For questions about BMS
medicines during this time,
please call 1-800-721-8909.

The first and only S1P receptor modulator FDA approved for ulcerative colitis1

Lasting Control1ab

Achieved significantly higher clinical remission than placebo at Weeks 10 and 52

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Demonstrated Safety Profile1c

Studied in 4 clinical trials with over 1370 ZEPOSIA-treated patients across multiple indications

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Oral Administration1

A once-daily capsule

Icon of a pill for ulcerative colitis

S1P=sphingosine 1-phosphate.

aStudy Design: 2 multicenter, randomized, double-blind, placebo-controlled studies in adult patients with moderately to severely active UC, UC Study 1 (induction 10 weeks, N=645) and UC Study 2 (maintenance 42 weeks, N=457). In both studies, patients were randomized to either once-daily ZEPOSIA 0.92 mg or placebo. To enter UC Study 2, patients had to have received ZEPOSIA in either UC Study 1 or in an open-label arm and be in clinical response (defined as a reduction from baseline in the 3-component Mayo score of ≥2 points and ≥35% and a reduction from baseline in the rectal bleeding subscore [RBS] of ≥1 point or an absolute RBS of 0 or 1) at Week 10. Primary Endpoint: Percent of patients in clinical remission at Weeks 10 and 52. ZEPOSIA 18% vs placebo 6% (p<0.0001) and 37% vs 19% (p<0.0001), respectively.1

bClinical Remission Is Defined as: RBS=0, stool frequency subscore (SFS) 0 or 1 (and a decrease of ≥1 point from the baseline of SFS), and endoscopy subscore 0 or 1 without friability.1

cZEPOSIA has been studied across multiple indications in 4 clinical trials including TRUE NORTH (NCT02435992), a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial; TOUCHSTONE (NCT01647516), a randomized, double-blind, placebo-controlled phase 2 clinical trial; and SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), 2 multicenter, randomized, double-blind, double-dummy, active treatment-controlled phase 3 clinical trials. 496 patients receiving the 0.92-mg dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92-mg dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis.1

The ZEPOSIA 360 SupportTM Program

Support for your patients every step of the way

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Initiation Support

  • Preinitiation Assessment Assistanced
    Provided at the homes of eligible patients:
    • Blood work
    • ECG with cardiologist overread
    • Macular edema screening with licensed eye clinician overread
    • VZV antibody testing
  • ZEPOSIA Starter Kit
    A 7-day Starter Pack along with a 30-day supply of ZEPOSIA

Access Support

  • Access Assistance
    Help with Benefits Investigation, Prior Authorization (PA), and Appeals
  • ZEPOSIA Bridge Programe

    A free supply of ZEPOSIA for up to 24 months to qualified, commercially insured patients who are at risk of an interruption in therapy

    • Up to 24 months of ZEPOSIA for $0, as long as program eligibility rules are met
    • Dispensed in 30-day increments

Financial Support

  • Co-Pay Assistance Programf
    For eligible, commercially insured patients, helps with:
    • Prescription Benefits
      Eligible patients pay as little as $0 in out-of-pocket costs for their ZEPOSIA prescription
    • Medical Benefits
      Commercially insured patients can be fully reimbursed for any out-of-pocket costs associated with initiation testing
  • Third-Party Referrals
    Suggestions for independent third-party foundations that may be able to assist with treatment costs

Dedicated GI Nurse Navigators to support patients
on every step of their treatment journey

For assistance with access for your appropriate patients, please
contact ZEPOSIA 360 Support™ at 1-833-ZEPOSIA (1-833-937-6742)

ECG=electrocardiogram; VZV=varicella-zoster virus.

dHome visits for initial routine medical tests are not available to people enrolled in Medicare, Medicaid, or other federal or state healthcare programs, or to people living in Rhode Island.

eThe Bridge Program is available at no cost for eligible commercially insured, on-label diagnosed patients if there is a delay in determining whether commercial prescription coverage is available, and is not contingent on any purchase requirement, for up to 24 months (dispensed in 30-day increments). The Bridge Program is not available to patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state program, or MI residents, and is available for no more than 12 months to patients in MA, MN, and RI. Appeal of any prior authorization denial must be made within 90 days or as per payer guidelines, to remain in the Program. Eligibility will be re-verified in January for patients continuing into the following year, and may be at other times during Program participation. Offer is not health insurance, and may be modified or discontinued at any time without notice. Once coverage is approved by the patient’s commercial insurance plan, the patient will no longer be eligible. Other limitations may apply.

 fDepending on insurance coverage and where the full cost is not covered by patient's insurance, eligible patients may receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription, as well as a medical assessment benefit offer for out-of-pocket costs for the initial blood tests, ECG screening, and eye exam. Maximum savings limit applies; patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please click here for Program Terms, Conditions, and Eligibility Criteria.

Reference: 1. ZEPOSIA. Prescribing Information. Bristol-Myers Squibb Company; 2021.

Resources to help you learn more about ZEPOSIA
for the treatment of UC and to get your patients started

GETTING STARTED

ZEPOSIA Start Form

ZEPOSIA UC Start Form

Enrolls patients in ZEPOSIA 360 Support™ and helps them get started on treatment. Sign in or register to submit the Start Form to the ZEPOSIA portal

Dosing, Initiation, and Patient Support Guide

Provides information on how to initiate treatment with ZEPOSIA, and education on the patient support offered to assist with the process

BMS eSign

Available for your patients who forget to sign the ZEPOSIA Start Form. BMS eSign enables your patients to electronically sign through www.BMSesign.com

Baseline Testing Clearance Form

Used by ZEPOSIA 360 Support™ clinical partners to verify that a patient’s baseline tests have been reviewed by their prescriber and that they are able to start therapy

ACCESS

Access and Reimbursement Guide

Provides information on the process for accessing ZEPOSIA from initiation to delivery, coverage authorizations and appeals, and patient support offered by ZEPOSIA 360 SupportTM

Specialty Pharmacy Resource

Provides a quick overview of the benefits of using specialty pharmacies (SPs) and a list of SPs ready to handle ZEPOSIA prescriptions

SUPPORT

ZEPOSIA Portal Assist

Provides an outline of how to enroll and manage patients using the ZEPOSIA portal

ZEPOSIA In-Home Support Overview

Provides a brief overview of in-home support available to patients

CoverMyMeds Overview

Overview of support available through CoverMyMeds® to enroll patients in ZEPOSIA 360 SupportTM and assist with access

FOR YOUR PATIENTS

Patient Brochure

Provides your patients with an overview of clinical study results, safety and support information for ZEPOSIA

Patient Getting Started Brochure

Provides a comprehensive guide to your patients about getting started on ZEPOSIA

ADDITIONAL CLINICAL RESOURCES

ZEPOSIA UC Patient Profiles

Helps identify which of your patients are potentially appropriate for ZEPOSIA

Tyramine and ZEPOSIA Food and Drug Interaction Information

A helpful list of foods and beverages that are high in tyramine (150 mg or more)—a compound that should be avoided if your patients are taking ZEPOSIA

IMPORTANT SAFETY INFORMATION

Contraindications:

  • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a presence of Mobitz type II second or third-degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
  • Patients with severe untreated sleep apnea
  • Patients taking a monoamine oxidase (MAO) inhibitor

Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA.

  • Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. 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 ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA
  • Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated
  • Progressive Multifocal Leukoencephalopathy (PML) is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability. PML has been reported in patients treated with S1P receptor modulators and other UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation. If confirmed, treatment with ZEPOSIA should be discontinued
  • In the UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects
  • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA

Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals:

  • with significant QT prolongation
  • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
  • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
  • with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block

Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease

Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA

Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA

Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated

Macular edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. 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, treatment with ZEPOSIA should be discontinued

Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended

Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA

Most Common Adverse Reactions: Most common adverse reactions (incidence ≥4%) are: liver test increased, upper respiratory infection, and headache

Use in Specific Populations: Hepatic Impairment: Use is not recommended

For additional safety information, please see the full Prescribing Information and Medication Guide.

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