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Early tolerability and safety of fingolimod in clinical practice.

ABSTRACT: 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.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.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.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).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.

SUBMITTER: Ontaneda D

PROVIDER: S-EPMC3970706 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Early tolerability and safety of fingolimod in clinical practice.

Ontaneda Daniel D Hara-Cleaver Claire C Rudick Richard A RA Cohen Jeffrey A JA Bermel Robert A RA

Journal of the neurological sciences 20121003 1-2

<h4>Background</h4>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.<h4>Objective</h4>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.<h4>Methods</h4>P ...[more]

PMID: 23040960

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Project description:IntroductionFingolimod 0.5 mg is an orally active sphingosine 1-phosphate receptor modulator approved for use in adults with relapsing multiple sclerosis (MS). The efficacy and safety profile of fingolimod has been well characterized in a large clinical development program. Here, we report the safety and tolerability of fingolimod in relapsing-remitting MS (RRMS) patients from Latin America.MethodsA total of 162 patients with RRMS, predominantly from Latin American countries (138/162), were enrolled in this 16-week, single treatment arm, open-label, multi-center study. Unlike the phase III pivotal studies, this study permitted enrollment of patients with controlled diabetes, certain cardiac and pulmonary conditions, older age, and higher baseline Expanded Disability Status Scale. All patients were monitored clinically for a minimum of 6 hours after the first dose. Safety and tolerability assessments were based on adverse events, clinically notable laboratory abnormalities, vital signs, ophthalmic examinations, and electrocardiograms.ResultsOverall, the safety and tolerability profile was consistent with that reported previously in phase 3 studies and the FIRST study. Adverse events (AEs) were predominantly mild (n = 49, 35.5%) or moderate (n = 27, 19.6%). Three patients (2.2%) discontinued fingolimod due to AEs. Infections were reported in 33 patients (23.9%) and were predominantly mild in nature (n = 28, 20.3%). Increases in alanine aminotransferase enzymes of ≥3, ≥5 and ≥10 upper limit of normal were reported in five (3.7%), three (2.2%) and one (0.7%) patients, respectively. Hypertension cases (n = 3; 2.2%) did not result in treatment discontinuation and were controlled with antihypertensive therapy. Following first-dose administration, the majority of patients (90.6%) were discharged at 6 h. During the first-dose monitoring, 5 cases of bradycardia were reported; none required extended monitoring or treatment for symptomatic bradycardia.ConclusionThe first dose of fingolimod 0.5 mg was well tolerated in RRMS patients from Latin America. The overall safety profile was clinically manageable and consistent with previous fingolimod studies.FundingNovartis.Trial registrationClinicalTrials.gov #NCT01497262.

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Early tolerability and safety of fingolimod in clinical practice.

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Early tolerability and safety of fingolimod in clinical practice.

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