Velsipity

Generic name: Etrasimod
Dosage form: tablet (2 mg)

Usage of 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.

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 “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.

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 have happened with medicines in the same class as Velsipity. Limit the amount of 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.

Before taking 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.

How to use Velsipity

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

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.

What other drugs will affect Velsipity

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.

Disclaimer

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