Ozanimod
اوزانیمود
🎗️ Antineoplastic And Immunomodulating AgentsS1P receptor modulator
Market / country: 🇺🇸 USA
Zeposia (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Zeposia · 2.2
- • Days 1–4: 0.23 mg; days 5–7: 0.46 mg. Mild/moderate hepatic impairment: 0.92 mg every other day. Missed dose in the first 2 weeks: restart titration. FDA Zeposia · 2.2, Table 1FDA Zeposia · 2.3FDA Zeposia · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Within 6 months: MI, unstable angina, stroke, TIA, decompensated or class III/IV heart failure; Mobitz II or third-degree AV block or sick sinus syndrome without a pacemaker; severe untreated sleep apnoea; concomitant MAO inhibitors. FDA Zeposia · 4
Warnings
- • Infections and PML; macular oedema; bradyarrhythmia at initiation; respiratory effects; liver injury; skin cancer; raised blood pressure; fetal risk; severe disability increase after stopping. FDA Zeposia · 5
Formulations
- 0.92 mg capsule — capsule 🇺🇸 USA FDA Zeposia · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Zeposia · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Zeposia · 8.2
“Risk Summary There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Zeposia · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Zeposia · 8.5
“Monitor elderly patients for cardiac and hepatic adverse reactions, because of the greater frequency of reduced cardiac and hepatic function in the elderly population.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Zeposia · 8.3
“Contraception Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment with ZEPOSIA [see Use in Specific Populations (8.1) ] .”
🔗 Reference links
- FDA (approval record)NDA209899
- DailyMed (FDA label)FDA Zeposia
- MedlinePlus (NIH)Ozanimod
- WHO ATC/DDDL04AE02
- Darooyab (Iran)Ozanimod
🇮🇷 Registered in Iran Darooyab · G-5538/Ozanimod
Dosage forms with Iranian generic codes, per Darooyab.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Zeposia · 3FDA Zeposia · 2.2FDA Zeposia · 2.2, Table 1FDA Zeposia · 2.3FDA Zeposia · 2.4FDA Zeposia · 4FDA Zeposia · 5FDA Zeposia · SPL approval / marketing categoryFDA Zeposia · 8.1FDA Zeposia · 8.2FDA Zeposia · 8.4FDA Zeposia · 8.5FDA Zeposia · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5538/Ozanimod
- Clinical review⚠ Unverified