title: Early tolerability and safety of fingolimod in clinical practice.
abstract: BACKGROUND
  Fingolimod is approved by the U.S. Food and Drug Administration to reduce relapses and disability progression in relapsing forms of MS. Several screening studies and a first-dose observation (FDO) period are recommended due to adverse effects observed in clinical trials.
  
  
  OBJECTIVE
  The objective of this study is to describe the early experience with fingolimod, including startup, tolerability and safety in a large academic multiple sclerosis (MS) center.
  
  
  METHODS
  Patients prescribed fingolimod from September 2010 to July 2011 were identified through electronic medical records. Demographics, MS disease history, pre-treatment screening studies, FDO experience during shared medical visits and three month follow-up data were analyzed.
  
  
  RESULTS
  Three hundred ninety-one patients were prescribed fingolimod of whom 317 started the medication and were included in the analysis. Fingolimod was most frequently used in relapsing remitting MS (n=256, 80.8%) and was prescribed as a first-line agent in 11 cases (3.5%). FDO was uneventful in 308 patients (96.8%). Adverse events during FDO were self limited and included symptomatic bradycardia (n=3), chest tightness (n=2) and hypertension (n=1). Fingolimod was discontinued in 30 patients (9.5%) at three months. Adverse effects leading to discontinuation by more than one patient included headache (n=4), macular edema (n=3), nausea (n=3) and hypertension (n=2).
  
  
  CONCLUSIONS
  Fingolimod was well tolerated during FDO and adverse events were self limited. The shared medical visit is an appropriate setting for FDO. Adverse effects were similar to those described in clinical trials but the discontinuation rate was higher.
authors.affiliation: Mellen Center, Department of Neurology, Cleveland Clinic, Cleveland, OH, USA. ontaned@ccf.org
authors.forename: Daniel
authors.initials: D
authors.lastname: Ontaneda
authors.forename: Claire
authors.initials: C
authors.lastname: Hara-Cleaver
authors.forename: Richard A
authors.initials: RA
authors.lastname: Rudick
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Cohen
authors.forename: Robert A
authors.initials: RA
authors.lastname: Bermel
mesh_terms: D000328:Adult; D001919:Bradycardia / Q000139:chemically induced; D002637:Chest Pain / Q000139:chemically induced; D057915:Drug Substitution; D005260:Female; D000068876:Fingolimod Hydrochloride; D006261:Headache / Q000139:chemically induced; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008231:Lymphopenia / Q000139:chemically induced; D008269:Macular Edema / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000453:epidemiology; D009325:Nausea / Q000139:chemically induced; D010342:Patient Acceptance of Health Care; D011358:Product Surveillance, Postmarketing; D011409:Propylene Glycols / Q000009:adverse effects* / Q000627:therapeutic use; D012189:Retrospective Studies; D013110:Sphingosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D011409:Propylene Glycols; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine