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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:  04/15/2011
 
Trade Name:  Actemra
 
Generic Name or Proper Name (*):  tocilizumab
 
Indications Studied:  Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA)
 
Label Changes Summary:  * Approved for the treatment of active SJIA in patients 2 years and older* Safety and effectiveness in pediatric patients with conditions other than SJIA have not been established* Children < 2 years have not been studied* Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia* Liver enzyme elevation, low neutrophil count, low platelet count and lipid elevations are noted with Actemra treatment in the SJIA population. * The most common adverse events Actemra treated patients in the controlled portion of the study were upper respiratory tract infection, headache, nasopharygitis and diarhea* Information on dosing, lab parameters, adverse reactions, clinical trial* New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE
 
Therapeutic Category:  Biological response modifier
 
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