Ozanimod

FDA label

Read the full label on DailyMed ↗

Titration Mandatory fixed 7-day initiation ramp (dose steps after Day 4 and Day 7); no up-titration beyond 0.92 mg QD

Renal Undefined

Hepatic Mild–moderate (Child-Pugh A/B): 0.92 mg once EVERY OTHER DAY after standard 7-day titration; severe (Child-Pugh C): not recommended

Instructions

• Swallow capsules whole, with or without food
• Before first dose: ECG; CBC with lymphocytes (within 6 months); transaminases/bilirubin; baseline fundus/macula exam; skin exam; VZV antibody test and vaccination if no confirmed history/vaccination
• Review current/prior immunosuppressants and drugs slowing heart rate or AV conduction; consider cardiology consult if conduction abnormalities
• Live attenuated vaccines: give ≥1 month before starting
• Missed dose in first 2 weeks: restart the 7-day titration; after 2 weeks: continue as planned

Available strengths

• cap 0.23, 0.46, 0.92 mg

Contraindications

• MI, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure in the last 6 months
• Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block — unless functioning pacemaker
• Severe untreated sleep apnea
• MAOIs (concurrently; ≥14 days should elapse after stopping ozanimod before starting an MAOI)

Cautions

• Infections: lymphocyte count falls to ~45% of baseline; monitor during and for 3 months after stopping; do not start with active infection; PML — withhold at first suggestive sign; cryptococcal and herpes infections reported
• Bradyarrhythmia/AV conduction delays at initiation — 7-day titration required; baseline ECG
• Liver injury — LFTs before and during; discontinue if unexplained injury
• Fetal risk — effective contraception during and for 3 months after stopping
• Increased blood pressure; respiratory function decline (spirometry if indicated)
• Macular edema — baseline and periodic fundus exams; diabetes and uveitis raise risk
• Cutaneous malignancies — baseline and periodic skin exams
• PRES; unintended additive immunosuppression from prior therapies; severe MS disability increase after stopping; immune effects persist up to 3 months post-discontinuation

Adverse reactions

• MS (≥4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, hypertension
• UC (≥4%): liver test increased, upper respiratory infection, headache

Pregnancy No adequate human data; embryolethality and malformations in animals at clinically relevant exposures (S1P role in vascular/neural embryogenesis); pregnancy exposure registry available; contraception during and 3 months after

Lactation No human data; ozanimod/metabolites in rat milk above maternal plasma; weigh benefit of breastfeeding vs risk