Complera Drug Label Includes Pediatric Updates
The Food and Drug Administration (FDA) has updated the label for Complera (emtricitabine, tenofovir disoproxil fumarate, rilpivirine; Gilead Sciences) tablets to include expanded use in pediatric patients aged 12 to less than 18 years old. Additional revisions were also made for consistency with the label for Edurant (rilpivirine; Janssen).
For patients aged ≥12 years and weighing ≥35kg, the recommended dose is one tablet once daily with food.
The Warnings and Precautions section was updated with data on the incidence of depressive disorders from a Phase 2 study in pediatric subjects aged 12 to less than 18 years old receiving rilpivirine through 48 weeks. The incidence of depressive disorders was 19.4% where most events were mild or moderate in severity.
The Adverse Reactions subsection on adrenal function was updated with data from pooled Phase 3 trials (C209, C215) in adult subjects treated with rilpivirine plus any of the allowed background regimens (n=686). At Week 96, an overall mean change from baseline in basal cortisol of -0.69mcg/dL was seen in the rilpivirine arm vs. -0.02mcg/dL in the efavirenz arm.
Also, additional adverse reactions data on pediatric subjects who received treatment with emtricitabine or rilpivirine were added including a weight increase update in the post-marketing experience section. Additional updates to the Pharmacokinetics section and Clinical Studies were made to include new data on pediatric subjects.
Complera combines nucleoside analogue reverse transcriptase inhibitors + non-nucleoside reverse transcriptase inhibitor and is indicated as a complete regimen for HIV-1 infection in certain antiretroviral treatment-naive adults. It is available as 200mg/300mg/25mg strength tablets.
For more information call (800) 455-3235 or visit Complera.com.