VELSIPITY™ Highlights

VELSIPITY is a sphingosine 1-phosphate receptor modulator indicated for the treatment of moderately to severely active ulcerative colitis in adults. (1)

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Assessments are required prior to initiating VELSIPITY. (2.1)

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The recommended dosage is 2 mg orally once daily. (2.2)

Tablets: 2 mg of etrasimod (3)

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In the last 6 months, experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. (4, 5.2)

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History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker. (4, 5.2)

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Infections: May increase the risk of infections. Obtain a complete blood count (CBC) before initiation of treatment. Monitor for infection during treatment and for 5 weeks after discontinuation. Consider interruption of treatment if a serious infection develops. Avoid use of live attenuated vaccines during and for up to 5 weeks after treatment. (5.1)

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Bradyarrhythmia and Atrioventricular Conduction Delays: May result in a transient decrease in heart rate and AV conduction delays. Obtain an electrocardiogram (ECG) to assess for preexisting cardiac conduction abnormalities before starting treatment. Consider cardiology consultation for conduction abnormalities or concomitant use with other drugs that decrease heart rate. (2.1, 5.2, 7)

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Liver Injury: Elevations of aminotransferases may occur. Obtain transaminase and bilirubin levels before initiating VELSIPITY. Discontinue if significant liver injury is confirmed. (2.1, 5.3)

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Macular Edema: May increase the risk of macular edema. Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with VELSIPITY. Periodically conduct an evaluation of the fundus, including the macula, while on therapy and any time there is a change in vision. Consider discontinuing VELSIPITY if macular edema develops. (2.1, 5.4)

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Increased Blood Pressure: Monitor blood pressure during treatment. (5.5)

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Fetal Risk: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for one week after stopping VELSIPITY. (5.6, 8.3)

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Cutaneous Malignancies: Obtain a skin examination prior to or shortly after the start of treatment and periodically during treatment, especially if risk factors. Promptly evaluate suspicious skin lesions. (2.1, 5.7)

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Posterior Reversible Encephalopathy Syndrome (PRES): If symptoms develop, obtain a physical and neurological exam, and consider MRI. (5.8)

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Respiratory Effects: May cause a decline in pulmonary function. Assess pulmonary function (e.g., spirometry) if clinically indicated. (5.9)

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Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs: Consider the half-life and mode of action of prior therapies. (5.10)

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Immune System Effects After Stopping VELSIPITY: If using concomitant immunosuppressants, monitor patients for infectious complications for up to 5 weeks after the last dose of VELSIPITY. (5.11)

Most common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See full prescribing information for a list of clinically important drug interactions. (7)

Severe Hepatic Impairment: Use is not recommended. (8.6)