Ganciclovir

IMPORTANT WARNING:

Ganciclovir 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 drugs 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/sulfamethoxazole (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 ganciclovir.

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

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

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

The manufacturer warns that ganciclovir should only be used for treatment of patients with certain diseases because the medication may cause severe side effects and there is currently not enough information to support safety and effectiveness in other groups of patients. (See the section, WHY is this medication is prescribed?)

Talk to your doctor about the risks of taking ganciclovir.

WHY is this medicine prescribed?

Ganciclovir capsules are used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people whose immune system is not working normally. Ganciclovir capsules are used to treat CMV retinitis after the condition has been controlled by intravenous (injected into a vein) ganciclovir. Ganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have acquired immunodeficiency syndrome (AIDS) or who have received an organ transplant and are at risk of CMV disease. Ganciclovir is in a class of medications called antivirals. It works by preventing the spread of CMV disease or slowing the growth of CMV.

Are there OTHER USES for this medicine?

The manufacturer states that this medication should not be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ganciclovir comes as a capsule to take by mouth. It is usually taken with food three to six times a day.To help you remember to take ganciclovir, take it at around the same times 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 ganciclovir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, split, chew, or crush them.

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

You generally will receive intravenous (into a vein) ganciclovir for several weeks before you begin to take ganciclovir capsules. If your condition gets worse during your treatment, you may be given a second course of intravenous ganciclovir. Your doctor may decrease your dose of ganciclovir capsules if you experience side effects.

Ganciclovir controls CMV but does not cure it.It may take some time before you feel the full benefit of ganciclovir. Continue to take ganciclovir even if you feel well. Do not stop taking ganciclovir without talking to your doctor. Stopping to take ganciclovir too soon may cause the amount of CMV in your blood to increase or the virus to become resistant to this medication.

What SPECIAL PRECAUTIONS should I follow?

Before taking ganciclovir,

• tell your doctor and pharmacist if you are allergic to ganciclovir, acyclovir (Zovirax), valganciclovir (Valcyte), or any other medications.

• do not take ganciclovir if you are taking valganciclovir (Valcyte).

• 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 (New-Rx, New-Fradin), netilmicin (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, 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 any of the conditions mentioned in the IMPORTANT WARNING section or any of the following conditions: mental illness; seizures; eye problems other than CMV retinitis; kidney, or liver disease.

• tell your doctor if you are breast-feeding. You should not breast-feed while taking ganciclovir. Talk to your doctor about when you may safely begin breast-feeding after you stop taking ganciclovir.

• you should know that ganciclovir may make you drowsy, dizzy, unsteady, confused or less alert, or may 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?

Be sure to drink plenty of fluids while you are taking ganciclovir.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. 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.

What SIDE EFFECTS can this medicine cause?

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

• nausea
• vomiting
• diarrhea
• constipation
• stomach pain
• belching
• loss of appetite
• changes in ability to taste food
• dry mouth
• mouth sores
• unusual dreams
• nervousness
• depression
• sweating
• flushing
• joint or muscle pain or cramps

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
• hives
• rash
• itching
• swelling of the hands, arms, feet, ankles, or lower legs
• numbness, pain, burning, or tingling in the hands or feet
• shaking hands that you cannot control
• difficulty breathing or swallowing
• chest pain
• mood changes
• seizures

Ganciclovir 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• nausea
• vomiting
• diarrhea
• loss of appetite
• unusual bleeding or bruising
• excessive tiredness
• weakness
• pale skin
• headache
• dizziness
• confusion
• fast heartbeat
• difficulty sleeping
• shortness of breath
• sore throat, fever, chills, cough, or other signs of infection
• decreased urination
• swelling of the hands, arms, feet, ankles, or lower legs
• seizures
• yellowing of the skin or eyes
• flu-like symptoms
• pain in the upper right part of the stomach

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 (eye exams).

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

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.