Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
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 olderSafety and effectiveness in pediatric patients with conditions other than SJIA have not been establishedChildren < 2 years have not been studiedInterruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopeniaLiver 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 diarheaInformation on dosing, lab parameters, adverse reactions, clinical trialNew indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Genentech
 
NNPS:  FALSE'
 
Therapeutic Category:  Biological response modifier
 
-
-