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VELSIPITY FILM-COATED TABLET 2 MG [SIN17015P]
Active ingredients: VELSIPITY FILM-COATED TABLET 2 MG
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Product Info
VELSIPITY FILM-COATED TABLET 2 MG
[SIN17015P]
Product information
Active Ingredient and Strength | ETRASIMOD L-ARGININE EQV ETRASIMOD - 2 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | PENN PHARMACEUTICAL SERVICES LIMITED - UNITED KINGDOM |
Registration Number | SIN17015P |
Licence Holder | EVEREST MEDICINES (SINGAPORE) PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L04AE05 |
4.1. Therapeutic indications
VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to, loss of response to, or intolerance to at least 1 therapy for ulcerative colitis.
4.2. Posology and method of administration
Posology
The recommended dose of VELSIPITY is 2 mg taken orally once daily. VELSIPITY should be swallowed whole and can be administered with or without food (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Missed dose
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
Dose interruption
If treatment is interrupted for 7 or more consecutive days, it is recommended to resume treatment with food for the first 3 doses.
Special populations
Elderly
No dose adjustment is needed in patients over 65 years of age.
Etrasimod should be used with caution in elderly patients over 65 years of age, given the limited data available and potential for an increased risk of adverse reactions in this population.
Renal impairment
No dose adjustment is needed for patients with renal impairment (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment
No dose adjustment is needed for patients with mild or moderate hepatic impairment.
VELSIPITY should not be used in patients with severe hepatic impairment (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
The safety and efficacy of VELSIPITY in children and adolescents have not been established.
4.3. Contraindications
VELSIPITY is contraindicated in the following circumstances:
Patients who in the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischaemic attack (TIA), decompensated heart failure requiring hospitalisation, or New York Heart Association (NYHA) Class III/IV heart failure.
Patients with a 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.
Severe active infections, active chronic infections.
Severe hepatic impairment.
During pregnancy and in women of childbearing potential not using effective contraception.
Active malignancies.
