Etrasimod (Oral Route) Description and Brand Names

Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

Velsipity

Descriptions

Etrasimod is used to treat moderate to severe active ulcerative colitis.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of etrasimod in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of etrasimod in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil
Cisapride
Dronedarone
Fluconazole
Ketoconazole
Mesoridazine
Pimozide
Piperaquine
Posaconazole
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Adagrasib
Adenovirus Vaccine, Live
Ajmaline
Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bacillus of Calmette and Guerin Vaccine, Live
Bedaquiline
Bretylium
Buprenorphine
Buserelin
Ceritinib
Chloroquine
Chlorpromazine
Cholera Vaccine, Live
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clozapine
Crizotinib
Cyclobenzaprine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Dengue Tetravalent Vaccine, Live
Desipramine
Deslorelin
Deutetrabenazine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Ebastine
Ebola Zaire Vaccine, Live
Efavirenz
Encorafenib
Entrectinib
Eribulin
Erythromycin
Escitalopram
Famotidine
Felbamate
Fexinidazole
Fingolimod
Flecainide
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Givinostat
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Influenza Virus Vaccine, Live
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Lapatinib
Lefamulin
Lenvatinib
Leuprolide
Levofloxacin
Lofexidine
Lumefantrine
Macimorelin
Measles Virus Vaccine, Live
Mefloquine
Methadone
Methotrimeprazine
Metronidazole
Mifepristone
Mizolastine
Mobocertinib
Moricizine
Moxifloxacin
Mumps Virus Vaccine, Live
Nafarelin
Nelfinavir
Nilotinib
Norfloxacin
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Pimavanserin
Pipamperone
Pitolisant
Poliovirus Vaccine, Live
Ponesimod
Prajmaline
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Ribociclib
Rifampin
Risperidone
Ritonavir
Rotavirus Vaccine, Live
Rubella Virus Vaccine, Live
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Smallpox Monkeypox Vaccine, Live Non-Replicating
Smallpox Vaccine
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sparteine
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Tedisamil
Telaprevir
Telavancin
Telithromycin
Tetrabenazine
Tolterodine
Toremifene
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Typhoid Vaccine, Live
Vandetanib
Vardenafil
Varicella Virus Vaccine, Live
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Yellow Fever Vaccine
Zoster Vaccine, Live
Zotepine
Zuclopenthixol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. You may take this medicine with or without food.

Dosing

For oral dosage form (tablet):
- For ulcerative colitis:
  - Adults—2 milligrams (mg) once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may increase your risk of developing infections, including a serious brain infection called progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have lupus or if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Etrasimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

Herpes zoster and other serious infections may occur while taking this medicine. Symptoms include painful blisters on the trunk of your body, itching skin, rash, or trouble breathing. These symptoms should be treated first before taking this medicine.

While you are being treated with etrasimod, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should not receive live vaccines at least 4 weeks before starting treatment, during treatment, and for 5 weeks after treatment with this medicine. Etrasimod may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor immediately if blurred vision or any other change in vision occurs during treatment with this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase your risk of cancer (eg, skin cancer) and make your skin more sensitive to sunlight. Tell your doctor right away if you have persistent non-healing sore, pink growth, reddish patch or irritated area, shiny bump, or white, yellow or waxy scar-like area. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bladder pain
bloody or cloudy urine
blurred vision
burning or stinging of the skin
dark urine
difficult, burning, or painful urination
dizziness
frequent urge to urinate
headache
large amount of cholesterol in the blood
light-colored stools
lower back or side pain
nausea and vomiting
nervousness
painful blisters on the trunk of body
painful cold sores or blisters on the lips, nose, eyes, or genitals
pounding in the ears
slow or fast heartbeat
stomach pain or bloating
yellow eyes or skin

Incidence not known

Back pain
changes in vision
chest pain, discomfort, or tightness
confusion
drowsiness
fever
general feeling of illness
mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin
persistent non-healing sore
pink growth
reddish patch or irritated area
seizures
shiny bump
stiff neck or back
trouble breathing
unusual tiredness or weakness
white, yellow or waxy scar-like area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Portions of this document last updated: May 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/etrasimod-oral-route/description/drg-20558092

Etrasimod (Oral Route)