What is Fingolimod?

Fingolimod is a medicine from the group of immunomodulatory agents used for relapsing forms of multiple sclerosis. It belongs to disease-modifying therapy and is used for long-term control of disease activity.

Multiple sclerosis is a chronic disease of the central nervous system in which the immune system may attack the protective covering of nerve fibers. This can lead to relapses, sensory disturbances, weakness, vision problems, coordination difficulties and other neurological symptoms.

Fingolimod is not a painkiller and is not used for rapid symptom relief. Its purpose is to influence immune system activity and help reduce the risk of new relapses in patients for whom this medicine is medically appropriate.

How Fingolimod works

Fingolimod belongs to sphingosine-1-phosphate receptor modulators. In simple terms, it affects the movement of certain immune cells called lymphocytes.

Under the action of fingolimod, some lymphocytes are retained in the lymph nodes and fewer of them enter the central nervous system. This may reduce inflammatory activity associated with multiple sclerosis.

That is why the medicine requires medical supervision: it affects not only symptoms, but the immune system as a whole.

When it is used

In international medical practice, fingolimod is used for relapsing forms of multiple sclerosis.
According to the European Medicines Agency, Gilenya/fingolimod is indicated for patients with highly active relapsing-remitting multiple sclerosis, including adults and children over 10 years of age in certain clinical situations.
Source: EMA

• relapsing forms of multiple sclerosis;
• active course of the disease;
• therapy prescribed by a neurologist;
• cases where the doctor considers fingolimod an appropriate treatment option.

Form and dosage

• Active substance: Fingolimod
• Form: capsules
• Common strength: 0.5 mg
• Route of administration: oral use, as prescribed by a doctor
• Type of medicine: immunomodulatory medicine

The exact dosage, duration of therapy and need for monitoring are determined only by a doctor. Do not change the treatment regimen on your own.

Why medical supervision is required

Fingolimod may affect heart rhythm, the immune system, liver parameters and vision. Therefore, before starting therapy, the doctor may prescribe additional examinations.

• ECG and heart rhythm monitoring;
• blood tests;
• liver function tests;
• assessment of infection risk;
• ophthalmological examination if risk factors are present;
• review of other medicines the patient is taking.

According to the FDA, due to the risk of bradycardia and AV conduction abnormalities, patients require observation when starting therapy.
Source: FDA Prescribing Information

Important warnings

Fingolimod should not be considered a regular medicine for self-administration. It is a serious therapy that is not suitable for every patient.

• Heart: a decrease in heart rate may occur at the beginning of therapy.
• Infections: the medicine affects the immune system and may increase the risk of infections.
• Liver: monitoring of liver enzymes may be required.
• Vision: there may be a risk of macular edema.
• Pregnancy: the medicine requires strict discussion with a doctor.
• Stopping therapy: treatment should be discontinued only after consulting a doctor.

Who should be especially careful?

Be sure to inform your doctor if the patient has or has had:

• heart disease;
• heart rhythm disorders;
• frequent or severe infections;
• liver disease;
• diabetes mellitus;
• vision problems;
• pregnancy or pregnancy planning;
• use of other medicines affecting the immune system.

How to store Fingolimod

Storage conditions may vary slightly depending on the manufacturer and the specific patient leaflet. Fingolimod is usually stored at room temperature, in the original packaging and protected from moisture.

• store at room temperature;
• many products specify storage at 20–25°C;
• do not store in humid places;
• do not leave in direct sunlight;
• keep in the original packaging;
• keep out of reach of children;
• do not use after the expiry date.

DailyMed states that fingolimod capsules should be stored at 20–25°C and protected from moisture.
Source: DailyMed

Order and delivery

On the iDoc website, you can check the availability of Fingolimod, the current price and delivery options.
Conditions depend on the recipient’s country and product availability.

If the patient has been prescribed fingolimod, it is recommended to confirm the exact dosage, manufacturer and number of capsules before placing an order.

Official information sources

For additional information, you can use official medical sources:

• European Medicines Agency — Gilenya / Fingolimod
• EMA — Fingolimod Mylan
• DailyMed — Fingolimod drug labels
• PubMed — studies on Fingolimod in multiple sclerosis

FAQ — Questions and answers