Velsipity (etrasimod) is a once-daily tablet used to treat ulcerative colitis that is moderate to severe in adults. Velsipity works to improve ulcerative colitis symptoms and to help achieve steroid-free remission of ulcerative colitis.  Velsipity tablets have a rapid onset action with ulcerative colitis (UC) symptoms improving and symptomatic remission starting as early as week 2 in some patients.

Velsipity is an S1P receptor modulator (selective sphingosine-1-phosphate) that helps control inflammation in the large intestine. Velsipity is not a biological drug. Pfizer’s Velsipity (etrasimod) became an FDA-approved medicine on October 12, 2023, to treat moderately to severely active ulcerative colitis (UC) in adults.  

What is Ulcerative colitis?

Ulcerative colitis is an autoimmune disorder where the immune cells (lymphocytes) are thought to incorrectly start attacking your healthy tissue, thinking that it is a foreign substance. In ulcerative colitis, the immune system attacks and causes inflammation in the lining of the large intestine which causes the symptoms of abdominal pain, rectal bleeding, bowel urgency, diarrhea, and tiredness.  UC can also negatively impact a patient's life due to the unpredictable nature of the symptoms of bowel urgency and diarrhea.

Infections:This medicine can increase your risk of serious infections which can be life-threatening and cause death as it lowers the number of white blood cells (lymphocytes) in your blood. This will usually return to normal within 4 to 5 weeks after you stop taking this medicine. Before you start this medicine, your healthcare provider will give you a blood test. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment and for 5 weeks after you stop treatment:

• fever or a high temperature
• pain when peeing or peeing more often than usual, which can be signs of a urinary tract infection. 
• tiredness
• flu-like symptoms
• headache with fever, neck stiffness, sensitivity to light, nausea, or confusion, which may be symptoms of meningitis, an infection of the lining around your brain and spine.

If you have an infection your healthcare provider may delay or stop your treatment.

Slow heart rate (also known as bradyarrhythmia): 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 start to take this medicine. 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.

Liver Injury: Your healthcare provider will check your liver function before and during treatment, and treatment may be stopped depending on your tests.

Also see “Velsipity side effects” for more information about side effects.

Before taking this medicine

You should not use Velsipity if you are allergic to the active ingredient etrasimod or any of the inactive ingredients. 

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 this medicine. Velsipity may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with this medicine 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 a 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.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as Velsipity may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. For females who can become pregnant, you should use effective birth control during your treatment with Velsipity and for 7 days after you stop taking this tablet. Talk to your healthcare provider about what birth control method is right for you during this time. You should tell your healthcare provider right away if you become pregnant while taking this medicine, or within 7 days after you stop taking them.

Velsipity Pregnancy Registry is a registry for women who become pregnant during treatment with this medicine. 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.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed as 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 this medicine.

Velsipity tablet is taken 1 time a day.

Velsipity should be swallowed whole, with or without food. 

The recommended dosage of Velsipity is 2 mg orally once daily.

You should not take Velsipity if:

• you have had in the last 6 months a heart attack, unstable angina, stroke or mini-stroke (transient ischemic attack or TIA), and certain types of heart failure requiring hospitalization
• have or have had a history of unusual heartbeats (arrhythmia) including Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block unless you have a functioning pacemaker.