Cidofovir

Cidofovir
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

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Black Box Warning

Warning See full prescribing information for complete Boxed Warning. Condition Name: Renal impairment is the major toxicity of vistide. Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of vistide. To reduce possible nephrotoxicity, intravenous prehydration with normal saline and administration of probenecid must be used with each vistide infusion. Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of vistide and the dose of vistide modified for changes in renal function as appropriate. vistide is contraindicated in patients who are receiving other nephrotoxic agents. Neutropenia has been observed in association with vistide treatment. Therefore, neutrophil counts should be monitored during visited therapy. Vistide is indicated only for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. In animal studies cidofovir was carcinogenic, teratogenic and caused hypospermia.

Overview

Cidofovir is an antiviral, cytosine nucleoside analog that is FDA approved for the treatment of Citomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). The safety and efficacy of Cidofovir have not been established for treatment of other CMV infections (such as pneumonitis or gastroenteritis), congenital or neonatal CMV disease, or CMV disease in non-HIV-infected individuals.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Cidofovir FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cidofovir in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cidofovir in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Cidofovir FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Cidofovir in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cidofovir in pediatric patients.

Contraindications

There is limited information regarding Cidofovir Contraindications in the drug label.

Warnings

Warning See full prescribing information for complete Boxed Warning. Condition Name: Renal impairment is the major toxicity of vistide. Cases of acute renal failure resulting in dialysis and/or contributing to death have occurred with as few as one or two doses of vistide. To reduce possible nephrotoxicity, intravenous prehydration with normal saline and administration of probenecid must be used with each vistide infusion. Renal function (serum creatinine and urine protein) must be monitored within 48 hours prior to each dose of vistide and the dose of vistide modified for changes in renal function as appropriate. vistide is contraindicated in patients who are receiving other nephrotoxic agents. Neutropenia has been observed in association with vistide treatment. Therefore, neutrophil counts should be monitored during visited therapy. Vistide is indicated only for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. In animal studies cidofovir was carcinogenic, teratogenic and caused hypospermia.

There is limited information regarding Cidofovir Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Cidofovir Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Cidofovir Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Cidofovir Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Cidofovir in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cidofovir in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cidofovir during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cidofovir in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Cidofovir in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Cidofovir in geriatric settings.

Gender

There is no FDA guidance on the use of Cidofovir with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cidofovir with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cidofovir in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cidofovir in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cidofovir in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cidofovir in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Cidofovir Administration in the drug label.

Monitoring

There is limited information regarding Cidofovir Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Cidofovir and IV administrations.

Overdosage

There is limited information regarding Cidofovir overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Cidofovir Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Cidofovir Mechanism of Action in the drug label.

Structure

There is limited information regarding Cidofovir Structure in the drug label.

Pharmacodynamics

There is limited information regarding Cidofovir Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Cidofovir Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Cidofovir Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Cidofovir Clinical Studies in the drug label.

How Supplied

There is limited information regarding Cidofovir How Supplied in the drug label.

Storage

There is limited information regarding Cidofovir Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Cidofovir Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Cidofovir interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Cidofovir Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Cidofovir Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Cidofovir
VISTIDE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

Overview

Cidofovir is an injectable antiviral medication for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. It suppresses CMV replication by selective inhibition of viral DNA synthesis.

Cidofovir demonstrated a statistically significant effect in delaying the progression of CMV retinitis lesions in newly diagnosed patients, as well as in previously treated patients who had failed other therapies. Maintenance therapy with cidofovir involves an infusion only once every two weeks, making it a convenient treatment option. Because dosing is relatively infrequent, a permanent catheter is not necessary for infusions. The major side effect of cidofovir is that it can be nephrotoxic.

Category

Antiviral

US Brand Names

CIDOFOVIR^®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages

Mechanism of Action

Cidofovir suppresses cytomegalovirus (CMV) replication by selective inhibition of viral DNA synthesis. Biochemical data support selective inhibition of CMV DNA polymerase by cidofovir diphosphate, the active intracellular metabolite of cidofovir. Cidofovir diphosphate inhibits herpesvirus polymerases at concentrations that are 8- to 600-fold lower than those needed to inhibit human cellular DNA polymerases alpha, beta, and gamma1, 2, 3. Incorporation of cidofovir into the growing viral DNA chain results in reductions in the rate of viral DNA synthesis.