Ganciclovir (Systemic)

• It is used to treat a viral infection of the eyes in people with immune system problems.
• It is used to prevent cytomegalovirus (CMV) disease after organ transplant.
• It may be given to you for other reasons. Talk with the doctor.

For all uses of this medicine:

• Tell all of your health care providers that you take ganciclovir. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Holes in the GI (gastrointestinal) tract, organ failure, pancreas irritation (pancreatitis), and a very bad blood infection (sepsis) have happened with ganciclovir. These health problems could be deadly. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 3 months after care ends. Use a condom.
• If you are a man and your sex partner gets pregnant while you take ganciclovir or within 3 months after your last dose, call your doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting this medicine. Talk with your doctor.
• Use birth control that you can trust to prevent pregnancy while taking ganciclovir and for at least 1 month after stopping this medicine.
• If you get pregnant while taking ganciclovir (systemic) or within 1 month after your last dose, call your doctor right away.

For CMV infections of the eye:

• This medicine is not a cure for CMV infections of the eye. Stay under the care of your doctor.
• Have an eye exam as you have been told by your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ganciclovir, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ganciclovir. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using ganciclovir.

Review Date: October 4, 2017

(gan SYE kloe veer)

CMV disease, chronic maintenance (secondary prophylaxis) in HIV-exposed/-infected patients (off-label use):

Infants and Children: IV: 5 mg/kg/dose daily (CDC 2009)

Adolescents (alternative to preferred therapy): Refer to adult dosing.

CMV esophagitis or colitis in HIV-infected patients (off-label use): Adolescents: Refer to adult dosing.

CMV neurological disease in HIV-exposed/-infected patients (off-label use): Infants, Children, and Adolescents: IV: Refer to adult dosing.

Varicella-zoster: Acute retinal necrosis (ARN) in HIV-infected patients (off-label use): Adolescents: Refer to adult dosing.

Varicella-zoster: Progressive outer retinal necrosis in HIV-exposed/-infected patients (off-label use):

Infants and Children: IV: 5 mg/kg/dose every 12 hours plus systemic foscarnet and intravitreal ganciclovir or intravitreal foscarnet (CDC 2009)

Adolescents: Refer to adult dosing.

Reconstitute 500 mg vial with 10 mL unpreserved sterile water (do not use bacteriostatic water; parabens may cause precipitation). Shake vial to dissolve. Typically, dilute in 100 mL D5W or NS to a concentration ≤10 mg/mL for infusion.

Granulocytopenia, anemia, thrombocytopenia, and pancytopenia have been reported with ganciclovir.

Based on animal data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and suppression of fertility in females.

Based on animal data, ganciclovir has the potential to cause birth defects in humans.

Based on animal data, ganciclovir has the potential to cause cancer in humans.

[US Boxed Warning]: Based on animal data, use may suppress fertility in females, inhibit spermatogenesis in males, and cause birth defects if used in pregnant women. Ganciclovir crosses the placenta. Female patients should undergo pregnancy testing prior to initiation and use effective contraception during and for at least 30 days after therapy. Male patients should use a barrier contraceptive during and for at least 90 days after therapy. The inhibition of spermatogenesis may be temporary or permanent.