ZEPOSIA

ZEPOSIA is the brand name for ozanimod and is available as an oral capsule.

ZEPOSIA is available as a 0.23 mg, 0.46 mg, 0.92 mg oral capsule.

ZEPOSIA is a sphingosine 1-phosphate (S1P) receptor modulator that is used to treat:

• Relapsing forms of multiple sclerosis (MS) in adults
• Moderate-to-severe ulcerative colitis (UC) in adults

ZEPOSIA is a sphingosine 1-phosphate (S1P) receptor modulator. It attaches to the S1P receptor protein that’s found on your white blood cells. It’s thought that this blocks white blood cells from leaving your lymph nodes and releasing into the body. This helps to lower inflammation in the body, which might help improve symptoms of UC and MS.

ZEPOSIA is typically dosed as follows:

• Days 1 to 4: The typical dose is 0.23 mg by mouth once daily
• Days 5 to 7: The typical dose is 0.46 mg by mouth once daily
• Day 8 and onward: The typical dose is 0.92 mg by mouth once daily

Your provider will adjust the dose if you have liver problems

ZEPOSIA is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication if any of the following apply:

• In the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
• Presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning
  pacemaker
• Severe untreated sleep apnea
• Concomitant use of a monoamine oxidase inhibitor

Common side effects of ZEPOSIA:

• Upper respiratory infection
• High liver enzyme tests
• Stomach pain
• Back pain
• Sudden low blood pressure when standing

Serious side effects are rare with ZEPOSIA. Contact your healthcare provider immediately if you experience any of the following.

• Serious infection: fever, chills, sweating, weakness, trouble breathing, cough, diarrhea, stomach pain, painful urination
• Serious brain infection (PML): weakness on one side of the body, clumsiness, confusion, changes in personality, changes in vision, headache, stiff neck, light sensitivity, fever, seizures
• Dangerously slow heart rate: tiredness, weakness, confusion, feeling faint, trouble breathing, chest pain
  Severely high blood pressure: severe headaches, nosebleeds, trouble breathing, vision changes, irregular heartbeat, chest pain
• Serious liver problems: nausea, vomiting, stomach pain, swelling of your stomach, yellowing of your skin or the whites of your eyes, clay-colored stool, confusion
  Posterior reversible encephalopathy syndrome (PRES): seizures; sudden, severe headaches; sudden changes in vision; sudden confusion

The following medications may interact with ZEPOSIA:

• Vaccination: Avoid use of live attenuated vaccines during and for up to 3 months after treatment with ZEPOSIA
• Co-administration of ZEPOSIA with drugs or over-the-counter medications that can increase norepinephrine or serotonin (e.g., opioid drugs, SSRIs
• SNRIs, tricyclics, tyramine) is not recommended Monitor patients for hypertension with concomitant use.
• Co-administration of ZEPOSIA with strong CYP2C8 inducers (e.g. rifampin) reduces the exposure of the major active metabolites of ozanimod, which may decrease the efficacy of ZEPOSIA and should be avoided.
• Co-administration of ZEPOSIA with MAO inhibitors (e.g., selegiline phenelzine, linezolid) is contraindicated. At least 14 days should elapse between discontinuation of ZEPOSIA and initiation of treatment with MAO inhibitors
• Co-administration of ZEPOSIA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended

Bristol-Myers Squibb

ZEPOSIA may harm your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant. If you are a female who can become pregnant, you should use effective birth control during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Talk with your healthcare provider about what birth control method is right for you during this time. Tell your healthcare provider right away if you become pregnant while taking ZEPOSIA or if you become pregnant within 3 months after you stop taking ZEPOSIA.Pregnancy Registry for MS patients: There is a pregnancy registry for women with multiple sclerosis who become pregnant during treatment with ZEPOSIA. If you become pregnant while taking ZEPOSIA, tell your healthcare provider right away. Talk to your healthcare provider about registering with the ZEPOSIA Pregnancy Registry. The purpose of this registry is to collect information about your health and your baby’s health. Either you or your healthcare provider can enroll you in this registry by calling 1-877-301-9314 or visiting Zeposia MS pregnancy registry 

• ozanimod