Sphingosine-1-phosphate receptor modulator Pregnancy: Contraindicated during pregnancy and in women of childbearing potential not using effective contraception. Post-marketing data suggest a 2-fold increased risk of major congenital malformations. A negative pregnancy test must be available before initiation; effective contraception must be used during treatment and for 2 months after discontinuation, and fingolimod should be stopped 2 months before planning a pregnancy. If a woman becomes pregnant during treatment, fingolimod must be discontinued. Women receiving fingolimod should not breastfeed.

Fingolimod

Brand names: Gilenya

Fingolimod is an oral disease-modifying therapy for highly active relapsing-remitting multiple sclerosis.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 0.5 mg (one capsule)

Route: Oral — capsules should always be swallowed intact, without opening them; may be taken with or without food

Frequency: Once daily

UK SPC §4.2: 'In adults, the recommended dose of fingolimod is one 0.5 mg capsule taken orally once daily' (multiple sclerosis). Treatment should be initiated and supervised by a physician experienced in multiple sclerosis. FIRST-DOSE MONITORING (§4.4): all patients should have an ECG and blood pressure measurement before and 6 hours after the first dose, and be monitored for 6 hours for signs and symptoms of bradycardia with hourly heart rate and blood pressure measurement; continuous (real time) ECG monitoring during this 6-hour period is recommended. If at 6 hours the heart rate is <45 bpm in adults, <55 bpm in paediatric patients aged 12 years and above, or <60 bpm in paediatric patients aged 10 to below 12 years, or the ECG shows new onset second degree or higher grade AV block or QTc >=500 msec, extend monitoring (at least overnight) until findings resolve. Third degree AV block at any time also requires extended monitoring. If the heart rate at 6 hours is the lowest since the first dose, extend monitoring by at least 2 hours and until heart rate increases again. REPEAT the same first-dose monitoring when treatment is interrupted for: 1 day or more during the first 2 weeks; more than 7 days during weeks 3 and 4; more than 2 weeks after one month of treatment. If the interruption is shorter, continue with the next dose as planned. PAEDIATRIC (10 years of age and above) — dose is by body-weight band, NOT per kg: body weight <=40 kg, one 0.25 mg capsule orally once daily; body weight >40 kg, one 0.5 mg capsule orally once daily. Paediatric patients who start on 0.25 mg and subsequently reach a stable body weight above 40 kg should be switched to 0.5 mg, repeating the same first-dose monitoring as for treatment initiation. Safety and efficacy below 10 years of age have not been established (no data); very limited data in children 10-12 years. Verify all paediatric use against a children's formulary. ELDERLY: use with caution in patients aged 65 years and over due to insufficient data. HEPATIC: must not be used in severe hepatic impairment (Child-Pugh C); no dose adjustment in mild or moderate impairment but caution on initiation.

Dose adjustments

Renal

Fingolimod was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to severe renal impairment.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Immunodeficiency syndrome
Patients with increased risk for opportunistic infections, including immunocompromised patients (currently or by prior therapies)
Suspected or confirmed progressive multifocal leukoencephalopathy (PML)
Severe active infections, active chronic infections (hepatitis, tuberculosis)
Active malignancies
Severe liver impairment (Child-Pugh class C)
Myocardial infarction, unstable angina, stroke/TIA, decompensated heart failure requiring inpatient treatment, or NYHA class III/IV heart failure in the previous 6 months
Severe cardiac arrhythmias requiring anti-arrhythmic treatment with class Ia or class III anti-arrhythmic medicinal products
Second-degree Mobitz type II or third-degree AV block, or sick-sinus syndrome, if not paced
Baseline QTc interval >=500 msec
During pregnancy and in women of childbearing potential not using effective contraception
Hypersensitivity to the active substance or to any of the excipients

Side effects

Headache (24.5%) — very common
Hepatic enzyme increased (increased ALT, GGT, AST) (15.2%) — very common
Diarrhoea (12.6%), cough (12.3%) — very common
Influenza (11.4%) and sinusitis (10.9%) — very common; also back pain (10.0%)
Bradycardia and atrioventricular block (common); lymphopenia and leucopenia (common); macular oedema (uncommon); progressive multifocal leukoencephalopathy and cryptococcal infections (frequency not known)

Interactions

QT-prolonging drugs (US label §7.1) — patients on QT-prolonging drugs with a known risk of torsades de pointes (e.g. citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility
Systemic ketoconazole (US label §7.2) — fingolimod and fingolimod-phosphate blood levels increased 1.7-fold; monitor closely
Vaccines (US label §7.3) — fingolimod reduces the immune response to vaccination; avoid live attenuated vaccines during, and for 2 months after stopping, treatment
Class Ia or class III anti-arrhythmics — contraindicated (§4.3)
NOTE: the UK SPC §4.5 was not captured in this bundle; the interaction entries above are taken from the US prescribing information and must be checked against the UK SPC §4.5

Clinical monograph

How it works

It is a sphingosine 1-phosphate receptor modulator that traps lymphocytes within lymph nodes, reducing the number of circulating lymphocytes available to enter the central nervous system.

Prescribing in practice

First-dose bradycardia and atrioventricular block can occur, so first-dose cardiac monitoring is required and it is contraindicated in patients with significant cardiac disease.
It increases the risk of serious infections and macular oedema, and varicella immunity should be checked with vaccination of seronegative patients before starting.
It is contraindicated in pregnancy and effective contraception is required; discontinuation may rarely be followed by severe rebound disease activity.

Monitoring

Monitor full blood count, liver function, blood pressure, ophthalmic review for macular oedema, and perform first-dose cardiac observation, with varicella serology before initiation.

Counselling the patient

Use reliable contraception, as this medicine can harm an unborn baby.
Report fever, signs of infection or any visual disturbance promptly.
Do not stop the medicine without discussing it with your neurologist, as relapses can return strongly.

Evidence & guidelines

Fingolimod reduced relapse rates compared with placebo and interferon in pivotal trials, and is used within NICE-defined criteria for highly active disease.

Reference: NICE TA254; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

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