ganciclovir

Pronunciation

Generic Name: ganciclovir (oral and injectable) (gan SYE kloe veer)
Brand Name: Cytovene

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 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.

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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 should I discuss with my healthcare provider before taking ganciclovir?

Before taking ganciclovir, tell your doctor if you have

  • had an allergic reaction to ganciclovir or acyclovir (Zovirax);

  • kidney disease; or

  • blood problems or low blood counts.

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.

How should I take ganciclovir?

Take ganciclovir exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each oral dose with a full glass of water.

Take each oral dose with food to increase the absorption of the drug in your body.

Your healthcare provider will administer injectable ganciclovir as an intravenous (into a vein) infusion.

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.

Do not use any ganciclovir that is discolored, has particles in it, or looks different from your previous doses. Throw away any unused ganciclovir after the amount of time determined by your pharmacist or doctor.

Take all of the ganciclovir that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

Your doctor may want you to have blood tests, eye exams, or other evaluations during treatment with ganciclovir to monitor progress and side effects.

Store oral ganciclovir at room temperature away from moisture and heat.

Dispose of used needles and syringes in a puncture resistant container out of the reach of children.

Your healthcare provider will store injectable ganciclovir as directed by the manufacturer or give you detailed storage instructions if you are storing the medication at home.

What happens if I miss a dose?

If a dose of oral ganciclovir is missed, take the missed dose as soon as you remember. If it is almost time for the next dose, skip that dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

Contact your healthcare provider if you miss a dose of injectable ganciclovir.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a ganciclovir overdose include seizures, diarrhea, kidney damage (decreased urine production), liver damage (yellowing of the skin or eyes, abdominal pain), and bone marrow damage (paleness, increased chance of infection, fever and chills).

What should I avoid while taking ganciclovir?

There are no restrictions on food, beverages, or activity during treatment with ganciclovir unless otherwise directed by your doctor.

Ganciclovir side effects

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.

Stop taking ganciclovir and seek emergency medical attention if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  • paleness and fatigue that may be signs of anemia (a low level of red blood cells);

  • unusual bleeding or bruising;

  • fever or signs of infection; or

  • numbness or tingling in a part of your body.

Other, less serious side effects may be more likely to occur. Continue to take ganciclovir and talk to your doctor if you experience

  • nausea, vomiting, diarrhea, or decreased appetite;

  • increased sweating;

  • itching; or

  • decreased sperm production or infertility.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ganciclovir dosing information

Usual Adult Dose for CMV Retinitis:

Induction therapy:
5 mg/kg IV at a constant rate over 1 hour, every 12 hours for 14 to 21 days.

Maintenance:
IV: 5 mg/kg IV at a constant rate over 1 hour once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg 3 times a day or 500 mg 6 times a day (every 3 hours while awake) with food.

Patients who experience progression of CMV retinitis while receiving maintenance treatment should receive reinduction treatment.

Because ganciclovir capsules are associated with risk of more rapid rate of CMV retinitis progression, they should be used as maintenance treatment only in those patients for whom this risk is balanced by the benefit associated with avoiding daily intravenous infusions. Oral ganciclovir should not be used for induction.

Usual Adult Dose for CMV Prophylaxis:

Patients with advanced HIV: 1000 mg orally 3 times a day with food.

Transplant Recipients:
Initial: 5 mg/kg IV over 1 hour every 12 hours for 7 to 14 days
Maintenance:
IV: 5 mg/kg IV once a day, 7 days/week or 6 mg/kg IV once a day, 5 days/week.
Oral: 1000 mg orally 3 times a day with food.

Usual Pediatric Dose for CMV Retinitis:

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

>3 months:
Induction therapy: 5 mg/kg IV every 12 hours for 14 to 21 days.
Maintenance: 5 mg/kg IV once daily for 7 days or 6 mg/kg IV once daily for 5 days.

Usual Pediatric Dose for CMV Prophylaxis:

The safety and efficacy of ganciclovir in pediatric patients has not been established. The use of ganciclovir in the pediatric population warrants extreme caution due to the probability of carcinogenicity and reproductive toxicity. Administration to pediatric patients should be undertaken only after careful evaluation and only if the potential benefits outweigh the risks.

Transplant recipients:
>1 year to 18 years:
Induction therapy: 5 mg/kg IV every 12 hours for 7 to 14 days.
Maintenance:
IV: 5 mg/kg IV once daily 7 days a week, or 6 mg/kg IV once daily, 5 days a week.
Oral:
>= 6 months: 10 mg/kg every 8 hours with food, not to exceed adult dose.


HIV-infected patients:
>1 month to 12 years: 5 mg/kg IV once daily.
>12 years: Adult dose

What other drugs will affect ganciclovir?

Before taking ganciclovir, tell your doctor if you are taking any of the following drugs:

  • zidovudine (Retrovir, AZT);

  • didanosine (Videx);

  • probenecid (Benemid); or

  • imipenem-cilastatin (Primaxin).

You may not be able to take ganciclovir, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with ganciclovir. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Where can I get more information?

  • Your pharmacist has additional information about ganciclovir written for health professionals that you may read.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.03. Revision Date: 2010-12-15, 5:01:39 PM.

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