Omalizumab
اومالیزومب
🌬️ Respiratory SystemAnti-IgE antibody
Market / country: 🇺🇸 USA
Xolair (US)
🧮 Dose calculator
Chronic idiopathic urticaria · Regimen source: FDA Xolair · 2.5
- • One dose every 4 WEEKS (not daily); independent of IgE and weight. FDA Xolair · 2.5
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Severe hypersensitivity reaction to omalizumab. FDA Xolair · 4
Warnings
- • Boxed warning: anaphylaxis (even after a year); start in a healthcare setting with observation after injection. FDA Xolair · Boxed Warning
Formulations
- 150 mg/mL prefilled syringe (also 75 mg/0.5 mL, 300 mg/2 mL) — injection 🇺🇸 USA FDA Xolair · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Xolair · 8.1
“Risk Summary A registry study of XOLAIR exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Xolair · 8.2
“Risk Summary There is no information regarding the presence of omalizumab in human milk, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Xolair · 8.4
“Asthma Safety and effectiveness of XOLAIR for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Xolair · 8.5
“In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with XOLAIR.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA103976
- DailyMed (FDA label)FDA Xolair
- MedlinePlus (NIH)Omalizumab Injection
- WHO ATC/DDDR03DX05
- Darooyab (Iran)Omalizumab
🇮🇷 Registered in Iran Darooyab · G-1476/Omalizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 07525 · OMALIZUMAB 150MG INJ · فرآورده تزریقی امالیزومب ۱۵۰ میلیگرم
- 18947 · OMALIZUMAB 75MG VIAL · ویال امالیزومب ۷۵ میلیگرم
- 53096 · OMALIZUMAB INJECTION, SOLUTION PARENTERAL 150 mg/1mL 1 mL · محلول تزریقی امالیزومب ۱۵۰ میلیگرم / ۱ میلیلیتر ۱ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Xolair · 3FDA Xolair · 2.5FDA Xolair · 2.2FDA Xolair · 4FDA Xolair · Boxed WarningFDA Xolair · SPL approval / marketing categoryFDA Xolair · 8.1FDA Xolair · 8.2FDA Xolair · 8.4FDA Xolair · 8.5
- 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-1476/Omalizumab
- Clinical review⚠ Unverified