Please refer to the full Summary of Product Characteristics (SmPC) before prescribing.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

Presentation:2 mg film-coated tablets. Green, round, film-coated tablet of approximately 6 mm diameter, debossed with “ETR” on one side and “2” on the other side.
Indications:See SmPC for full details. Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
Dosage and administration:See SmPC for full details.Oral Use. The recommended dose is 2 mg etrasimod taken once daily. It is recommended that etrasimod be administered with food for the first 3 days to attenuate potential transient heart rate lowering effects related to initiation of treatment. Etrasimod can then be taken with or without food. Tablets should be swallowed whole with water and not be split, crushed or chewed because these methods have not been studied in clinical trials.Missed dose: if a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.Dose interruption: if treatment is interrupted for 7 or more consecutive days, it is recommended to resume treatment with food for the first 3 doses. Given the limited data in adolescents aged 16 and over, Velsipity should be used with caution especially when body weight is less than 40 kg due to the potential for increase in exposure.Contraindications:See SmPC for full details. Hypersensitivity to the active substance or to any of the excipients listed. Immunodeficient state. Patients who in the last 6 months experienced myocardial infarction, unstable angina pectoris, stroke, TIA, decompensated heart failure requiring hospitalisation, or NYHA Class III/IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker. Severe active infections, active chronic infections such as hepatitis or tuberculosis. Active malignancies. Severe hepatic impairment. During pregnancy and in women of childbearing potential not using effective contraception.Warnings and precautions:See SmPC for full details.Bradyarrhythmia and atrioventricularconduction delays:Treatment initiation with etrasimod:Prior to treatment initiation with etrasimod, an electrocardiogram (ECG) should be obtained in all patients to assess for pre- existing cardiac abnormalities. In patients with certain pre-existing conditions, first dose monitoring is recommended. When reinitiating treatment after an interruption of 7 or more consecutive days, consideration may be given to repeating the baseline ECG and/or monitoring depending on the results of the first evaluation, change in patient characteristics, and duration of interruption. Initiation of etrasimod may result in a transient decrease in heart rate and AV conduction delays. Caution should be applied when etrasimod is initiated in patients receiving treatment with a beta blocker because of the potential additive effects on lowering heart rate. Similar caution should be applied if patients receive calcium channel blockers, QT prolonging medicinal products, Class Ia and Class III anti-arrhythmic substances, since co-administration of these substances with etrasimod may lead to additive effects. Temporary interruption of beta-blocker treatment may be needed prior to initiation of etrasimod, depending on the resting HR before initiation of etrasimod. If interruption is deemed necessary, treatment with a beta- blocker can be reinitiated depending on the time of reaching the baseline heart rate. Beta- blocker treatment can be initiated in patients receiving stable doses of etrasimod. (See SmPC for further details)Cardiologist advice should be obtained before initiation of etrasimod todetermine overall benefit risk and the most appropriate monitoring strategy in patients with thefollowing conditions:Significant QT prolongation (QTcF ≥ 450 msec in males, ≥ 470 msec in females). Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic medicinal products. Unstable ischaemic heart disease, history of cardiac arrest, cerebrovascular disease (occurring more than 6 months prior to treatment initiation), or uncontrolled hypertension. History of symptomatic bradycardia, recurrent cardiogenic syncope, or severe untreated sleep apnoea.First dose monitoring in patients with certain pre-existing cardiac conditions:Due to the risk of transient decreases in heart rate with the initiation of etrasimod 4-hour monitoring for signs and symptoms of symptomatic bradycardia after the first dose is recommended in patients with resting heart rate < 50 bpm, second-degree [Mobitz type I] AV block, or a history of myocardial infarction or heart failure. Patients should be monitored with hourly pulse and blood pressure measurement during this 4-hour period. An ECG prior to and at the end of this 4-hour period is recommended. Additional monitoring may be required at the end of the 4-hour monitoring period, please refer to SmPC for further information.Infections:Etrasimod causes a mean reduction in peripheral blood lymphocyte count ranging from 43 to 55% of baseline values over 52 weeks because of reversible sequestration of lymphocytes in lymphoid tissues. Etrasimod may, therefore, increase the susceptibility to infections. Before initiating treatment, a recent complete blood count (CBC), including lymphocyte count (i.e., within the last 6 months or after discontinuation of prior UC therapy), should be obtained. Assessments of CBC are also recommended periodically during treatment. The initiation of etrasimod in patients with any active infection should be delayed until the infection is resolved. (see “Contraindications” section). Please refer to SmPC for further information.Progressive multifocalleukoencephalopathy (PML):PML has been reported in multiple sclerosis patients treated with S1P receptor modulators and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or unexplained neurologic findings that may be suggestive of PML. If PML is suspected, treatment with etrasimod should be suspended until PML has been excluded by an appropriate diagnostic evaluation. If PML is confirmed, treatment with etrasimod should be discontinued.Prior and concomitant treatment with anti-neoplastic,immune-modulating, or non-corticosteroid immunosuppressive therapies:In clinical studies, patients who received etrasimod were not to receive concomitant treatment with anti- neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies used for the treatment of UC. In clinical studies, concomitant use of corticosteroids was allowed; however, long-term data on concomitant use of etrasimod and corticosteroids are limited. Anti- neoplastic, immune-modulating, or immunosuppressive therapies (including corticosteroids) should be co-administered with caution because of the risk of additive immune system effects during such therapy. When switching to etrasimod from immunosuppressive therapies, the duration of effects and mechanism of action should be considered to avoid unintended additive immune system effects. An appropriate washout period may need to be applied.Vaccinations:No clinical data are available on the safety and efficacy of vaccinations in patients taking etrasimod. Vaccinations may be less effective if administered during etrasimod treatment. If live attenuated vaccine immunisations are required, these should be administered at least 4 weeks prior to initiation of etrasimod. The use of live attenuated vaccines during and for at least 2 weeks after treatment with etrasimod should be avoided. It is recommended to update immunisations in agreement with current immunisation guidelines prior to initiating etrasimod therapy.Liver injury:Elevations of aminotransferases may occur in patients receiving etrasimod. Recent transaminase and bilirubin levels (i.e., within last 6 months) should be available before initiation of treatment with etrasimod. In the absence of clinical symptoms, liver transaminases and bilirubin levels should be monitored at months 1, 3, 6, 9, and 12 on therapy and periodically thereafter. Patients who develop symptoms suggestive of hepatic dysfunction, should have hepatic enzymes checked. Etrasimod should be discontinued if significant liver injury is confirmed.Increased blood pressure:In clinical studies, hypertension was more frequently reported in patients treated with etrasimod than in patients treated with placebo. Blood pressure should be monitored during treatment with etrasimod and managedappropriately.Macular oedema:S1P receptor modulators, including etrasimod, have been associated with an increased risk of macular oedema. Macular oedema with or without visual symptoms has been reported in 0.3% of patients treated with Velsipity. Patients with a history of diabetes mellitus, uveitis, and/or underlying/co-existing retinal disease, are at increased risk of macular oedema during etrasimod therapy (see section 4.8 of the SmPC). It is recommended that these patients undergo an ophthalmic evaluation prior to treatment initiation with etrasimod and have follow up evaluations while receiving therapy. In patients without the risk factors above, an ophthalmic evaluation of the fundus, including the macula, is recommended within 3-4 months after starting etrasimod treatment (cases reported with etrasimod occurred within this timeframe) and at any time if there is a change in vision while taking etrasimod. Patients who present with visual symptoms of macular oedema should be evaluated and, if confirmed, treatment with etrasimod should be discontinued. A decision on whether etrasimod should be re initiated after resolution needs to take into account the potential benefits and risks for the individual patient.Malignancies:Cases of malignancies (including cutaneous malignancies) have been reported in patients treated with S1P receptor modulators. If a suspicious skin lesion is observed, it should be promptly evaluated. Since there is a potential risk of malignant skin growths, patients treated with etrasimod should be cautioned against exposure to sunlight without protection. These patients should not receive concomitant phototherapy with UV-B-radiation or PUVA-photochemotherapy.Posterior reversibleencephalopathy syndrome (PRES):Rare cases of PRES have been reported in patients receiving S1P receptor modulators. If PRES is suspected, treatment with etrasimod should be discontinued.Respiratory effects: Etrasimod should be used with caution in patients with severe respiratory disease (e.g., pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease).Drug Interactions:Interaction studies have only been performed in adults.Effect ofinhibitors of CYP2C8, CYP2C9, and CYP3A4 on etrasimod:Co-administration of etrasimod with a therapeutic agent or a combination of agents that are moderate to strong inhibitors of two or more of the following CYP enzymes (CYP2C8, CYP2C9, and CYP3A4) (e.g., fluconazole, rifampicin, enzalutamide) increases the exposure of etrasimod and is not recommended.Effect of CYP2C9 polymorphism:Due to the potential for increased exposure of etrasimod, co-administration of etrasimod in patients who are known or suspected to be CYP2C9 poor metabolisers (< 5% of the population) and who take medicinal products that are moderate or strong inhibitors of CYP2C8 and/or CYP3A4 is not recommended.Beta blockersand calcium channel blockers:Caution is recommended for patients receiving medicinal products that slow heart rate or atrioventricular conduction because of the potential additive effects on lowering heart rate. Patients on other medicinal products that lower the heart rate and on antiarrhythmic medicinal products (which have been associated with cases of torsades de pointes in patients with bradycardia) have not been studied with etrasimod.Oralcontraceptives:No clinically significant differences in the pharmacokinetics and pharmacodynamics of an oral contraceptive containing 30 mcg ethinyl oestradiol and 150 mcg levonorgestrel were observed when co administered with etrasimod.Fertility, pregnancy and lactation:Women of childbearing potential/Contraception in females:Velsipity is contraindicated in women of childbearing potential not using effective contraception. (see “Contraindications” section) Therefore, before initiation of treatment in women of childbearing potential, a negative pregnancy test result must be available and counselling should be provided regarding the serious risk to the foetus. Due to the time it takes to eliminate etrasimod from the body after stopping treatment, the potential risk to the foetus may persist and women of childbearing potential must use effective contraception during etrasimod treatment and for at least 14 days after treatment discontinuation.Pregnancy:There is a limited amount of data from the use of etrasimod in pregnant women. Velsipity is contraindicated during pregnancy. Etrasimod should be stopped at least 14 days before a pregnancy is planned. Breast-feeding: It is unknown whether etrasimod is excreted in human milk. Etrasimod should not be used during breast-feeding.Fertility:The effect of etrasimod on human fertility has not been evaluated.Effects on ability to drive and use machines:Etrasimod has no or negligible influence on theability to drive and use machines.Undesirable effects:The most common adverse reactions are lymphopenia (11%) and headache (7%). See SmPC for further details.Very common (≥1/10).Lymphopenia.Common (≥1/100 to <1/10).Urinary tract infection, lower respiratory tract infection, Neutropenia, Hypercholesterolaemia, Headache, Dizziness, Visual impairment, Bradycardia, Hypertension, Hepatic enzyme increased.Uncommon (≥1/1000 to <1/100).Macular oedema, Atrioventricular block.Legal category:S1A.Marketing Authorisation Number:EU/1/23/1790/001.For further information on this medicine please contact:Pfizer Medical Information on 1800 633 363 or at[email protected]For queries regarding product availability please contact:Pfizer Healthcare Ireland Unlimited Company, The Watermarque Building, Ringsend Road, Dublin 4, D04 K7N3, Ireland + 353 1 4676500.Marketing Authorisation Holder:Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium.

Revision Date: 01/2025

Version: 2_0

PP-V1A-IRL-0052 Date of Preparation: June 2025