Loading…
Velsipity is a brand name for Etrasimod. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated under the supervision of a physician experienced in the management of ulcerative colitis. Posology The recommended dose is 2 mg etrasimod taken once daily. 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. 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.
2). Hepatic impairment No dose adjustment is needed for patients with mild or moderate hepatic impairment. 2). Paediatric population 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. 2). Method of administration Oral use. 4). 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.
Summary of the safety profile The most common adverse reactions are lymphopenia (11%) and headache (7%). Tabulated list of adverse reactions The adverse reactions observed in patients treated with etrasimod are listed below by system organ class (SOC) and frequency category.
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000).
Table 1:
Adverse reactions System organ class (SOC) Very common Common Uncommon Infections and infestations Urinary tract infectiona, lower respiratory tract infectionb Blood and lymphatic system disorders Lymphopeniac Neutropenia 11 Metabolism and nutrition disorders Hypercholesterolaemiad Nervous system disorders Headache, dizziness Eye disorders Visual impairment Macular oedema Cardiac disorders Bradycardiae Atrioventricular blockf Vascular disorders Hypertension Hepatobiliary disorders Hepatic enzyme increased a Urinary tract infection includes urinary tract infection and cystitis.
b Lower respiratory tract infection includes bronchitis and pneumonia. c Lymphopenia includes lymphopenia, lymphocyte count decreased, and lymphocyte percentage decreased. d Hypercholesterolaemia includes hypercholesterolaemia and blood cholesterol increased.
e Bradycardia includes bradycardia and sinus bradycardia. See “Description of selected adverse reactions” below. f Atrioventricular block includes first- or second-degree Mobitz type I. See “Description of selected adverse reactions” below.
5% of patients treated with etrasimod. 4% of patients treated with etrasimod. 1). 6% of patients treated with etrasimod. Events of AV block were mostly transient and asymptomatic. 1). 9%, respectively). Etrasimod increased the risk of urinary tract infections and lower respiratory tract infections (see Table 1).
Bradyarrhythmia and atrioventricular conduction delays Treatment initiation with etrasimod Prior to treatment initiation with etrasimod, an electrocardiogram (ECG) should be obtained in all patients to assess for pre-existing cardiac abnormalities.
In patients with certain pre-existing conditions, first dose monitoring is recommended (see below). When reinitiating treatment after an interruption of 7 or more consecutive days, consideration may be given to repeating the baseline ECG and/or monitoring depending on the results of the first evaluation, change in patient characteristics, and duration of interruption.
1). Caution should be applied when etrasimod is initiated in patients receiving treatment with a beta-blocker because of the potential additive effects on lowering heart rate. 5), since co-administration of these substances with etrasimod may lead to additive effects.
5). If interruption is deemed necessary, treatment with a beta-blocker can be reinitiated depending on the time of reaching the baseline heart rate. Beta-blocker treatment can be initiated in patients receiving stable doses of etrasimod.
Cardiologist advice should be obtained before initiation of etrasimod to determine overall benefit risk and the most appropriate monitoring strategy in patients with the following conditions: Significant QT prolongation (QTcF ≥ 450 msec in males, ≥ 470 msec in females).
Arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic medicinal products. Unstable ischaemic heart disease, history of cardiac arrest, cerebrovascular disease (occurring more than 6 months prior to treatment initiation), or uncontrolled hypertension.
History of symptomatic bradycardia, recurrent cardiogenic syncope, or severe untreated sleep apnoea. 3). Patients should be monitored with hourly pulse and blood pressure measurement during this 4-hour period. An ECG prior to and at the end of this 4-hour period is recommended.
1. 4). Patients who in the last 6 months experienced 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 history or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless patient has a functioning pacemaker. 4). Active malignancies. Severe hepatic impairment.
6). 4
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1). 5% in ELEVATE UC 52 and ELEVATE UC 12. These events did not lead to treatment discontinuation. 2% in ELEVATE UC 52 and ELEVATE UC 12. These events did not lead to treatment discontinuation. 0% of patients treated with etrasimod, respectively.
The majority (75%) of patients with ALT greater than 3-fold the ULN continued treatment with etrasimod with values returning to less than 3-fold the ULN while on treatment. 4% in patients treated with etrasimod. 12 Hepatic enzyme increased includes events of gamma glutamyl transferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzyme increased, hepatic function abnormal, liver disorder, liver function test abnormal, and transaminases increased (see Table 1).
Increased blood pressure In ELEVATE UC 52 and ELEVATE UC 12, patients treated with etrasimod had an average increase of approximately 1 to 4 mm Hg in systolic blood pressure and approximately 1 to 2 mm Hg in diastolic blood pressure.
The increase was first detected after 2 weeks of treatment and remained within the specified average range in blood pressure increases throughout treatment. 1% of patients treated with etrasimod. All the events were mild to moderate in severity.
4% of patients treated with etrasimod. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Additional monitoring is recommended in patients, if at the end of 4-hour period: Heart rate is < 45 bpm. Heart rate is the lowest value post dose, suggesting that the maximum decrease in heart rate may not have occurred yet. ECG shows evidence of a new onset second-degree or higher AV block.
QTc interval is ≥ 500 msec. In these cases, appropriate management should be initiated, and observation should continue until the symptoms/findings have resolved. If medical treatment is required, monitoring should be continued overnight, and a 4-hour monitoring period should be repeated after the second dose of etrasimod.
1). 8). , within the last 6 months or after discontinuation of prior UC therapy), should be obtained. Assessments of CBC are also recommended periodically during treatment. 2). 3). Patients should be instructed to promptly report symptoms of infection to their physician.
Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy. If a patient develops a serious infection, interruption of etrasimod should be considered. 1). Progressive multifocal leukoencephalopathy (PML) PML is an opportunistic viral infection of the brain caused by the John Cunningham virus (JCV) that typically occurs in patients who are immunocompromised, and that may lead to death or severe disability.
Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
, immunocompromised patients, polytherapy with immunosuppressants). Physicians should be vigilant for clinical symptoms or unexplained neurologic findings that may be suggestive of PML. If PML is suspected, treatment with etrasimod should be suspended until PML has been excluded by an appropriate […]