptomycin, tobramycin (Nebcin, Tobi), and others; amphotericin B (Fungizone); captopril (Capoten, in Capozide); diuretics ('water pills'); foscarnet (Foscavir); gold compounds such as auranofin (Ridaura) or aurothioglucose (Solganal); imipenem-cilastatin (Primaxin); immune globulin (gamma globulin, IGIV, BayGam, Carimmune, Gammagard, others): methicillin (Staphcillin); muromonab-CD3 (OKT3); mycophenolate mofetil (CellCept); nitrates such as isosorbide dinitrate (Isordil, Sorbitrate) or nitroglycerin products; penicillamine (Cuprimine, Depen); primaquine; probenecid; rifampin (Rifadin, Rimactane); or other nucleoside analogues such as acyclovir (Zovirax), famciclovir (Famvir), and ribavirin (Copegus, Rebetol, Virazole, in Rebetron). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or any of the following conditions: seizures; an eye problem other than CMV retinitis; high blood pressure; higher than normal calcium in your blood; kidney, or liver disease; or if you are being treated with hemodialysis (a special machine that removes waste products from blood).
• tell your doctor if you are breast-feeding. You should not breastfeed while taking valganciclovir. Talk to your doctor about when you may safely begin breastfeeding after you stop taking valganciclovir.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking valganciclovir.
• you should know that valganciclovir may make you drowsy, dizzy, unsteady, confused, less alert, or cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. Then take the next dose at the usual scheduled time. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Valganciclovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• upset stomach
• vomiting
• stomach pain
• loss of appetite
• thirst
• constipation
• headache
• back pain
• leg swelling
• trouble walking

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• seeing specks, flashes of light, or a dark curtain over everything
• decreased urination
• swelling of the hands, arms, feet, ankles, or lower legs
• hives
• rash
• itching
• yellowing of the skin or eyes
• shaking hands that you cannot control
• numbness, pain, burning, or tingling in the hands or feet
• seizures

Valganciclovir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• upset stomach
• vomiting
• stomach pain
• diarrhea
• shaking hands that you cannot control
• seizures
• decreased urination
• bloody urine
• sore throat, fever, chills, cough, or other signs of infection
• excessive tiredness
• pale skin
• yellowing of the skin or eyes
• headache
• dizziness
• confusion
• fast heartbeat
• difficulty falling asleep or staying asleep
• weakness
• shortness of breath
• unusual bleeding or bruising

What other information should I know

Your doctor may order regular eye exams while you are taking this medication. Keep all appointments with the ophthalmologist (appointments for eye exams).

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking valganciclovir.

Do not let anyone else take your medication. Do not let your valganciclovir supply run out. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Valcyte®