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ADVERSE EVENTS & TOLERABILITY

Demonstrated safety and tolerability profile1

ADULT PATIENTS
Primary system organ class adverse events occurring in GILENYA vs placebo

Additional safety considerations from MS clinical trials1

  • Macular edema was 0.5% in GILENYA 0.5 mg vs 0.4% in placebo
SafetyandTolerability
SafetyandTolerability
PEDIATRIC PATIENTS
    • In PARADIGMS, the controlled pediatric trial, the safety profile in pediatric patients (10 to less than 18 years of age) receiving GILENYA 0.25 mg or 0.5 mg daily was similar to that seen in adult patients
    • In the pediatric study, cases of seizures were reported in 5.6% of patients treated with GILENYA and 0.9% of patients treated with interferon beta-1a
    • The safety and efficacy of GILENYA in children less than 10 years of age have not been studied
AST=aspartate transaminase;
ALT=alanine transaminase;
DLCO=diffusion lung capacity for carbon monoxide;
FEV1=forced expiratory volume at 1 second;
GGT=gamma-glutamyl transpeptidase;
LFT=liver function test;
ULN=upper limit of normal.
 
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