VELSIPITY™ What is the most important information I should know about VELSIPITY?

(etrasimod)

What is the most important information I should know about VELSIPITY?

VELSIPITY can cause serious side effects, including:
1.
Infections. VELSIPITY can increase your risk of serious infections. These infections can be life-threatening and cause death.

VELSIPITY lowers the number of white blood cells (lymphocytes) in your blood. This usually returns to normal within 4 to 5 weeks after you stop taking VELSIPITY. Your healthcare provider will test your blood before you start taking VELSIPITY. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with VELSIPITY, and for 5 weeks after you stop taking VELSIPITY:
fever or high temperature
tiredness
flu-like symptoms
pain when peeing or peeing more often than usual. These can be signs of a urinary tract infection.
headache with fever, neck stiffness, sensitivity to light, nausea, or confusion. These may be symptoms of meningitis, an infection of the lining around your brain and spine.

Your healthcare provider may delay or stop your VELSIPITY treatment if you have an infection.

2.
Slow heart rate (also known as bradyarrhythmia) when you start taking VELSIPITY. VELSIPITY may cause your heart rate to temporarily slow down especially after you take your first dose. You will have a test called an electrocardiogram (ECG) to check the electrical activity of your heart before you take your first dose of VELSIPITY.

Call your healthcare provider if you experience these symptoms of slow heart rate:
feeling dizzy
feeling lightheaded
feeling like your heart is beating slowly or skipping beats
feeling short of breath
feeling confused
feeling tired
chest pain

See "What are the possible side effects of VELSIPITY?" for more information about side effects.

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What is the most important information I should know about VELSIPITY?

What is the most important information I should know about VELSIPITY?

VELSIPITY can cause serious side effects, including:
1.
Infections. VELSIPITY can increase your risk of serious infections. These infections can be life-threatening and cause death.

VELSIPITY lowers the number of white blood cells (lymphocytes) in your blood. This usually returns to normal within 4 to 5 weeks after you stop taking VELSIPITY. Your healthcare provider will test your blood before you start taking VELSIPITY. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with VELSIPITY, and for 5 weeks after you stop taking VELSIPITY:
fever or high temperature
tiredness
flu-like symptoms
pain when peeing or peeing more often than usual. These can be signs of a urinary tract infection.
headache with fever, neck stiffness, sensitivity to light, nausea, or confusion. These may be symptoms of meningitis, an infection of the lining around your brain and spine.

Your healthcare provider may delay or stop your VELSIPITY treatment if you have an infection.

2.
Slow heart rate (also known as bradyarrhythmia) when you start taking VELSIPITY. VELSIPITY may cause your heart rate to temporarily slow down especially after you take your first dose. You will have a test called an electrocardiogram (ECG) to check the electrical activity of your heart before you take your first dose of VELSIPITY.

Call your healthcare provider if you experience these symptoms of slow heart rate:
feeling dizzy
feeling lightheaded
feeling like your heart is beating slowly or skipping beats
feeling short of breath
feeling confused
feeling tired
chest pain

See "What are the possible side effects of VELSIPITY?" for more information about side effects.

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Health Professional Information

What is the most important information I should know about VELSIPITY?

What is the most important information I should know about VELSIPITY?

VELSIPITY can cause serious side effects, including:
1.
Infections. VELSIPITY can increase your risk of serious infections. These infections can be life-threatening and cause death.

VELSIPITY lowers the number of white blood cells (lymphocytes) in your blood. This usually returns to normal within 4 to 5 weeks after you stop taking VELSIPITY. Your healthcare provider will test your blood before you start taking VELSIPITY. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with VELSIPITY, and for 5 weeks after you stop taking VELSIPITY:
fever or high temperature
tiredness
flu-like symptoms
pain when peeing or peeing more often than usual. These can be signs of a urinary tract infection.
headache with fever, neck stiffness, sensitivity to light, nausea, or confusion. These may be symptoms of meningitis, an infection of the lining around your brain and spine.

Your healthcare provider may delay or stop your VELSIPITY treatment if you have an infection.

2.
Slow heart rate (also known as bradyarrhythmia) when you start taking VELSIPITY. VELSIPITY may cause your heart rate to temporarily slow down especially after you take your first dose. You will have a test called an electrocardiogram (ECG) to check the electrical activity of your heart before you take your first dose of VELSIPITY.

Call your healthcare provider if you experience these symptoms of slow heart rate:
feeling dizzy
feeling lightheaded
feeling like your heart is beating slowly or skipping beats
feeling short of breath
feeling confused
feeling tired
chest pain

See "What are the possible side effects of VELSIPITY?" for more information about side effects.

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