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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:  03/30/2017
 
Trade Name:  Orencia
 
Generic Name or Proper Name (*):  abatacept
 
Indications Studied:  Treatment of moderately to severely active Polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older
 
Label Changes Summary:  *Approved for use in pJIA in pediatric patients 2 years and older as monotherapy or concominatly with methotrexate. *For pJIA, Orencia may be administered as an intraveneous infusion in 6 years and older or a subcutaneous injection in 2 years and older. Intraveneous dosing has not been studied in pediatric patients younger than 6 years of age. *Orencia with intravenous administration has not been studied in patients younger than 6 years of age. *Efficacy of Orencia for subcutaneous injection in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy of intravenous Orencia in polyarticular JIA patients and subcutaneous Orencia in patients with RA. *Safety and efficacy of Orencia ClickJect autoinjector for subcutaneous injection have not been studied in patients under 18 years of age. *Safety and efficacy in pediatric patients for uses other than juvenile idiopathic arthritis have not been established. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, immunogenicity, dosing, clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Bristol-Myers Squibb
 
Pediatric Exclusivity Granted Date:  02/17/2017
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory
 
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