Lucietras Etrasimod 2mg Tablets 30's

Etrasimod is an oral, selective sphingosine-1-phosphate (S1P) receptor modulator. It helps regulate immune-cell movement and reduces inflammation in the intestinal tract.

Etrasimod is a prescription medicine for moderately to severely active ulcerative colitis in adults. Its main safety considerations are infection risk, cardiac conduction effects, liver injury, and macular edema. Appropriate screening and follow-up are essential.

Etrasimod is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the colon and rectum. Symptoms may include diarrhea, rectal bleeding, abdominal pain, and an urgent need to pass stools.

In some countries, the approved indication also includes eligible patients aged 16 years and older who have not responded adequately to, have lost response to, or cannot tolerate conventional or biological therapy. Check the locally approved product information.

• Reduces intestinal inflammation: Modulates immune-cell activity involved in ulcerative colitis.
• Regulates lymphocyte movement: Reduces the number of circulating lymphocytes by limiting their movement out of lymphoid organs, potentially reducing their migration into the intestinal tissues.
• Improves clinical remission: Can help reduce symptoms such as rectal bleeding and frequent bowel movements.
• Supports disease control: May improve endoscopic outcomes and help maintain remission during continued treatment.

The precise mechanism by which etrasimod produces its therapeutic effects in ulcerative colitis is not fully established. Response varies between patients, and ongoing monitoring by a gastroenterologist is essential.

• Recommended adult dose: 2 mg orally once daily.
• Swallow the tablet whole, with or without food.
• Take it at approximately the same time each day.
• If a dose is missed, take the next dose at its usual scheduled time. Do not double the dose.
• Before treatment, the doctor should assess blood counts, heart rhythm, liver function, eye health, vaccination history, and relevant medical conditions.
• Treatment should continue according to the gastroenterologist's instructions and response to therapy.

Common

Reported side effects include:

• Headache
• Elevated liver enzymes
• Dizziness
• Nausea
• Joint pain
• Respiratory or urinary tract infections
• Increased blood pressure

Some patients may experience changes in heart rate or blood-cell counts.

Serious

Serious infections

Etrasimod can reduce circulating lymphocytes and increase the risk of infections. Seek prompt medical attention for fever, persistent cough, painful urination, or other signs of infection. Infection risk can continue for five weeks after discontinuation.

Slow heart rate and heart-conduction problems

A temporary reduction in heart rate or delayed electrical conduction in the heart may occur, particularly when starting treatment. Fainting, chest pain, or severe dizziness requires urgent assessment.

Liver injury

Elevated liver enzymes can occur. Symptoms such as yellowing of the skin or eyes, dark urine, unusual fatigue, or persistent abdominal discomfort require prompt evaluation.

Macular edema

Swelling in the central part of the retina can cause blurred vision, visual distortion, or reduced vision. Eye assessment is required before treatment and during therapy as clinically indicated.

High blood pressure

Blood pressure may increase and should be monitored regularly.

Skin cancers and other serious neurological effects

Skin malignancies have been reported with medicines in this class. Rarely, posterior reversible encephalopathy syndrome (PRES) can occur, causing severe headache, confusion, seizures, or visual changes. These symptoms require urgent medical evaluation.

Etrasimod is metabolized mainly through CYP2C8, CYP2C9, and CYP3A4 pathways. Some medicines can increase its exposure or reduce its effectiveness.

Important interactions include:

• Fluconazole: Avoid concomitant use because combined CYP2C9 and CYP3A4 inhibition can substantially increase etrasimod exposure.
• Rifampicin: Avoid concomitant use because it can reduce etrasimod exposure.
• Medicines that slow heart rate: Beta-blockers, certain calcium channel blockers, and anti-arrhythmic medicines may increase the risk of a slow heart rate or conduction abnormalities.
• Other immunosuppressants: Combining treatments may increase infection risk.
• Live vaccines: Avoid during treatment and for five weeks after stopping etrasimod.
• Other medicines: Tell the doctor about all prescription medicines, supplements, and herbal products before treatment.

Do not start, stop, or adjust medicines without consulting the prescribing specialist.

• Store at 20°C–25°C, with permitted excursions between 15°C and 30°C.
• Keep tablets in their original packaging and protect them from moisture.
• Keep out of reach of children.
• Do not use expired or damaged tablets.

• Use etrasimod only under the supervision of a gastroenterologist.
• Complete recommended vaccinations before starting treatment where possible, particularly varicella-zoster vaccination when indicated.
• Have a baseline ECG, complete blood count, liver function tests, and eye examination.
• Monitor blood pressure and report any changes in vision.
• Avoid live vaccines during treatment and for five weeks after stopping.
• Report signs of infection, fainting, unusual headache, or visual disturbance promptly.
• Do not stop treatment or restart it after a prolonged interruption without consulting your doctor.