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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:  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  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Aventis
Pediatric Exclusivity Granted Date:  11/10/2003
Therapeutic Category:  Anti-inflammatory