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Benralizumab

بنرالیزوماب

⚠ Unverified

🌬️ Respiratory SystemAnti-IL-5 receptor antibody

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list ⛔ 1 contraindications 🇺🇸 FDA approved (BLA) BLA761070 ATC R03DX10

Market / country: 🇺🇸 USA

Fasenra (US)

🧮 Dose calculator

Disease / regimen

Asthma and chronic lung disease (reversible airflow obstruction) · Regimen source: FDA Fasenra · 2.1

Formulation

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🛡️ Safety & information

Contraindications

⛔ Hypersensitivity to benralizumab. FDA Fasenra · 4

Warnings

• Hypersensitivity; not for acute asthma; do not stop corticosteroids abruptly; treat helminth infection before starting. FDA Fasenra · 5

Formulations

30 mg/mL prefilled syringe or pen — injection 🇺🇸 USA FDA Fasenra · 3
10 mg/0.5 mL prefilled syringe — injection 🇺🇸 USA FDA Fasenra · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Fasenra · 8.1
“Risk Summary The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Fasenra · 8.2
“Risk Summary There is no information regarding the presence of benralizumab in human or animal milk, and the effects of benralizumab on the breast fed infant and on milk production are not known.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Fasenra · 8.4
“Asthma The safety and effectiveness of FASENRA for add-on maintenance treatment of patients with severe asthma and with an eosinophilic phenotype have been established in pediatric patients 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 Fasenra · 8.5
“Asthma Of the total number of patients in asthma clinical trials of benralizumab, 13% (n=320) were 65 and over, while 0.4% (n=9) were 75 and over.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA761070
DailyMed (FDA label)FDA Fasenra
MedlinePlus (NIH)Benralizumab Injection
WHO ATC/DDDR03DX10
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)✅ Present
FDA Fasenra · 3 FDA Fasenra · 2.1 FDA Fasenra · 2.1, Table 1 FDA Fasenra · 2.2 FDA Fasenra · 2.3 FDA Fasenra · 4 FDA Fasenra · 5 FDA Fasenra · SPL approval / marketing category FDA Fasenra · 8.1 FDA Fasenra · 8.2 FDA Fasenra · 8.4 FDA Fasenra · 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)✅ Present
Darooyab · search
Clinical review⚠ Unverified