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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  08/26/2015
 
Trade Name:  Edurant
 
Generic Name or Proper Name (*):  rilpivirine
 
Indications Studied:  HIV-1 infection in treatment-naïve pediatric patients from 12 to less than 18
 
Label Changes Summary:  *Expanded the indication from adults to pediatric patients 12 to less than 18 years and weighing at least 32 kg. *Safety, efficacy and PK were evaluated in an open-label, Phase 2 trial that enrolled 36 antiretroviral treatment-naïve, HIV-1 infected pediatric patients. *Safety and effectiveness in pediatric patients less than 12 years have not been established. *Information added to Warnings on pediatric depression: During the Phase 2 trial, the incidence of depressive disorders was 19.4% (7/36). Most events were mild or moderate. The incidence of Grade 3 and 4 depressive disorders was 5.6% (2/36). Suicidal ideation and suicide attempt were reported in 1 subject. *The most common ADRs reported in at least 2 subjects (regardless of severity) include headache (19.4%), depression (19.4%), somnolence (13.9%), nausea (11.1%), dizziness (8.3%), abdominal pain (8.3), vomiting (5.6%) and rash (5.6%). *Information on dosing, adverse reactions, abnormal adrenal function, PK, and clinical trial
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Janssen
 
NNPS:  FALSE
 
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