Velsipity® ▼ (etrasimod)| Cardiac and Ocular Adverse Events

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Cardiac and ocular adverse events (AEs) with Velsipity^®1,2

Incidence of these events in ELEVATE UC 52 and ELEVATE UC 12²

Scroll left to view table

	ELEVATE UC 52		ELEVATE UC 12
Adverse events	VELSIPITY	Placebo (n=144)	VELSIPITY	Placebo (n=116)
Bradycardia	<1%	0%	<1%	0%
Sinus bradycardia	<0%	0%	<2%	0%
AV block, first degree	<1%	0%	<1%	0%
AV block, second degree (Mobitz type I)	<1%	0%	<0%	0%
Macular edema	<1%	0%	<1%	1%

Transient, first-dose decreases in heart rate or AV conduction delays may occur^1,2

Initiation of VELSIPITY^® may result in a transient decrease in heart rate and AV conduction delays
On day 1, after the first dose of VELSIPITY^®, the greatest mean decrease from baseline in heart rate was observed at hour 2 or hour 3 post dose
Patients who experienced bradycardia were generally asymptomatic
Few patients experienced symptoms, such as dizziness, and these symptoms resolved without intervention. To reduce the risk of such side effects, the medicine should be taken with food for the first 3 days of treatment.

All macular edema events were resolved in the phase 3 trials^1,2

Risk of macular edema is higher if patients have diabetes, uveitis, or certain other eye problems
An eye exam of the fundus, including the macula, is recommended within 3-4 months of starting treatment in all patients and at any time if there is any change in vision while taking VELSIPITY^®.
Patients who present with visual symptoms of macular edema should be evaluated; if confirmed, treatment with etrasimod should be discontinued

Contraindications¹

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SMPC.
Immunodeficient state (see section 4.4 of the SMPC).
Patients who in the last 6 months experienced myocardial infarction, unstable angina pectoris, stroke, transient ischaemic attack (TIA), decompensated heart failure requiring hospitalisation, or New York Heart Association (NYHA) Class III/IV heart failure.
Patients with history or presence of Mobitz type II second-degree or third-degree atrioventricular (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 (see section 4.4 of the SMPC).
Active malignancies.
Severe hepatic impairment.
During pregnancy and in women of childbearing potential not using effective contraception (see sections 4.4 and 4.6 of the SMPC).

VELSIPITY^® is contraindicated in patients with certain preexisting cardiac abnormalities^*

Patients in the last 6 months who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or New York Heart Association (NYHA) class III or class IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker.¹

References

▼ 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.

References:

VELSIPITY^® (etrasimod) Summary of Product Characteristics. Available online at www.medicines.ie.

Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.

Legal Category S1A
Further information available on request

PP-V1A-IRL-0037 Date of preparation June 2025

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If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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PP-UNP-IRL-0937. July 2025

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