Cytovene IV (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 in the eyes for 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 prevent the symptoms from getting worse. It is also used to help prevent CMV infection in patients who have 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, such as the common cold or the flu.

This medicine may cause some serious side effects, including anemia and other blood issues. Before starting treatment with ganciclovir, you and your doctor should discuss the benefits this medicine will provide and the risks associated with its use.

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

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

• Contact your doctor right away if you think you are getting an infection or if you develop a fever or chills.
• Contact your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or small red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may suggest other ways to clean your teeth and gums. Consult your medical 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.

Both men and women are advised to use birth control. 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 at regular visits for any blood issues that may be caused by this medicine.

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

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. Here are some important points to consider:

Allergies

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

Pediatric

Ganciclovir can cause serious side effects in any patient. Therefore, it is very important to discuss with the child's doctor both the potential benefits and risks of using this medicine.

Geriatric

Many medicines have not been tested specifically in older adults. This means it might not be clear if they work the same way 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 its use in other age groups.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be taken together at all, while others may be used together even if there is a chance of interaction. In such cases, your doctor may change the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions are highlighted based on their importance, but this list may not include all possible interactions.

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 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 change the dose or how often you take one or both medicines.

• Didanosine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Be sure to inform your doctor of any other medical issues you have, especially:

• Kidney disease—Ganciclovir may accumulate in the blood of patients with kidney disease, increasing 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 injection site
• 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.