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
Side effects of Velsipity (etrasimod)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (9%)
- Higher liver enzyme levels (6%)
- Dizziness (5%)
Less Common Side Effects
- Joint pain
- Nausea
- High blood pressure
- High cholesterol
- Urinary tract infection (UTI)
- Herpes viral infection (e.g., painful sores, fever, body aches)
Velsipity (etrasimod) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- 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
The following Velsipity (etrasimod) 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
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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.
Common questions about Velsipity (etrasimod)
No, Velsipity (etrasimod) isn't a biologic. Biologics are made in the lab from living sources, like cells. And, they're usually given as injections. Instead, Velsipity (etrasimod) is called a small molecule drug. It's made in the lab from chemicals. This medication is a tablet that you take by mouth. Ask your prescriber if you have more questions about how Velsipity (etrasimod) is made.
Yes. Velsipity (etrasimod) was approved by the FDA in October 2023. It's approved for adults with moderate-to-severe ulcerative colitis.
Velsipity (etrasimod) has a risk of causing some side effects that affect the eyes. One example is macular edema. This is an eye problem caused by swelling in the macula (the part of the retina that helps you see clearly). Macular edema can make you have problems with yoruu vision. It can cause blurry vision, vision that gets worse over time, wavy vision, and dull color vision. Velsipity (etrasimod) also has a rare risk of serious brain problems that can make your eyes sensitive to light or cause changes in vision. If you notice any changes in your vision, tell your prescriber right away so they can check it out.
In a study, almost 1 out of every 3 people got to remission after 3 months of taking Velsipity (etrasimod). This was about the same after they took the medication for a whole year. In comparison, less than 1 out of every 10 people who took a placebo got to remission. Getting to remission means having little or no symptoms of ulcerative colitis (UC). In this study, people had already tried other medications for UC, like biologics. But those medications didn't help enough. If you have questions about how well Velsipity (etrasimod) might work for you, ask your prescriber.
In studies, some people had fewer symptoms of ulcerative colitis within the first 2 weeks of taking Velsipity (etrasimod). This included having to go to the bathroom less often and less rectal bleeding. But it can take a few months or longer to see the full effects of this medication. If you have questions about how long Velsipity (etrasimod) is taking to work for you, ask your prescriber.
Velsipity (etrasimod) and Zeposia (ozanimod) are medications that work in the same way. They can both help treat ulcerative colitis in adults. But Zeposia can also treat multiple sclerosis. The two medications are both pills that are taken by mouth once a day. But the dosing is a little different. For Velsipity, you take the same dose throughout the entire treatment. But for Zeposia, you start off at a lower dose and then your dose gets slowly raised over a week. Both medications can slow your heart rate at first, but Zeposia is approved with an initial dose ramp-up schedule to help with this side effect. Talk to your prescriber to compare the medications and see which is right for you.
No. Velsipity (etrasimod) isn't FDA approved to treat Crohn's disease. The CULTIVATE study was looking into using this medication to treat moderate-to-severe Crohn's disease in adults. But there wasn't enough evidence that it worked well for this gut problem. So, the study ended early. Talk to your prescriber to learn about your treatment options for Crohn's disease.
It depends. If you want to get a vaccine while taking Velsipity (etrasimod), talk to your prescriber or pharmacist. They can help you understand the risks and benefits of getting the vaccine you want. They can also tell you the best time to get it. It's not clear if Velsipity (etrasimod) can make some vaccines not work as well. If you need to get a live vaccine, get it at least 4 weeks before you start Velsipity (etrasimod). You can also wait at least 5 weeks after you finish treatment to get it. Examples of live vaccines include Varivax (varicella vaccine) and FluMist (nasal spray flu vaccine). But you might be able to get other kinds of vaccines, if your care team recommends them. This can include most flu shots and the COVID-19 vaccine.
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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
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 2mg | 30 tablets | $6,436.83 | $214.56 |
Typical dosage for Velsipity (etrasimod)
The typical dose is 2 mg by mouth once a day.
How much does Velsipity (etrasimod) cost?
$6,436.83
Velsipity (etrasimod) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Velsipity (etrasimod) will not be safe for you to take.
- 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)?
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