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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:  05/11/2018
 
Trade Name:  Actemra
 
Generic Name or Proper Name (*):  tocilizumab
 
Indications Studied:  Treatment of polyarticular juvenile idiopathic arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA)
 
Label Changes Summary:  *PJIA - Subcutaneous Use: Actemra by subcutaneous use is indicated for the treatment of pediatric patients with active PJIA in patients 2 years of age and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. *Subcutaneous administration has not been studied in SJIA pediatric patients. *SJIA – Intravenous Use: A multi-center, open-label, single arm study to evaluate the PK, safety and exploratory PD and efficacy of Actemra over 12-weeks in SJIA patients (N=11) under 2 years of age was conducted. *The primary PK endpoints at steady-state in this study were within the ranges of these parameters observed in patients with SJIA aged 2 to 17 years. *Safety and immunogenicity of Actemra for patients with SJIA under 2 years of age was assessed descriptively. *SAEs, AEs leading to discontinuation, and infectious AEs were reported by 27.3%, 36.4%, and 81.8% of patients. Six patients (54.5%) experienced hypersensitivity reactions. There were no cases of macrophage activation syndrome (MAS) based on the protocol-specified criteria, but 2 cases of suspected MAS based on Ravelli criteria. *Information on PK parameters, adverse reactions and clinical trial. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Genentech, Inc.
 
NNPS:  FALSE
 
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