These highlights do not include all the information needed to use VIDEX safely and effectively. See full prescribing information for VIDEX.
VIDEX (didanosine, USP) pediatric powder for oral solution
Initial U.S. Approval: 1991
WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS
See full prescribing information for complete boxed warning.
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Fatal and nonfatal pancreatitis. VIDEX should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. (5.1)
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration
Instructions for Reconstitution (2.4) 8/2014
INDICATIONS AND USAGE
VIDEX (didanosine, USP) is a nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection. (1)
DOSAGE AND ADMINISTRATION
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Adult patients: Administered on an empty stomach at least 30 minutes before or 2 hours after eating. Dosing is based on body weight. (2.1)
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at least 60 kg |
less than 60 kg |
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Preferred dosing
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200 mg twice daily
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125 mg twice daily
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Dosing for patients whose management requires once-daily frequency
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400 mg once daily
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250 mg once daily
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Pediatric patients (2 weeks old to 18 years old): Administered on an empty stomach at least 30 minutes before or 2 hours after eating.
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Between 2 weeks and 8 months old, dosing is 100 mg per m 2 twice daily.
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For those greater than 8 months old, dosing is 120 mg per m 2 twice daily but not to exceed the adult dosing recommendation. (2.1)
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Renal impairment: Dose reduction is recommended. (2.2)
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Coadministration with tenofovir: Dose reduction is recommended. Patients should be monitored closely for didanosine-associated adverse reactions. (2.3, 7.1)
DOSAGE FORMS AND STRENGTHS
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4-ounce glass bottle containing 2 g of VIDEX (3)
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8-ounce glass bottle containing 4 g of VIDEX (3)
CONTRAINDICATIONS
Coadministration with allopurinol or ribavirin is contraindicated. (4)
WARNINGS AND PRECAUTIONS
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Pancreatitis: Suspension or discontinuation of didanosine may be necessary. (5.1)
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Lactic acidosis and severe hepatomegaly with steatosis: Suspend didanosine in patients who develop clinical symptoms or signs with or without laboratory findings. (5.2)
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Hepatic toxicity: Interruption or discontinuation of didanosine must be considered upon worsening of liver disease. (5.3)
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Non-cirrhotic portal hypertension: Discontinue didanosine in patients with evidence of non-cirrhotic portal hypertension. (5.4)
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Patients may develop peripheral neuropathy (5.5), retinal changes and optic neuritis (5.6), immune reconstitution syndrome (5.7), and redistribution/accumulation of body fat (5.8).
ADVERSE REACTIONS
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In adults, the most common adverse reactions (greater than 10%, all grades) are diarrhea, peripheral neurologic symptoms/neuropathy, abdominal pain, nausea, headache, rash, and vomiting. (6.1)
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Adverse reactions in pediatric patients were consistent with those in adults. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Coadministration of VIDEX can alter the concentration of other drugs and other drugs may alter the concentration of didanosine. The potential drug-drug interactions must be considered prior to and during therapy. (4, 7, 12.3)
USE IN SPECIFIC POPULATIONS
Pregnancy: Fatal lactic acidosis has been reported in pregnant women who received both didanosine and stavudine with other agents. This combination should be used with caution during pregnancy and only if the potential benefit clearly outweighs the potential risk. (5.2, 8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 8/2015
