Etragut

Indications

Etrasimod is used in adults to treat moderately to severely active ulcerative colitis, a long-term inflammatory disease of the large bowel, when other treatments have not worked well enough or are not suitable.

How It Works

Etrasimod is a sphingosine 1-phosphate (S1P) receptor modulator. It acts on S1P receptors on certain white blood cells (lymphocytes) and keeps many of them inside the lymph nodes. This means fewer of these immune cells reach the bowel, which reduces inflammation, bleeding and diarrhoea.

Dosage and Administration

Take exactly as prescribed by your specialist. The usual dose is one 2 mg tablet once a day, taken with food, swallowed whole. Some heart, eye, liver and blood tests are done before starting. If you miss doses for several days in a row, contact your doctor before restarting, as heart checks may be needed again.

Interactions

Medicines that slow the heart, such as beta blockers, Verapamil, Diltiazem, Digoxin and Ivabradine, can increase the risk of a slow heartbeat, especially when starting. Medicines that affect heart rhythm (for example Amiodarone, Sotalol, Quinidine) are generally avoided. Fluconazole and other medicines that block the enzymes CYP2C9 and CYP3A4 can raise its level; Rifampicin and similar inducers can lower it. Other immune-suppressing or cancer medicines increase infection risk. Avoid live vaccines during treatment and for some weeks after stopping.

Contraindications

Do not use if you are allergic to Etrasimod; have had a heart attack, unstable angina, stroke, mini-stroke (TIA) or serious heart failure in the last 6 months; have certain heart rhythm problems (second-degree Mobitz type II or third-degree heart block, or sick sinus syndrome) without a working pacemaker; have a weakened immune system or a serious active infection; have active cancer; have macular oedema; or are pregnant or not using effective contraception.

Side Effects

Common side effects include headache, dizziness, raised liver enzymes, high cholesterol, joint pain, urinary tract and chest infections, nausea and a low lymphocyte count. A slow heartbeat may occur after the first doses. Less common but serious effects include swelling in the back of the eye (macular oedema), raised blood pressure, serious infections including shingles and, rarely, brain infection (PML) or a brain swelling syndrome (PRES).

Get urgent medical help for fever with chills or feeling very unwell, very slow or irregular heartbeat, fainting, chest pain, shortness of breath, changes in vision, severe headache, confusion, seizures, new weakness on one side, or yellowing of the skin or eyes.

Pregnancy and Lactation

Etrasimod may harm an unborn baby. Women who can become pregnant must use effective contraception during treatment and for at least 14 days after the last dose. If you become pregnant, tell your doctor straight away. Do not breastfeed while taking it.

Precautions and Warnings

• An ECG, blood count, liver tests and, if you have diabetes or past eye inflammation, an eye check are done before starting.
• Your doctor may check your immunity to chickenpox and advise vaccination before starting.
• Report any infection promptly; the effect on immune cells can last for up to a few weeks after stopping.
• Have your skin checked regularly and protect it from the sun.
• Ulcerative colitis can flare after stopping; do not stop without medical advice.

Overdose

Overdose may cause a slow heartbeat and changes in heart rhythm. Seek medical help straight away; heart monitoring and supportive treatment are given in hospital.

Therapeutic Class

Immunomodulator, sphingosine 1-phosphate (S1P) receptor modulator

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.