Gaxenim

Leaflet accompanying the packaging: patient information

Gaxenim, 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gaxenim and what is it used for
• 2. Important information before taking Gaxenim
• 3. How to take Gaxenim
• 4. Possible side effects
• 5. How to store Gaxenim
• 6. Contents of the pack and other information

1. What is Gaxenim and what is it used for

What is Gaxenim

Gaxenim contains the active substance fingolimod.

What is Gaxenim used for

Gaxenim 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 a rapidly evolving, severe form of MS.

Gaxenim 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 Gaxenim works

Gaxenim 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, the medicine reduces nerve damage caused by MS. Gaxenim also weakens some immune responses of the body.

2. Important information before taking Gaxenim

When not to take Gaxenim

• If the patient has a reduced immune response(due to immunodeficiency syndrome, disease, or taking immunosuppressive medications); if the doctor suspects that the patient has a rare brain infection called progressive multifocal leukoencephalopathy (PML) or if the patient has been diagnosed with PML;
• If the patient has a severe active infection or chronic active infection, such as hepatitis or tuberculosis;
• If the patient has an active malignant disease;
• If the patient has severe liver disease;
• If the patient has had a heart attack, angina, stroke, or symptoms of stroke in 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 Gaxenim;
• If the patient is currently taking or has recently taken medications for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol;
• If the patient is pregnant or breastfeeding;
• If the patient is allergicto fingolimod or any of the other ingredients of this medicine (listed in section 6). If this is the case or the patient has doubts, consult a doctor before taking Gaxenim.

Warnings and precautions

Before starting treatment with Gaxenim, discuss with your doctor:

• -if the patient has severe breathing difficulties during sleep (sleep apnea);
• -if the patient has been informed that their ECG is abnormal;
• -if the patient has symptoms of slow heart rate (such as dizziness, nausea, or palpitations);
• -if the patient is taking or has recently taken medications that slow heart rate(such as beta-blockers, verapamil, diltiazem, or ivabradine, digoxin, cholinesterase inhibitors, or pilocarpine);
• -if the patient has had sudden loss of consciousness or fainting in the past;
• -if the patient plans to be vaccinated;
• -if the patient has never had chickenpox;
• -if the patient has or has had vision problemsor other symptoms of macular edema (such as blind spots) or inflammation or infection of the eye (uveitis) or if the patient has diabetes, which can cause vision problems;
• -if the patient has liver problems;
• -if the patient has high blood pressure that cannot be controlled with medication;
• -if the patient has severe lung disease or a cough typical of smokers.If any of these situations occur or the patient has doubts, consult a doctor before taking Gaxenim.

Slow heart rate (bradycardia) and irregular heartbeat

At the beginning of treatment or after taking the first dose of 0.5 mg in patients who previously took a daily dose of 0.25 mg, Gaxenim 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 the doctor, as immediate treatment may be necessary.

Gaxenim may also cause irregular heartbeat, especially after taking the first dose. Irregular heartbeat usually returns to normal within less than one day. Slow 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 Gaxenim 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 side effects occur at the beginning of treatment, appropriate treatment can be applied. Before the first dose of Gaxenim and after the end of the 6-hour observation, 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 resolve. The same procedure may be recommended if the patient resumes treatment with Gaxenim after a break in treatment, depending on how long the break lasted and how long the patient took Gaxenim 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, Gaxenim may not be suitable for them.

If the patient has a history of sudden loss of consciousness or slow heart rate, Gaxenim may not be suitable for them. The patient may need to consult a cardiologist who will advise on how to start treatment with Gaxenim, including how to monitor the patient at night.

If the patient is taking medications that can slow down the heart rate, Gaxenim may not be suitable. The patient may need to consult a cardiologist who will check if the patient can switch to other medications that do not slow down the heart rate, to enable treatment with Gaxenim. If such a change in treatment is not possible, the cardiologist will advise the patient on how to start treatment with Gaxenim, taking into account monitoring until the next day after administration of the first dose of Gaxenim.

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 Gaxenim. If this is the case, the doctor will delay the start of treatment with Gaxenim for one month after the full vaccination course.

Infections

Gaxenim reduces the number of white blood cells (especially lymphocytes). White blood cells fight infections. During treatment with Gaxenim (and up to 2 months after the end of treatment), the patient may be more susceptible to infections. Existing infections may worsen. Infections can be severe and life-threatening. If the patient thinks they have an infection, have a fever, flu-like symptoms, shingles, or a headache with stiff neck, sensitivity to light, nausea, rash, and/or confusion or seizures (which may be symptoms of meningitis and/or encephalitis caused by fungal or viral infections), they should contact their doctor immediately, as this condition can be severe and life-threatening.

In patients treated with fingolimod, infections with the human papillomavirus (HPV) have been reported, including cases of warts, dysplasia, and HPV-related malignant tumors. The doctor will consider the need for HPV vaccination before starting treatment with Gaxenim. In women, the doctor will also recommend screening for HPV.

PML

PML is a rare brain disorder caused by infection that can lead to severe disability or death. The treating doctor will order an MRI scan before starting treatment and during treatment to monitor the risk of PML.

If the patient thinks their MS is getting worse or notices new symptoms, such as changes in mood or behavior, new weakness or worsening of existing weakness on one side of the body, changes in vision, confusion, or difficulty with speech and communication, they should talk to their doctor as soon as possible. These may be symptoms of PML.

The patient should also talk to their partner or caregivers and inform them about the treatment they are taking. There may be symptoms that the patient is not aware of.

If the patient develops PML, the condition can be treated, and treatment with Gaxenim will be discontinued. In some patients, after removal of Gaxenim from the body, an inflammatory reaction may occur (called immune reconstitution inflammatory syndrome, IRIS). This reaction can worsen the patient's condition, including brain function.

Macular edema

Before starting treatment with Gaxenim, the doctor may refer patients with existing or past vision problems or other symptoms of macular edema (such as blind spots) or inflammation or infection of the eye (uveitis) or diabetes for ophthalmological examinations.

The doctor may refer the patient for ophthalmological examinations after 3 to 4 months of starting treatment with Gaxenim.

The macula is a small area of the retina at the back of the eye that allows for sharp, clear vision of shapes, colors, and other details. Gaxenim may cause macular edema, a condition called macular edema. Macular edema usually occurs within the first 4 months of treatment with Gaxenim.

The risk of macular edema is higher in patients with diabetesor with a history of uveitis. In such cases, the doctor will recommend regular ophthalmological examinations to detect macular edema.

If the patient develops macular edema, they should inform their doctor before resuming treatment with Gaxenim.

Macular edema can cause certain vision problems, similar to those experienced during an MS relapse (optic neuritis). In the early stages, symptoms may not occur at all.

The patient should inform their doctor about any changes in vision. The doctor may refer the patient for ophthalmological examinations, especially if:

• The center of the visual field becomes blurry or shaded;
• A blind spot appears in the center of the visual field;
• There are difficulties with color vision or fine details.

Liver function tests

Patients with severe liver disease should not take Gaxenim. Gaxenim may affect liver function tests. The patient is unlikely to experience any symptoms, but if they notice yellowing of the skin or whites of the eyes, dark (brown) urine, pain in the right side of the abdomen, fatigue, decreased appetite, or unexplained nausea and vomiting, they should tell their doctor immediately.

If the patient experiences any of these symptoms after starting treatment with Gaxenim, they should tell their doctor immediately.

Before, during, and after treatment, the doctor will order blood tests to monitor liver function. If the test results indicate liver function disorders, treatment with Gaxenim may be discontinued.

High blood pressure

The doctor may regularly check the patient's blood pressure, as Gaxenim can cause a slight increase in blood pressure.

Lung problems

Gaxenim has a minor effect on lung function. Patients with severe lung disease or a cough typical of smokers are at higher risk of side effects.

Blood cell count

A expected effect of Gaxenim is a decrease in the number of white blood cells in the blood. Their number usually returns to normal within 2 months after the end of treatment. If blood tests are necessary, the patient should inform their doctor that they are taking Gaxenim. 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 to be taken than usual.

Before starting treatment with Gaxenim, 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 repetition of blood tests. If there are not enough white blood cells, it may be necessary to discontinue treatment with Gaxenim.

Posterior reversible encephalopathy syndrome (PRES)

In patients with MS treated with fingolimod, rare cases of a condition called posterior reversible encephalopathy syndrome (PRES) have been reported. 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 Gaxenim, they should tell their doctor immediately, as this condition can be severe.

Cancer

In patients with MS treated with fingolimod, cases of skin cancer have been reported. If the patient notices any lumps on their skin (e.g., shiny lumps with a pearl-like color), patches, or open sores that do not heal within a few weeks, they should tell their doctor immediately. Symptoms of skin cancer may include abnormal growths or changes in skin tissue (e.g., new moles) that change color, shape, or size over time. Before starting treatment with Gaxenim, it is necessary to examine the skin for any lumps. The treating doctor will also perform regular skin checks during treatment with Gaxenim. If skin problems occur, the treating doctor may refer the patient to a dermatologist, who may decide on the need for regular visits after consulting with the patient.

In patients with MS treated with fingolimod, cases of a type of lymphoma (a type of cancer of the lymphatic system) have been reported.

Exposure to sunlight and protection from ultraviolet radiation

Fingolimod weakens the immune system. This increases the risk of developing malignant tumors, especially skin cancer. The patient should limit exposure to sunlight and UV radiation by:

• wearing protective clothing;
• regularly applying sunscreen with a high sun protection factor.

Unusual changes in the brain associated with MS relapse

In patients treated with fingolimod, rare cases of unusually large brain lesions associated with MS relapse have been reported. In the case of a severe MS relapse, the treating doctor will consider performing an MRI scan to assess this condition and decide on the possible need to discontinue Gaxenim.

Changing treatment from other medicines to Gaxenim

The doctor may change treatment directly from interferon-beta, glatiramer acetate, or dimethyl fumarate to Gaxenim 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 Gaxenim. In the case of a change in 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 Gaxenim is suitable for them.

Women of childbearing age

If Gaxenim is used during pregnancy, it may harm the unborn child. Before starting treatment with Gaxenim, the doctor will explain the risk to the patient and ask them to perform a pregnancy test to rule out pregnancy. The doctor will provide the patient with a card explaining why they should not become pregnant while taking Gaxenim.

Female patients must use effective contraception during treatment and for 2 months after discontinuing treatment (see "Pregnancy and breastfeeding").

Worsening of MS after discontinuing Gaxenim

The patient should not stop taking Gaxenim or change the dose without consulting their doctor.

The patient should tell their doctor immediately if they think their MS is getting worse after stopping treatment with Gaxenim. This situation can be serious (see "Discontinuing Gaxenim" in section 3 and section 4 "Possible side effects").

Elderly patients

Experience with fingolimod in elderly patients (over 65 years) is limited. In case of doubts, the patient should consult their doctor.

Children and adolescents

Gaxenim is not intended for use in children under 10 years of age, as it has not been studied in this age group with MS.

The warnings and precautions mentioned above also apply to children and adolescents. The following information is particularly important for children and adolescents and their caregivers:

• -Before starting treatment with Gaxenim, the doctor will check the patient's vaccination status. If the patient has not received certain vaccinations, they may need to be vaccinated before starting treatment with Gaxenim.
• -During the first administration of Gaxenim or when changing the daily dose from 0.25 mg to 0.5 mg, the doctor will monitor the patient's heart rate and pulse (see "Slow heart rate (bradycardia) and irregular heartbeat" above)
• -If the patient experiences seizures or epileptic fits before or during treatment with Gaxenim, they should tell their doctor.
• -If the patient experiences depression or anxiety or feels low or anxious while taking Gaxenim, they should tell their doctor. The patient may need closer monitoring.

Gaxenim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Immunosuppressive or immunomodulatory medicines, including other MS treatments, such as interferon-beta, glatiramer acetate, natalizumab, mitoxantrone, teriflunomide, dimethyl fumarate, or alemtuzumab. Gaxenim should not be taken with these medicines, as this may increase the effect on the immune system (see also "When not to take Gaxenim").
• Corticosteroids, due to the potential for additive effects on the immune system.
• Vaccines. If the patient needs to be vaccinated, they should consult their doctor first. During and up to 2 months after treatment with Gaxenim, patients should not receive certain types of vaccines (live attenuated vaccines), as they may cause the infection they are intended to prevent. Other vaccines may also not be effective if given during this period.
• Medicines that slow heart rate(such as beta-blockers, e.g., atenolol). Taking Gaxenim with these medicines may increase the effect on heart rate in the first days of treatment with Gaxenim.
• Medicines for irregular heartbeat, such as quinidine, disopyramide, amiodarone, or sotalol. Gaxenim should not be taken by patients taking these medicines, as this may increase the effect on irregular heartbeat (see also "When not to take Gaxenim").
• Other medicines: protease inhibitors, antifungal medicines such as ketoconazole, azole antifungals, clarithromycin, or telithromycin; carbamazepine, rifampicin, phenobarbital, phenytoin, efavirenz, or St. John's wort products (possible risk of reduced efficacy of Gaxenim).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.

Pregnancy

Gaxenim should not be taken during pregnancy, if the patient is trying to become pregnant, or if the patient can become pregnant and is not using effective contraception. If Gaxenim is taken during pregnancy, there is a risk of harm to the unborn child. The incidence of birth defects in children exposed to fingolimod during pregnancy is about twice that observed in the general population (where the incidence of birth defects is about 2-3%). The most commonly reported birth defects include heart, kidney, and musculoskeletal developmental abnormalities.

Therefore, if the patient is of childbearing age:

• -before starting treatment with Gaxenim, the doctor will inform the patient about the risk to the unborn child and ask them to perform a pregnancy test to ensure the patient is not pregnant, and
• -the patient should use effective contraception during treatment with Gaxenim and for 2 months after the end of treatment to avoid becoming pregnant. The patient should discuss effective contraception methods with their doctor.

The doctor will provide the patient with a card explaining why they should not become pregnant while taking Gaxenim.

If the patient becomes pregnant while taking Gaxenim, they should tell their doctor immediately.

The doctor will decide whether to discontinue treatment(see "Discontinuing Gaxenim" in section 3 and section 4 "Possible side effects"). The patient will also need to attend prenatal check-ups.

Breastfeeding

Gaxenim should not be taken during breastfeeding.Gaxenim may pass into breast milk, posing a risk of severe side effects in the child.

Driving and using machines

The doctor will inform the patient whether their condition allows them to drive vehicles, including riding a bicycle and operating machines. It is not expected that Gaxenim will affect the ability to drive vehicles and operate machines.

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 Gaxenim. During this time and potentially after it, the patient's ability to drive vehicles and operate machines may be impaired.

Gaxenim contains less than 1 mmol (23 mg) of sodium per hard capsule, which means the medicine is considered "sodium-free".

3. How to take Gaxenim

Treatment with Gaxenim will be supervised by a doctor with experience in treating multiple sclerosis.

This medicine should always be taken as directed 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.

Since 0.5 mg hard capsules are not suitable for children with a body weight of 40 kg or less, other fingolimod-containing medicines with lower strengths (0.25 mg capsules) are available.

Children and adolescents starting treatment with one 0.25 mg capsule per day and later reaching 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 Gaxenim.

The patient should not exceed the recommended dose.

Gaxenim is for oral use.

Gaxenim should be taken once a day, with a glass of water. Gaxenim capsules should always be swallowed whole, without opening. Gaxenim can be taken with or without food.

Taking Gaxenim 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 Gaxenim, they should consult their doctor or pharmacist.

Taking a higher dose of Gaxenim than recommended

If the patient takes too much Gaxenim, they should contact their doctor immediately.

Missing a dose of Gaxenim

If the patient takes Gaxenim for less than 1 month and forgets to take 1 dose for the whole 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 takes Gaxenim for at least 1 month and forgets to take it 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 forgets to take Gaxenim for up to 2 weeks, they can take the next dose as planned.

The patient should not take a double dose to make up for a missed dose.

Discontinuing Gaxenim

The patient should not stop taking Gaxenim or change the dose without consulting their doctor.

Gaxenim remains in the body for up to 2 months after discontinuing 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 discontinuing Gaxenim, the patient should wait 6-8 weeks before starting new MS treatment.

In patients resuming treatment with Gaxenim after more than 2 weeks of discontinuing 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. The patient should not resume treatment with Gaxenim after a break of more than 2 weeks without consulting their doctor.

The treating doctor will decide whether and how to monitor the patient after discontinuing Gaxenim. The patient should tell their doctor immediately if they think their MS is getting worse after stopping treatment with Gaxenim. 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, Gaxenim can cause side effects, although not everybody gets them.

Some side effects may be or may become severe

Very common(may affect up to 1 in 10 people):

• Cough with expectoration, unspecified unpleasant chest sensation, fever (respiratory symptoms)
• Herpesvirus infections (shingles or herpes) with symptoms such as blisters, burning, itching, or pain on the skin, usually on the upper body or face. Other symptoms may include fever and weakness at the onset of infection, followed by numbness, itching, or red spots with severe pain.
• Slow heart rate (bradycardia), 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 appearances
• Depression and anxiety are known to occur more frequently in the MS population and have also been reported in children and adolescents treated with fingolimod.
• Weight loss

Common(may affect up to 1 in 100 people):

• Pneumonia with symptoms such as fever, cough, difficulty breathing
• Macular edema with symptoms such as blind spots or shaded areas in the center of the visual field, blurred vision, difficulty with color vision and fine details
• Decreased platelet count, which increases the risk of bleeding or bruising
• Malignant melanoma (a type of skin cancer that usually develops from an abnormal mole). Possible symptoms of melanoma include moles that change in size, shape, or color over time or new moles that appear. Moles can be itchy, bleed, or ulcerate.
• Seizures, epileptic fits (more common in children and adolescents than in adults)

Uncommon(may affect up to 1 in 1,000 people):

• 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 area of an existing scar

Rare(may affect up to 1 in 10,000 people):

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

Unknown(frequency cannot be estimated from the 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 Gaxenim
• Liver disease symptoms (including liver failure) such as yellowing of the skin or whites of the eyes, 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 those of an MS relapse. There may also be symptoms that the patient is not aware of, such as changes in mood or behavior, transient memory lapses, or difficulty with speech and communication, which the doctor should evaluate to rule out PML. Therefore, if the patient thinks their MS is getting worse or if the patient or their caregivers notice any new or unusual symptoms, it is very important to tell their doctor as soon as possible.
• Inflammatory reactions after discontinuing Gaxenim (known as immune reconstitution inflammatory syndrome or IRIS)
• Cryptococcal infections (a type of fungal infection), including cryptococcal meningitis with symptoms such as headache, stiff neck, sensitivity to light, nausea, and/or confusion
• Cancer of the skin (Merkel cell carcinoma). Possible symptoms of Merkel cell carcinoma include a painless nodule or mass, often 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 may affect the risk of Merkel cell carcinoma.
• After discontinuing Gaxenim, MS symptoms may recur and worsen compared to the period before treatment and during treatment.
• Autoimmune hemolytic anemia (a condition in which red blood cells are destroyed)

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

Very common(may affect more than 1 in 10 people):

• 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(may affect up to 1 in 10 people):

• Fungal skin infections (dermatophyte infections) (ringworm)
• Dizziness
• Severe headache, often 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 "Macular edema" under "Some side effects may be or may become severe")
• Hypertension (Gaxenim may cause a mild increase in blood pressure)
• Muscle pain
• Joint pain

Uncommon(may affect up to 1 in 100 people):

• Low neutrophil count
• Depressed mood
• Nausea

Rare(may affect up to 1 in 1,000 people):

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

Unknown(frequency cannot be estimated from the available data):

• Peripheral edema

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

5. How to store Gaxenim

The medicinal product should be stored out of sight and reach of children. Do not use this medicinal product after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month stated. PVC/PVDC/Aluminium blisters:Do not store above 30°C. PVC/PE/PVDC/Aluminium blisters:No special storage precautions are required. Do not use this medicinal product if you notice that the packaging is damaged or shows signs of opening. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gaxenim contains

The active substance is fingolimod. Each hard capsule contains fingolimod hydrochloride equivalent to 0.5 mg of fingolimod. The other ingredients are: Capsule filling: calcium hydrogen phosphate dihydrate, sodium croscarmellose, hydroxypropylcellulose, magnesium stearate; Capsule shell - body: gelatin, titanium dioxide (E 171); Capsule shell - cap: gelatin, titanium dioxide (E 171), iron oxide, yellow (E 172); Ink: shellac (E 904), propylene glycol, iron oxide, black (E 172), potassium hydroxide (E 525)

What Gaxenim looks like and contents of the pack

Gaxenim, 0.5 mg, hard capsules are capsules of length 15.9 mm with a yellow cap and a white opaque body, with a black ink print "FD 0.5 mg" on the cap. Gaxenim 0.5 mg, hard capsules are available in packs of 28 or 98 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer

Genepharm S.A, 18th km Marathonos Avenue, 153 51 Pallini Attiki, Greece; Bausch Health Poland sp. z o.o., ul. Kosztowska 21, 41-409 Mysłowice, Poland

Date of last update of the leaflet: 04/2025