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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(gan SYE kloe veer)

What is the most important information I should know about ganciclovir?

If you are injecting ganciclovir at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Serious side effects affecting the blood have been reported with the use of ganciclovir. Decreased levels of blood cells (white blood cells, red blood cells, and platelets) have occurred. Your doctor may monitor your blood with blood tests.

Ganciclovir has caused birth defects in animals, and it is generally not recommended for use during pregnancy. Women should use an effective form of birth control during treatment with ganciclovir. Also, men should use a form of barrier contraception (e.g., condom) during and for at least 90 days following treatment with ganciclovir. Take all of the ganciclovir that has been prescribed, even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Take oral ganciclovir with food to increase its absorption by the body.

What is ganciclovir?

Ganciclovir is an antiviral drug. It slows the growth and spread of the cytomegalovirus.

Ganciclovir is used to treat and prevent infections caused by cytomegalovirus. This infection usually occurs in patients who have suppressed immune systems such as patients with AIDS and organ transplant patients.

Ganciclovir may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking ganciclovir?

Before taking ganciclovir, tell your doctor if you have

You may not be able to take ganciclovir, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Ganciclovir is in the FDA pregnancy category C. This means that it is not known whether ganciclovir will be harmful to an unborn baby. Ganciclovir has caused birth defects in animals, and it is generally not recommended for use during pregnancy. Women should use an effective form of birth control during treatment with ganciclovir. Also, men should use a form of barrier contraception (e.g., condom) during and for at least 90 days following treatment with ganciclovir. It is not known whether ganciclovir passes into breast milk. Generally, breast-feeding should be avoided during treatment with ganciclovir. Do not take ganciclovir without first talking to your doctor if you are breast-feeding a baby.
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