• 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:  05/05/2008
Trade Name:  Argatroban
Generic Name or Proper Name (*):  argatroban
Indications Studied:  Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis
Label Changes Summary:  * Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients * Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages <6 months  16 years diagnosed with HIT or suspected HIT requiring an alternative to heparin anticoagulation showed clearance in pediatric patients was 50% lower compared to healthy adults and led to dose recommendations * Information on dose, AEs and PK
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Encysive
Therapeutic Category:  Hematology/Coagulation