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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:  05/27/2014
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
Therapeutic Category:  Antiemetic