Pronunciation:

gan-SYE-kloe-vir

Brand Names:

• Cytovene
• Cytovene IV

Dosage Forms:

• Powder for Solution
• Solution

Warnings:

The clinical toxicity of ganciclovir includes granulocytopenia, anemia, and thrombocytopenia. Ganciclovir capsules are indicated only for prevention of cytomegalovirus (CMV) disease in patients with advanced HIV infection at risk for CMV disease, for maintenance treatment of CMV retinitis in immunocompromised patients, and for prevention of CMV disease in solid organ transplant recipients. Because ganciclovir is associated with a risk of more rapid rate of CMV retinitis progression, it should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily IV infusions .

Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with ganciclovir sodium. Based on animal data and limited human data, ganciclovir sodium may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females. Based on animal data, ganciclovir sodium has the potential to cause birth defects in humans. Based on animal data, ganciclovir sodium has the potential to cause cancers in humans .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Viral DNA Polymerase Inhibitor

Chemical—

Guanosine Nucleoside Analog

Uses of This Medicine:

Ganciclovir 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.

Before Using 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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Emtricitabine
• Imipenem
• Levoketoconazole
• Maribavir
• Methotrexate
• Tenofovir Alafenamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Didanosine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. 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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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 While Using 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:

More common

For oral capsules and injection into the vein only

Sore throat and fever

unusual bleeding or bruising

Less common

For oral capsules and injection into the vein only

Mood or other mental changes

nervousness

pain at place of injection

skin rash

tremor

unusual tiredness and weakness

For injection into the eye only

Decreased vision or any change in vision

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abdominal or stomach pain

loss of appetite

nausea and vomiting

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

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