fingolimod hydrochloride at a glance
Medicine class
Sphingosine-1-phosphate receptor modulator and selective immunosuppressant
Main role
Single disease-modifying therapy for specified highly active relapsing-remitting multiple sclerosis
Who may receive it
Adults and children aged 10 years and over who meet product-specific criteria
What is fingolimod hydrochloride used for?
Licensed uses represented by the selected products:
Single disease-modifying therapy for highly active relapsing-remitting multiple sclerosis despite treatment with at least one disease-modifying therapy.
Single disease-modifying therapy for rapidly evolving severe relapsing-remitting multiple sclerosis with disabling relapses and significant MRI activity.
How does fingolimod hydrochloride work?
The body converts fingolimod to fingolimod phosphate, which modulates sphingosine-1-phosphate receptors. This retains many lymphocytes within lymph nodes rather than destroying them, reducing their movement into the central nervous system and limiting inflammatory nerve damage.
fingolimod hydrochloride preparations and strengths
Capsule
Route: Oral
Strengths: 0.25 mg, 0.5 mg
How to take fingolimod hydrochloride
Follow the specialist's instructions. Swallow each capsule whole with water without opening, crushing or chewing it. Food does not materially affect absorption. Treatment initiation and some restarts require supervised heart-rate, blood-pressure and ECG monitoring.
Do not alter or stop treatment without discussing it with the multiple-sclerosis team.
Tell the team before restarting after a significant interruption because cardiac monitoring may need to be repeated.
fingolimod hydrochloride side effects
Common or expected effects
- Headache, dizziness or migraine
- Influenza, sinusitis, cough or bronchitis
- Diarrhoea
- Back, muscle or joint pain
- Raised liver enzymes
- Low lymphocyte or white-cell counts
- Slow heart rate or atrioventricular conduction changes, particularly at initiation
- Raised blood pressure
- Blurred vision
- Itching, eczema or hair loss
- Depression or tiredness
Get urgent medical advice
- Serious or opportunistic infections, including herpes infections, cryptococcal meningitis and progressive multifocal leukoencephalopathy
- Significant liver injury or acute liver failure
- Macular oedema causing blurred, distorted or reduced central vision
- Serious bradycardia, heart block or arrhythmia
- Seizures or posterior reversible encephalopathy syndrome
- Skin cancers or lymphoma
- Severe allergic reaction, including angioedema
- Severe return of multiple-sclerosis activity after treatment stops
fingolimod hydrochloride in pregnancy
Fingolimod is contraindicated during pregnancy because exposure is associated with an increased risk of major congenital malformations. Pregnancy should be excluded before treatment, and effective contraception is required during treatment and for two months after stopping. Anyone planning pregnancy or becoming pregnant while taking it needs prompt specialist review. Treatment changes must be medically supervised because multiple-sclerosis activity can rebound after withdrawal.
fingolimod hydrochloride interactions
Check prescription, over-the-counter and herbal products before treatment or vaccination.
Live attenuated vaccines
Avoid because vaccination may cause infection; other vaccines may be less effective during treatment and for a period after stopping.
Antineoplastic, immunomodulatory or immunosuppressive therapies
Combined immune effects can increase infection and immunosuppression risks, so co-administration or switching requires specialist planning.
Common questions about fingolimod hydrochloride
Answers are fully visible for fast scanning and source review.
Does fingolimod hydrochloride cure multiple sclerosis?
No. It is intended to reduce relapses and slow disability progression in eligible people with highly active relapsing-remitting multiple sclerosis.
Why is treatment monitored when it starts?
Fingolimod can temporarily slow heart rate and atrioventricular conduction. ECG, pulse and blood-pressure monitoring identifies people who need longer observation or treatment.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.