VELSIPITY 2 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Velsipity 2mg film-coated tablets

Etrasimod

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will give you a patient card containing important safety information that you should be aware of. Carry this card with you at all times.

Contents of the pack

1. What is Velsipity and what is it used for
2. What you need to know before you take Velsipity
3. How to take Velsipity
4. Possible side effects
5. How to store Velsipity
6. Contents of the pack and other information

1. What is Velsipity and what is it used for

Velsipity contains the active substance etrasimod, which belongs to a group of medicines known as sphingosine-1-phosphate receptor modulators.

Velsipity is used in adults and adolescents from 16 years of age to treat moderately to severely active ulcerative colitis (UC). Ulcerative colitis is an inflammatory disease of the large intestine. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or cannot take those medicines, you may be given Velsipity to reduce the signs and symptoms of the disease.

The active substance in Velsipity, etrasimod, prevents lymphocytes (a type of white blood cell) from moving from the lymph nodes (part of the body's immune system that contains lymphocytes) into the blood. These lymphocytes are involved in the inflammation associated with the development of ulcerative colitis. By reducing the number of lymphocytes circulating in the blood surrounding the large intestine, etrasimod helps to reduce intestinal inflammation and the symptoms associated with the disease.

2. What you need to know before you take Velsipity

Do not take Velsipity

• if you are allergic to etrasimod or any of the other ingredients of this medicine (listed in section 6);
• if your doctor has told you that you have a severely weakened immune system;
• if you have had a heart attack, unstable angina (chest pain caused by interruptions in the blood supply to the heart that occurs at rest or without a clear trigger), stroke, transient ischaemic attack (TIA, also known as a mini-stroke) or certain types of severe heart failure in the last 6 months;
• if you have certain types of irregular heartbeat; your doctor will check your heart before starting treatment;
• if you have a severe active infection or a chronic active infection, such as hepatitis (inflammation of the liver) or tuberculosis;
• if you have cancer;
• if you have severe liver problems;
• if you are pregnant or are a woman of childbearing potential who is not using effective contraceptive methods.

Warnings and precautions

Talk to your doctor or pharmacist before starting Velsipity if:

• you have a low heart rate or are taking or have recently taken medicines that slow the heart rate (such as beta-blockers or calcium channel blockers);
• you have ever had a stroke or other cerebrovascular diseases;
• you have liver problems;
• you have an infection;
• you have a low number of lymphocytes (a type of white blood cell);
• you have been vaccinated recently or are scheduled to be vaccinated;
• you have ever had vision problems or other symptoms of fluid accumulation in the back of the eye;
• you have eye inflammation;
• you have diabetes (which can cause eye problems);
• you have high blood pressure;
• you have severe lung disease, such as pulmonary fibrosis (scarring and thickening of lung tissue), asthma or chronic obstructive pulmonary disease (a type of lung disease characterized by permanent damage to lung tissue).

Slow heart rate and irregular heartbeat

Before starting Velsipity, your doctor will check your heart with an electrocardiogram (ECG; a test of the heart's electrical activity). This is because Velsipity may cause a temporary decrease in heart rate and other heart rhythm disorders when starting treatment. When this happens, you may feel dizzy or tired, notice your heartbeats, or have low blood pressure. If these effects are severe, tell your doctor, as you may need immediate treatment. If you restart treatment after stopping it for 7 or more consecutive days, your doctor may re-check your heart with an ECG.

If you have certain heart diseases, your doctor will also monitor you for at least the first 4 hours after the first dose. Your doctor will ask you to stay in the hospital or medical center for 4 hours and will check your pulse and blood pressure every hour after taking the first dose of Velsipity. An ECG should be performed before the first administration of Velsipity and after the 4-hour monitoring period. If after the 4-hour period you have a very slow or decreasing heart rate, or if your ECG shows abnormalities, you may need to be monitored for a longer period until they have resolved.

High blood pressure

As Velsipity may increase blood pressure, your doctor may want to check it regularly.

Infections

Velsipity reduces the levels of white blood cells in the blood (especially lymphocyte count). White blood cells fight infections. While you are taking Velsipity (and for up to 2 weeks after stopping it), you are more likely to get infections, and if you do get an infection, it may become worse. Talk to your doctor if you get an infection. If you think you have an infection, have a fever, feel like you have the flu, have blisters (cold sores) or a headache with stiff neck, sensitivity to light, nausea, rash and/or confusion or seizures (fits) (these can be symptoms of meningitis and/or encephalitis caused by a fungal or viral infection), contact your doctor immediately, as it could be serious and potentially life-threatening.

Progressive multifocal leukoencephalopathy (PML) has been reported with medicines similar to Velsipity. PML is a rare viral infection of the brain that can cause severe disability or death. The symptoms of PML include changes in vision, progressive weakness, clumsiness, loss of memory or confusion. If you experience any of these symptoms, talk to your doctor immediately.

Macular edema

Velsipity may cause a vision problem called macular edema (swelling of the macula, the central part of the retina in the back of the eye). The risk of macular edema is greater if you have diabetes, uveitis (inflammation of the uvea, the layer under the white part of the eyeball) or some other eye problems. If you have any of these conditions, your doctor will check your vision before starting Velsipity and regularly during treatment. If you do not have any of these conditions, your doctor will check your vision 3-4 months after starting treatment. Tell your doctor about any changes in your vision while taking Velsipity.

Call your doctor immediately if you experience any of the following symptoms:

• blurred vision or shadows in the center of your vision;
• a blind spot in the center of your vision;
• increased sensitivity to light;
• unusually colored vision (tinted).

Cancer

Velsipity weakens your immune system. This increases the risk of getting cancer, especially skin cancer. Cases of skin cancer have been reported with medicines similar to Velsipity. Talk to your doctor immediately if you notice any nodules on your skin (e.g., shiny, pearly nodules), spots or open sores that do not heal within a few weeks. The symptoms of skin cancer may include unusual growths or changes in skin tissue (e.g., unusual moles) that change color, shape, or size over time. Since there is a risk of skin cancer, you should limit your exposure to sunlight and UV rays (using protective clothing and applying sunscreen regularly).

Posterior reversible encephalopathy syndrome (PRES)

Posterior reversible encephalopathy syndrome (PRES) is a condition in which the brain becomes inflamed. The symptoms of PRES include headache, changes in vision, decreased consciousness, confusion, and seizures (fits). If you develop any of these symptoms, talk to your doctor immediately.

Vaccines

If you need to receive a vaccine, ask your doctor for advice. Vaccines may not work as well as they should while you are taking Velsipity. It is recommended that you check that you are up-to-date with all your vaccines before starting treatment. Live vaccines may trigger the infection they are supposed to prevent and should be given at least 4 weeks before starting treatment or at least 2 weeks after stopping Velsipity.

Liver function tests

Velsipity may affect liver function. Tell your doctor immediately if you experience any of the following symptoms: yellowing of the skin or the whites of the eyes, unusually dark urine (brown color), pain in the right side of the stomach area (abdomen), tiredness, loss of appetite or nausea and vomiting without apparent cause.

Before, during, and after treatment, your doctor will request a blood test to check your liver function.

Lung problems

Velsipity may have an effect on lung function. Patients with severe lung problems are more likely to experience these side effects.

Other treatments for ulcerative colitis

Usually, your doctor will advise you to stop other treatments for ulcerative colitis, except for corticosteroids (such as cortisone) and mesalazine. Some medicines for ulcerative colitis can also be used to treat other diseases. Tell your doctor about all the medicines you are taking. When switching from previous treatment, due to the risk of additive immunosuppressive effects, the risk of infection may increase for some time. Do not take any other immunosuppressant unless your doctor tells you to.

Women of childbearing potential

If Velsipity is used during pregnancy, it may harm the unborn baby. Before starting treatment with Velsipity, your doctor will explain the risk and ask you to have a pregnancy test to make sure you are not pregnant. Your doctor will give you a patient card explaining why you should not become pregnant while taking Velsipity. It also explains what you should do to avoid becoming pregnant while taking Velsipity. You must use an effective contraceptive method during treatment and for 14 days after stopping treatment (see "Pregnancy, contraception and breastfeeding" in section 2).

If any of these cases apply to you, tell your doctor or pharmacist before taking Velsipity.

Children and adolescents

Do not give this medicine to children and adolescents under 16 years of age. This is because Velsipity has not been studied in this age group.

Other medicines and Velsipity

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Velsipity may affect the way other medicines work. Also, other medicines may affect the way Velsipity works.

In particular, before taking Velsipity, tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:

• Medicines to control heart rate and blood pressure (beta-blockers and calcium channel blockers); the use of these medicines may enhance the effect of Velsipity on irregular heartbeats.
• Medicines to control your heart rhythm or heartbeats.
• Medicines that affect your immune system; the use of these medicines with Velsipity may weaken the immune system.
• Vaccines; if you need to receive a vaccine, talk to your doctor. You should not take Velsipity for at least 2 weeks before vaccination. You should not take Velsipity for at least 4 weeks after receiving a live vaccine.
• Fluconazole (an antifungal treatment) and other medicines may increase the levels of Velsipity in the blood, increasing the risk of side effects with Velsipity. It is recommended that you do not take them while taking Velsipity, and your doctor will advise you on this.
• Rifampicin, enzalutamide, and other medicines may decrease the levels of Velsipity in the blood, reducing its effectiveness. It is recommended that you do not take them while taking Velsipity, and your doctor will advise you on this.

Velsipity may slightly increase the levels of hormones released by some oral contraceptives. You will still be protected against pregnancy, but you may be more likely to experience side effects from the oral contraceptive. If you experience side effects, talk to your doctor or pharmacist.

Pregnancy, contraception and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy and contraception

Do not use Velsipity during pregnancy, if you are trying to become pregnant, or if you are a woman who could become pregnant and is not using effective contraceptive methods. If Velsipity is used during pregnancy, there is a risk of harming the unborn baby. If you are a woman who could become pregnant, your doctor will inform you about this risk before starting treatment with Velsipity and will ask you to have a pregnancy test to make sure you are not pregnant. You must use an effective contraceptive method while taking Velsipity and for at least 14 days after stopping it. Ask your doctor about reliable contraceptive methods.

Your doctor will give you a patient card explaining why you should not become pregnant while taking Velsipity.

If you become pregnant while taking Velsipity, tell your doctor immediately. Your doctor will probably stop treatment (see "If you stop taking Velsipity" in section 3) and prenatal checks will be performed to monitor the health of the fetus.

Breastfeeding

Do not breastfeed while taking Velsipity. This is to avoid the risk of side effects for the baby, as Velsipity may pass into breast milk.

Driving and using machines

Velsipity is not expected to have any effect on your ability to drive or use machines. However, you may feel dizzy after taking Velsipity. If this happens, do not drive or use machines.

Velsipity contains tartrazine (E102)

The colorant in Velsipity contains tartrazine (E102), which may cause allergic reactions.

Velsipity contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Velsipity

Treatment with Velsipity will be initiated under the supervision of a doctor with experience in the treatment of ulcerative colitis. Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take it

• The recommended dose of Velsipity is one 2 mg tablet once a day.
• Take Velsipity with food during the first 3 days. After that, you can take Velsipity every day with or without food.
• Swallow the tablet whole with water. Do not break, crush, or chew the tablet before swallowing, as this may alter the amount of medication you ingest.

If you take more Velsipity than you should

If you have taken more Velsipity than you should, call your doctor or go to a hospital immediately. Bring the medication packaging and this leaflet with you.

If you forget to take Velsipity

If you forget to take a dose of Velsipity, take the next dose at the usual time. Do not take a double dose.

If you interrupt treatment with Velsipity

Do not stop taking Velsipity or change the dose without consulting your doctor first. If your doctor decides to interrupt your treatment for 7 days or more consecutively, the medication should be taken with food during the first 3 days after restarting treatment with Velsipity. After that, you can take Velsipity with or without food.

If you restart Velsipity after suspending treatment for 7 days or more consecutively, the effect on heart rate that may be observed when starting treatment for the first time may reappear, and it may need to be controlled in a hospital or medical center. Do not restart treatment with Velsipity after interrupting it for more than 7 days without consulting your doctor.

Velsipity will remain in your body for up to 14 days after you stop taking it. The white blood cell count (lymphocyte count) may remain low for up to 2 weeks, and the adverse effects described in this leaflet may continue to appear (see "Possible side effects" in section 4) during this period.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects

Tell your doctor or pharmacist immediately if you notice any of the following side effects, which could become serious:

Common(may affect up to 1 in 10 people)

• bradycardia (slow heart rate)
• hypertension (high blood pressure)
• urinary tract infection (infection of the parts of the body that collect and expel urine)
• lower respiratory tract infection (infection of the lower airways or lungs)

Uncommon(may affect up to 1 in 100 people)

• atrioventricular block (a type of heart rhythm disorder)
• macular edema (swelling in the macula, the central part of the retina in the back of the eye)

Other side effects

Tell your doctor or pharmacist immediately if you notice any of the following side effects:

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

• lymphopenia (low levels of lymphocytes, a type of white blood cell)

Common(may affect up to 1 in 10 people)

• hypercholesterolemia (elevated cholesterol levels in the blood)
• headache
• dizziness
• increased liver enzyme levels in blood tests, which may be a sign of liver function problems
• neutropenia (low levels of neutrophils, a type of white blood cell)
• visual impairment

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Velsipity

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the bottle, blister pack, and carton after EXP. The expiration date is the last day of the month indicated.
• This medication does not require any special storage temperature.
• Store in the original packaging to protect it from moisture.
• Do not use this medication if you notice damage or signs of tampering with the packaging.
• Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Velsipity composition

• The active ingredient is etrasimod. Each film-coated tablet contains etrasimod arginine equivalent to 2 mg of etrasimod.
• The other ingredients are:

Tablet core

Magnesium stearate (E470b), mannitol (E421), microcrystalline cellulose (E460i), sodium starch glycolate (type A).

Tablet coating

Brilliant blue FCF aluminum lake (E133), carmine aluminum lake (E132), tartrazine aluminum lake (E102), macrogol 400 (E1521), polyvinyl alcohol (E1203), talc (E553b), and titanium dioxide (E171).

Appearance of Velsipity and package contents

Velsipity 2 mg are film-coated tablets of green color, round, approximately 6 mm in diameter, and engraved with "ETR" on one side and "2" on the other.

Package sizes:

• Bottle with 30 film-coated tablets
• Blister packs with 28 film-coated tablets
• Blister packs with 98 film-coated tablets

Not all package sizes may be marketed.

Marketing authorization holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturers

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk, A91 P9KD

Ireland

Almac Pharma Services Limited

Seagoe Industrial Estate

Portadown, Craigavon, BT63 5UA

United Kingdom

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet: 05/2025.

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website: https://www.ema.europa.eu.