Cytovene (Oral, Intravenous)

Ganciclovir is an antiviral medicine. 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 fully working. This includes patients with acquired immune deficiency syndrome (AIDS). Ganciclovir will not cure this eye infection, but it may help to prevent the symptoms from getting worse. It is also used to help prevent CMV infection in patients who are receiving 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 decided by your doctor. However, it does not work for treating certain viruses, like the common cold or the flu.

This medicine may cause some serious side effects, including anemia and other blood issues. Before you start treatment with ganciclovir, you and your doctor should discuss the benefits of this medicine along with the risks of using it.

Ganciclovir is to be given only by or under the supervision of your doctor.

Ganciclovir can reduce the number of white blood cells in your blood, increasing the risk of infection. It can also lower the number of platelets, which are needed for proper blood clotting. If this happens, there are specific precautions you can take to lower the risk of infection or bleeding:

• Check with your doctor right away if you think you are getting an infection or if you have a fever or chills.
• Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in your urine or stools; or small red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your doctor, dentist, or nurse may suggest other methods to clean your teeth and gums. Check with your doctor before having any dental work done.
• Be cautious not to cut yourself when using sharp objects like a safety razor or fingernail or toenail clippers.

Using birth control is advised for both men and women. Women should use effective birth control methods while taking this medicine. Men should use a condom during treatment with this medicine and for at least 90 days after treatment has ended.

It is very important for your doctor to check you regularly for any blood issues that might be caused by this medicine.

If you have CMV retinitis: It is also very important for your ophthalmologist (eye doctor) to examine your eyes regularly since there is still a chance that you may experience some loss of eyesight during ganciclovir treatment.

In deciding to use a medicine, you and your doctor will consider the risks of the medicine against the benefits it may provide. Here are some important points to discuss:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Ganciclovir can cause serious side effects in any patient. Therefore, it is particularly important to talk with the child's doctor about the benefits this medicine may provide along with the risks involved.

Geriatric

Many medicines have not been studied specifically in older adults. As a result, it may be unclear whether they work the same way in older people as they do in younger adults or if they cause different side effects or issues in older individuals. There is no specific information comparing the use of ganciclovir in elderly patients with other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there could be an interaction. In these cases, your doctor may adjust the dose, or other precautions may be needed. When you are using this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not be the complete list.

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

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Didanosine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime, or with certain types of food, due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how this medicine works for you. Make sure to inform your doctor if you have any other medical issues, especially:

• Kidney disease—Ganciclovir may accumulate in the blood of patients with kidney disease, raising the risk of side effects.

• Low platelet count or
• Low white blood cell count—Ganciclovir may worsen these blood conditions.

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

In the U.S.

• Cytovene
• Cytovene IV

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

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.