VELSIPITY™ Full Patient Information

(etrasimod)

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Infections

Inform patients that they may be more likely to get infections, some of which could be life-threatening, when taking VELSIPITY and for 5 weeks after stopping it, and that they should contact their healthcare provider if they develop symptoms of infection [see Warnings and Precautions (5.1)]. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection.

Advise patients that some vaccines containing live virus (live attenuated vaccines) should be avoided during treatment with VELSIPITY. Advise patients that if immunizations are planned, they should be administered at least 4 weeks prior to initiation of VELSIPITY. Inform patients that the use of live attenuated vaccines should be avoided during and for 5 weeks after treatment with VELSIPITY.

Cardiac Effects

Advise patients that initiation of VELSIPITY treatment may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].

Liver Injury

Inform patients that VELSIPITY may increase liver enzymes. Advise patients that they should contact their healthcare provider if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine [see Warnings and Precautions (5.3)].

Macular Edema

Advise patients that VELSIPITY may cause macular edema, and that they should obtain an eye exam near the start of treatment with VELSIPITY, have their eyes monitored periodically by an eye care professional while receiving therapy, and contact their healthcare provider if they experience any changes in their vision while taking VELSIPITY [see Warnings and Precautions (5.4)].

Fetal Risk

VELSIPITY may cause fetal harm. Advise females to immediately inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with VELSIPITY and for one week after stopping VELSIPITY [see Use in Specific Populations (8.3)].

Pregnancy and Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VELSIPITY during pregnancy [see Use in Specific Populations (8.1)].

Cutaneous Malignancies

Advise patients to limit exposure to sunlight and ultraviolet (UV) light, wear protective clothing, and use a sunscreen with a high protection factor. Concomitant phototherapy with UV-B radiation or PUVA‑photochemotherapy is not recommended in patients taking VELSIPITY. If a suspicious skin lesion is observed, patients should immediately report it to their healthcare provider [see Warnings and Precautions (5.7)].

Posterior Reversible Encephalopathy Syndrome

Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological consequences [see Warnings and Precautions (5.8)].

Respiratory Effects

Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.9)].

Immune System Effects after Stopping VELSIPITY

Advise patients that VELSIPITY continues to have effects, such as lowering effects on peripheral lymphocyte count, for up to 5 weeks after the last dose, and to monitor for signs and symptoms of infection during that time [see Warnings and Precautions (5.11)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For Medical Information about VELSIPITY, please visit www.pfizermedinfo.com or call 1-800-438-1985.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2024
MEDICATION GUIDE VELSIPITY™ (Vel-sip-itee) (etrasimod) tablets, for oral use
Read this Medication Guide before you start taking VELSIPITY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
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.
What is VELSIPITY? • VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis. It is not known if VELSIPITY is safe and effective in children.
Do not take VELSIPITY if you: • have had a heart attack, chest pain (unstable angina), stroke or mini stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization in the last 6 months. • have or have had a history of unusual heartbeats (arrhythmia) that is not corrected by a pacemaker. Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.
Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you: • have a serious infection or an infection that does not go away or that keeps coming back (chronic). • are unable to fight infections due to a disease. • have received a vaccine in the past 4 weeks or are scheduled to receive a vaccine. You should be brought up to date with all age required vaccines before starting treatment with VELSIPITY. VELSIPITY may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with VELSIPITY before receiving a vaccine. • have chickenpox or received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the chickenpox vaccine and then wait 4 weeks before you start taking VELSIPITY. • have a slow heart rate. • have an irregular or abnormal heartbeat (arrhythmia). • have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure. • have cerebrovascular disease or history of a stroke or ministroke. • history of repeated fainting. • have or have had liver problems. • have or have had skin cancer. • have breathing problems, including untreated sleep apnea. • are pregnant or plan to become pregnant. VELSIPITY may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with VELSIPITY and for 7 days after you stop taking VELSIPITY. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking VELSIPITY or within 7 days after you stop taking VELSIPITY. Pregnancy Registry: There is a registry for women who become pregnant during treatment with VELSIPITY. If you become pregnant while taking VELSIPITY, talk to your healthcare provider about registering with the VELSIPITY Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can contact this registry by calling 1-800-616-3791. • are breastfeeding or plan to breastfeed. It is not known if VELSIPITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VELSIPITY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken: • medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers. • medicines that affect your immune system. • certain medicines known as moderate to strong inhibitors of both CYP2C9 and CYP3A4, medicines such as fluconazole. If you are taking fluconazole, you should not take VELSIPITY. • Rifampin. If you are taking rifampin, you should not take VELSIPITY. You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of your medicines to show the list to your healthcare provider and pharmacist when you get a new medicine.
How should I take VELSIPITY? • Take VELSIPITY exactly as your healthcare provider tells you to take it. • Take VELSIPITY 1 time each day. • Swallow VELSIPITY tablets whole. • Take VELSIPITY with or without food. • If a dose is missed, take the missed dose at the next scheduled time; do not double the next dose.
What are the possible side effects of VELSIPITY? VELSIPITY can cause serious side effects, including: • See "What is the most important information I should know about VELSIPITY?" • Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• unexplained nausea • vomiting • stomach area (abdominal pain) • tiredness		• loss of appetite • yellowing of the whites of your eyes or skin • dark colored urine
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY. • Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed. • A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• blurriness or shadows in the center of your vision • sensitivity to light				• a blind spot in the center of your vision • unusually colored vision
• Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin. • Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms: o sudden severe headache o sudden confusion o sudden loss of vision or other changes in your vision o seizure o If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY. • Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems. The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
How should I store VELSIPITY? • Store VELSIPITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep VELSIPITY and all medicines out of the reach of children.
General information about the safe and effective use of VELSIPITY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VELSIPITY for a condition for which it was not prescribed. Do not give VELSIPITY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VELSIPITY that is written for health professionals.
What are the ingredients in VELSIPITY? Active ingredient: etrasimod arginine. Inactive ingredients: Tablet core: magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. Tablet coating: FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C yellow #5/tartrazine aluminum lake, macrogol 4000 JP/PEG 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. LAB-1541-2.0

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Medication Guide

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Infections

Cardiac Effects

Advise patients that initiation of VELSIPITY treatment may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].

Liver Injury

Macular Edema

Fetal Risk

Advise females of reproductive potential to use effective contraception during treatment with VELSIPITY and for one week after stopping VELSIPITY [see Use in Specific Populations (8.3)].

Pregnancy and Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VELSIPITY during pregnancy [see Use in Specific Populations (8.1)].

Cutaneous Malignancies

Posterior Reversible Encephalopathy Syndrome

Respiratory Effects

Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.9)].

Immune System Effects after Stopping VELSIPITY

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For Medical Information about VELSIPITY, please visit www.pfizermedinfo.com or call 1-800-438-1985.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2024
MEDICATION GUIDE VELSIPITY™ (Vel-sip-itee) (etrasimod) tablets, for oral use
Read this Medication Guide before you start taking VELSIPITY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
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.
What is VELSIPITY? • VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis. It is not known if VELSIPITY is safe and effective in children.
Do not take VELSIPITY if you: • have had a heart attack, chest pain (unstable angina), stroke or mini stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization in the last 6 months. • have or have had a history of unusual heartbeats (arrhythmia) that is not corrected by a pacemaker. Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.
Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you: • have a serious infection or an infection that does not go away or that keeps coming back (chronic). • are unable to fight infections due to a disease. • have received a vaccine in the past 4 weeks or are scheduled to receive a vaccine. You should be brought up to date with all age required vaccines before starting treatment with VELSIPITY. VELSIPITY may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with VELSIPITY before receiving a vaccine. • have chickenpox or received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the chickenpox vaccine and then wait 4 weeks before you start taking VELSIPITY. • have a slow heart rate. • have an irregular or abnormal heartbeat (arrhythmia). • have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure. • have cerebrovascular disease or history of a stroke or ministroke. • history of repeated fainting. • have or have had liver problems. • have or have had skin cancer. • have breathing problems, including untreated sleep apnea. • are pregnant or plan to become pregnant. VELSIPITY may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with VELSIPITY and for 7 days after you stop taking VELSIPITY. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking VELSIPITY or within 7 days after you stop taking VELSIPITY. Pregnancy Registry: There is a registry for women who become pregnant during treatment with VELSIPITY. If you become pregnant while taking VELSIPITY, talk to your healthcare provider about registering with the VELSIPITY Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can contact this registry by calling 1-800-616-3791. • are breastfeeding or plan to breastfeed. It is not known if VELSIPITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VELSIPITY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken: • medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers. • medicines that affect your immune system. • certain medicines known as moderate to strong inhibitors of both CYP2C9 and CYP3A4, medicines such as fluconazole. If you are taking fluconazole, you should not take VELSIPITY. • Rifampin. If you are taking rifampin, you should not take VELSIPITY. You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of your medicines to show the list to your healthcare provider and pharmacist when you get a new medicine.
How should I take VELSIPITY? • Take VELSIPITY exactly as your healthcare provider tells you to take it. • Take VELSIPITY 1 time each day. • Swallow VELSIPITY tablets whole. • Take VELSIPITY with or without food. • If a dose is missed, take the missed dose at the next scheduled time; do not double the next dose.
What are the possible side effects of VELSIPITY? VELSIPITY can cause serious side effects, including: • See "What is the most important information I should know about VELSIPITY?" • Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• unexplained nausea • vomiting • stomach area (abdominal pain) • tiredness		• loss of appetite • yellowing of the whites of your eyes or skin • dark colored urine
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY. • Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed. • A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• blurriness or shadows in the center of your vision • sensitivity to light				• a blind spot in the center of your vision • unusually colored vision
• Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin. • Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms: o sudden severe headache o sudden confusion o sudden loss of vision or other changes in your vision o seizure o If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY. • Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems. The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
How should I store VELSIPITY? • Store VELSIPITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep VELSIPITY and all medicines out of the reach of children.
General information about the safe and effective use of VELSIPITY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VELSIPITY for a condition for which it was not prescribed. Do not give VELSIPITY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VELSIPITY that is written for health professionals.
What are the ingredients in VELSIPITY? Active ingredient: etrasimod arginine. Inactive ingredients: Tablet core: magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. Tablet coating: FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C yellow #5/tartrazine aluminum lake, macrogol 4000 JP/PEG 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. LAB-1541-2.0

Prescribing Information

Download Prescribing Information

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Risk of Infections

Cardiac Effects

Advise patients that initiation of VELSIPITY treatment may result in transient decrease in heart rate [see Warnings and Precautions (5.2)].

Liver Injury

Macular Edema

Fetal Risk

Advise females of reproductive potential to use effective contraception during treatment with VELSIPITY and for one week after stopping VELSIPITY [see Use in Specific Populations (8.3)].

Pregnancy and Pregnancy Registry

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to VELSIPITY during pregnancy [see Use in Specific Populations (8.1)].

Cutaneous Malignancies

Posterior Reversible Encephalopathy Syndrome

Respiratory Effects

Advise patients that they should contact their healthcare provider if they experience new onset or worsening dyspnea [see Warnings and Precautions (5.9)].

Immune System Effects after Stopping VELSIPITY

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

For Medical Information about VELSIPITY, please visit www.pfizermedinfo.com or call 1-800-438-1985.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 06/2024
MEDICATION GUIDE VELSIPITY™ (Vel-sip-itee) (etrasimod) tablets, for oral use
Read this Medication Guide before you start taking VELSIPITY and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
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.
What is VELSIPITY? • VELSIPITY is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis. It is not known if VELSIPITY is safe and effective in children.
Do not take VELSIPITY if you: • have had a heart attack, chest pain (unstable angina), stroke or mini stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization in the last 6 months. • have or have had a history of unusual heartbeats (arrhythmia) that is not corrected by a pacemaker. Talk to your healthcare provider before taking VELSIPITY if you have any of these conditions or do not know if you have any of these conditions.
Before taking VELSIPITY, tell your healthcare provider about all of your medical conditions, including if you: • have a serious infection or an infection that does not go away or that keeps coming back (chronic). • are unable to fight infections due to a disease. • have received a vaccine in the past 4 weeks or are scheduled to receive a vaccine. You should be brought up to date with all age required vaccines before starting treatment with VELSIPITY. VELSIPITY may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with VELSIPITY before receiving a vaccine. • have chickenpox or received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the chickenpox vaccine and then wait 4 weeks before you start taking VELSIPITY. • have a slow heart rate. • have an irregular or abnormal heartbeat (arrhythmia). • have heart disease, Class I or II heart failure, history of a heart attack, high blood pressure or uncontrolled high blood pressure. • have cerebrovascular disease or history of a stroke or ministroke. • history of repeated fainting. • have or have had liver problems. • have or have had skin cancer. • have breathing problems, including untreated sleep apnea. • are pregnant or plan to become pregnant. VELSIPITY may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with VELSIPITY and for 7 days after you stop taking VELSIPITY. Talk to your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking VELSIPITY or within 7 days after you stop taking VELSIPITY. Pregnancy Registry: There is a registry for women who become pregnant during treatment with VELSIPITY. If you become pregnant while taking VELSIPITY, talk to your healthcare provider about registering with the VELSIPITY Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can contact this registry by calling 1-800-616-3791. • are breastfeeding or plan to breastfeed. It is not known if VELSIPITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take VELSIPITY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using VELSIPITY with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken: • medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. These may be called beta blockers or calcium channel blockers. • medicines that affect your immune system. • certain medicines known as moderate to strong inhibitors of both CYP2C9 and CYP3A4, medicines such as fluconazole. If you are taking fluconazole, you should not take VELSIPITY. • Rifampin. If you are taking rifampin, you should not take VELSIPITY. You should not receive live vaccines at least 4 weeks before starting VELSIPITY, during treatment with VELSIPITY and for 5 weeks after you stop taking VELSIPITY. Talk to your healthcare provider before you receive a vaccine during treatment and for 5 weeks after treatment with VELSIPITY. If you receive a live vaccine, you may get the infection the vaccine was meant to prevent. Vaccines may not work as well when given during treatment with VELSIPITY. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Know the medicines you take. Keep a list of your medicines to show the list to your healthcare provider and pharmacist when you get a new medicine.
How should I take VELSIPITY? • Take VELSIPITY exactly as your healthcare provider tells you to take it. • Take VELSIPITY 1 time each day. • Swallow VELSIPITY tablets whole. • Take VELSIPITY with or without food. • If a dose is missed, take the missed dose at the next scheduled time; do not double the next dose.
What are the possible side effects of VELSIPITY? VELSIPITY can cause serious side effects, including: • See "What is the most important information I should know about VELSIPITY?" • Liver problems. VELSIPITY may cause liver problems. Your healthcare provider will do blood tests to check your liver before you start taking VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• unexplained nausea • vomiting • stomach area (abdominal pain) • tiredness		• loss of appetite • yellowing of the whites of your eyes or skin • dark colored urine
If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment with VELSIPITY. • Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with VELSIPITY and treat you as needed. • A problem with your vision called macular edema. Your healthcare provider should test your vision around the time you start taking VELSIPITY or at any time you notice vision changes during your treatment with VELSIPITY. Call your healthcare provider right away if you have any of the following symptoms:
	• blurriness or shadows in the center of your vision • sensitivity to light				• a blind spot in the center of your vision • unusually colored vision
• Types of skin cancer. Certain types of skin cancer have happened with medicines in the same class as VELSIPITY. Limit the amount of time you spend in sunlight and ultraviolet (UV) light while taking VELSIPITY. Wear protective clothing and use a sunscreen with a high sun protection factor. Tell your healthcare provider if you have any changes in the appearance of your skin. • Swelling and narrowing of the blood vessels in your brain. A condition called Posterior Reversible Encephalopathy Syndrome (PRES) has happened with drugs in the same class. Symptoms of PRES usually get better when you discontinue treatment. If not treated, PRES may cause a stroke. Call your healthcare provider right away if you have any of the following symptoms: o sudden severe headache o sudden confusion o sudden loss of vision or other changes in your vision o seizure o If you develop any of these symptoms, your healthcare provider will stop treatment with VELSIPITY. • Breathing problems. Some people who take medicines in the same class as VELSIPITY may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with VELSIPITY. Call your healthcare provider right away if you have new or worsening breathing problems. The most common side effects of VELSIPITY include headache, elevated liver tests, and dizziness. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of VELSIPITY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
How should I store VELSIPITY? • Store VELSIPITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep VELSIPITY and all medicines out of the reach of children.
General information about the safe and effective use of VELSIPITY. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VELSIPITY for a condition for which it was not prescribed. Do not give VELSIPITY to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about VELSIPITY that is written for health professionals.
What are the ingredients in VELSIPITY? Active ingredient: etrasimod arginine. Inactive ingredients: Tablet core: magnesium stearate, mannitol, microcrystalline cellulose, and sodium starch glycolate. Tablet coating: FD&C blue #1/brilliant blue FCF aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C yellow #5/tartrazine aluminum lake, macrogol 4000 JP/PEG 3350, polyvinyl alcohol (partially hydrolyzed), talc, and titanium dioxide. LAB-1541-2.0

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