VELSIPITY™ Dosage and Administration

(etrasimod)

2 DOSAGE AND ADMINISTRATION

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)].

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)].

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)].

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)].
•
If a dose is missed, take the missed dose at the next scheduled time; do not double the next dose.

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

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)].

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)].

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)].

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)].
•
If a dose is missed, take the missed dose at the next scheduled time; do not double the next dose.
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