Generic name: Ganciclovir sodium
Dosage form: injection, powder, lyophilized, for solution
Drug class: Purine nucleosides
WARNING: HEMATOLOGIC TOXICITY, IMPAIRMENT OF FERTILITY,
FETAL TOXICITY, MUTAGENESIS AND CARCINOGENESIS
- Hematologic Toxicity: Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported in patients treated with Ganciclovir [see Warnings and Precautions.
- Impairment of Fertility: Based on animal data and limited human data, Ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females [see Warnings and Precautions
- Fetal Toxicity: Based on animal data, Ganciclovir has the potential to cause birth defects in humans [see Warnings and Precautions.
- Mutagenesis and Carcinogenesis: Based on animal data, Ganciclovir has the potential to cause cancers in humans [see Warnings and Precautions.
Ganciclovir is an antiviral medicine used to treat CMV retinitis in people with immunosuppression caused by HIV or AIDS. Ganciclovir is also used to prevent CMV disease in people with immunosuppression due to an organ transplant.
Ganciclovir may also be used for purposes not listed in this medication guide.
Warnings
Ganciclovir can weaken (suppress) your immune system, and you may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath, or signs of infection (fever, chills, tiredness, mouth sores, skin sores, frequent or recurring illness).
Ganciclovir can cause birth defects. Both men and women using ganciclovir should use effective birth control to prevent pregnancy. Keep using birth control for at least 30 days (for women) or 90 days (for men) after your last dose. ganciclovir may also affect fertility in a man or a woman.
Before taking this medicine
You should not use this medicine if you are allergic to ganciclovir or valacyclovir.
Tell your doctor if you have ever had:
- kidney disease (or if you are on dialysis);
- low blood cell counts; or
- radiation treatment.
Using ganciclovir may increase your risk of developing certain types of cancers. Ask your doctor about this risk.
Ganciclovir can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.
- If you are a woman, do not use ganciclovir if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 30 days after your last dose.
- If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 90 days after your last dose.
- Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ganciclovir.
This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because ganciclovir can harm an unborn baby.
Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Do not give this medicine to a child without medical advice.
How should I use ganciclovir?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Ganciclovir is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.
Read and carefully follow any Instructions for Use provided with your medicine. Do not use ganciclovir if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.
Ganciclovir injection powder must be mixed with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.
Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.
ganciclovir can be dangerous if it gets in your mouth, eyes, or nose, or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water. Ask your pharmacist how to safely dispose of a medicine spill.
Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses may increase the risk of your virus becoming resistant to medication.
Ganciclovir can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests and eye exams.
Drink plenty of liquids while you are using ganciclovir, to keep your kidneys working properly.
Ganciclovir is not a cure for CMV. Every person with CMV should remain under the care of a doctor.
Store at room temperature away from moisture and heat. You may store mixed medicine at room temperature, but you must use it within 12 hours after mixing.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
Detailed Ganciclovir dosage information
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include vomiting, diarrhea, decreased urination, yellowing of the skin or eyes, seizure, or infections (fever, chills, frequent illness).
What should I avoid while using ganciclovir?
Avoid driving or hazardous activity until you know how ganciclovir will affect you. Your reactions could be impaired.
Ganciclovir side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
- pain or burning when you urinate;
- a seizure; or
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.
Side effects may be more likely in older adults.
Common side effects may include:
- nausea, diarrhea, stomach pain, loss of appetite;
- fever, weakness, low blood cell counts;
- headache;
- cough, trouble breathing; or
- increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ganciclovir side effects (more detail)
What other drugs will affect ganciclovir?
Ganciclovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).
Tell your doctor about all your other medicines, especially:
- didanosine;
- probenecid; or
- drugs that weaken the immune system such as cancer medicine or steroids.
This list is not complete. Other drugs may affect ganciclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.