Velsipity

Italy
Brand name Velsipity
Form tablets, film-coated
Active substance / Dosage
ETRASIMOD
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
L04AE05
Registration number 051115
Manufacturer PFIZER EUROPE MA EEIG
Velsipity tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

Velsipity 2 mg film-coated tablets

etrasimod

A black equilateral triangle pointing downward on a white background

This medicinal product is under additional monitoring. This will allow for rapid identification of
new safety information. You can help by reporting any side effects you experience while taking
this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

In addition to this package leaflet, your doctor will provide you with a patient card containing important safety information you should be aware of. Keep this patient card with you.
Contents of this leaflet

  1. What Velsipity is and what it is used for
  2. What you need to know before taking 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 Velsipity is and what it is 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 aged 16 years and older for the treatment of 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 prescribed other medicines. If you do not respond adequately or cannot take these medicines, Velsipity may be given to you in order to reduce the signs and symptoms of the disease.
The active substance in Velsipity, etrasimod, prevents lymphocytes (a type of white blood cells) 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 circulating lymphocytes in the blood surrounding the large intestine, etrasimod helps reduce intestinal inflammation and the symptoms associated with the disease.

2. What you should know before taking Velsipity

Do not take Velsipity

  • if you are allergic to etrasimod or to any of the other ingredients of this medicine (listed in section 6);
  • if your healthcare provider 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 blood supply to the heart, occurring at rest or without an obvious trigger), stroke, transient ischaemic attack (TIA, also known as a mini-stroke), or certain types of severe heart failure within the past 6 months;
  • if you have certain types of arrhythmia (irregular or abnormal heartbeat) – your doctor will check your heart before starting treatment;
  • if you have a severe active infection or an active chronic 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 an effective method of contraception.

Warnings and precautions
Talk to your doctor or pharmacist before taking Velsipity if:

  • you have a slow 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 conditions related to blood vessels in the brain;
  • you have liver problems;
  • you have an infection;
  • you have low levels of lymphocytes (a type of white blood cell);
  • you have recently received or are planning to receive a vaccination;
  • you have ever had vision problems or other symptoms of fluid accumulation at the back of the eye;
  • you have eye inflammation;
  • you have diabetes (which can cause eye problems);
  • you have high blood pressure;
  • you have a serious lung disease, such as pulmonary fibrosis (lung damage with scarring and thickening of lung tissue), asthma, or chronic obstructive pulmonary disease (a type of lung disease characterised by permanent damage to lung tissue).

Slow heart rate and irregular heart rhythm
Before you start taking 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 disturbances at the beginning of treatment. If this occurs, you may feel dizzy or fatigued, feel your heartbeat clearly, or your blood pressure may drop. If these effects are severe, inform your doctor immediately, as you may require urgent treatment. If you restart treatment after having stopped for 7 or more consecutive days, your doctor may repeat the ECG check.
If you have certain heart conditions, your doctor will also monitor you for at least the first 4 hours after your first dose. Your doctor will ask you to stay in hospital or clinic for 4 hours and will measure your heart rate and blood pressure every hour after you take your first dose of Velsipity.
You must undergo an ECG before your first dose of Velsipity and again 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 these abnormalities resolve.

High blood pressure
Since Velsipity may increase blood pressure, your doctor may wish to monitor you regularly.

Infections
Velsipity lowers the levels of white blood cells in the blood (particularly lymphocyte count). White blood cells fight infections. While taking Velsipity (and for up to about 2 weeks after stopping treatment), you may be more susceptible to infections, and any existing infection you have may worsen. Talk to your doctor if you develop an infection. If you think you have an infection, have a fever, experience flu-like symptoms, have herpes zoster, or have a headache accompanied by a stiff neck, sensitivity to light, nausea, rash and/or confusion or seizures (fits) (these may be symptoms of meningitis and/or encephalitis caused by a fungal infection or Herpes virus), contact your doctor immediately, as you may have a serious and potentially life-threatening condition.
Cases of progressive multifocal leukoencephalopathy (PML) have been reported with medicines similar to Velsipity. PML is a rare viral infection of the brain that can lead to severe disability or death. Symptoms of PML include vision problems, progressive weakness, clumsiness, memory loss, or confusion. If you develop any of these symptoms, contact your doctor immediately. Your doctor will consider performing further tests to evaluate your condition and will discontinue treatment with Velsipity if PML is confirmed.

Macular oedema
Velsipity may cause a vision problem called macular oedema (swelling of the macula, the central part of the retina at the back of the eye). The risk of developing macular oedema is higher if you have diabetes, uveitis (inflammation of the uvea, the layer beneath the white of the eyeball), or certain other eye problems. If you have any of these conditions, your doctor will check your vision before starting treatment with Velsipity and regularly during treatment. If you do not have these conditions, your doctor will check your vision within 3–4 months after starting treatment. Inform your doctor of any changes in vision while taking Velsipity.
Contact your doctor immediately if you experience any of the following symptoms:

  • blurred vision or shadows in the centre of your vision;
  • a blind spot in the centre of your vision;
  • sensitivity to light;
  • unusual colour vision.

Cancer
Velsipity weakens the immune system, increasing the risk of developing cancer, particularly skin cancer. Skin cancers have been reported with medicines similar to Velsipity. Contact your doctor immediately if you notice skin nodules (e.g., shiny, pearly nodules), spots, or open sores that do not heal within a few weeks. Symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) with changes in colour, shape, or size over time. Because of the risk of developing skin cancer, you should limit exposure to sunlight and ultraviolet (UV) rays by wearing protective clothing and regularly applying sunscreen (with a high sun protection factor).

Reversible posterior encephalopathy syndrome (PRES)
Reversible posterior encephalopathy syndrome (PRES) is a condition in which the brain swells. Symptoms of PRES include headache, changes in vision, reduced awareness, confusion, and seizures (fits). If you develop these symptoms, contact your doctor immediately.

Vaccinations
If you need to receive a vaccine, talk to your doctor first. During treatment with Velsipity, vaccines may not be as effective. You should ensure your vaccinations are up to date before starting treatment. Live vaccines may trigger the infection they are meant to prevent and should therefore be administered at least 4 weeks before starting treatment, or at least 2 weeks after stopping Velsipity.

Liver function tests
Velsipity may affect liver function. Inform your doctor immediately if you develop any of the following symptoms: yellowing of the skin or the whites of the eyes, unusually dark urine (brown in colour), pain in the right side of the abdomen, fatigue, loss of appetite, or unexplained nausea and vomiting.
Before, during, and after treatment, your doctor will order blood tests to monitor liver function.

Lung problems
Velsipity may affect lung function. Patients with serious lung problems are more likely to develop these side effects.

Other treatments for ulcerative colitis
Your doctor will usually advise you to stop other treatments for ulcerative colitis, except for corticosteroids (such as cortisone) and mesalazine. Some medicines for ulcerative colitis may also be used for other conditions. Inform your doctor about all other medicines you are taking.
When switching from a previous treatment, the risk of infection may increase for a certain period due to the potential additive immunosuppressive effects. Do not take other immunosuppressive medicines unless instructed by your doctor.

Women of childbearing potential
If used during pregnancy, Velsipity may harm the unborn baby. Before starting treatment with Velsipity, your doctor will explain the risks and ask you to take a pregnancy test to ensure you are not pregnant. Your doctor will give you a patient card explaining why you must not become pregnant while taking Velsipity. It also explains what you need to do to avoid pregnancy during treatment with Velsipity. You must use an effective method of contraception during treatment and for at least 14 days after stopping treatment (see “Pregnancy, contraception and breastfeeding” in section 2).

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

Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age, as Velsipity has not been studied in this age group.

Other medicines and Velsipity
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Velsipity may affect how other medicines work. In addition, some other medicines may affect how Velsipity works.
In particular, before taking Velsipity, inform 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); using these medicines may increase the effect of Velsipity on irregular heartbeat;
  • medicines to control heart rhythm (antiarrhythmics) or heart rate;
  • medicines that affect the immune system; using these medicines with Velsipity may weaken the immune system;
  • vaccines; if you need to receive a vaccine, talk to your doctor. You must not take Velsipity for at least 2 weeks before vaccination. You must not take Velsipity for at least 4 weeks after receiving a live vaccine;
  • fluconazole (an antifungal treatment) and some other medicines may increase the levels of Velsipity in the blood, increasing the risk of side effects with Velsipity. It is recommended not to take them during treatment with Velsipity; your doctor will advise you accordingly;
  • rifampicin, enzalutamide, and some other medicines may reduce the levels of Velsipity in the blood, reducing its effectiveness. It is recommended not to take them during treatment with Velsipity; your doctor will advise you accordingly.

Velsipity may slightly increase the levels of hormones released from certain contraceptive pills. You will still be protected from pregnancy, but the likelihood of side effects from the contraceptive pills may increase. If you experience any side effects, talk to your doctor or pharmacist.

Pregnancy, contraception and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor 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 are not using an effective method of contraception. If Velsipity is used during pregnancy, there is a risk of harm to the unborn baby. If you are a woman who could become pregnant, your doctor will inform you of this risk before starting treatment with Velsipity and will ask you to take a pregnancy test to ensure you are not pregnant. You must use an effective method of contraception during treatment with Velsipity and for at least 14 days after stopping treatment. Ask your doctor for advice on reliable contraceptive methods.
Your doctor will give you a patient card explaining why you must not become pregnant while taking Velsipity.
If you become pregnant while taking Velsipity, inform your doctor immediately. Your doctor will likely stop treatment (see “If you stop taking Velsipity” in section 3), and prenatal monitoring will be performed to assess the health of the unborn baby.

Breastfeeding
You must not breastfeed while taking Velsipity. This is to avoid the risk of side effects in the baby, as Velsipity may pass into breast milk.

Driving and using machines
Velsipity is not expected to affect your ability to drive or use machines. However, you may experience dizziness after taking Velsipity. If this occurs, do not drive or operate machinery.

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

Velsipity contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially “sodium-free”.

3. How to take Velsipity

Treatment with Velsipity will be initiated under the supervision of a physician experienced in the treatment of ulcerative colitis. Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

How to take the medicine

  • The recommended dose of Velsipity is one 2 mg tablet taken once daily.
  • Take Velsipity with food for the first 3 days. After this, you may take Velsipity daily with or without food.
  • Swallow the tablet whole with water. Do not divide, crush, or chew the tablet before swallowing, as this could alter the amount of medicine absorbed by your body.

If you take more Velsipity than you should
If you have taken more Velsipity than prescribed, contact your doctor immediately or go to the hospital straight away. Bring the medicine package and this leaflet with you.

If you forget to take Velsipity

  • If you miss a dose of Velsipity, take it as soon as you remember. However, if you forget the dose for the entire day, skip the missed dose and take the next dose at your usual time.
  • Do not take a double dose to make up for the missed dose.

If you stop taking Velsipity
Do not stop taking Velsipity or change the dose without first speaking to your doctor. If your doctor decides to interrupt treatment for 7 consecutive days or longer, when restarting Velsipity, the medicine should be taken with food for the first 3 days. After this, you may take Velsipity with or without food.

If you restart Velsipity after having stopped for 7 or more consecutive days, the effect on heart rate that may have been observed at the beginning of treatment could reoccur, and you may need to be monitored in a hospital or clinic. Do not restart Velsipity after stopping 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. White blood cell count (lymphocyte count) may remain low for up to approximately 2 weeks, and the side effects described in this leaflet may continue to occur (see “Possible side effects” in section 4) during this period.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Serious side effects
Contact 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 at the back of the eye)

Other side effects
Contact 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 (high levels of cholesterol in the blood)
  • headache
  • dizziness
  • increased levels of liver enzymes in blood tests (which may indicate liver function problems)
  • neutropenia (low levels of neutrophils, a type of white blood cell)
  • visual impairment

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Velsipity

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date stated on the bottle, blister pack, and carton after "Exp.". The expiry date refers to the last day of that month.
  • This medicine does not require any special storage temperature.
  • Store in the original packaging to protect the medicine from moisture.
  • Do not use this medicine if you notice any damage or sign of tampering with the packaging.
  • Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Velsipity contains

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

Tablet core
Magnesium stearate (E470b), mannitol (E421), microcrystalline cellulose (E460i), sodium
starch glycolate (Type A)
Film coating
Aluminium lake of brilliant blue FCF (E133), aluminium lake of indigo carmine (E132),
aluminium lake of tartrazine (E102), macrogol 4000 (E1521), poly(vinyl alcohol) (E1203),
talc (E553b) and titanium dioxide (E171)

Description of the appearance of Velsipity and package contents
Velsipity 2 mg is a round, film-coated tablet, green in colour, approximately 6 mm in
diameter, with the imprint “ETR” on one side and “2” on the other side.

Pack sizes:

  • Bottle containing 30 film-coated tablets
  • Blister pack containing 28 film-coated tablets
  • Blister pack containing 98 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Luxembourg/Luxemburg Pfizer Luxembourg SARL filialas Lietuvoje
Pfizer NV/SA Tel: +370 5 251 4000
Tél/Tel: +32 (0)2 554 62 11

България Magyarország
Пфайзер Люксембург САРЛ, Клон Pfizer Kft.
България Tel.: +36 1 488 37 00
Тел.: +359 2 970 4333

Česká republika Malta
Pfizer, spol. s r.o. Vivian Corporation Ltd.
Tel: +420 283 004 111 Tel: +356 21344610

Danmark Nederland
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)800 63 34 636

Deutschland Norge
PFIZER PHARMA GmbH Pfizer AS
Tel: +49 (0)30 550055-51000 Tlf: +47 67 52 61 00

Eesti Österreich
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 666 7500 Tel: +43 (0)1 521 15-0

Ελλάδα Polska
Pfizer Ελλάς A.E. Pfizer Polska Sp. z o.o.
Τηλ: +30 210 6785800 Tel.: +48 22 335 61 00

España Portugal
Pfizer, S.L. Laboratórios Pfizer, Lda.
Tel: +34 91 490 99 00 Tel: +351 21 423 5500

France România
Pfizer Pfizer Romania S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 (0) 21 207 28 00

Hrvatska Slovenija
Pfizer Croatia d.o.o. Pfizer Luxembourg SARL
Tel: +385 1 3908 777 Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Irlanda Slovenská republika
Pfizer Healthcare Ireland Pfizer Luxembourg SARL, organizačná zložka
Tel: 1800 633 363 (toll free) Tel: +421 2 3355 5500
+44 (0)1304 616161

Ísland Suomi/Finland
Icepharma hf. Pfizer Oy
Sími: +354 540 8000 Puh/Tel: +358 (0)9 430 040

Italia Sverige
Pfizer S.r.l. Pfizer AB
Tel: +39 06 33 18 21 Tel: +46 (0)8 550 520 00

Kύπρος United Kingdom (Northern Ireland)
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer Limited
Tηλ: +357 22817690 Tel: +44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.