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|Cytovene-IV

GANCICLOVIR (Systemic)

Some commonly used brand names are:

In the U.S.—

• Cytovene
• Cytovene-IV

In Canada—

• Cytovene

Another commonly used name is DHPG .

Category

• Antiviral, systemic

Description

Ganciclovir (gan-SYE-kloe-vir) is an antiviral. It is used to treat infections caused by viruses.

Ganciclovir is used to treat the symptoms of cytomegalovirus (CMV) infection of the eyes in people whose immune system is not working fully. This includes patients with acquired immune deficiency syndrome (AIDS). Ganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse. It is also used to help prevent CMV infection in patients who receive organ or bone marrow transplants, as well as in patients with advanced human immunodeficiency virus (HIV) infection. Ganciclovir may be used for other serious CMV infections as determined by your doctor. However, it does not work in treating certain viruses, such as the common cold or the flu.

This medicine may cause some serious side effects, including anemia and other blood problems. Before you begin treatment with ganciclovir, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Ganciclovir is to be administered only by or under the supervision of your doctor. It is available in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ganciclovir, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to acyclovir or ganciclovir. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of ganciclovir during pregnancy should be avoided whenever possible since ganciclovir has caused cancer and birth defects in animal studies. The use of birth control is recommended during ganciclovir therapy. Men should use a condom while receiving ganciclovir, and for at least 90 days following treatment. Also, animal studies have shown that ganciclovir causes a decrease in fertility.

Breast-feeding—Breast-feeding should be stopped during treatment with this medicine because ganciclovir may cause serious unwanted effects in nursing babies.

Children—Ganciclovir can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child"s doctor the good that this medicine may do as well as the risks of using it.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ganciclovir in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ganciclovir, it is especially important that your health care professional know if you are taking any of the following:

• Amphotericin B by injection (e.g., Fungizone) or
• Antineoplastics (cancer medicine) or
• Antithyroid agents (medicine for overactive thyroid) or
• Azathioprine (e.g., Imuran) or
• Chloramphenicol (e.g., Chloromycetin) or
• Colchicine or
• Cyclophosphamide (e.g., Cytoxan) or
• Flucytosine (e.g., Ancobon) or
• Interferon (e.g., Intron A, Roferon-A) or
• Mercaptopurine (e.g., Purinethol) or
• Zidovudine (e.g., AZT, Retrovir)—Caution should be used if these medicines and ganciclovir are used together; receiving ganciclovir while you are using these medicines may make anemia and other blood problems worse

• Carmustine (e.g., BiCNU) or
• Cisplatin (e.g., Platinol) or
• Combination pain medicine containing acetaminophen and aspirin (e.g., Excedrin) or other salicylates (with large amounts taken regularly) or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine, except narcotics, or
• Lithium (e.g., Lithane) or
• Other anti-infectives (e.g., amphotericin B) or
• Penicillamine (e.g., Cupramine) or
• Streptozocin (e.g., Zanosar) or
• Tiopronin (e.g., Thiola)—Use of these medicines may increase the chance of side effects affecting the kidneys

• Methotrexate (e.g., Mexate) or
• Plicamycin (e.g., Mithracin)—These medicines may increase the chance of side effects affecting the blood and the kidneys

Other medical problems—The presence of other medical problems may affect the use of ganciclovir. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Ganciclovir may build up in the blood in patients with kidney disease, increasing the chance of side effects

• Low platelet count or
• Low white blood cell count—Ganciclovir may make these blood diseases worse

Proper Use of This Medicine

It is important that you take ganciclovir capsules with food . This is to make sure the medicine is fully absorbed into the body and will work properly.

To get the best results, ganciclovir must be given for the full time of treatment . Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, ganciclovir must be given on a regular schedule.

Dosing—The dose of ganciclovir will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of ganciclovir. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (capsules):
  • For treatment of CMV retinitis after you have received ganciclovir injection for at least fourteen to twenty-one days:
    • Adults and teenagers—1000 milligrams (mg) three times a day with food; or 500 mg six times a day, every three hours with food, during waking hours.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of CMV disease in transplant patients and patients with advanced HIV infection:
    • Adults and teenagers—1000 mg three times a day with food.
    • Children—Use and dose must be determined by your doctor.
• For injection dosage form:
  • For treatment of CMV retinitis:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for fourteen to twenty-one days. Then, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of CMV in transplant patients:
    • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for seven to fourteen days. Then the dose is reduced to 5 mg per kilogram (2.3 mg per pound) of body weight once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
    • Children—Use and dose must be determined by your doctor.

Precautions After Receiving This Medicine

Ganciclovir can lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take to reduce the risk of infection or bleeding:

• Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.

The use of birth control is recommended for both men and women . Women should use effective birth control methods while receiving this medicine. Men should use a condom during treatment with this medicine and for at least 90 days after treatment has been completed.

It is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

If you have CMV retinitis: It is also very important that your ophthalmologist (eye doctor) check your eyes at regular visits since it is still possible that you may have some loss of eyesight during ganciclovir treatment.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 04/04/2001

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