Etrasimod Dosage

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Usual Adult Dose for Ulcerative Colitis

Recommended dosage: 2 mg orally once daily

Comments:

• The tablet should be swallowed whole, with or without food.

Use: For the treatment of moderately to severely active ulcerative colitis

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

• Mild Liver Dysfunction (Child-Pugh Class A): No adjustment recommended.
• Moderate Liver Dysfunction (Child-Pugh Class B): No adjustment recommended.
• Severe Liver Dysfunction (Child-Pugh Class C): Not recommended.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

CONTRAINDICATIONS:

• Patients that in the last 6 months experienced myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure.
• History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker.

Safety and efficacy have not been established in patients younger than 18 years.

To report suspected adverse reactions, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before initiation of treatment with this drug, assess the following:
• Complete blood count (CBC), including lymphocyte count
• Cardiac evaluation, including ECG to determine preexisting conditions
• Liver function tests
• Ophthalmic assessment including baseline evaluation of the fundus, including the macula
• Check list of prior medications to determine if the patient is taking drugs that can affect the heart rate or conduction, immunosuppressives, immune-modulating or anti-neoplastic drugs that can cause additive immunosuppressive effects.
• Vaccinations - verify if history of varicella infection, documentation of a full course of vaccination against varicella zoster virus (VZV), and the need for antibody testing, or the need of vaccination (should be at least 4 weeks prior to treatment initiation).
• Skin examination: Observe prior to treatment and examine promptly any new suspicious skin lesions that appear during therapy.
• Swallow the tablet whole with or without food.

Storage requirements:

• Store at 20C to 25C (68F to 77F), with excursions permitted between 15C to 30 C (59F to 89F)

Reconstitution/preparation techniques:

• Read the US FDA-approved patient labeling for further preparation and administration instructions.

Monitoring:

• CBC including lymphocyte counts
• Symptoms and signs of infection, infectious complications, and Immune reconstitution inflammatory syndrome (IRIS)
• Blood pressure
• Suspicious skin lesions
• Changes in the eye (including evaluation of fundus and macula), and vision changes
• Pulmonary function is clinically indicated

Patient advice:

• Read the Patient Information and Instructions for Use.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer