Select therapeutic use:

Colorectal disorders:

Indications for: ZEPOSIA

Moderately to severely active ulcerative colitis (UC) in adults.

Adult Dosage:

Swallow whole. Initiate dose titration regimen (Days 1–4): 0.23mg once daily; (Days 5–7): 0.46mg once daily. Maintenance (starting Day 8): 0.92mg once daily. Re-initiation after dose interruption (during 1st 2 weeks): start with Day 1 of titration regimen; (after the 1st 2 weeks): continue treatment as planned.

Children Dosage:

Not established.

ZEPOSIA Contraindications:

Recent (within last 6 months) occurrence of: MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, Class III/IV heart failure. Presence of Mobitz Type II 2nd- or 3rd-degree AV block, sick sinus syndrome, or sino-atrial block, unless paced. Severe untreated sleep apnea. Concomitant MAOIs during and within 14 days (eg, selegiline, phenelzine, linezolid).

ZEPOSIA Warnings/Precautions:

Increased risk of infections (may be fatal). Obtain recent CBC (within last 6 months or after discontinuation of prior MS or UC therapy) prior to initiation. Monitor for infections during and for up to 3 months after discontinuation. Consider treatment interruption if serious infection develops. Active infection: do not start until infection resolved. Test for antibodies to varicella zoster virus prior to initiation; if negative, consider immunization before starting ozanimod. Withhold and evaluate if progressive multifocal leukoencephalopathy (PML) suspected. Immunosuppressed. Risk of bradyarrhythmia, AV conduction delays: titration is required for treatment initiation. Obtain ECG prior to initiation to determine if preexisting conduction abnormalities are present. Significant QT prolongation, arrhythmias, ischemic heart disease, HF, history of cardiac arrest or MI, cerebrovascular disease, uncontrolled hypertension: refer to cardiologist if treatment is considered. Monitor BP during treatment. Obtain recent LFTs (within 6 months) prior to initiation. Monitor for hepatic dysfunction; discontinue if significant liver injury is confirmed. History of severe liver disease. Respiratory function: perform spirometric evaluation as needed. Diabetes, history of uveitis: increased risk of macular edema. Do ophthalmic exam at baseline, and if any change in vision during therapy. MS: monitor for severe increase in disability after treatment discontinuation. Hepatic impairment: not recommended. Elderly. Pregnancy. Advise females of reproductive potential to use effective contraception during and for 3 months after discontinuation. Nursing mothers.

ZEPOSIA Classification:

Sphingosine 1-phosphate receptor modulator.

ZEPOSIA Interactions:

See Contraindications. Concomitant antineoplastic, immunosuppressant or immune-modulating therapies may increase risk of immunosuppression; use caution when switching from long-acting immunotherapies or initiating other drugs 4 weeks after discontinuing ozanimod. Initiation after treatment with alemtuzumab: not recommended. Concomitant QT prolonging drugs (eg, quinidine, procainamide, amiodarone, sotalol): risk of torsades de pointes (in bradycardia). Avoid live attenuated vaccines during and for up to 3 months after discontinuing ozanimod; may have suboptimal response; if live vaccines are required, administer at least 1 month prior to initiating ozanimod. Potentiated by strong CYP2C8 (eg, gemfibrozil); avoid concomitant use. Antagonized by strong CYP2C8 inducers (eg, rifampin); avoid concomitant use. Concomitant drugs or OTC meds that increase norepinephrine or serotonin (eg, opioids, SSRIs, SNRIs, tricyclics, tyramine): not recommended. Potential additive effects on HR when concomitant with both a beta blocker and a calcium channel blocker (eg, verapamil, diltiazem); do not initiate ozanimod, if necessary, refer to cardiologist. Avoid high amounts (>150mg) of tyramine-containing food (eg, aged cheese, pickled herring).

Adverse Reactions:

Upper respiratory infection, hepatic transaminase elevation, headache; also for MS: orthostatic hypotension, urinary tract infection, back pain, hypertension; transient reduction in HR, malignancies, macular edema, respiratory effects; rare: posterior reversible encephalopathy syndrome (discontinue if suspected).

Generic Drug Availability:

NO

How Supplied:

Caps 0.92mg—30; 7-Day Starter Pack—7 (4 × 0.23mg + 3 × 0.46mg); Starter Pack—37 (7-cap starter pack + 30 × 0.92mg)

Multiple sclerosis:

Indications for: ZEPOSIA

Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult Dosage:

Swallow whole. Initiate dose titration regimen (Days 1–4): 0.23mg once daily; (Days 5–7): 0.46mg once daily. Maintenance (starting Day 8): 0.92mg once daily. Re-initiation after dose interruption (during 1st 2 weeks): start with Day 1 of titration regimen; (after the 1st 2 weeks): continue treatment as planned.

Children Dosage:

Not established.

ZEPOSIA Contraindications:

Recent (within last 6 months) occurrence of: MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, Class III/IV heart failure. Presence of Mobitz Type II 2nd- or 3rd-degree AV block, sick sinus syndrome, or sino-atrial block, unless paced. Severe untreated sleep apnea. Concomitant MAOIs during and within 14 days (eg, selegiline, phenelzine, linezolid).

ZEPOSIA Warnings/Precautions:

Increased risk of infections (may be fatal). Obtain recent CBC (within last 6 months or after discontinuation of prior MS or UC therapy) prior to initiation. Monitor for infections during and for up to 3 months after discontinuation. Consider treatment interruption if serious infection develops. Active infection: do not start until infection resolved. Test for antibodies to varicella zoster virus prior to initiation; if negative, consider immunization before starting ozanimod. Withhold and evaluate if progressive multifocal leukoencephalopathy (PML) suspected. Immunosuppressed. Risk of bradyarrhythmia, AV conduction delays: titration is required for treatment initiation. Obtain ECG prior to initiation to determine if preexisting conduction abnormalities are present. Significant QT prolongation, arrhythmias, ischemic heart disease, HF, history of cardiac arrest or MI, cerebrovascular disease, uncontrolled hypertension: refer to cardiologist if treatment is considered. Monitor BP during treatment. Obtain recent LFTs (within 6 months) prior to initiation. Monitor for hepatic dysfunction; discontinue if significant liver injury is confirmed. History of severe liver disease. Respiratory function: perform spirometric evaluation as needed. Diabetes, history of uveitis: increased risk of macular edema. Do ophthalmic exam at baseline, and if any change in vision during therapy. MS: monitor for severe increase in disability after treatment discontinuation. Hepatic impairment: not recommended. Elderly. Pregnancy. Advise females of reproductive potential to use effective contraception during and for 3 months after discontinuation. Nursing mothers.

ZEPOSIA Classification:

Sphingosine 1-phosphate receptor modulator.

ZEPOSIA Interactions:

See Contraindications. Concomitant antineoplastic, immunosuppressant or immune-modulating therapies may increase risk of immunosuppression; use caution when switching from long-acting immunotherapies or initiating other drugs 4 weeks after discontinuing ozanimod. Initiation after treatment with alemtuzumab: not recommended. Concomitant QT prolonging drugs (eg, quinidine, procainamide, amiodarone, sotalol): risk of torsades de pointes (in bradycardia). Avoid live attenuated vaccines during and for up to 3 months after discontinuing ozanimod; may have suboptimal response; if live vaccines are required, administer at least 1 month prior to initiating ozanimod. Potentiated by strong CYP2C8 (eg, gemfibrozil); avoid concomitant use. Antagonized by strong CYP2C8 inducers (eg, rifampin); avoid concomitant use. Concomitant drugs or OTC meds that increase norepinephrine or serotonin (eg, opioids, SSRIs, SNRIs, tricyclics, tyramine): not recommended. Potential additive effects on HR when concomitant with both a beta blocker and a calcium channel blocker (eg, verapamil, diltiazem); do not initiate ozanimod, if necessary, refer to cardiologist. Avoid high amounts (>150mg) of tyramine-containing food (eg, aged cheese, pickled herring).

Adverse Reactions:

Upper respiratory infection, hepatic transaminase elevation, headache; also for MS: orthostatic hypotension, urinary tract infection, back pain, hypertension; transient reduction in HR, malignancies, macular edema, respiratory effects; rare: posterior reversible encephalopathy syndrome (discontinue if suspected).

Generic Drug Availability:

NO

How Supplied:

Caps 0.92mg—30; 7-Day Starter Pack—7 (4 × 0.23mg + 3 × 0.46mg); Starter Pack—37 (7-cap starter pack + 30 × 0.92mg)