Required prior to initiation of treatment

FOR ALL PATIENTS¹

• Obtain a recent complete blood count, including lymphocyte count (i.e. within the last 6 months or after discontinuation of prior UC therapy)
  
• Review vaccination records and update immunisations in agreement with current immunisation guidelines
  
• Elevations of aminotransferases may occur in patients receiving VELSIPITY; recent transminase and bilirubin levels (i.e. within last 6 months) should be available prior to treatment initiation
  

• Obtain a one-time ECG to determine whether pre-existing cardiac abnormalities* are present
  
• In patients with pre-existing conditions, advice from a cardiologist should be sought†
  
• >99% of patients screened for ELEVATE UC 52 and ELEVATE UC 12 were eligible for treatment following the cardiac assessment²
  

*For example, second-degree (Mobitz type I) atrioventricular block, myocardial infarction and heart failure.¹ 
†Cardiologist advice should be obtained before initiation of VELSIPITY in the following patients to determine overall benefit risk and the most appropriate monitoring:¹ In patients with significant QT prolongation (QTcF ≥450 msec in males, ≥470 msec in females);¹ in patients with arrhythmias requiring treatment with Class Ia or Class III anti-arrhythmic drugs;¹ in patients with unstable ischaemic heart disease, history of cardiac arrest, cerebrovascular disease (occurring more than 6 months prior to treatment initiation) or uncontrolled hypertension;¹ in patients with history of symptomatic bradycardia, recurrent cardiogenic syncope or severe untreated sleep apnoea.¹

FOR SELECTED PATIENTS¹

• Patients with a history of diabetes mellitus, uveitis, and/or underlying/co-existing retinal disease, are at increased risk of macular oedema during therapy. It is recommended that these patients undergo an ophthalmic evaluation prior to treatment initiation and have follow-up evaluations while receiving therapy.

• In patients without the risk factors above, an ophthalmic evaluation of the fundus, including the macula, is recommended within 3-4 months after starting treatment (cases reported with etrasimod occurred within this timeframe) and at any time if there is a change in vision while taking etrasimod.