Edurant Label Updated With New Pediatric Indication, Warning

The Food and Drug Administration announced that the Edurant (rilpivirine; Janssen) labeling has been updated to include a new pediatric indication and changes in the Warnings and Precautions and Adverse Reactions sections.

Edurant is now approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve pediatric patients from ages 12–18 years with HIV-1 RNA ≤100,000 copies/mL. This expanded indication is based on a safety and efficacy analysis through 48 weeks from a Phase 2 single-arm, open-label trial in 36 antiretroviral treatment-naïve HIV-1 infected subjects 12–18 years of age weighing ≥32kg. The recommended dosage in patients ≥12 years and weighing ≥35kg is 25mg once daily with a meal.

The Warnings and Precautions section was updated with a depressive disorders warning. During Phase 3 trials (n=1,368) through 96 weeks, depressive disorders (eg, depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) were reported with use of Edurant (9%) and efavirenz (8%).

The Adverse Reactions section was updated with changes in adrenal function. an overall mean change from baseline in basal cotisol was seen in the Edurant group (-0.69mcg/dL [-1.12, 0.27]) and in the efavirenz group (-0.02 mcg/dL [-0.48, 0.44]) in the pooled Phase 3 trials at Week 96. Overall, there were no serious adverse events, deaths, or treatment discontinuations that could clearly be attributable to adrenal insufficiency. Safety assessment data for pediatric patients were included as well with comparable laboratory abnormalities to those in adults.

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