VELSIPITY (etrasimod) | Hjerte- og øyebivirkninger

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Hjerte- og øyebivirkninger med 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 (n=289)	Placebo (n=144)	VELSIPITY (n=238)	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%

Table made by Pfizer from data in ref. 2 table 2

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

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
- Det anbefales at disse pasientene gjennomgår en øyeundersøkelse før behandlingstart med VELSIPITY, samt får oppfølgende undersøkelser under behandling.
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 VELSIPITY.
Patients who present with visual symptoms of macular edema should be evaluated; if confirmed, treatment with etrasimod should be discontinued

Cardiac contraindications¹

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

The information above pertains to cardiac and ocular AEs associated with required baseline assessments. Please see Summary of Product Characteristics for all adverse events.

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

References:

VELSIPITY (etrasimod) Summary of Product Characteristics.

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.

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Getting Started on VELSIPITY

Discover how to get your patients started on treatment.

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Preparatomtale

PP-V1A-NOR-0028 | Utarbeidet 11.2024

Pfizer AS, Org.nr 915 213 596

Postadresse: Postboks 3, 1324 Lysaker
Besøksadresse: Drammensveien 288, 0283 Oslo

Tlf.: +47 67 52 61 00

PP-BCP-NOR-0001 juni 2023

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