Nirsevimab
نیرسویماب
🦠 Antiinfectives For Systemic UseAnti-RSV monoclonal antibody
Market / country: 🇺🇸 USA
Beyfortus (US)
🧮 Dose calculator
RSV prophylaxis in infants · Regimen source: FDA Beyfortus · 2.1, Table 1
- • Born during the RSV season: from birth. Born outside the season: once before the season starts. Second season for high-risk children up to 24 months: 200 mg regardless of weight. Can be given with childhood vaccines (separate syringe and site). FDA Beyfortus · 2.1, Table 1FDA Beyfortus · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of serious hypersensitivity (including anaphylaxis) to nirsevimab. FDA Beyfortus · 4
Formulations
- 50 mg/0.5 mL prefilled syringe — injection 🇺🇸 USA FDA Beyfortus · 3
- 100 mg/mL prefilled syringe — injection 🇺🇸 USA FDA Beyfortus · 3
👥 Special populations
- 🤰 PregnancyNo data
Label: an infant product; not indicated for adult women. FDA Beyfortus · 8.1
“BEYFORTUS is not indicated for use in females of reproductive potential.”
- 🤱 BreastfeedingNo data
Label: an infant product; not indicated for adult women. FDA Beyfortus · 8.2
“BEYFORTUS is not indicated for use in females of reproductive potential.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Beyfortus · 8.4
“The safety and effectiveness of BEYFORTUS have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.”
- 👴 Older adultsNo data
The source for this drug has no section for this group.
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA761328
- DailyMed (FDA label)FDA Beyfortus
- MedlinePlus (NIH)Nirsevimab-alip
- WHO ATC/DDDJ06BD08
- Darooyab (Iran)❌ None
🇮🇷 Not found in Iran list Darooyab · search
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Beyfortus · 3FDA Beyfortus · 2.1, Table 1FDA Beyfortus · 2.2FDA Beyfortus · 4FDA Beyfortus · 8.1FDA Beyfortus · 8.2FDA Beyfortus · 8.4FDA Beyfortus · SPL approval / marketing category
- 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 · search
- Clinical review⚠ Unverified