Fingolimod

GILENYA

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Pronunciation: fin-GOL-i-mod (je-LEN-ya)

Fingolimod ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Fingolimod ballicule

Fingolimod GILENYA mascot mnemonic cartoon — Visual mnemonic: Fingolimod mascot
**“Jill’s Fingerly mods”**
QT prolongation

What it isSphingosine-1-phosphate receptor modulator trapping lymphocytes in nodes; relapsing multiple sclerosis.

Why this oneFirst oral disease-modifying therapy in MS, once daily.

What limits itFirst-dose bradycardia requires six hours of observation. Macular edema, lymphopenia, and severe rebound disease on stopping.

Fingolimod molecular structure (skeletal formula) — Molecular structure: Fingolimod

FDA-approved for

relapsing multiple sclerosis (2010)

Principal riskFirst-dose bradycardia; severe rebound on stopping

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades2 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilitySerious infection, cytopenias, hepatic injury and malignancy risk require laboratory and clinical monitoring.

FDA label

Read the full label on DailyMed ↗

NO BOXED WARNINGS

FDA dosing	Population	Start	Target	Max
Relapsing forms of multiple sclerosis	Adults	0.5 mg QD	0.5 mg QD	0.5 mg QD
Relapsing forms of multiple sclerosis	Peds ≥10y, >40 kg	0.5 mg QD	0.5 mg QD	0.5 mg QD
Relapsing forms of multiple sclerosis	Peds ≥10y, ≤40 kg	0.25 mg QD	0.25 mg QD	0.25 mg QD

Renal Undefined

Hepatic No adjustment for mild-moderate impairment; closely monitor severe impairment

Instructions

Take with or without food
First-dose 6-hour cardiac monitoring (hourly pulse/BP; ECG before and after) at initiation, at reinitiation after >14-day interruption, and with pediatric dose increases
Observe overnight if higher risk of symptomatic bradycardia, heart block, prolonged QTc, or on drugs with torsades risk

Available strengths

cap 0.25, 0.5 mg

Contraindications

Within prior 6 months: MI, unstable angina, stroke, TIA, decompensated HF requiring hospitalization, or Class III/IV HF
History of Mobitz II 2nd-degree or 3rd-degree AV block or sick sinus syndrome, unless a pacemaker is present
Baseline QTc ≥500 msec
Cardiac arrhythmias requiring Class Ia or Class III antiarrhythmic drugs

Cautions

Bradyarrhythmia and AV block (first-dose)
Infections, incl. PML, cryptococcal, and herpes viral infections
Macular edema
Liver injury
Posterior reversible encephalopathy syndrome (PRES)
Fetal risk
Severe increase in disability after stopping
Increased blood pressure
Malignancies (skin); baseline skin exam

Adverse reactions

Headache
Liver transaminase elevation
Diarrhea
Cough
Influenza
Sinusitis
Back pain
Abdominal pain
Pain in extremity

Pregnancy May cause fetal harm; registry data suggest increased major birth defects. Stop 2 months before conception; use effective contraception during and for 2 months after.

Lactation No human data; present in rat milk. Weigh developmental/health benefits of breastfeeding against maternal need.

Cost

Fingolimod (GILENYA)

What pharmacies pay · NADAC 9/30/26

Strength		#/mo	generic $/mo	CostPlus
0.25 mg	cap	30 qd		not offered
0.5 mg	cap	30 qd	$47.37	offered

Generic entry2019

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Self-check

How long is fingolimod’s first-dose bradycardia observation?
6 hours.
What can happen after fingolimod is stopped?
Rebound disease activity.