VELSIPITY Film-coated tablet Ref.[107279] Active ingredients: Etrasimod

2.1 Assessments, Medications, and Vaccinations Prior to First Dose of VELSIPITY

Before initiation of treatment with VELSIPITY, assess the following:

Complete Blood Count:

Obtain a recent (i.e., within the last 6 months or after discontinuation of prior UC therapy) complete blood count (CBC), including lymphocyte count [see Warnings and Precautions (5.1)].

Cardiac Evaluation:

Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present. In patients with certain preexisting conditions, advice from a cardiologist should be sought [see Warnings and Precautions (5.2)].

Liver Function Tests:

Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels [see Warnings and Precautions (5.3)].

Ophthalmic Assessment:

Obtain a baseline evaluation of the fundus, including the macula, near the start of treatment with VELSIPITY [see Warnings and Precautions (5.4)].

Current or Prior Medications:

• Determine if patients are taking drugs that could slow heart rate or atrioventricular (AV) conduction [see Warnings and Precautions (5.2) and Drug Interactions (7)].
• If patients are taking anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating treatment with VELSIPITY [see Warnings and Precautions (5.10) and Drug Interactions (7)].

Vaccinations:

Patients without a healthcare professional-confirmed history of varicella (chickenpox) or without documentation of a full course of vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV before initiating VELSIPITY; VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with VELSIPITY.

If live attenuated vaccine immunizations are required, administer at least 4 weeks prior to initiation of VELSIPITY.

Update immunizations in agreement with current immunization guidelines prior to initiating VELSIPITY therapy [see Warnings and Precautions (5.1)].

Skin Examination:

Obtain a skin examination prior to or shortly after initiation of VELSIPITY. If a suspicious skin lesion is observed, it should be promptly evaluated [see Warnings and Precautions (5.7)].

2.2 Recommended Dosage

• The recommended dosage of VELSIPITY is 2 mg orally once daily.
• Swallow the tablet whole, with or without food [see Clinical Pharmacology (12.3)].

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].