Fingolimod hydrochloride: indication and adverse reactions

Multiple sclerosis (MS) is a chronic disease that causes damage to the nervous system, causing disturbances in the communication between the brain and the body. It usually affects young people, between 20 and 30 years old.

With physiotherapy and drugs that suppress the immune system, it is possible to relieve some symptoms and slow the progress of the disease.

The Fingolimode hydrochloride is one such medication. Know a little more about him in this article.


What is Fingolimod Hydrochloride?

Fingolimod Hydrochloride is an active substance present in medicines used to treat recurrent remitting multiple sclerosis, in which crises occur that can lead to new symptoms or aggravate existing ones.

Multiple sclerosis is a neurological, chronic and autoimmune disease, in which the body’s defense cells attack the central nervous system itself and cause damage to the brain and spinal cord.

Fingolimod Hydrochloride does not cure the disease, but it helps to reduce its progression and worsening, as the substance reduces the frequency of attacks. The medicine is taken orally, only under medical recommendation.

What is the medicine fingolimod for?

Multiple sclerosis is an autoimmune disease, in which the body attacks a healthy part of the body itself. Fingolimod works by suppressing cells in the immune system, which would be harmful and be in the process of nerve inflammation and cause damage to nerve tissue.

In addition, the drug can directly benefit brain cells involved in restoring or decreasing the damage caused by the disease and reducing seizures by 50%.

Reference and generic Fingolimod hydrochloride

Fingolimod hydrochloride, in addition to the reference drug, also has generic options from different manufacturers. Check out what they are:

  • Gilenya: Reference Medication, manufacturer Novartis;
  • Fingolimod Hydrochloride: Generic medication, manufacturer EMS;
  • Fingolimod Hydrochloride: Generic medication, manufacturer Teva;
  • Fingolimod Hydrochloride : Generic medication, manufacturer UFRN (Institute of Chemistry – Federal University of Rio Grande do Norte).

How to take?

The recommendation for adults is that Fingolimod Hydrochloride is taken orally once a day (fingolimod 0.5mg capsule), with half a glass of water, with or without food.

This is the maximum recommended daily dose. The medicine should not be broken, opened or chewed.

Try to take preferably at the same time every day so as not to forget. In case of this happening, the treatment should continue normally the next day, without exceeding the recommended dose to compensate for the missed one.

If you have been using the medication for less than 2 weeks and have forgotten to take the dose for 1 day, contact your doctor immediately.

It may be recommended that the patient be under observation, in the period until the next dose, to monitor heart rate and blood pressure, or to perform tests such as an electrocardiogram .

Do not stop taking the medication or change the dose on your own. Medical or pharmaceutical guidelines regarding treatment must be followed correctly.

Side effects and reactions

Every drug can have side effects and reactions in the body, although this is not a rule that applies to everyone who uses it.

In the case of Fingolimod Hydrochloride, weight loss is reported by the package insert, however its frequency during treatment is unknown. Thus, it is possible that among the adverse effects, treatment causes a reduction in weight.

Some side effects can occur with varying frequency and intensity, according to ANVISA’s estimate:

Very common

Side effects that can affect more than 1 in 10 people:

  • Infection with the flu virus: showing symptoms such as tiredness, chills, sore throat, joint or muscle pain and fever;
  • Feeling of pressure or pain: in places such as cheeks and forehead, similar to the symptoms of sinusitis;
  • Headache;
  • Diarrhea;
  • Back pain;
  • Increased levels of liver enzymes;
  • Cough.


Side effects that can affect 1 to 10 in 100 people:

  • Fungal skin infection (mycosis);
  • Dizziness;
  • Tingling or numbness;
  • Severe headache always accompanied by nausea, vomiting and sensitivity to light (migraine);
  • Weakness;
  • Itching, redness and skin burn (eczema);
  • Loss of hair;
  • Itchy skin;
  • Weight loss;
  • Increased levels of fat (triglycerides) in the blood;
  • Lack of air;
  • Abnormal results on the pulmonary function test after one month of treatment, remaining stable after that and reversible after discontinuation of treatment;
  • Depression;
  • Pain in the eye;
  • Blurred vision;
  • Hypertension: slight increase in blood pressure;
  • Low level of white blood cells (lymphopenia and leukopenia);
  • Bronchitis: presents symptoms such as cough with phlegm, chest pain and fever;
  • Gastroenteritis: with symptoms such as vomiting, nausea, diarrhea and fever;
  • Herpes zoster infections: may show symptoms such as fever, weakness, red spots, blisters, burning, itching or pain in the skin (more common in the upper body or face);
  • Low heart rate (bradycardia): it is characterized as a decrease in the frequency of heart beats;
  • Basal Cell Carcinoma (BCC): it is a type of skin cancer that may present white nodules or brown scaly patches in areas more exposed to the sun such as face and neck.


Adverse effects that may affect 1 in 1000 people:

  • Pneumonia: presents symptoms such as fever, cough and difficulty breathing;
  • Macular edema: it is the swelling of the central vision area of ​​the posterior retina of the eye. It presents symptoms such as shadows and blind spots in the center of the vision, blurred vision, difficulty in seeing colors and details;
  • Melanoma : a type of skin cancer usually developed from a melanocyte nevus. Possible signs and symptoms include melanocyte nevi that may change in size, shape, elevation or color over time, or new nevi. Nevi can itch, bleed, or ulcerate;
  • Crises convulsivas.


Adverse reactions that may affect 1 in 10,000 people:

  • Posterior Reversible Encephalopathy Syndrome: is characterized by severe headache (headache), sensory changes, seizures and visual loss.

Unknown frequency

The frequency of effects cannot be estimated from the available data:

  • Sickness;
  • Allergic reactions: there may be rashes or itching (hives),
  • Swelling: in areas such as lips, tongue or face. The probability of happening is greater on the day the treatment starts with the drug.
  • Progressive Multifocal Leukoencephalopathy (PML): it is a rare brain disease caused by an infection by the virus called JC (John Cunningham). Symptoms may be similar to those of multiple sclerosis such as weakness, motor difficulties and visual changes;
  • Cryptococcal infections: it is a type of fungal infection, which can include cryptococcal meningitis and the symptoms are headache accompanied by stiff neck, sensitivity to light, nausea and mental confusion.

If any of the symptoms are severely noted, or any other adverse effects not mentioned, seek medical or pharmaceutical advice.

Drug interaction

It is advisable to inform the doctor about the use of any medication during treatment with Fingolimod Hydrochloride, even if these are exempt from medical prescription.

In addition, some specific medications may interact when used during treatment with Fingolimod:

  • Remedies for irregular heartbeat, such as quinidine, procainamide, amiodarone or sotalol;
  • Medicines that slow the heartbeat, like atenolol (beta-blockers), like verapamil or diltiazem (calcium channel blockers), ivabradine or others like digoxin;
  • Other drugs used to treat multiple sclerosis, such as betainterferone, glatiramer acetate, natalizumab, mitoxantrone, dimethyl fumarate, teriflunomide, alemtuzumab or corticosteroids;
  • If you need to get vaccinated, consult your doctor first because, up to 2 months after treatment with fingolimod hydrochloride, vaccines that contain live viruses may not work properly or cause an infection that she should prevent.


Fingolimod Hydrochloride is not indicated for women who are pregnant or planning to become pregnant, as it can cause malformations in the fetus.

After discontinuing the medication, it is necessary to wait at least 2 months to be able to get pregnant, as it is the time it takes for the substance to be completely eliminated from the bloodstream.

Price and where to find

The hydrochloride Fingolimode can be found in large pharmacies and you can also request a quote, compare prices and buy through the portal consultation Remedies .

In addition, the drug is also supplied by the Ministry of Health (MS) and distributed by the State Health Secretariats (SESA), in the regional offices of each state, according to the Clinical Protocol and Therapeutic Guidelines (PCDT) for Multiple Sclerosis.

For this, according to the MS, patients need to meet the clinical criteria and therapeutic guidelines determined by the Multiple Sclerosis Clinical Protocol.

In such cases, it is necessary to file a legal appeal, requesting to obtain treatment. In general, it is necessary to present a legal budget for high-cost drugs. To learn more about the procedure, patients can count on the personalized advisory service on high cost medication quotation.

In a simple and quick way, it is possible to have access to the legal quotation, simply by accessing the link .

The price can vary between R $ 4 thousand and R $ 8 thousand reais *.

 * Prices consulted at Consulta Remédios in October 2019. Prices may change.

As soon as the diagnosis of Multiple Sclerosis is confirmed, it is necessary to start treatment, to reduce the symptoms and crises caused by the disease.

Always seek medical advice and pay attention to the instructions for the medications, which indicate the recommendations and contraindications of the substance.

If you like to know more about health and medications, keep following the Healthy Minute.