Etrasimod

Etrasimod is used to treat moderate to severe active ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults. Etrasimod is in a class of medications called sphingosine l-phosphate receptor modulators. It works by decreasing the action of immune cells that may cause damage in the intestine.

Etrasimod comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take etrasimod at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take etrasimod exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will order a series of tests prior to putting you on etrasimod and may also recommend you receive certain vaccines. It is important to keep these testing and vaccination appointments to keep your treatment with etrasimod from being delayed.

Swallow the tablets whole; do not split, chew, or crush them.

Etrasimod controls ulcerative colitis but does not cure it. Continue to take etrasimod even if you feel well. Do not stop taking etrasimod without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking etrasimod,

• tell your doctor and pharmacist if you are allergic to etrasimod, any other medications, or any of the ingredients in etrasimod oral tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with etrasimod. Other medications may cause dosing changes or extra monitoring when taken with etrasimod. Make sure you have discussed any medications you are currently taking or plan to take before starting etrasimod with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking etrasimod, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with etrasimod: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking etrasimod. Do not start any of these medications while taking etrasimod without discussing with your healthcare provider.
• tell your doctor if you have or have had angina (chest pain), heart disease, an arrhythmia (irregular heart beat) or heart failure or have had a heart attack or stroke. Your doctor may tell you not to take etrasimod.
• tell your doctor if you have an active or chronic infection, including herpes or shingles, or have or have ever had a suppressed or weakened immune system (from either a condition or a medication), have chickenpox or have received the chickenpox vaccine, recently received or are scheduled to receive a vaccine, an abnormal or slow heart rate, liver disease, macular edema (swelling in the retina), high blood pressure, history of repeated fainting, skin cancer, or breathing problems (such as asthma, COPD, emphysema, or sleep apnea).
• tell your doctor if you are pregnant or plan to become pregnant. Etrasimod may harm the unborn baby if taken during pregnancy. Your doctor may order a pregnancy test before you can start etrasimod. If you are a woman who can become pregnant, you should use effective birth control during and for 7 days following your final dose of etrasimod. Talk to your doctor or pharmacist about what birth control may be best for you. If you become pregnant while taking, or within 7 days of stopping, etrasimod, call your doctor immediately.
• tell your doctor if you are planning to breastfeed while taking etrasimod.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking etrasimod.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Etrasimod may increase your risk of developing skin cancer.
• do not have any vaccinations without talking to your doctor.
• you should know that etrasimod has caused serious infections such as progressive multifocal leukoencephalopathy (PML) and cryptococcal infection (a fungal infection that can affect lungs or brain tissue). Call your doctor right away if you have any of the following symptoms: fever or high temperatures, tiredness, flu-like symptoms, or headache with fever, stiff neck, sensitivity to light, nausea, or confusion.
• you should know that etrasimod has caused slow heart rate. Call your doctor right away if you have any of the following symptoms: feeling dizzy, feeling lightheaded, feeling your heart is beating slowly or skipping beats, shortness of breath, confusion, fatigue or tiredness, or chest pain.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Etrasimod may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dizziness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• nausea, vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin or eyes, dark colored urine
• blurriness or shadows in your vision, sensitivity to light, a blind spot in the center of your vision, unusually colored vision
• changes in the appearance of your skin or new or changed moles or skin lesions
• sudden severe headache, sudden confusion, loss of vision or changes in vision, seizure
• shortness of breath
• difficulty or pain on urination or increased frequency of urination
• cough, difficulty breathing, severe congestion

Etrasimod may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to etrasimod.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Velsipity^®