Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  05/11/2018
 
Trade Name:  Gilenya
 
Generic Name or Proper Name (*):  fingolimod
 
Indications Studied:  Treatment of relapsing forms of multiple sclerosis to include pediatric patients 10 years of age and above
 
Label Changes Summary:  *Safety and effectiveness for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years were established in one randomized, double-blind clinical study in 215 patients. *Safety and effectiveness in pediatric patients below the age of 10 years have not been established. *Safety in pediatric patients was similar to that observed in adult patients. *In the pediatric study, cases of seizures were reported in 5.6% of Gilenya treated patients and 0.9% of interferon beta-1a treated patients. *It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating Gilenya therapy. *Information on dosing, dosing in pediatric patients with renal impairment, PK parameters, adverse reactions, and clinical trial. *Postmarking study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  04/16/2018
 
NNPS:  FALSE
 
-
-