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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:
03/05/2004
Trade Name:
Arava
Generic Name or Proper Name (*):
leflunomide
Indications Studied:
Polyarticular Juvenile Rheumatoid Arthritis
Label Changes Summary:
Safety and efficacy in pediatric patients with polyarticular JRA have not been fully evaluated 94 patients with polyarticular JRA were studied in a double-blind active controlled trial (1:1 randomization); approximately 68% of pediatric patients receiving Arava versus 89% receiving active comparator demonstrated improvement on the primary endpoint by week 16 Pediatric patients with a body weight d 40 kg have a reduced clearance relative to adult rheumatoid arthritis patients Information on PK of M1, the active metabolite responsible for in vivo activity in children 3-17 years old Most common adverse events in 74 polyarticular JRA patients 3-17 years old included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness 14 of the 74 patients experienced ALT and/or AST elevations; 5/14 were between 3 and 8 fold the upper limit of normal
Product Labeling:
Labeling
BPCA(B) and PREA(P):
B, P
Sponsor:
Aventis
Pediatric Exclusivity Granted Date:
11/10/2003
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory
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