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Drug Notebook

FDA Alerts

  • Clinical toxicity of oral and IV ganciclovir includes granulocytopenia, anemia, and thrombocytopenia.
  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis.
  • The only FDA-approved indications for IV ganciclovir are treatment of CMV retinitis in immunocompromised patients and prevention of CMV disease in transplant recipients at risk.
  • The only FDA-approved indications for oral ganciclovir are prevention of CMV disease in patients with advanced HIV infection, maintenance treatment of CMV retinitis in immunocompromised patients, and prevention of CMV disease in solid organ transplant recipients.
  • Because oral ganciclovir is associated with a risk of more rapid progression of CMV retinitis, it should be used as maintenance treatment only in those for whom this risk is balanced by the benefits associated with avoiding daily IV infusions.

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ganciclovir
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(gan SYE kloe veer)

What is this medicine?

GANCICLOVIR (gan SYE kloe veer) is an antiviral medicine. It is used to treat or prevent infections caused by certain kinds of viruses. It is commonly used to treat and prevent cytomegalovirus (CMV) infections of the eye or body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

How should I use this medicine?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine. If you have a CMV eye infection have your eyes checked every 4 to 6 weeks.

Drink 6 to 8 glasses of water or fluids daily while taking this medicine to help prevent side effects.

This medicine may cause birth defects to an unborn child if taken during pregnancy. Use contraception while taking this medicine. Males must use barrier contraception during therapy and for 90 days after stopping this medicine. If you think you may have become pregnant and are taking this medicine, contact your doctor right away.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in vision
  • dizziness, lightheaded
  • fever or chills, sore throat
  • mouth sores
  • pain at site where injected
  • pain, tingling, numbness in the hands or feet
  • trouble passing urine or change in the amount of urine
  • unusual bleeding or bruising
  • unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • loss of appetite
  • nausea
  • stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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