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Multiple Sclerosis — Disease-Modifying Therapy Pregnancy: Contraindicated — teratogenic in animals; effective contraception required; washout period at least 2 months before planned pregnancy

Fingolimod

Brand names: Gilenya

Adult dose

Dose: 0.5 mg once daily
Route: Oral
Frequency: Once daily
Max: 0.5 mg/day
MANDATORY 6-hour cardiac monitoring after FIRST dose and after any interruption of 2+ weeks. Do NOT use in patients with resting HR below 55, second/third degree AV block, or prolonged QT. ECG and HR/BP before first dose.

Paediatric dose

Dose: 10 years and above: 0.25 mg once daily (under 40 kg); 0.5 mg once daily (40 kg and above) mg/day/kg
Route: Oral
Frequency: Once daily
Max: 0.5 mg/day
Licensed from age 10 in UK for RRMS; seek specialist paediatric neurology opinion; cardiac monitoring also mandatory in paediatric patients

Dose adjustments

Renal

No dose adjustment required

Hepatic

Use with caution in severe hepatic impairment — fingolimod exposure doubled; reduce dose or avoid

Paediatric weight-based calculator

Licensed from age 10 in UK for RRMS; seek specialist paediatric neurology opinion; cardiac monitoring also mandatory in paediatric patients

Clinical pearls

  • Mechanism: first oral disease-modifying therapy for MS — sphingosine-1-phosphate (S1P) receptor modulator; fingolimod-phosphate sequesters lymphocytes in lymph nodes by downregulating S1P1 receptor on lymphocytes, preventing lymphocyte egress; reduces CNS lymphocytic inflammation
  • TRANSFORMS (NEJM 2010): fingolimod vs interferon beta-1a IM in RRMS — 52% relative reduction in annualised relapse rate; significant MRI activity reduction
  • FREEDOMS trial (NEJM 2010): fingolimod vs placebo — 54% reduction in annualised relapse rate; 30% relative risk reduction in disability progression
  • MHRA — FIRST-DOSE CARDIAC MONITORING: mandatory 6-hour monitoring after first dose (ECG, HR, BP hourly); HR falls typically 5–7 bpm below baseline; AV block usually resolves within 24 hours; facility for cardiac resuscitation must be available
  • MACULAR OEDEMA: OCT of macula MANDATORY at 3–4 months after starting — check again immediately for any visual symptoms; relative risk in diabetes and uveitis is higher; macular oedema usually reversible on stopping
  • VARICELLA: check VZV IgG status before starting — if negative, vaccinate (with live vaccine) at least 4 weeks before starting; fingolimod greatly increases reactivation risk including disseminated VZV (fatal cases reported — MHRA DSU 2015)

Contraindications

  • Immunodeficiency
  • Active severe infections
  • Resting bradycardia below 55 bpm, sick sinus syndrome, or second/third degree AV block
  • Prolonged QTc (above 500 ms)
  • Stroke or TIA within 6 months
  • Recent MI or decompensated heart failure
  • Macular oedema (previous history)

Side effects

  • Bradycardia and AV block (FIRST DOSE — mandatory monitoring requirement)
  • Macular oedema (0.5% — onset 3–4 months; OCT screening mandatory at 3–4 months and with any visual symptoms)
  • Serious infections (cryptococcal meningitis, PML — JC virus)
  • Lymphopenia (therapeutic mechanism — expect lymphocyte count below 0.5)
  • Hypertension
  • Liver enzyme elevation (check LFTs)
  • Varicella zoster infection reactivation

Interactions

  • Antiarrhythmics, beta-blockers, calcium channel blockers (additive bradycardia/AV block — avoid)
  • Drugs prolonging QTc (additive QT prolongation)
  • Immunosuppressants (additive immunosuppression)
  • Live vaccines (contraindicated)

Monitoring

  • ECG, HR, and BP (6-hour monitoring after first dose — mandatory)
  • Lymphocyte count (monthly for 3 months, then every 3 months — do not use if persistently below 0.2)
  • LFTs at 1, 3, 6, 9, and 12 months
  • OCT/ophthalmic review at 3–4 months (macular oedema)
  • MRI brain (annual or per specialist)
  • Blood pressure (hypertension monitoring)

Reference: BNFc; BNF 90; TRANSFORMS NEJM 2010;362(5):387-401; FREEDOMS NEJM 2010;362(5):402-415; NICE TA254; MHRA DSU 2015 (VZV); MHRA SPC. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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