Etrasimod (e-TRAS-i-mod)

Treats ulcerative colitis.

Brand Name(s):

Velsipity

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the tablet whole.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose of this medicine, take the missed dose at your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take fluconazole or rifampin if you are taking etrasimod.
• Some medicines can affect how etrasimod works. Tell your doctor if you are using any of the following:
  • Gemfibrozil, itraconazole
  • Blood pressure medicine (including beta blockers, calcium channel blockers)
  • Medicine for heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine that weakens the immune system (including cancer medicine, steroid medicine)
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. You should not receive live vaccines for at least 4 weeks before starting treatment, during treatment, and for 5 weeks after treatment with this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective birth control during treatment and for at least 1 week after the last dose.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, breathing problems (including asthma, COPD, untreated sleep apnea), high blood pressure, eye or vision problems, any type of infection (including chickenpox), a weak immune system, or a history of skin cancer or repeated fainting.
• This medicine may cause the following problems:
  • Increased risk of infections, which may be life-threatening (including meningitis, herpes, progressive multifocal leukoencephalopathy)
  • Heart rhythm problems
  • Liver problems
  • High blood pressure
  • Increased risk of macular edema (swelling at the back of your eye)
  • Increased risk of skin cancer, including basal cell carcinoma, melanoma, squamous cell carcinoma
  • Brain problems, including posterior reversible encephalopathy syndrome (PRES)
  • Lung or breathing problems
• This medicine lowers the number of white blood cells. This weakens your immune system, so you may get infections more easily. Wash your hands often. Avoid people who are sick.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or other changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fainting, dizziness, lightheadedness
• Fast, slow, or uneven heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches, neck stiffness, sensitivity to light
• Skin growths, patches, or sores on the skin that do not heal quickly
• Sudden or severe headache, confusion, seizures
• Trouble breathing, chest tightness
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088