Velsipity
Velsipity (etrasimod) is a sphingosine 1-phosphate (S1P) receptor modulator for ulcerative colitis (UC). It works by lowering white blood cells in the gut, thus relieving symptoms of UC. Velsipity (etrasimod) is taken by mouth, typically once daily, and can only be used by adults. It can cause potentially serious side effects, such as a higher risk for infections and heart problems.
What is Velsipity (etrasimod)?
What is Velsipity (etrasimod) used for?
Treatment of 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. But it's thought that Velsipity (etrasimod) lowers the number of white blood cells in your gut, which helps to lessen 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 enzymes (6%)
- Dizziness (5%)
Other Side Effects
- Joint pain
- Urinary tract infection (e.g., pain while urinating, frequent urination)
- Nausea
- High cholesterol levels
- Herpes viral infection (e.g., painful ulcers, fever, body aches)
Serious Side Effects
- Brain infections: weakness on one side of the body, clumsiness, confusion, changes in personality, changes in vision, headache, stiff neck, light sensitivity, fever, seizures
- Serious infections: fever, difficulty breathing, diarrhea, weakness, cough, stomach pain, sweating, chills
- Dangerously slow heart rate: tiredness, weakness, confusion, feeling faint, trouble breathing, chest pain
- Abnormal heart rhythm: chest pounding, irregular heart beat, chest pain, short of breath, feeling faint or lightheaded
- Liver problems: nausea, vomiting, not feeling hungry, pain in the right side of the stomach, yellowing of the whites of the eyes or skin, dark-colored urine, light-colored stool
- Swelling in your brain: severe headache, sudden confusion, change in vision, seizure
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
Might work well for people who didn’t see benefits with other medications for UC
Only taken by mouth once a day
Can take with or without food
Cons
Risk of serious infections
Might interact with vaccines or immunosuppressants
Not safe for use in adults with heart or severe liver problems
Pharmacist tips for Velsipity (etrasimod)
Check in with your healthcare team to see if you're up-to-date on your vaccines before starting Velsipity (etrasimod). You won't be able to receive live vaccines, starting 4 weeks before and 5 weeks after treatment.
Let your care team know about all the medications you're taking before you start Velsipity (etrasimod) and during treatment. Taking certain medications can raise your risk of serious side effects from Velsipity (etrasimod). For example, taking medications that weaken your immune system might put you at higher risk for severe infection. Depending on what medications you're taking, your care team might make changes to your treatment plan.
Get medical help right away if you have a fever, chills, painful ulcers, pain while urinating, frequent urination, and confusion after treatment with Velsipity (etrasimod). This is because the medication can affect your immune system and raise your risk of developing serious infections, such as herpes viral infection or urinary tract infection.
Let your care team know about all of your health conditions before starting Velsipity (etrasimod). Since this medication can worsen certain health problems, they might monitor you more closely during treatment. For example, if you have high blood pressure, they might ask you to check your blood pressure more often to make sure it's not too high.
Velsipity (etrasimod) might raise your risk of skin cancer or worsen your vision. To be safe, your care team will check your skin and eyes before treatment, and as needed during treatment. Protect yourself by limiting your time in the sun or wearing sunscreen. Talk with an eye specialist immediately if you notice changes in your vision.
Velsipity (etrasimod) might cause harm to babies if taken during pregnancy. If you're able to become pregnant, use birth control during treatment and for a week after you stop taking this medication.
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.
Serious infections
Risk factors: Active, chronic (long-term), or recurrent infection | History of immune system problems, such as diabetes or human immunodeficiency virus (HIV) | Taking other medications that can weaken the immune system | Receiving live vaccines
Taking Velsipity (etrasimod) can raise your risk of serious infections because it lowers your white blood cell (WBC) count. Your WBC count can stay low during treatment and for up to 5 weeks after stopping the medication. Before starting Velsipity (etrasimod), your healthcare team will order blood tests to check your WBC count. If you have an infection, your care team will treat it before you can start Velsipity (etrasimod).
The most common types of infections reported by people who took Velsipity (etrasimod) are urinary tract infection (UTI) and herpes viral infections, including cold sores and shingles. If you have a UTI or a herpes viral infection, your care team can prescribe medications to treat your infection.
Rarely, serious brain infections like meningitis or progressive multifocal leukoencephalopathy (PML) have been reported with similar medications (other S1P receptor modulators). Get immediate medical attention if you experience symptoms like fatigue, weakness on one side of the body, headache, neck stiffness, sensitivity to light, nausea, vision changes, or confusion.
Slow heart rhythm and high blood pressure
Risk factors: History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | History of uncontrolled high blood pressure | Taking medications that affect heart rhythm
Velsipity (etrasimod) can slow your heart rhythm or lower your heart rate, which can be life-threatening. Before you start treatment, let your healthcare team if you have heart rhythm problems. Also, let them know if you're taking other medications that can affect your heart rhythm or heart beat, including amiodarone (Pacerone) and atenolol (Tenormin). If needed, your care team might periodically check your heart and perform electrocardiograms (EKGs). If you feel dizzy, lightheaded, short of breath, confused, or have chest pain while taking Velsipity (etrasimod), call 911 right away.
In addition, Velsipity (etrasimod) can also raise your blood pressure. Typically, this is mild. You might notice a change in your blood pressure starting 2 weeks after you begin treatment. Your health care team might ask you to monitor your blood pressure regularly while you're taking Velsipity (etrasimod) to make sure it's in a safe range.
Liver problems
Rarely, people who take Velsipity (etrasimod) can experience liver irritation. They might not feel any symptoms but might see higher liver enzymes on their labs. Before you start this medication, your healthcare team will order labs to check your liver health. Get medical help right away if you experience signs and symptoms of liver damage, such as upper right stomach pain, yellowing of the skin or whites of the eyes, or dark urine.
Eye problems
Risk factors: Diabetes
Velsipity (etrasimod) can raise your risk of an eye condition called macular edema. This condition happens when blood vessels leak into a part of the retina, causing blurry vision and vision loss. Before and during treatment of Velsipity (etrasimod), your eye specialist will give you an eye exam to check your vision. Let your care team know right away if you've symptoms of blurry vision, sensitivity to light, and a blind spot in the center of your vision.
Harm to unborn babies
Based on animal studies, it's possible that Velsipity (etrasimod) can harm unborn babies when taken during pregnancy. If you can become pregnant, make sure to use birth control and avoid pregnancy during treatment and for a week after the last dose of Velsipity (etrasimod). Let your healthcare team know right away if you become pregnant or think you might be pregnant while taking Velsipity (etrasimod).
Possible risk of skin cancer
Risk factors: Past skin cancer
Rarely, some people have developed skin cancer after taking medications like Velsipity (etrasimod). Your risk is higher if you've had skin cancer before. During treatment with this medication, your care team will monitor you for any unusual changes in your skin. You can lower the risk of skin cancer by limiting the amount of time you spend in sunlight, wearing protective clothing, and using sunscreen. Let your care team know if you notice a new skin growth, a sore that doesn’t heal, or a change in an old skin growth.
Brain problems
Rarely, people who take medications similar to Velsipity (etrasimod) have had a brain problem called posterior reversible encephalopathy syndrome (PRES). This condition can cause swelling in the brain, which can sometimes lead to a stroke. Get medical attention right away if you have a sudden severe headache, confusion, loss of vision, or a seizure. Your care team will order tests to see what might be causing these symptoms. If they think you have PRES, they'll ask you to stop taking Velsipity (etrasimod).
Breathing problems
Risk factors: Asthma | Chronic obstructive pulmonary disease (COPD)
Some people who take medications similar to Velsipity (etrasimod) have experienced shortness of breath. This can happen as early as 3 months after you start the medication. If you've a history of lung problems, such as asthma or chronic obstructive pulmonary disease (COPD), let your healthcare team know before starting Velsipity (etrasimod). Your care team might check your lung health regularly during treatment with this medication. If you have breathing problems, make sure you have a rescue inhaler, such as albuterol (Ventolin), in case of trouble breathing.
Velsipity (etrasimod) dosage forms
Typical dosing for Velsipity (etrasimod)
Adults: The typical dose is 2 mg by mouth once a day.
How much does Velsipity (etrasimod) cost?
Velsipity (etrasimod) contraindications
Heart attack, chest pain, stroke, mini stroke, or certain types of heart failure in the last 6 months
Heart rhythm problems (e.g., atrioventricular block, sick sinus syndrome) without a pacemaker
What are alternatives to Velsipity (etrasimod)?
Treatment of 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 juvenile idiopathic arthritis (pJIA) in children ages 2 years and older - immediate-release tablets and liquid only
Velsipity (etrasimod) images
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References
Best studies we foundDakkak, W., et al. (2023). Sick sinus syndrome. StatPearls.
Kashou, A. H., et al. (2024). Atrioventricular block. StatPearls.
National Eye Institute. (2024). Macular edema.
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 Inc. (2024). Velsipity® (etrasimod) 2 mg tablets.
Pfizer Laboratories Div Pfizer Inc. (2024). Velsipity- etrasimod tablet, film coated [package insert]. DailyMed.
Sudulagunta, S. R., et al. (2017). Posterior reversible encephalopathy syndrome (PRES). Oxford Medical Case Reports.
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