Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium
Velsipity is indicated for the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
Treatment should be initiated under the supervision of a physician experienced in the management of ulcerative colitis.
The recommended dose is 2 mg etrasimod taken once daily.
If a dose is missed, the prescribed dose should be taken at the next scheduled time; the next dose should not be doubled.
If treatment is interrupted for 7 or more consecutive days, it is recommended to resume treatment with food for the first 3 doses.
No dose adjustment is needed in patients over 65 years of age (see section 5.2).
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.
No dose adjustment is needed for patients with renal impairment (see section 5.2).
No dose adjustment is needed for patients with mild or moderate hepatic impairment. Etrasimod should not be used in patients with severe hepatic impairment (see sections 4.3 and 5.2).
The safety and efficacy of etrasimod in children and adolescents less than 16 years of age have not yet been established. No data are available.
Given the limited data in adolescents aged 16 and over, etrasimod should be used with caution especially when body weight is less than 40 kg due to the potential for increase in exposure (see section 5.2).
Oral use.
It is recommended that etrasimod be administered with food for the first 3 days to attenuate potential transient heart rate lowering effects related to initiation of treatment (see section 4.4). Etrasimod can then be taken with or without food (see section 5.2).
Tablets should be swallowed whole with water and not be split, crushed or chewed because these methods have not been studied in clinical trials.
In patients with overdose of etrasimod, signs and symptoms of bradycardia should be monitored, which may include overnight monitoring. Regular measurements of heart rate, blood pressure, and ECGs should be performed. There is no specific antidote to etrasimod available. The decrease in heart rate induced by etrasimod can be reversed by parenteral atropine.
3 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
High-density polyethylene (HDPE) bottle closed with a polypropylene cap, desiccant integrated directly into the cap. Pack size of 30 film-coated tablets.
Aluminium blister strip laminated to an oriented polyamine (oPA) film and integrated desiccant layer (HDPE/LDPE), with a paper/aluminium/LDPE backing. Pack size of 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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