Efigalo

Leaflet accompanying the packaging: patient information

Efigalo, 0.5 mg, hard capsules
fingolimod

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Efigalo and what is it used for
• 2. Important information before taking Efigalo
• 3. How to take Efigalo
• 4. Possible side effects
• 5. How to store Efigalo
• 6. Package contents and other information

1. What is Efigalo and what is it used for

What is Efigalo

Efigalo contains the active substance fingolimod.

What is Efigalo used for

Efigalo is used in adults and children and adolescents (aged 10 years and older) to treat relapsing-remitting multiple sclerosis (MS), particularly in:

• patients who have not responded to MS treatment or
• patients who have rapidly evolving, severe MS.

Efigalo does not cure MS, but it helps reduce the number of relapses and slows down the progression of disability caused by MS.

What is multiple sclerosis

MS is a chronic disease of the central nervous system (CNS), consisting of the brain and spinal cord. In MS, the inflammatory process destroys the nerve sheath (called myelin) in the CNS, preventing it from functioning properly. This phenomenon is called demyelination.

How Efigalo works

Efigalo helps protect the CNS from immune system attacks, reducing the ability of certain white blood cells (lymphocytes) to move freely in the patient's body and preventing them from entering the brain and spinal cord. In this way, Efigalo limits nerve damage caused by MS. Efigalo also weakens some immune responses of the body.

2. Important information before taking Efigalo

When not to take Efigalo

• if the patient has reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive drugs)
• if the patient has severe active infection or chronic active infection, such as hepatitis or tuberculosis
• if the patient has active cancer
• if the patient has severe liver disease
• if the patient has had a heart attack, angina pectoris, stroke, or symptoms of stroke within the last 6 months
• if the patient has a certain type of irregular or abnormal heartbeat(arrhythmia), including patients who have had an electrocardiogram (ECG) showing a prolonged QT interval before starting treatment with Efigalo
• if the patient is currently taking or has recently taken drugs for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol
• if the patient is pregnantor is of childbearing age and not using effective contraception
• if the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6) If such a situation occurs or the patient has doubts, they should consult their doctor before taking Efigalo.

Warnings and precautions

Before starting treatment with Efigalo, the patient should discuss the following with their doctor:

• -if the patient has severe respiratory disorders during sleep(severe sleep apnea)
• -if the patient has been informed that their ECG is abnormal
• -if the patient experiences symptoms of slow heart rate(e.g., dizziness, nausea, or palpitations)
• if the patient is taking or has recently taken drugs that slow heart rate(such as beta blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine)
• if the patient has had a history of sudden loss of consciousness or fainting
• if the patient plans to get vaccinated
• if the patient has never had chickenpox
• if the patient has vision problemsor other symptoms of macular edema (a condition where the macula, the part of the retina responsible for central vision, becomes swollen)
• if the patient has liver disease
• if the patient has high blood pressurethat cannot be controlled with medication
• if the patient has severe lung diseaseor a cough typical of smokers If any of these situations occur or the patient has doubts, they should consult their doctor before taking Efigalo.

Low heart rate (bradykardia) and irregular heartbeat
At the beginning of treatment or after taking the first dose of 0.5 mg in patients who have previously taken a daily dose of 0.25 mg, Efigalo slows down the heart rate. As a result, the patient may experience dizziness, fatigue, palpitations, or a decrease in blood pressure. If these symptoms are severe, the patient should inform their doctor, as they may require immediate treatment.Efigalo may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Low heart rate usually returns to normal within one month. During this period, no clinically significant effect on heart rate is expected.
The doctor will ask the patient to stay in the doctor's office or clinic for at least 6 hours after taking the first dose of Efigalo or after the first dose of 0.5 mg in case of a change in treatment from a daily dose of 0.25 mg, with hourly measurements of pulse and blood pressure, so that if any adverse reactions occur at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Efigalo and after the 6-hour observation period, the patient will undergo an ECG. During this time, the doctor may continuously monitor the patient's heart activity using an electrocardiogram. If after 6 hours of observation, the patient has a very slow or decreasing heart rate or if the ECG shows abnormalities, there may be a need for longer monitoring of the patient's condition (for at least 2 hours longer or possibly until the next day), until these symptoms subside. The same procedure may be recommended if the patient resumes treatment with Efigalo after a break in treatment, depending on how long the break lasted and how long the patient took Efigalo before the break.
If the patient has irregular or abnormal heartbeat, or risk factors for these events, or abnormal ECG or heart disease, or heart failure, Efigalo may not be suitable for them.
If the patient has a history of sudden loss of consciousness or slow heart rate, Efigalo may not be suitable for them. There may be a need for consultation with a cardiologist (a specialist in heart diseases), who will advise on how to start treatment with Efigalo, including how to monitor the patient at night.
If the patient is taking drugs that can slow down the heart rate, Efigalo may not be suitable. There may be a need for consultation with a cardiologist, who will check if the patient can switch to other drugs that do not slow down the heart rate, to allow treatment with Efigalo. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Efigalo, taking into account monitoring until the next day after administration of the first dose of Efigalo.
Patients who have never had chickenpox
If the patient has never had chickenpox, the doctor will check the patient's immunity to the varicella-zoster virus. If the patient is not protected against the virus, they may need to be vaccinated before starting treatment with Efigalo. If this is the case, the doctor will delay the start of treatment with Efigalo by one month after the full vaccination course.
Infections
Efigalo reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Efigalo (and up to 2 months after stopping treatment), the patient may be more susceptible to infections. Any existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, feel flu-like symptoms, have shingles, or have a headache with stiff neck, sensitivity to light, nausea, and/or vomiting, they should contact their doctor immediately, as this condition can be serious.
If the patient experiences any of the above symptoms after starting treatment with Efigalo, they should contact their doctor immediately.
Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver dysfunction, treatment with Efigalo may be discontinued.
High blood pressure
The doctor may regularly check the patient's blood pressure, as Efigalo can cause a slight increase in blood pressure.
Lung diseases
Efigalo has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of adverse reactions.
Blood cell count
A expected effect of Efigalo is a decrease in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after stopping treatment. If blood tests need to be performed, the patient should inform their doctor about taking Efigalo. Otherwise, the doctor may not be able to interpret the blood test results, and in the case of certain tests, the doctor may order a larger amount of blood than usual.
Before starting treatment with Efigalo, the doctor will check if the patient has a sufficient number of white blood cells in the blood to start treatment and may order regular blood tests. If there are not enough white blood cells, it may be necessary to discontinue treatment with Efigalo.
Posterior reversible encephalopathy syndrome (PRES)
In patients with MS treated with Efigalo, there have been rare reports of a condition called posterior reversible encephalopathy syndrome (PRES). The symptoms of this condition may include severe headache, confusion, seizures, and/or vision changes. If the patient experiences any of these symptoms during treatment with Efigalo, they should contact their doctor immediately, as this condition can be serious.
Cancer
There have been reports of cancer in patients with MS treated with Efigalo.
Exposure to sunlight and protection against ultraviolet radiation
Fingolimod weakens the immune system. This increases the risk of developing cancer, especially skin cancer. The patient should limit exposure to sunlight and ultraviolet radiation by:

• -wearing protective clothing
• -regularly applying sunscreen with a high level of protection against ultraviolet radiation

Unusual changes in the brain associated with MS relapse
There have been rare reports of unusually large changes in the brain associated with MS relapse in patients treated with Efigalo. In the case of a severe MS relapse, the treating doctor will consider performing an MRI to assess this condition and decide on the possible need to discontinue Efigalo.
Switching from other drugs to Efigalo
The doctor may switch treatment directly from interferon beta, glatiramer acetate, or dimethyl fumarate to Efigalo, if there are no symptoms of abnormalities caused by previous treatment. The doctor may order a blood test to rule out these abnormalities.
After stopping treatment with natalizumab, it may be necessary to wait 2 to 3 months before starting treatment with Efigalo. In the case of switching treatment from teriflunomide, the doctor may advise the patient to wait for a certain period or undergo an accelerated elimination procedure. Patients previously treated with alemtuzumab require careful evaluation and discussion with their doctor before deciding whether Efigalo is suitable for them.
Women of childbearing age
If Efigalo is used during pregnancy, it may harm the unborn child. Before starting treatment with Efigalo, the doctor will inform the patient about the risk to the unborn child and ask them to perform a pregnancy test to ensure that the patient is not pregnant, and

The doctor will give the patient a card explaining why they should not become pregnant while taking Efigalo.

If the patient becomes pregnant while taking Efigalo, they should contact their doctor immediately.

The doctor will decide whether to discontinue treatment(see "Discontinuing Efigalo" in section 3, and also section 4 "Possible side effects"). The patient will also need to undergo prenatal check-ups.
Breastfeeding
Efigalo should not be used during breastfeeding. Efigalo may pass into breast milk, posing a risk of serious side effects in the child.

Driving and operating machinery

The doctor will inform the patient whether their condition allows them to drive vehicles, including cycling and operating machinery. It is not expected that Efigalo will affect the ability to drive vehicles and operate machinery.
However, at the beginning of treatment, the patient must stay in the doctor's office or clinic for 6 hours after taking the first dose of Efigalo. During this time and potentially after it, the ability to drive vehicles and operate machinery may be impaired.

3. How to take Efigalo

Treatment with Efigalo will be supervised by a doctor with experience in treating multiple sclerosis.
This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.
The recommended dose is:

Adults:

The dose is one 0.5 mg capsule per day.

Children and adolescents (aged 10 years and older):

The dose depends on body weight:

• -Children and adolescents with a body weight of 40 kg or less: one 0.25 mg capsule per day.
• -Children and adolescents with a body weight over 40 kg: one 0.5 mg capsule per day. Children and adolescents starting treatment with one 0.25 mg capsule per day and then achieving a stable body weight over 40 kg will be advised by their doctor to switch to one 0.5 mg capsule per day. In this case, it is recommended to repeat the observation period, as after the first dose of Efigalo.

Efigalo is not available in a 0.25 mg dose. For this dose, the patient should take another available fingolimod-containing drug. The patient should ask their doctor or pharmacist.
Do not exceed the recommended dose.
Efigalo is intended for oral use.
Efigalo should be taken once a day, with a glass of water. Efigalo capsules should always be swallowed whole, without opening them. Efigalo can be taken with or without food.
Taking Efigalo at the same time every day will help the patient remember to take their medicine.
If the patient has questions about the duration of treatment with Efigalo, they should consult their doctor or pharmacist.

Taking a higher dose of Efigalo than recommended

If the patient has taken too much Efigalo, they should contact their doctor immediately.

Missing a dose of Efigalo

If the patient has been taking Efigalo for less than 1 month and has missed a dose for the entire day, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the administration of the next dose.
If the patient has been taking Efigalo for at least 1 month and has missed taking the medicine for more than 2 weeks, they should contact their doctor before taking the next dose. The doctor may decide to keep the patient under observation during the administration of the next dose.
However, if the patient has missed taking the medicine for up to 2 weeks, they can take the next dose as planned.
Do not take a double dose to make up for a missed dose.

Discontinuing Efigalo

Do not stop taking Efigalo or change the dose without first consulting your doctor.
Efigalo remains in the body for up to 2 months after stopping treatment. During this time, the number of white blood cells (lymphocytes) may also be reduced, and side effects described in this leaflet may still occur. After stopping treatment with Efigalo, the patient should wait 6-8 weeks before starting new MS treatment.
In patients resuming treatment with Efigalo after more than 2 weeks of stopping the medicine, the effect on heart rate observed after the first dose may recur, and monitoring of the patient's condition in the doctor's office or clinic will be necessary due to the resumption of treatment. Do not resume treatment with Efigalo after a break of more than 2 weeks without consulting the treating doctor.
The treating doctor will decide whether and how to monitor the patient after stopping treatment with Efigalo. If the patient thinks that their MS has worsened after stopping treatment with Efigalo, they should contact their doctor immediately. This situation can be serious.
In case of further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Efigalo can cause side effects, although not everybody gets them.
Some side effects may be or may become serious

Very common (occurring in up to 1 in 10 patients)

• Cough with expectoration, unspecified unpleasant feeling in the chest, fever (symptoms of respiratory disorders)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or skin pain, usually above the upper body or face. Other symptoms may include fever and weakness at the beginning of the infection, followed by numbness, itching, or red spots with severe pain.
• Slow heartbeat (bradykardia), irregular heartbeat.
• A type of skin cancer called basal cell carcinoma (BCC), which often appears as a pearl-like nodule, although it can have other forms.
• Depression and anxiety are known to occur more frequently in the population of patients with MS and have also been reported in children and adolescents treated with Efigalo.
• Weight loss.

Common (occurring in up to 1 in 100 patients)

• Pneumonia with symptoms such as fever, cough, difficulty breathing.
• Macular edema (swelling in the center of the visual field in the retina, at the back of the eye) with symptoms such as shadows or gaps in the center of the visual field, blurred vision, difficulty perceiving colors and details.
• Decreased platelet count, which increases the risk of bleeding or bruising.
• Malignant melanoma (a type of skin cancer that usually develops from an unusual mole). Possible symptoms of melanoma include moles whose size, shape, elevation, or color changes over time or new moles. Moles can be itchy, bleeding, or ulcerated.
• Seizures, epileptic seizures (more common in children and adolescents than in adults).

Uncommon (occurring in up to 1 in 1,000 patients)

• A condition called posterior reversible encephalopathy syndrome (PRES). Symptoms may include severe headache, confusion, seizures, and/or vision changes.
• Lymphoma (a type of cancer affecting the lymphatic system).
• Squamous cell carcinoma: a type of skin cancer that can appear as a hard, red nodule, an ulcer covered with a scab, or a fresh ulcer in the place of an existing scar.

Rare (occurring in up to 1 in 10,000 patients)

• Abnormalities in the ECG recording (T-wave inversion).
• A tumor associated with human herpesvirus 8 infection (Kaposi's sarcoma).

Frequency not known (cannot be estimated from available data)

• Allergic reactions, including symptoms such as rash or itchy hives, swelling of the lips, tongue, or face, which are more likely to occur on the day of starting treatment with Efigalo.
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes (jaundice), nausea or vomiting, pain in the right side of the abdomen, dark (brown) urine, decreased appetite, fatigue, and abnormal liver function test results. In very rare cases, liver failure can lead to liver transplantation.
• Risk of a rare brain infection called progressive multifocal leukoencephalopathy (PML). PML symptoms may be similar to an MS relapse. There may also be symptoms that the patient is not aware of, such as mood or behavior changes, transient memory problems, difficulty speaking or communicating, which the doctor should assess to rule out PML. Therefore, if the patient thinks that their MS is worsening or if the patient or their relatives notice any new or unusual symptoms, it is very important to contact their doctor immediately.
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion.
• Merkel cell carcinoma (a type of skin cancer). Possible symptoms of Merkel cell carcinoma include a painless nodule, a red or blue-red nodule, usually located on the face, head, or neck. Merkel cell carcinoma can also appear as a hard, painless nodule or mass. Prolonged sun exposure and weakened immune system can affect the risk of Merkel cell carcinoma.
• After stopping treatment with Efigalo, MS symptoms may recur and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition where red blood cells are destroyed).

If the patient experiences any of these side effects, they should contact their doctor immediately.

Other side effects

Very common (occurring in more than 1 in 10 patients)

• Influenza infection with symptoms such as fatigue, chills, sore throat, joint or muscle pain, fever
• Feeling of pressure or pain in the cheeks and forehead (sinusitis)
• Headache
• Diarrhea
• Back pain
• Increased liver enzyme activity in blood tests
• Cough

Common (occurring in up to 1 in 10 patients)

• Fungal skin infections (dermatophyte infections) (ringworm)
• Dizziness
• Severe headache, usually accompanied by nausea, vomiting, and sensitivity to light (migraine symptoms)
• Low white blood cell count (lymphocytes, leukocytes)
• Weakness
• Itchy, red, burning rash (rash)
• Itching
• Increased triglyceride levels in the blood
• Hair loss
• Shortness of breath
• Depression
• Blurred vision (see also the section on macular edema under "Some side effects may be or may become serious")
• Hypertension (Efigalo may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon (occurring in up to 1 in 100 patients)

• Low neutrophil count
• Depressed mood
• Nausea

Rare (occurring in up to 1 in 1,000 patients)

• Lymphoma (a type of cancer affecting the lymphatic system)

Frequency not known (cannot be estimated from available data)

• Peripheral edema

If any of these symptoms occur with significant severity, the patient should contact their doctor.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Efigalo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Blisters:
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Bottle:
Do not store above 25°C.
Store the bottle tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Efigalo contains

The active substance of Efigalo is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod.

• Other ingredients are: microcrystalline cellulose, povidone K30, magnesium stearate. Capsule shell - body:titanium dioxide (E171), carrageenan, potassium chloride, hypromellose. Capsule shell - cap:titanium dioxide (E171), iron oxide, yellow (E172), carrageenan, potassium chloride, hypromellose. Printing ink: shellac, iron oxide, black (E172).

How the Efigalo medicine looks like and what the packaging contains

The cap of the capsule is brown-yellow with a black inscription "F 0.5 mg" and a black company logo. The body of the capsule is white. The contents of the capsule are white or off-white powder. The length of the capsule: 15-17 mm.
The Efigalo medicine is available in packages containing:

• 7, 14, 28, 30, 56, 60, 90, 98 and 100 hard capsules, in blisters.
• 30 x 1, 60 x 1, 90 x 1 and 100 x 1 hard capsules, in perforated blisters, divisible into single doses.
• calendar packaging: 7 x 1, 14 x 1, 28 x 1, 56 x 1 and 98 x 1 hard capsules, in perforated blisters, divisible into single doses.

The Efigalo medicine is available in containers containing 30 hard capsules, in a cardboard box.

Marketing Authorisation Holder

Krka, d.d., Novo mesto
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia

Manufacturer

Krka, d.d., Novo mesto
Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
Ardena Pamplona S.L.
Poligono Mocholi, C/Noain,
n°1 de Noain, 31110 Navarra,
Spain
In order to obtain more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
tel. 22 57 37 500
Date of last update of the leaflet:12/2024