Velsipity
Velsipity (etrasimod) is a medication that treats ulcerative colitis (UC) in adults. It works as a sphingosine 1-phosphate (S1P) receptor modulator to help relieve gut inflammation and symptoms of UC. The usual dose is 1 tablet by mouth once a day. Velsipity (etrasimod) can cause side effects like headache and dizziness. It also has a few serious risks, including infection, heart problems, and liver damage. Velsipity (etrasimod) is available as a brand-name medication.
What is Velsipity (etrasimod)?
What is Velsipity (etrasimod) used for?
Moderate-to-severe ulcerative colitis (UC) in adults
How Velsipity (etrasimod) works
Velsipity (etrasimod) is a sphingosine 1-phosphate (S1P) receptor modulator. It's not exactly clear how this medication works to treat UC.
Researchers think that Velsipity (etrasimod) lowers the number of white blood cells that get to your gut. This is thought to help lessen gut inflammation and relieve symptoms of UC.
Drug Facts
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What are the side effects of Velsipity (etrasimod)?
Common Side Effects
- Headache (9%)
- Higher liver enzyme levels (6%)
- Dizziness (5%)
Other Side Effects
- Joint pain
- Nausea
- High blood pressure
- High cholesterol
- Urinary tract infection (UTI)
- Herpes viral infection (e.g., painful sores, fever, body aches)
Serious Side Effects
- Serious infection: fever, sweating, chills, body aches, weakness, trouble breathing, diarrhea, stomach pain, weakness on one side of the body, confusion, changes in personality, changes in vision, headache, stiff neck
- Slow heart rate or heart rhythm: tiredness, dizziness, weakness, feeling faint, trouble breathing, short of breath, chest pain, chest pounding
- Liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellow skin or eyes, dark-colored urine, light-colored stool
- Vision problems: blurry vision, wavy vision, dull color vision, sensitivity to light
- Swelling in the brain: dull headaches that get worse, strange behavior, vision changes, confusion, seizures
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Dizziness, loss of balance or coordination, confusion or trouble speaking
- Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
- Increase in blood pressure
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Shortness of breath
- Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Dizziness
- Headache
- Nausea
Pros and cons of Velsipity (etrasimod)
Pros
Taken by mouth, with or without food
Only taken once a day
Can be an option when other medications for UC haven't worked well enough
Cons
Risk of serious infections
Might interact with vaccines or immunosuppressants
Might not be safe if you have heart problems or severe liver problems
Pharmacist tips for Velsipity (etrasimod)
Take Velsipity (etrasimod) with or without food. Swallow the tablet whole with water.
If you miss a dose of Velsipity (etrasimod), skip the missed dose. Just wait until the next day to take your usual dose of the medication. Don't double up on the dose to make up for the one you missed.
Velsipity (etrasimod) can slow your heart rate when you first start the medication. You might not feel anything, but you could also feel dizzy. Talk to your prescriber if you get too dizzy.
Your care team might tell you to check your blood pressure at home. Velsipity (etrasimod) can raise your blood pressure a little. If your blood pressure stays higher than usual, let your care team know.
Get urgent care if you think you have an infection. Signs can include fever, chills, body aches, painful sores, and pain while urinating. Velsipity (etrasimod) can raise your risk of getting an infection. If you have an infection, it should get treated as soon as possible.
Before you start Velsipity (etrasimod), check with your care team to see if you're up to date on your vaccinations. It's a good idea to get all the vaccines you need before you start this medication. That's because Velsipity (etrasimod) might make vaccines not work as well. Get any live vaccines at least 4 weeks before treatment. Your care team can help make you with your vaccinations.
Before getting any vaccines during treatment, tell the healthcare professional that you're taking Velsipity (etrasimod). Vaccines might not work as well while you're taking this medication. The healthcare professional can check to make sure the vaccine is okay for you to get. For example, wait until 5 weeks after you stop Velsipity (etrasimod) to get any live vaccines.
Tell your care team about all the medications you take and plan to take. Some medications can raise your risk of serious side effects from Velsipity (etrasimod). For example, medications that make your immune system weaker can put you at a higher risk of serious infections. Your care team can check for drug interactions. They can make changes to your treatment plan to keep you safe if needed.
Protect your skin by trying not to be in direct sunlight for too long. Also, wear protective clothing and use sunscreen. Tell your care team if you see a new spot on your skin or any unusual changes in your skin. Velsipity (etrasimod) might raise your risk of skin cancer. So, it's important to take these steps to protect yourself.
If you can get pregnant, use birth control while you take Velsipity (etrasimod). Keep using birth control for another week after you stop the medication. Velsipity (etrasimod) might harm an unborn baby if you take it while pregnant. If you become pregnant, tell your prescriber right away.
Frequently asked questions about Velsipity (etrasimod)
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What are the risks and warnings for Velsipity (etrasimod)?
Velsipity (etrasimod) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk of infections
Risk factors: Active, chronic (long-term), or recurrent infection | Have a weak immune system | Taking other medications that can weaken the immune system
Velsipity (etrasimod) can lower your white blood cell (WBC) count. It can stay low while you're taking the medication and for up to 5 weeks after you stop. Before you start, your care team will check your WBC count with a blood test.
Having a low WBC count can make it easier to get an infection. Some infections can be serious. If you already have an infection, you'll need to get it treated before you can start Velsipity (etrasimod).
In studies with Velsipity (etrasimod), the most common infections were urinary tract infection (UTI) and herpes viral infections (like cold sores or shingles). If you think you have an infection, talk to your care team. You might need medication to treat it. You also might need to stop Velsipity (etrasimod) until you get better.
In rare cases, some people taking medications like Velsipity (etrasimod) have had serious brain infections. Examples include meningitis and progressive multifocal leukoencephalopathy (PML). Get medical help right away if you have signs like weakness on one side of your body, headache, stiff neck, nausea, changes in vision, and confusion. The medical team will check what's causing these symptoms.
Slow heart rhythm and heart rate
Risk factors: Heart problems, like heart failure | Slow heart rate | Heart block | QT prolongation | Other abnormal heart rhythms (arrhythmias) | History of cardiac arrest | History of uncontrolled high blood pressure | Severe untreated sleep apnea
Velsipity (etrasimod) can slow down your heart rate. This can happen after first starting the medication, but it usually goes away over time. Some people might not feel anything, but others might feel dizzy. Rarely, Velsipity (etrasimod) can also slow your heart rhythm.
Before starting Velsipity (etrasimod), tell your prescriber if you have any heart problems. This includes having a slow heartbeat when you're at rest or other problems with heart rhythm (arrhythmia). Your prescriber might order a test called an electrocardiogram (EKG) to check your heart.
Also, let your prescriber know if you take other medications that can affect your heartbeat. Examples include amiodarone (Pacerone) and atenolol (Tenormin). Your prescriber can check that Velsipity (etrasimod) is safe for you.
If you feel dizzy, lightheaded, short of breath, confused ,or have chest pain while taking Velsipity (etrasimod), call your care team right away. These can be signs of a slow heart rate or a slow heart rhythm.
High blood pressure
Velsipity (etrasimod) can raise your blood pressure. In studies, blood pressure went up by a little (an average of 1 mmHg to 4 mmHg). This change in blood pressure started 2 weeks after beginning treatment.
Your healthcare team might ask you to check your blood pressure at home while you're taking Velsipity (etrasimod). Tell them if it stays higher than usual.
Liver problems
Some people who take Velsipity (etrasimod) can have higher liver enzyme levels on their lab tests. This can be a sign that the liver is irritated. Before you start Velsipity (etrasimod), you'll need to get a blood test. This helps your prescriber check your liver and decide if the medication is safe to take.
While you're taking Velsipity (etrasimod), watch for any pain in the upper right side of your stomach, yellow skin or whites of your eyes, or dark urine. These could be signs of liver problems. If this happens, let your care team know. You'll need a blood test to make sure your liver is okay.
Eye problem (macular edema)
Velsipity (etrasimod) can raise your risk of an eye condition called macular edema. This eye problem happens when a part of the retina called the macula swells. It can cause blurry vision and, over time, possibly vision loss.
Your prescriber will refer you to an eye specialist before you start Velsipity (etrasimod). You'll get an eye exam to check your vision. You'll also need eye exams from time to time during treatment.
Let your care team know right away if you have any blurry or wavy vision or see things in dull color. They'll have you get an eye exam to check for macular edema. If you have macular edema, you might need to stop taking Velsipity (etrasimod).
Harm to an unborn baby
Animal studies show that Velsipity (etrasimod) might harm an unborn baby when taken during pregnancy. If you can get pregnant, use birth control while taking this medication. Continue to use birth control and try not to get pregnant for one week after your last dose. If you become pregnant or think you might be, tell your healthcare team right away.
Possible risk of skin cancer
Some people have gotten skin cancer after taking medications like Velsipity (etrasimod). Phototherapy or light therapy isn't recommended for people taking Velsipity (etrasimod) because of the risk of skin cancer.
Your care team will check your skin every so often while you're taking Velsipity (etrasimod). They can help check for any unusual changes in your skin. They might check your skin more often if you're more at risk for skin cancer. This includes having light skin, skin that burns easily, or a personal or family history of skin cancer.
To help protect yourself, stay out of direct sunlight as much as possible. Wear protective clothing and use sunscreen. Tell your care team if you see a new spot on your skin, a sore that doesn’t heal, or any unusual changes in your skin. They might refer you to a dermatologist to check it out.
Brain problems
Although rare, some people taking medications like Velsipity (etrasimod) have had a brain problem called posterior reversible encephalopathy syndrome (PRES). This problem can cause swelling in the brain and can be serious. Sometimes, it can lead to a stroke.
Get medical help right away if you have signs of PRES. Look out for dull headaches that get worse, strange behavior, vision changes, confusion, or seizures. Your care team will run tests to see what might be going on. If they think you have PRES, they'll tell you to stop taking Velsipity (etrasimod).
Breathing problems
Risk factors: Asthma | Chronic obstructive pulmonary disease (COPD)
Some people who took Velsipity (etrasimod) had breathing problems. This can happen as early as 3 months after you start the medication.
Before starting Velsipity (etrasimod), tell your healthcare team if you have lung problems. This includes asthma and chronic obstructive pulmonary disease (COPD). Your care team might check your lungs regularly during treatment. Make sure you have a rescue inhaler like albuterol (Ventolin) to use if you have trouble breathing.
Let your healthcare team know if you feel short of breath or have any breathing problems while taking Velsipity (etrasimod). They can help see what's going on.
Velsipity (etrasimod) dosage forms
Typical dosing for Velsipity (etrasimod)
The typical dose is 2 mg by mouth once a day.
How much does Velsipity (etrasimod) cost?
Velsipity (etrasimod) contraindications
Heart attack or sudden chest pain (unstable angina) in the last 6 months
Stroke or "ministroke" in the last 6 months
Certain stages of heart failure or need to be hospitalized for heart failure in the last 6 months
Heart rhythm problems (e.g., certain types of heart block, sick sinus syndrome), and you don't have a pacemaker
What are alternatives to Velsipity (etrasimod)?
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe Crohn's disease (CD)
Moderate-to-severe ulcerative colitis (UC)
Moderate-to-severe rheumatoid arthritis (RA)
Ankylosing spondylitis (AS)
Psoriatic arthritis (PsA)
Severe plaque psoriasis (PsO)
Moderate-to-severe rheumatoid arthritis (RA) in adults
Psoriatic arthritis (PsA) in adults
Ankylosing spondylitis (AS) in adults
Moderate-to-severe ulcerative colitis (UC) in adults
Moderate-to-severe polyarticular course juvenile idiopathic arthritis (pcJIA) in children 2 years and older - immediate-release tablets and liquid only
Velsipity (etrasimod) images
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). Skin cancer risk factors.
ClinicalTrials.gov. (n.d.). A study evaluating the efficacy and safety of oral etrasimod in the treatment of adult participants With moderately to severely active Crohn's disease (CULTIVATE).
MedlinePlus. (2024). Sick sinus syndrome.
Moss, A. C. (2014). Residual inflammation and ulcerative colitis in remission. Gastroenterology & Hepatology.
National Eye Institute. (2024). Macular edema.
National Heart, Lung, and Blood Institute. (2022). What are pacemakers?
National Institute of Neurological Disorders and Stroke. (2024). Progressive multifocal leukoencephalopathy.
Pfizer Inc. (2023). U.S. FDA approves Pfizer’s VELSIPITY™ for adults with moderately to severely active ulcerative colitis (UC). Business Wire.
Pfizer Laboratories Div Pfizer Inc. (2024). Velsipity- etrasimod tablet, film coated [package insert]. DailyMed.
Rathod, D. G., et al. (2023). Phototherapy. StatPearls.
Sandborn, W. J., et al. (2023). Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies. The Lancet.
Triplett, J. D., et al. (2022). Posterior reversible encephalopathy syndrome (PRES): Diagnosis and management. Practical Neurology.
U.S. Department of Health and Human Services. (2022). Vaccine types.
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