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Click here for VELSIPITY▼ (etrasimod) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

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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.1

Cardiac and ocular adverse reactions with VELSIPITY1,2

Scroll left to view table
  ELEVATE UC 52 (N=433) ELEVATE UC 12 (N=354)
Adverse reactions VELSIPITY (n=289) Placebo (n=144) VELSIPITY (n=238) Placebo (n=116)
Bradycardia/sinus
bradycardia
4 events reported  No events reported 5 events reported  No events reported
AV block, first- or
second- degree
0.7% 0% 0.4% 0%
Macular oedema* 0.3% 0% 0.4% 0.9%
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Content Content Content Content Content
Content Content Content Content Content
Content Content Content Content Content
Content Content Content Content Content
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*All macular oedema events were resolved.2
 

Transient decreases in heart rate and AV conduction delays may occur upon initiation of VELSIPITY1,2

  • Initiation of VELSIPITY may result in a transient decrease in heart rate and AV conduction delays 
  • Most events of bradycardia were mild and asymptomatic
  • Bradycardia was reported in 1.5% of patients treated with VELSIPITY on the day of treatment initiation, and in 0.4% of patients treated with VELSIPITY on Day 2 
  • Of the 9 events across ELEVATE UC 52 and ELEVATE UC 12, 8 were reported on Day 1 and the remaining event on Day 2

Macular oedema1

  • Risk of macular oedema is higher in patients with diabetes mellitus, uveitis or underlying/co-existing retinal disease
  • It is recommended that these patients undergo an ophthalmic evaluation prior to treatment initiation with Velsipity and have follow-up evaluations while receiving therapy.

Cardiac contraindications1

  • VELSIPITY is contraindicated in patients with certain pre-existing cardiac abnormalities 
    • Patients in the last 6 months who experienced myocardial infarction, unstable angina pectoris, stroke, transient ischaemic attack, decompensated heart failure requiring hospitalisation, or New York Heart Association Class III or Class IV heart failure. Patients with history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sinoatrial block, unless patient has a functioning pacemaker1
The information above pertains to cardiac and ocular adverse reactions associated with required baseline assessments. Please see Summary of Product Characteristics for all adverse reactions.

Getting started on VELSIPITY

Discover how to get your patients started on treatment.

HOW TO GET STARTEDLoading
ReferencesAV – atrioventricular. 

References: 
1. VELSIPITY Summary of Product Characteristics 
2. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171 
3. Sandborn WJ et al. Lancet 2023;401(10383):1159-1171 (supplementary appendix).
Safety Profile
PP-V1A-GBR-0021. September 2024

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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