Dedicated GI Nurse Navigators* are available to support patients on every step of their treatment journey
*Nurse Navigators do not provide medical advice.
aHome 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.
bThe 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.
cDepending 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.
ECG=electrocardiogram; GI=gastrointestinal; VZV=varicella-zoster virus.
Additional Support for Your Patients
Assistance designed to meet the needs of your patients
Resources to help you learn more about ZEPOSIA for the treatment of ulcerative colitis and to get your patients started
ZEPOSIA Gastroenterology Start Form
Enrolls patients in the ZEPOSIA 360 Support™ Program and helps them get started on treatment. Sign in or register to submit the Start Form to the ZEPOSIA Portal
ZEPOSIA Start Form Instructions & Support
A step-by-step guide that outlines how to enroll patients in the ZEPOSIA 360 Support™ Program and get them started on treatment
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
Available for your patients who forget to sign the ZEPOSIA Start Form. BMS eSign enables your patients to electronically sign through ZEPOSIA.com/esign
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 Resources for HCPs
Brochure highlighting tools for healthcare providers to assist in getting appropriate patients access to ZEPOSIA
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 the ZEPOSIA 360 Support™ Program
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
Patient Access Letters
Template letters (Formulary Exception, Medical Necessity, Appeals) to assist in getting appropriate patients access for ZEPOSIA
ZEPOSIA 360 Support™ Guide
Helps providers and office staff get appropriate patients the support they need
ZEPOSIA Portal Assist
Provides an outline of how to enroll and manage patients using the ZEPOSIA portal
Overview of support available through CoverMyMeds® to enroll patients in the ZEPOSIA 360 Support™ Program and assist with access
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
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
Learn more about ZEPOSIA efficacy, safety, and support
ZEPOSIA® (ozanimod) is indicated for the treatment of:
IMPORTANT SAFETY INFORMATION
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 MS or 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.
Progressive Multifocal Leukoencephalopathy (PML): 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, including ZEPOSIA, and other MS and 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.
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:
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. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com.
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.
Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation.
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 that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.
In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, 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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This information is intended for U.S. Healthcare Professionals.