Velsipity

Pronunciation: Vel-sip-itee
Generic name: etrasimod
Dosage form: tablet (2 mg)
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Jun 20, 2024.

What is Velsipity?

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.

How does Velsipity work?

Velsipity is thought to work by preventing immune cells (lymphocytes) from entering the large intestine. It does this by trapping the immune cells in the lymph nodes, which prevents them travelling to the colon and rectum where they could cause harmful inflammation. By reducing the inflammation that lymphocytes would otherwise cause, Velsipity may help improve the symptoms of ulcerative colitis.

Control of the lymphocytes moving out of lymph nodes and to sites of inflammation in the gastrointestinal tract is controlled by the S1P1 receptor. Velsipity works by acting on the S1P receptor which means more lymphocytes stay in lymph nodes, so fewer immune cells can travel to sites of inflammation which helps relieve symptoms and may result in remission of UC.

How well does Velsipity work?

In the clinical trial (ELEVATE UC 52) Velsipity was shown to work well for ulcerative colitis.
Velsipity had 20% more patients achieving clinical remission compared to placebo at week 12.
Velsipity had 25% more patients achieving clinical remission compared to placebo at week 52.

Week 12: Velsipity group 27% - placebo group 7% = difference 20%.

Week 52: Velsipity group 32% - placebo group 7% = difference 25%.

Velsipity side effects

Common Velsipity side effects

The most common Velsipity side effects include dizziness, headache, and elevated liver tests.

Serious Velsipity side effects

Also see the “Warning” section below.

Serious side effects include breathing problems, liver problems, increased blood pressure, macular edema (an eye problem), skin cancer, and Posterior Reversible Encephalopathy Syndrome (PRES) which is the swelling and narrowing of the blood vessels in your brain.

Longer treatment durations of Velsipity (more than 18 months) increase the risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain infection.

Liver problems. Your healthcare provider will do blood tests to check your liver before you start taking this medicine. Call your healthcare provider right away if you have any of the following symptoms:

• unexplained nausea
• loss of appetite
• vomiting
• yellowing of the whites of your eyes or skin
• stomach area (abdominal pain)
• dark colored urine
• tiredness

If you develop any of these symptoms, your healthcare provider will do blood tests to check your liver and may stop your treatment.

Increased blood pressure. Your healthcare provider should check your blood pressure during treatment with this medicine and treat you for high blood pressure if you need it.

A vision problem called macular edema. Your healthcare provider should test your vision around the time you start taking this medicine or at any time you notice vision changes during your treatment with this medicine. Call your healthcare provider right away if you have any of the following symptoms:

• blurriness or shadows in the center of your vision
• a blind spot in the center of your vision
• sensitivity to light or
• unusually colored vision.

Types of skin cancer. Certain types of skin cancer, including basal cell carcinoma, squamous cell carcinoma, and melanoma, have been reported with S1P receptor modulators, including Velsipity. Limit the time you spend in sunlight and ultraviolet (UV) light while taking this medicine. Wear protective clothing and use 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:

• sudden severe headache
• sudden confusion
• sudden loss of vision or other changes in your vision or
• seizure.

If you develop any of these symptoms, your healthcare provider will stop treatment with this medicine.

Breathing problems. Some people who take medicines in the same class as this medicine may experience shortness of breath. Your healthcare provider may do tests to check your breathing during treatment with this tablet. Call your healthcare provider right away if you have new or worsening breathing problems.

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 this medicine. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.

Related/similar drugs

How should I take Velsipity?

Velsipity tablet is taken 1 time a day.

Velsipity should be swallowed whole, with or without food.

Dosing information

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

Who should not take Velsipity?

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.

Warnings

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.

Interactions

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.

It is especially important to tell your healthcare provider if you take or have taken:

• medicines to control your heart rhythm (antiarrhythmics), heartbeat, or blood pressure. This includes medicines 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 (Diflucan), you should not take Velsipity.
• If you are taking rifampin (Rifadin), you should not take Velsipity.

Vaccines: You should not receive live vaccines at least 4 weeks before starting taking Velsipity, during treatment, and for 5 weeks after you stop taking this medicine. 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 this medicine

This list is not complete, and many other medications may also interact with Velsipity so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. To check for interactions with Velsipity click on the link below.

Storage

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Ingredients

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.

Manufacturer

Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10001.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer