Something went wrong

We encountered an unexpected error, we encourage you to try again later.

We're here to help

Should you have additional questions please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

PP-UNP-USA-5796
Order samples Unable to confirm your eligibility

Unfortunately, your registration is incomplete and we are unable to confirm your eligibility for sample ordering.

To gain access please enter your professional information within your account.

Open your account We're here to help

Should you need further support updating your account information, please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

​​​​​​​PP-UNP-USA-5796
Order samples
Thank you for expressing interest in Pfizer samples. Currently there are no samples available to order. Samples renew periodically, we encourage you to check back soon.
 We're here to help

Should you have additional questions please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

​​​​​​​PP-UNP-USA-5796
Order samples

All samples available online to you are included below. Availability is updated periodically.

PP-UNP-USA-5796
Important Notice

Savings cards will be shipped with Product Samples, if applicable.

Signature

Use your mouse, finger, or stylus to sign below.

Legal Notice

I certify that I am a licensed prescriber, eligible to request and receive the drug samples listed in the quantities indicated. I am also confirming that these samples will be used exclusively for the medical treatment of my patients in conformity with all relevant state and/or local prescribing and dispensing requirements. My signature will also serve as confirmation of my receipt of these medications, if delivered by a company representative, or my intention to acknowledge them upon delivery to my medical office if shipped via common carrier. I understand that these samples cannot be sold, traded, bartered returned for credit or utilized to seek or obtain reimbursement.

Your order has been placed

We have received your order and are getting it ready

More to explore Patient assistance

Download available co-pay cards and patient savings offers across select Pfizer products.

Explore patient assistance Loading Vaccines

Find out more about the diseases, treatments and prevention methods that are impacted by our Pfizer Vaccine portfolio.

Explore Vaccines Loading
PP-UNP-USA-5796
Leave ordering?

Changes you have made will not be saved.

This site is intended for U.S. healthcare professionals.

For patient resources and support click HERE

Menu

Close

Sign InLog OutTherapy AreasProductsOrder VaccinesOrder SamplesOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
SearchAbout VELSIPITYAbout VELSIPITYUncontrolled DiseasePatient ProfilesVELSIPITY OverviewMOAEfficacyEfficacyTrial DesignEfficacy DataSafetySafetyELEVATE UCENLIGHT UCStarting TreatmentAccess & SupportAccess & SupportVelsipityForMe Patient SupportEnrollment ResourcesResourcesResourcesRequest a RepEventsMaterialsVideos
Prescribing InformationMedication GuideIndication Patient SiteRequest Samples
In moderate to severe UCVELSIPITY was studied in two separate randomized, placebo-controlled clinical trial programs
Select ELEVATE UC and ENLIGHT UC trial program criteria
Scroll left to view table
  Both Trial Programs
ELEVATE UC
Pivotal trial for US registration
 ENLIGHT UC
Registrational trial in select Asian countries
Trial Design  Randomized, multicenter, double-blind, placebo-controlled phase 3 trials1-3​ Treat-through Design​ Rerandomization​ Design 
Trial Population  Adult patients with moderate to severe UC who had failed ≥1 predefined UC treatments​​1-3*† Multinational Asian 
Biologic/JAKi naive  Largely biologic/JAKi-naive patient populations1,3 UC-11‡: 70% of patients
UC-21‡: 66% of patients 		83% of patients
Oral Corticosteroids at Baseline Included patients who were taking oral steroids at baseline1,3 ​ UC-11: 31% of patients
UC-21: 28% of patients		 5% of patients
Primary Endpoint Clinical remission1,3
Definition:
  • SF subscore of 0 or 1
  • RB subscore of 0
  • ES ≤1 (excluding friability)
Definition (more stringent):
  • SF subscore=0 (or=1 with a ≥1 point decrease from baseline)
  • RB subscore=0
  • ES ≤1 (excluding friability)

These trials were not predefined for cross-trial comparisons, and comparisons should not be made.

Failed=inadequate response, loss of response, or intolerance.1In ELEVATE UC 1 and UC 2, the primary efficacy analysis was performed on data from patients with an mMS of 5 to 9. In ENLIGHT UC, the primary efficacy analysis was performed on data from patients with an mMS of 4 to 9, and a secondary prespecified analysis was performed on data from patients with an mMS of 5 to 9. Note that the FDA uses an mMS score of 5 to 9 as the definition of moderate to severe UC, and therefore only the ENLIGHT UC prespecified analysis of mMS of 5 to 9 are shown in this communication for ENLIGHT UC.1,3,4UC-1=ELEVATE UC 52; UC-2=ELEVATE UC 12.JAKi=Janus kinase inhibitors.

ELEVATE UC

ENLIGHT UC

Tab Number 3

Tab Number 4

Tab Number 5

ELEVATE UC: 52-week trial with a treat-through design1,2 Studies with treat-through design are NOT enriched with responders.Adapted with permission from Sandborn et al, Lancet. 2023.2ELEVATE UCPrimary efficacy analysis was done in patients with an mMS‡ of 5 to 9.1

Primary endpoints1:
Clinical remission at week 12 (UC-1 and UC-2) and at week 52 (UC-1)

Select key secondary endpoints1,2:
Corticosteroid-free remission (UC-1), symptomatic remission, and endoscopic improvement

Other prespecified secondary endpoint2:
Clinical response

Select inclusion criteria1,2:
  • Adults with moderately to severely active UC with an inadequate response, a loss of response, or an intolerance to ≥1 treatment options: oral aminosalicylates, corticosteroids, thiopurines, JAKi, or biologics (eg, TNF blockers, anti-integrins, and anti-IL 12/23)
  • Primary efficacy analysis conducted in modified Mayo score (mMS) of 5 to 9 with an endoscopy score (ES) ≥2 and a rectal bleeding score (RB) ≥1
  • Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll
  • Patients were permitted to receive other concomitant UC therapies§ including stable daily doses of oral 5-ASA compounds and/or oral corticosteroids (prednisone ≤20 mg/day, budesonide ≤9 mg/day, or equivalent corticosteroid)
Select exclusion criteria1:
  • Concomitant treatment with immunomodulators, biologics, JAKi, rectal 5-ASAs, or rectal corticosteroids
See additional inclusion/exclusion criteria below
In UC-1, patients whose disease had not improved or had worsened vs baseline (per investigator judgment), could discontinue treatment and, if objective disease worsening criteria were met (having an RB subscore ≥2 or an RB subscore and an SF subscore ≥4 at 2 time points ≥7 and ≤14 days apart), enroll in the OLE. In UC-2, at the end of week 12, patients could enroll in the OLE. In both trials, patients who did not enroll in the OLE entered a 4-week follow-up period, with visits at week 2 and at week 4.2Modified Mayo score (an mMS of 0 to 9) consists of stool frequency (0 to 3), rectal bleeding (0 to 3), and findings on a centrally read endoscopy score (0 to 3).1Oral aminosalicylates and/or oral corticosteroids (≤20 mg/day prednisone, ≤9 mg/day budesonide, or equivalent steroid). Therapies not permitted were immunomodulators, biologics, JAKi, rectal 5-ASAs, or rectal corticosteroids.1OLE=open-label extension; R=randomization; TNF=tumor necrosis factor.SafetySafety

Take a look at safety information for VELSIPITY.

View Safety Data LoadingView ELEVATE UC baseline characteristics ELEVATE UC included1:
  • Patients who may have received concomitant treatment for UC at baseline
  • A multinational patient population
  • Patients who were biologic or JAKi naive or who had prior exposure*
Scroll left to view table
 
UC-1
(N=408)
UC-2
(N=333)
Mean age (range) 41 years (18‑78) 41 years (18‑73)
Gender (female) 45% 41%
Race or ethnicity    
White 89% 76%
Asian 7% 19%
Black or African American 2% 1%
American Indian or Alaska Native 1% 2%
Multiple ethnic groups or did not report 1% 2%
Biologic/JAKi exposure*    
Biologic or JAKi naive 70% 66%
Biologic or JAKi prior exposure
   >1 biologic or JAKi exposure
 30%
14%		 34%
17%
Concomitant treatment for UC at baseline    
Oral corticosteroids 31% 28%
Oral aminosalicylates (5-ASAs) 68% 66%
Baseline mMS    
5-6 36% 42%
7-9 64% 58%
Extent of disease (from Site Investigator)    
Proctosigmoiditis/Left-sided colitis 59% 59%
Pancolitis 34% 34%
Proctitis 6% 7%
Missing  1% 0%
Fecal Calprotectin (µg/g)     
Mean (SD)  2,580 (4,915) 2,404 (5,128)
Median 1,137 953
Min; Max 3.8; 46,190 4.2; 41,794
*Prior biologics included TNF blockers, anti-integrins, and anti-IL 12/23.1ELEVATE UC endpoints and definitions
Primary and secondary endpoints1,2,4
Scroll left to view table
  Time points when endpoints were assessed Met endpoints
  Endpoints UC-1 UC-2 (UC-1) (UC-2)
Primary
endpoint		 Clinical remission
  • SF subscore of 0 or 1
  • RB subscore of 0
  • ES ≤1 (excluding friability)
 Week 12;
week 52
(co-primary endpoints)		 Week 12
(primary endpoint)
Key secondary endpoints Endoscopic improvement
  • ES ≤1 (excluding friability)
 Week 12;
week 52		 Week 12
Symptomatic remission
  • SF subscore of 0 (or SF subscore of 1 with a ≥1-point decrease from baseline)
  • RB subscore of 0
Histologic-endoscopic mucosal improvement
  • ES ≤1 (excluding friability)
  • Histologic remission measured by a Geboes Index score <2.0
Corticosteroid-free clinical remission
  • Clinical remission at week 52 in patients who had not received corticosteroids for ≥12 weeks prior to week 52
 Week 52 N/A
Maintenance of clinical remission
  • Clinical remission at week 12 and at week 52 
Scroll left to view table
Other prespecified
secondary endpoint
 Definitions Time points when endpoint was assessed
Clinical response
  • ≥2-point and a ≥30% decrease from baseline in mMS
  • ≥1-point decrease from baseline in RB subscore or absolute RB ≤1
 UC-1 UC-2
Week 12; week 52 Week 12
Not controlled for multiplicity.
Endoscopic normalization
  • ES=0
 Week 12; week 52 Week 12
Not controlled for multiplicity.
ELEVATE UC inclusion and exclusion criteria

Inclusion criteria1,2:

  • Adults with moderately to severely active UC with an inadequate response, a loss of response, or an intolerance to ≥1 treatment options: oral aminosalicylates, corticosteroids, thiopurines, JAKi, or biologics (eg, TNF blockers, anti-integrins, and anti-IL 12/23)
  • Primary efficacy analysis conducted in modified Mayo score (mMS*) of 5 to 9 with an endoscopy score (ES) ≥2 and a rectal bleeding score (RB) ≥1
  • Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll
  • Patients were permitted to receive other concomitant UC therapies including stable daily doses of oral 5-ASA compounds and/or oral corticosteroids (prednisone ≤20 mg/day, budesonide ≤9 mg/day, or equivalent corticosteroid)

Exclusion criteria1,2:

  • Concomitant treatment with immunomodulators, biologics, JAKi, rectal 5-ASAs, or rectal corticosteroids
  • High risk of requiring a colectomy in the next 3 months (per investigator)
  • Previous treatment with ≥3 biologics or ≥2 biologics and a JAKi
  • Pregnancy or lactation
  • Clinically relevant cardiac condition†
  • History of macular edema or opportunistic infections
Modified Mayo score (an mMS of 0 to 9) consists of stool frequency (0 to 3), rectal bleeding (0 to 3), and findings on a centrally read endoscopy score (0 to 3).1Contraindicated in patients with specific cardiovascular conditions. Select cardiovascular Warnings & Precautions: Bradyarrhythmia & AV Conduction Delays. See USPI.1Learn about treat-through vs responder rerandomization trial design

Treat-through trial design2

  • In a treat-through trial, patients remain in their treatment arm for the duration of the trial, and the maintenance phase is not enriched with responders
  • UC-1 remains the first and only 52-week, phase 3, treat-through trial of an S1P receptor modulator in UC
  • Treat-through trials have been used previously to assess the efficacy of some TNF inhibitors for UC

ELEVATE UC

Do not make cross-trial comparisons.

Responder rerandomization withdrawal trial design3,5-7

  • In a rerandomization trial, only induction responders are rerandomized for maintenance treatment, ie, the maintenance phase is enriched with responders5
  • Rerandomization trial designs are commonly used in UC trials and have been used to assess the efficacy of JAK inhibitors and most biologics in UC6,7

ENLIGHT UC

Do not make cross-trial comparisons.

R=randomization; RR=rerandomization.

ENLIGHT UC: 52-week trial with a responder rerandomization design3 R=randomization; RR=rerandomization.ENLIGHT UC
  • Although primary efficacy analysis was conducted using a modified Mayo score (mMS) of 4 to 9, with an endoscopy score (ES) ≥2 and a rectal bleeding (RB) subscore ≥1, a prespecified analysis was performed on data from patients with an mMS of 5 to 9, which is shown in this website. This prespecified analysis was not controlled for multiplicity (type I error)

Primary endpoint3:
Clinical remission

Select key secondary endpoints3:
Clinical response and endoscopic improvement

Other prespecified secondary endpoints3:
Endoscopic normalization, endoscopic improvement histologic remission (HEMI), and symptomatic remission

Select inclusion criteria3,8:
  • Adults with moderately to severely active UC with an inadequate response, a loss of response, or an intolerance to ≥1 treatment options: oral aminosalicylates, corticosteroids, thiopurines, JAKi, or biologics (eg, TNF blockers, anti-integrins, and anti-IL 12/23)
  • Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll
  • Patients were permitted to receive other concomitant UC therapies including stable daily doses of oral 5-ASA compounds and/or oral corticosteroids (prednisone ≤20 mg/day or equivalent corticosteroid)
Select exclusion criteria1:
  • Concomitant treatment with immunomodulators, biologics, JAKi, rectal 5-ASAs, or rectal corticosteroids
See additional inclusion/exclusion criteria below
Modified Mayo score (an mMS of 0 to 9) consists of stool frequency (0 to 3), rectal bleeding (0 to 3), and findings on a centrally read endoscopy score (0 to 3).1OLE=open-label extension; R=randomization; TNF=tumor necrosis factor.Safety

Take a look at safety information for VELSIPITY.

View Safety Data LoadingView ENLIGHT UC baseline characteristics ENLIGHT UC included patients3,4:
  • Who were biologic or JAKi naive or who had prior exposure
  • Who may have received concomitant treatment for UC at baseline
Scroll left to view table
  ENLIGHT
(N=308)
Mean age (range) 42 years 
(18‑73)
Gender (female) 38%
Race or ethnicity  
Asian 100%
Biologic/JAKi exposure  
Biologic or JAKi naive 83%
Biologic or JAKi prior exposure 17%
Concomitant treatment for UC at baseline  
Oral corticosteroids 5%
Baseline mMS  
5-7 86%
8-9 14%
Extent of disease (from Site Investigator)  
Proctosigmoiditis/Left-sided colitis 59%
Pancolitis 28%
Proctitis 13%
ENLIGHT UC endpoints and definitions (not controlled for type I error)
Scroll left to view table
  Endpoints Definitions Time points when endpoints were assessed
Primary
endpoint		 Clinical remission
  • SF subscore=0 (or=1 with a ≥1 point decrease from baseline)
  • RB subscore=0
  • ES ≤1 (excluding friability)
 Week 12; week 52
Key secondary endpoints Clinical response
  • ≥2 point and ≥30% decrease from baseline in mMS
  • ≥1-point decrease from baseline in RB subscore, or absolute RB ≤1
Endoscopic improvement
  • ES ≤1 (excluding friability)
Other secondary endpoints Endoscopic normalization
  • ES=0

HEMI
  • ES ≤1 (excluding friability)
  • Geboes Index score <2.0
Symptomatic remission
  • RB subscore of 0
  • SF subscore of 0 or 1 (or 1 with a ≥1-point decrease from induction period baseline)
ENLIGHT UC inclusion and exclusion criteria

Inclusion criteria3,8:

  • Adults with moderately to severely active UC with an inadequate response, a loss of response, or an intolerance to ≥1 treatment options: oral aminosalicylates, corticosteroids, thiopurines, JAKi, or biologics (eg, TNF blockers, anti-integrins, and anti-IL 12/23)
  • Although primary efficacy analysis was conducted using a modified Mayo score (mMS*) of 4 to 9, with an endoscopy score (ES) ≥2 and a rectal bleeding (RB) subscore ≥1, a prespecified analysis was performed on data from patients with an mMS of 5 to 9, which is shown in this website. This prespecified analysis was not controlled for multiplicity (type I error)
  • Patients with isolated proctitis at baseline (<10 cm rectal involvement) who met other eligibility criteria could enroll
  • Patients were permitted to receive other concomitant UC therapies including stable daily doses of oral 5-ASA compounds and/or oral corticosteroids (prednisone ≤20 mg/day or equivalent corticosteroid)

Exclusion criteria3,8:

  • Concomitant treatment with immunomodulators, biologics, JAKi, rectal 5-ASAs, or rectal corticosteroids
  • High risk of requiring a colectomy in the next 3 months (per investigator)
  • Previous treatment with ≥3 biologics or ≥2 biologics and a JAKi
  • Pregnancy or lactation
  • Clinically relevant cardiac condition†
  • History of macular edema or opportunistic infections
Modified Mayo score (an mMS of 0 to 9) consists of stool frequency (0 to 3), rectal bleeding (0 to 3), and findings on a centrally read endoscopy score (0 to 3).1Contraindicated in patients with specific cardiovascular conditions. Select cardiovascular Warnings & Precautions: Bradyarrhythmia & AV Conduction Delays. See USPI.1Learn about treat-through vs responder rerandomization trial design

Treat-through trial design2

  • In a treat-through trial, patients remain in their treatment arm for the duration of the trial, and the maintenance phase is not enriched with responders
  • UC-1 remains the first and only 52-week, phase 3, treat-through trial of an S1P receptor modulator in UC
  • Treat-through trials have been used previously to assess the efficacy of some TNF inhibitors for UC

ELEVATE UC

Do not make cross-trial comparisons.

Responder rerandomization withdrawal trial design3,5-7

  • In a rerandomization trial, only induction responders are rerandomized for maintenance treatment, ie, the maintenance phase is enriched with responders5
  • Rerandomization trial designs are commonly used in UC trials and have been used to assess the efficacy of JAK inhibitors and most biologics in UC6,7

ENLIGHT UC

Do not make cross-trial comparisons.

R=randomization; RR=rerandomization.

References:VELSIPITY [prescribing information]. New York, NY: Pfizer Inc.; August 2025.Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies [published correction appears in Lancet. 2023;401(10381):1000]. Lancet. 2023;401(10383):1159-1171.Wu K, Zheng C, Cao Q, et al; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. Published Online: September 30, 2025. doi:10.1016/S2468-1253(25)00198-0Data on file. Pfizer Inc.Ghosh S, Sandborn WJ, Colombel JF, et al. Interpreting registrational clinical trials of biological therapies in adults with inflammatory bowel diseases. Inflamm Bowel Dis. 2016;22(11):2711-2723.XELJANZ [prescribing information]. New York, NY: Pfizer Inc.; October 2025.Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology. 2020;158(3):562-572.e12.Wu K, Zheng C, Cao Q, et al; ENLIGHT UC Study Group. Etrasimod as induction and maintenance treatment for patients with moderately to severely active ulcerative colitis in East Asia (ENLIGHT UC): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. Appendix 2. Published online: September 30, 2025. doi:10.1016/S2468-1253(25)00198-0Efficacy
Request a Representative
Get answers to your questions and find out about sample availability
Connect with a Rep Loading

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2026 Pfizer Inc. All rights reserved.

PP-V1A-USA-1340
IndicationVELSIPITY® (etrasimod) is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.
Important Safety Information Contraindications
  • Patients in the last 6 months who experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
  • Patients with a history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
Infections 

VELSIPITY may increase the susceptibility to infections. Life-threatening and rare fatal infections have been reported in association with other sphingosine 1-phosphate (S1P) receptor modulators. Before starting VELSIPITY, obtain a recent (i.e., within 6 months) CBC, including lymphocyte count. Delay initiation of VELSIPITY in patients with an active infection until the infection is resolved. Consider interruption of treatment with VELSIPITY if a patient develops a serious infection. Continue monitoring for infections up to 5 weeks after discontinuing VELSIPITY.

  • Progressive multifocal leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and usually leads to death or severe disability. PML has been reported in multiple sclerosis (MS) patients treated with S1P receptor modulators and has been associated with risk factors and duration of use. Longer treatment duration (≥18 months) increases the risk of PML. VELSIPITY is not indicated in MS. If PML is suspected, suspend VELSIPITY and discontinue if PML is confirmed by appropriate diagnostic evaluation. Immune reconstitution inflammatory syndrome (IRIS) has been reported in patients with MS treated with S1P receptor modulators who developed PML and discontinued treatment. Clinical decline may be rapid, can lead to serious neurological complications or death, and is often associated with characteristic MRI changes. Onset was generally within a few months after S1P receptor modulator discontinuation. Monitoring for IRIS should be undertaken.
  • Herpes simplex encephalitis, varicella zoster meningitis, and localized herpes viral infections have been reported with S1P receptor modulators. In UC-1, herpes zoster was reported in 0.7% of subjects treated with VELSIPITY and in none of the subjects who received placebo. 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. A full course of VZV vaccination for antibody-negative patients is recommended prior to commencing treatment with VELSIPITY.
  • Cases of fatal cryptococcal meningitis (CM) and disseminated cryptococcal infections have been reported with S1P receptor modulators. VELSIPITY treatment should be suspended until a cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
  • VELSIPITY has not been studied in combination with anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies. Avoid concomitant administration of these therapies with VELSIPITY. 
  • Update immunizations according to current guidelines prior to VELSIPITY treatment. Avoid the use of live attenuated vaccines during and for 5 weeks after treatment with VELSIPITY. If live attenuated vaccine immunizations are required, administer at least 4 weeks prior to initiation of VELSIPITY.
Bradyarrhythmia and Atrioventricular (AV) Conduction Delays
Initiation of VELSIPITY may result in a transient decrease in heart rate and AV conduction delays. Before starting VELSIPITY, obtain an ECG to assess for preexisting cardiac conduction abnormalities. Seek advice of a cardiologist for patients with: significant QT prolongation; arrhythmia requiring treatment with Class Ia or Class III anti-arrhythmic drugs or QT prolonging drugs; unstable ischemic heart disease, Class I or Class II heart failure, history of cardiac arrest, cerebrovascular disease, or uncontrolled hypertension; resting HR<50bpm; history of symptomatic bradycardia, recurrent cardiogenic syncope, or severe untreated sleep apnea; history of Mobitz type I second-degree AV block in the absence of a functioning pacemaker.

Liver Injury
Elevations of aminotransferases may occur in patients receiving VELSIPITY. Obtain transaminase and bilirubin levels, if not recently available (i.e., within the last 6 months), before initiation of VELSIPITY or in patients who develop symptoms suggestive of hepatic dysfunction. Discontinue VELSIPITY if significant liver injury is confirmed. Use of VELSIPITY in patients with severe hepatic impairment is not recommended.

Macular Edema
S1P receptor modulators have been associated with an increased risk of macular edema. Obtain baseline evaluation of the fundus, including the macula near the start of VELSIPITY treatment. Periodically assess the fundus, including the macula, during treatment or if there is a change in vision. Consider discontinuing VELSIPITY if macular edema develops. 

Increased Blood Pressure 
VELSIPITY patients in clinical trials had average increases of 1 to 4 mm Hg systolic and 1 to 2 mm Hg diastolic blood pressure (BP). Increases were first detected after 2 weeks of treatment and remained within the specified average range of BP increases throughout treatment. Monitor BP during treatment with VELSIPITY and manage appropriately.

Fetal Risk
Based on animal studies, VELSIPITY may cause fetal harm. Advise pregnant females and females of reproductive potential of the potential risk to a fetus and to use effective contraception to avoid pregnancy during and for one week after stopping VELSIPITY. Pregnant females exposed to VELSIPITY are encouraged to contact the pregnancy registry by calling 1-800-616-3791.

Cutaneous Malignancies
Risk of cutaneous malignancies is increased in patients treated with S1P receptor modulators in clinical trials and cutaneous malignancies have been reported in the postmarketing setting. Skin examinations are recommended prior to or shortly after the start of treatment and periodically thereafter for all patients, particularly those with risk factors for skin cancer. Monitor for suspicious skin lesions. Limit UV exposure including phototherapy.

Posterior Reversible Encephalopathy Syndrome
Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving S1P receptor modulators. If a patient develops neurological or psychiatric symptoms/signs or any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration, complete a physical and neurological examination promptly and consider an MRI. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, discontinue treatment with VELSIPITY.

Respiratory Effects
VELSIPITY may cause a decline in pulmonary function. Spirometric evaluation should be conducted during therapy if clinically indicated.

Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs
When switching to VELSIPITY from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

Immune System Effects After Stopping VELSIPITY
After stopping VELSIPITY, lymphocyte counts returned to the normal range in 90% of subjects within 4 to 5 weeks. Use of immunosuppressants within this period may lead to an additive effect on the immune system, and therefore monitor patients receiving concomitant immunosuppressants for infectious complications up to 5 weeks after the last dose of VELSIPITY.

Most Common Adverse Reactions
Most common adverse reactions reported in ≥ 2% of subjects and at a higher rate than placebo included: headache, elevated liver tests, dizziness, arthralgia, nausea, hypertension, bradycardia, UTI, hypercholesterolemia, and herpes viral infection.

Please see full Prescribing Information, including Medication Guide.Indication

VELSIPITY is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.