Cytovene

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.

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.

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.

Overdose

Reports of adverse reactions after overdoses with CYTOVENE-IV, some with fatal outcomes, have been received from clinical trials and during post-marketing experience. One or more of the following adverse reactions has been reported with overdoses:

Hematological toxicity: myelosuppression including pancytopenia, leukopenia, neutropenia, granulocytopenia, thrombocytopenia, bone marrow failure

Hepatotoxicity: hepatitis, liver function disorder

Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine

Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting

Neurotoxicity: seizures

Since ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of CYTOVENE-IV [see CLINICAL PHARMACOLOGY]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered in patients with cytopenias [see WARNINGS AND PRECAUTIONS].

Patient information

Hematologic Toxicity

Inform patients that CYTOVENE-IV may cause hematologic toxicity including granulocytopenia (neutropenia), anemia, and thrombocytopenia. Inform patients that their blood counts and platelet counts should be closely monitored while on treatment [see WARNINGS AND PRECAUTIONS].

Impairment Of Renal Function

Inform patients that CYTOVENE-IV has been associated with decreased renal function and that serum creatinine or creatinine clearance should be monitored while on treatment to allow for dosage adjustment in patients with renal impairment [see WARNINGS AND PRECAUTIONS].

Impairment Of Fertility

Inform patients that CYTOVENE-IV may cause temporary or permanent infertility in humans [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].

Pregnancy And Contraception

Advise female patients to use effective contraception during and for at least 30 days following treatment with CYTOVENE-IV. Similarly, advise men to practice barrier contraception during and for at least 90 days following treatment with CYTOVENE-IV [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].

Carcinogenicity

Inform patients that CYTOVENE-IV should be considered a potential carcinogen [see WARNINGS AND PRECAUTIONS].

Drug Interactions

Inform patients that CYTOVENE-IV may interact with other drugs. Advise patients to report to their healthcare provider the use of any other medication [see DRUG INTERACTIONS].

Impairment Of Cognitive Ability

Based on the adverse reaction profile, ganciclovir may affect cognitive abilities including on the ability to drive and operate machinery as seizures, dizziness, and/or confusion have been reported with the use of CYOVENE-IV [see ADVERSE REACTION].

Ophthalmological Examination In Patients With CMV Retinitis

Inform patients that CYTOVENE-IV is not a cure for CMV retinitis, and they may continue to experience progression of retinitis during or following treatment. Advise patients to have frequent ophthalmological follow-up examinations while being treated with CYTOVENE-IV. Some patients may require more frequent ophthalmological follow-up [see DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS].

Lactation

Advise nursing mothers not to breastfeed if they are receiving CYTOVENE-IV because of the potential for serious adverse events in nursing infants and because HIV can be passed to the baby in breast milk [see Use in Specific Populations].

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.

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 1996-2013 Cerner Multum, Inc. Version: 4.03. Revision date: 12/15/2010.

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Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Ganciclovir

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

250 mg*

Cytovene

Roche

Ganciclovir Capsules

500 mg*

Cytovene

Roche

Ganciclovir Capsules

Ganciclovir Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

For injection, for iv infusion only

500 mg (of ganciclovir)

Cytovene-iv

Roche

Before Using Cytovene

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Ganciclovir can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ganciclovir in the elderly with use in other age groups.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Imipenem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Didanosine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease—Ganciclovir may build up in the blood in patients with kidney disease, increasing the chance of side effects
  • Low platelet count or
  • Low white blood cell count—Ganciclovir may make these blood diseases worse

Proper Use of ganciclovir

This section provides information on the proper use of a number of products that contain ganciclovir. It may not be specific to Cytovene. Please read with care.

It is important that you take ganciclovir capsules with food. This is to make sure the medicine is fully absorbed into the body and will work properly.

To get the best results, ganciclovir must be given for the full time of treatment. Also, this medicine works best when there is a constant amount in the blood. To help keep the amount constant, ganciclovir must be given on a regular schedule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For treatment of CMV retinitis after you have received ganciclovir injection for at least fourteen to twenty-one days:
      • Adults and teenagers—1000 milligrams (mg) three times a day with food; or 500 mg six times a day, every three hours with food, during waking hours.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of CMV disease in transplant patients and patients with advanced HIV infection:
      • Adults and teenagers—1000 mg three times a day with food.
      • Children—Use and dose must be determined by your doctor.
  • For injection dosage form:
    • For treatment of CMV retinitis:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for fourteen to twenty-one days. Then, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
      • Children—Use and dose must be determined by your doctor.
    • For prevention of CMV in transplant patients:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. At first, 5 mg per kilogram (2.3 mg per pound) of body weight is injected into a vein every twelve hours for seven to fourteen days. Then the dose is reduced to 5 mg per kilogram (2.3 mg per pound) of body weight once a day for seven days of the week; or 6 mg per kilogram (2.7 mg per pound) of body weight is injected into a vein once a day for five days of the week.
      • Children—Use and dose must be determined by your doctor.

Cytovene Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Medicines like ganciclovir can sometimes cause serious side effects such as blood problems; these are described below. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

More commonFor oral capsules and injection into the vein only
  • Sore throat and fever
  • unusual bleeding or bruising
Less commonFor oral capsules and injection into the vein only
  • Mood or other mental changes
  • nervousness
  • pain at place of injection
  • skin rash
  • tremor
  • unusual tiredness and weakness
For injection into the eye only
  • Decreased vision or any change in vision

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abdominal or stomach pain
  • loss of appetite
  • nausea and vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some other side effects of Cytovene?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling sleepy.
  • Not hungry.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Headache.
  • Belly pain.
  • Gas.
  • Hard stools (constipation).
  • Strange or odd dreams.
  • Dry mouth.
  • Not able to sleep.
  • Hair loss.
  • Dry skin.
  • Change in taste.
  • Weight loss.
  • Back pain.
  • Muscle or joint pain.
  • Muscle spasm.
  • Leg cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Cytovene?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
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