Didanosine

Didanosine
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: Gloria Picoy [2]

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Black Box Warning

WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete Boxed Warning. Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine delayed-release capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

Overview

Didanosine is a nucleoside reverse transcriptase inhibitor that is FDA approved for the treatment of human immunodeficiency virus (HIV)-1 infection.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include highlights: diarrhea, peripheral neurologic symptoms/neuropathy, nausea, headache, rash and vomiting

MICROMEDEX: Dermatologic: Pruritus (7% to 9% ), Rash (7% to 30% ) Gastrointestinal: Abdominal pain (7% to 13% ), Diarrhea (19% to 70% ), Nausea (24% to 53% ), Vomiting (12% to 30% ) Hepatic: Increased liver enzymes Neurologic: Headache (21% to 46%).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Didanosine in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection.

• Should be administered on an empty stomach
• Total daily dose is based on body weight

• 20 kg to less than 25 kg: 200 mg once daily
• 25 kg to less than 60 kg: 250 mg once daily
• At least 60 kg: 400 mg once daily

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

• Prophylaxis of occupational exposure to HIV

• Didanosine: 400 mg (if body weight is less than 60 kg, 125 mg twice daily or 250 mg once daily) daily, on an empty stomach, AND
• Lamivudine: 300 mg once daily or 150 mg twice daily for 4 weeks.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Didanosine in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection.

• Should be administered on an empty stomach
• Total daily dose is based on body weight

• 20 kg to less than 25 kg: 200 mg once daily
• 25 kg to less than 60 kg: 250 mg once daily
• At least 60 kg: 400 mg once daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

• Prophylaxis of occupational exposure to HIV

• Didanosine: 400 mg (if body weight is less than 60 kg, 125 mg twice daily or 250 mg once daily) daily, on an empty stomach, AND
• Lamivudine: 300 mg once daily or 150 mg twice daily for 4 weeks.

Contraindications

These recommendations are based on either drug interaction studies or observed clinical toxicities.

Allopurinol

• Coadministration of didanosine and allopurinol is contraindicated because systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity.

Ribavirin

• Coadministration of didanosine and ribavirin is contraindicated because exposures of the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin.

Warnings

WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS See full prescribing information for complete Boxed Warning. Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Didanosine delayed-release capsules should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B There is no FDA guidance on usage of Didanosine in women who are pregnant.
Pregnancy Category (AUS): B2 There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Didanosine in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Monitoring

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

IV Compatibility

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

Overdosage

There is no known antidote for didanosine overdosage. In phase 1 studies, in which buffered formulations of didanosine were initially administered at doses ten times the currently recommended dose, toxicities included: pancreatitis, peripheral neuropathy, diarrhea, hyperuricemia, and hepatic dysfunction. Didanosine is not dialyzable by peritoneal dialysis, although there is some clearance by hemodialysis.

Pharmacology

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

Mechanism of Action

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

Structure

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

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

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

Storage

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

Precautions with Alcohol

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

Brand Names

• Videx
• Videx EC
• Videx Pediatric

Look-Alike Drug Names

There is limited information regarding Didanosine 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.

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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]

Overview

Didanosine (2′,3′-dideoxyinosine,DDI) is sold under the trade names Videx and Videx EC. It is a reverse transcriptase inhibitor, effective against HIV and used in combination with other antiretroviral drug therapy as part of highly active antiretroviral therapy (HAART).

Category

Antiretroviral

US Brand Names

VIDEX^®, VIDEX EC^®

FDA Package Insert

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

Mechanism of Action

Didanosine (ddI) is a nucleoside structural analogue of guanosine. It differs from other nucleoside analogues, because it does not have any of the regular bases, instead it has hypoxanthine attached to the sugar ring. Within the cell, ddI is phosphorylated to the active metabolite of dideoxyadenosine triphosphate, ddATP, by cellular enzymes. Like other anti-HIV nucleoside analogs, it acts as a chain terminator by incorporation and inhibits viral reverse transcriptase by competing with natural deoxyadenosine triphosphate (dATP).