Ganciclovir Injection (patient information)

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 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/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; 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 using 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 currently is not enough information to support safety and effectiveness in other groups of patients. (See the section, About Your Treatment.)

Talk to your doctor about the risks of using ganciclovir.

About your treatment

Your doctor has ordered ganciclovir, an antiviral medication, to help treat or prevent an infection with cytomegalovirus (CMV). This medication will be added to an IV ( intravenous) fluid that will drip through a needle (catheter) placed in your vein, and will be given to you two times a day for 2-3 weeks, and then once a day, 5-7 days of each week.Your dose of ganciclovir will be given at a constant rate over at least 60 minutes. Giving ganciclovir too quickly may increase the side effects of this medication.The manufacturer states that this medication should not be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ganciclovir works by preventing the spread of CMV disease or slowing the growth of CMV. Ganciclovir injection is used to treat cytomegalovirus (CMV) retinitis (eye infection) that can cause blindness in people whose immune system is not working normally, including people with acquired immune deficiency syndrome (AIDS). Ganciclovir is also used to prevent cytomegalovirus (CMV) disease in people who have received an organ transplant and who are at risk of getting CMV disease.

Ganciclovir does not cure CMV retinitis. Your doctor may increase your dose if your condition gets worse, or decrease your dose if you develop side effects.

Ganciclovir injection is for intravenous (into a vein) use only. Giving ganciclovir through intramuscular (into a muscle) or subcutaneous (just under the skin) injection may cause severe skin and tissue irritation.

Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations, including eye exams. It is important to keep all appointments with your doctor, the laboratory, and the ophthalmologist (eye exams). The length of treatment depends on how your infection and symptoms respond to the medication.

Precautions

Before administering ganciclovir:

• tell your doctor and pharmacist if you are allergic to ganciclovir, acyclovir (Zovirax), valganciclovir (Valcyte), or any other medications.
• do not use 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 (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, 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: seizures; mental illness; eye problems other than CMV retinitis; kidney, or liver disease.
• tell your doctor if you are breast-feeding. You should not breastfeed while using ganciclovir. *Talk with your doctor about when you may safely begin breast-feeding after you stop using ganciclovir.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are using 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.
• you should drink plenty of fluids while using this medication.

Administering your medication

Before you administer ganciclovir, look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed. Do not stop your therapy on your own for any reason because your infection could worsen and result in hospitalization. Do not change your dosing schedule without talking to your health care provider. Your health care provider may tell you to stop your infusion if you have a mechanical problem (such as a blockage in the tubing, needle, or catheter); if you have to stop an infusion, call your health care provider immediately so your therapy can continue.

Be careful not to get the ganciclovir solution on your skin, eyes, mouth, or nose. If such contact occurs, wash your skin thoroughly with soap and water and rinse your eyes thoroughly with plain water.

Side effects

Minor side effects

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

• upset stomach
• 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

Severe side effects

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:

• swelling of the hands, arms, feet, ankles, or lower legs
• numbness, pain, burning, or tingling in the hands or feet
• chest pain
• seeing specks, flashes of light, or a dark curtain over everything
• decreased urination
• pain at the injection site
• hives
• rash
• itching
• difficulty breathing or swallowing
• shaking hands that you cannot control
• mood changes
• seizures

Ganciclovir may cause other side effects. Call your doctor if you have any unusual problems while using 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].

Storing your medication

Your health care provider may give you several doses (enough for a day's supply) of premixed ganciclovir injection solution at one time. You should store premixed ganciclovir solution in the refrigerator. Do not freeze ganciclovir. Use premixed ganciclovir solution within 24 hours. Throw away any ganciclovir solution that is not used within 24 hours of preparation. Ask your health care provider if you have any questions about the storage of ganciclovir solution.

Store your medication only as directed. Make sure you understand what you need to do to store your medication properly.

Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury.

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
• 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

Signs of infection

If you are receiving ganciclovir injection you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:

• tenderness
• warmth
• irritation
• drainage
• redness
• swelling
• pain

Brand names

• Cytovene®-IV

Other names

• Nordeoxyguanosine
• DHPG Sodium
• GCV Sodium