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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
06/24/2004
Trade Name:
Camptosar
Generic Name or Proper Name (*):
irinotecan
Indications Studied:
Refractory solid tumors
Label Changes Summary:
Effectiveness in pediatric patients has not been established Adverse event profile from a Phase 2 trial with 170 children with refractory solid tumors comparable to that seen in adults; Grade 3-4 neutropenia experienced by 54 (31.8%) patients, neutropenia complicated by fever in 15 (8.8%) patients, Grade 3-4 diarrhea observed in 35 (20.6%) patients. Accrual for phase 2 study with 21 children with previously untreated rhabdomyosarcoma halted due to high rate (23.6%) of progressive disease and early deaths (14%) Adverse event profile seen in the 21 children different than that observed in adults; most significant Grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%)(across all courses of therapy and irrespective of causal relationship) PK parameters comparable to adults Minimal accumulation of irinotecan and SN-38 (active metabolite) observed in children on daily dosing
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
Pfizer
Pediatric Exclusivity Granted Date:
03/10/2004
NNPS:
FALSE'
Therapeutic Category:
Antineoplastic
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