Indications for ZEPOSIA:
Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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.
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).
Increased risk of infections (may be fatal). Obtain recent CBC prior to initiation. Monitor for infections during and for up to 3 months. 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. 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.
Sphingosine 1-phosphate receptor modulator.
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 therapy and for up to 3 months after discontinuing ozanimod; may have suboptimal response. Potentiated by strong CYP2C8 (eg, gemfibrozil) or BCRP inhibitors (eg, cyclosporine, eltrombopag); concomitant use not recommended. 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. Avoid high amounts (>150mg) of tyramine-containing food (eg, aged cheese, pickled herring).
Upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, hypertension; macular edema, respiratory effects; rare: posterior reversible encephalopathy syndrome (discontinue if suspected).
Fecal, renal. Half-life: ~21 hours.
Generic Drug Availability:
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)