fingolimod (Gilenya, FTY720)
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Indications
- persistence of relapsing-remitting multiple sclerosis despite interferon-beta treatment (NGC-NICE)
Contraindications
- myocardial infarction, stroke, transient ischemic attack within the previous 6 months
- concurrent use of
- pregnancy[7]
Pregnancy category: C (contraindicated during pregnancy)[7]
Dosage
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
- 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
More general terms
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
- ↑ Jump up to: 5.0 5.1 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
- ↑ Jump up to: 7.0 7.1 7.2 7.3 Medical Knowledge Self Assessment Program (MKSAP) 17, 18. American College of Physicians, Philadelphia 2015, 2018
- ↑ Jump up to: 8.0 8.1 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: https://www.ncbi.nlm.nih.gov/pubmed/22371414
- ↑ Jump up to: 10.0 10.1 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