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fingolimod (Gilenya, FTY720)
Indications:
- persistence of relapsing-remitting multiple sclerosis despite interferon-beta treatment (NGC-NICE)
- FDA approved for adults & children >= 10 years [8]
Contraindications:
- myocardial infarction, stroke, transient ischemic attack within the previous 6 months
- concurrent use of
- class Ia antiarrhythmic agent
- class III antiarrhythmic agent
- pregnancy [7]
Pregnancy category: C (contraindicated during pregnancy) [7]
Dosage:
- 0.5-1.25 mg PO QD
Monitor:
- continuous electrocardiographic monitoring for 24 hours after 1st dose
- ophthalmoscopy
- serum transaminases
- complete blood count (CBC)
Adverse effects:
- bradycardia, AV node conduction block
- biphasic drop in heart rate, at about 6 hours & at 12-20 hours after the 1st dose
- macular edema
- elevated serum transaminases
- mild hypertension
- lymphopenia
- fatal Herpes virus infections may occur
a) disseminated primary varicella zoster
b) herpes simplex encephalitis
- skin cancer (possibly)
- progressive multifocal leukoencephalopathy (PML) (case report) [5]; probable additional case [7]
- risk of severe exacerbation of multiple sclerosis after stopping fingolimod [10]
Mechanism of action:
- sphingosine-1-phosphate-receptor modulator
- prevents exit of lymphocytes from lymph nodes
General
neurologic agent
References
- Kappos L et al
A Placebo-Controlled Trial of Oral Fingolimod in Relapsing
Multiple Sclerosis
NEJM www.nejm.org January 20, 2010
http://content.nejm.org/cgi/content/full/NEJMoa0909494
- Cohen JA et al
Oral Fingolimod or Intramuscular Interferon for Relapsing
Multiple Sclerosis
NEJM www.nejm.org January 20, 2010
http://content.nejm.org/cgi/content/full/NEJMoa0907839
- FDA MedWatch, May 14, 2012
Gilenya (fingolimod): Drug Safety Communication -
Safety Review of a Reported Death After the First Dose
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284355.htm
- FDAA MedWatch
Gilenya (fingolimod) - Drug Safety Communication:
Investigating Rare Brain Infection
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366751.htm
- GILENYA (fingolimod) capsules
HIGHLIGHTS OF PRESCRIBING INFORMATION
http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022527s008lbl.pdf
- FDA Safety Alert. August 4, 2015
Gilenya (fingolimod): Drug Safety Communication - FDA Warns
About Cases of Rare Brain Infection.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457183.htm
- Medical Knowledge Self Assessment Program (MKSAP) 17, 18.
American College of Physicians, Philadelphia 2015, 2018
- FDA News Release. May 11, 2018
FDA expands approval of Gilenya to treat multiple sclerosis
in pediatric patients.
First drug approved to treat MS in ages 10 and older.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607501.htm
- Jain N, Bhatti MT.
Fingolimod-associated macular edema: incidence, detection, and management.
Neurology. 2012 Feb 28;78(9):672-80. Review.
PMID: 22371414
- FDA Safety Alert. Nov 20, 2018
Gilenya (fingolimod): Drug Safety Communication - Severe
Worsening of Multiple Sclerosis After Stopping the Medicine.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm