• 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:  05/27/2014
 
Trade Name:  Aloxi
 
Generic Name or Proper Name (*):  palonosetron hydrochloride
 
Indications Studied:  Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) and postoperative nausea and vomiting (PONV)
 
Label Changes Summary:  Chemotherapy-Induced Nausea and Vomiting *Approved for prevention of acute CINV in 1 month - < 17 years* Safety and effectiveness in neonates less than 1 month of age have not been established* Pediatric patients require a higher palonosetron dose than adults (20 mcg/kg with max of 1.5 mg x 1 vs 0.25 mg x 1 *Adverse reactions were similar to those observed in adults *Information on dosing, PK parameters, clinical trial, adverse reactions Postoperative Nausea and Vomiting Studies *Safety and efficacy have not been established in pediatric patients for PONV *Adverse reactions were similar to those observed in adults* Information on dosing, clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Helsinn Healthcare SA
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
-
-