Cytovene

Ganciclovir is an anti-viral drug. It is used to prevent disease caused by a virus called cytomegalovirus (CMV) in people with advanced HIV disease (AIDS) and in people who have received organ transplants. CMV disease can lead to serious infections in the body, including an infection in the eye, called CMV retinitis, that can cause blindness. Ganciclovir works by slowing the growth of the CMV virus. It helps prevent the spread of infection to other areas of the body. It also helps control CMV retinitis and decrease the risk of blindness. Ganciclovir is also used to treat people with weakened immune systems (including people with AIDS) who have CMV retinitis. Ganciclovir injection is given first to stabilize the disease and then usually continued to control the symptoms of the disease (maintenance treatment). However, in some people, ganciclovir is given by mouth for maintenance treatment when the injection cannot be used. Use of the oral form of ganciclovir instead of the injection may increase the rate of progression of CMV retinitis. Ganciclovir is not a cure for CMV disease. Some people may have worsening CMV retinitis even with treatment. Therefore, it is important to have your eyes checked regularly by your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Take this medication by mouth with food, usually 3 to 6 times daily or as directed by your doctor. Swallow the capsules whole. Do not open, crush, or chew the capsules. Drink plenty of fluids while taking this medication unless your doctor directs you otherwise. Wash your hands well after handling this drug. Avoid direct contact with the contents of the capsules (such as getting the contents on your skin, in the mucous membranes and eyes, or breathing in the powder). Avoid contact with broken or crushed capsules. If contact should occur, wash the area thoroughly with soap and water. If this medication gets in your eyes, rinse them thoroughly with plain water. Do not throw this medication in the garbage or down the drain. Special disposal is required for this medication. Contact your pharmacist for more information. The dosage and length of treatment is based on your medical condition and response to treatment. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day. Continue taking this medication exactly as prescribed by your doctor. Do not change your dose or stop taking it even for a short time unless directed to do so by your doctor. Changing or skipping your dose without approval from your doctor may increase the risk of side effects or make the infection worse. Do not take valganciclovir instead of ganciclovir on your own without consulting your doctor or pharmacist. The effects and the dosages of ganciclovir and valganciclovir are not equal. Keep all medical and laboratory appointments. Tell your doctor if your condition worsens (such as worsening vision).

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: didanosine, imipenem/cilastatin, mycophenolate, probenecid. You may be taking other drugs that decrease bone marrow function and lower your number of blood cells (such as cancer chemotherapy, trimethoprim/sulfamethoxazole, zidovudine) or other drugs that may cause kidney problems (such as cyclosporine). Your doctor or pharmacist will monitor you closely and adjust your medications to decrease your risk of serious side effects. Ganciclovir is very similar to valganciclovir. Do not use medications containing valganciclovir while using ganciclovir. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (such as blood tests, kidney tests, eye exams) should be performed often to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before taking ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir or acyclovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, a low number of blood cells (red or white blood cells, platelets), radiation treatment. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to the side effects of this drug. Based on animal studies, this medication may reduce fertility in men and women. Women who are pregnant or who may become pregnant should not handle this medication. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. To prevent pregnancy, men with female partners should always use effective barrier protection (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women of child-bearing age who are taking ganciclovir should use at least 2 reliable forms of birth control (such as birth control pills and condoms). Consult your doctor for more details. It is unknown if this medication passes into breast milk. It may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. If you have HIV, do not breast-feed because breast milk can transmit HIV.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section. Diarrhea, upset stomach, dizziness, drowsiness, unsteadiness, or shaking (tremors) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), change in the amount of urine, seizures. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to help prevent CMV disease in patients receiving cancer chemotherapy treatment.

Ganciclovir can decrease bone marrow function. This serious, possibly life-threatening side effect may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, and cause bleeding problems. Your doctor will check the results of your blood tests and adjust your treatment to reduce your risk for these side effects. Seek immediate medical attention if you develop signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of infection (such as fever, chills, cough, persistent sore throat), and signs of bleeding (such as easy bruising/bleeding, nose bleeds, bleeding gums, bloody/black/tarry stools, vomit that looks like coffee grounds). Ganciclovir has caused decreased sperm production in animals and may decrease the ability of men to father a baby. Ganciclovir has caused tumors in laboratory animals. Although there is no information in humans, ganciclovir should be considered cancer-causing (carcinogenic). See also How to Use and Precautions sections.