Document Detail

Early tolerability and safety of fingolimod in clinical practice.
MedLine Citation:
PMID:  23040960     Owner:  NLM     Status:  MEDLINE    
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.
Daniel Ontaneda; Claire Hara-Cleaver; Richard A Rudick; Jeffrey A Cohen; Robert A Bermel
Publication Detail:
Type:  Journal Article     Date:  2012-10-03
Journal Detail:
Title:  Journal of the neurological sciences     Volume:  323     ISSN:  1878-5883     ISO Abbreviation:  J. Neurol. Sci.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-10-29     Completed Date:  2013-04-18     Revised Date:  2014-04-01    
Medline Journal Info:
Nlm Unique ID:  0375403     Medline TA:  J Neurol Sci     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  167-72     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Elsevier B.V. All rights reserved.
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MeSH Terms
Bradycardia / chemically induced
Chest Pain / chemically induced
Drug Substitution
Headache / chemically induced
Hypertension / chemically induced
Lymphopenia / chemically induced
Macular Edema / chemically induced
Middle Aged
Multiple Sclerosis, Relapsing-Remitting / drug therapy*,  epidemiology
Nausea / chemically induced
Patient Acceptance of Health Care
Product Surveillance, Postmarketing
Propylene Glycols / adverse effects*,  therapeutic use
Retrospective Studies
Sphingosine / adverse effects,  analogs & derivatives*,  therapeutic use
Grant Support
Reg. No./Substance:
0/Propylene Glycols; 3QN8BYN5QF/fingolimod; NGZ37HRE42/Sphingosine

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