Emicizumab
امیسیزوماب
🩸 Blood And Blood Forming OrgansBispecific antibody (factor VIII mimetic)
Market / country: 🇺🇸 USA
Hemlibra (US)
🧮 Dose calculator
Haemophilia A · Regimen source: FDA Hemlibra · 2.1
- • Stop prophylactic bypassing agents the day before starting; prophylactic factor VIII may continue in week 1. FDA Hemlibra · 2.1
Enter age and weight.
🛡️ Safety & information
Warnings
- • Boxed warning: thrombotic microangiopathy and thromboembolism with aPCC (>100 U/kg/24 h for ≥24 h). Interferes with coagulation tests (aPTT). FDA Hemlibra · Boxed WarningFDA Hemlibra · 5.4
Formulations
- 30 mg/mL vial — injection 🇺🇸 USA FDA Hemlibra · 3
- 150 mg/mL vial (60 mg/0.4, 105 mg/0.7, 150 mg/1, 300 mg/2 mL) — injection 🇺🇸 USA FDA Hemlibra · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Hemlibra · 8.1
“Risk Summary There are no available data on HEMLIBRA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Hemlibra · 8.2
“Risk Summary There is no information regarding the presence of emicizumab-kxwh in human milk, the effects on the breastfed child, 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 Hemlibra · 8.4
“The safety and efficacy of HEMLIBRA have been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Hemlibra · 8.5
“Clinical studies of HEMLIBRA did not include a sufficient number of patients aged 65 and over to determine whether they respond differently from younger patients.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Hemlibra · 8.3
“Contraception Women of childbearing potential should use contraception while receiving HEMLIBRA.”
🔗 Reference links
- FDA (approval record)BLA761083
- DailyMed (FDA label)FDA Hemlibra
- MedlinePlus (NIH)Emicizumab-kxwh Injection
- WHO ATC/DDDB02BX06
- Darooyab (Iran)Emicizumab
🇮🇷 Registered in Iran Darooyab · G-5488/Emicizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 52947 · EMICIZUMAB 30 mg/1mL INJECTION · فرآورده تزریقی امیسیزومب ۳۰ میلیگرم / ۱ میلیلیتر
- 52950 · EMICIZUMAB 150 mg/1mL 1 ML INJECTION · فرآورده تزریقی امیسیزومب ۱۵۰ میلیگرم / ۱ میلیلیتر ۱ میلیلیتر
- 52949 · EMICIZUMAB 150 mg/1mL 0.7 ML INJECTION · فرآورده تزریقی امیسیزومب ۱۵۰ میلیگرم / ۱ میلیلیتر ۰٫۷ میلیلیتر
- 52948 · EMICIZUMAB 150 mg/1mL 0.4 ML INJECTION · فرآورده تزریقی امیسیزومب ۱۵۰ میلیگرم / ۱ میلیلیتر ۰٫۴ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Hemlibra · 3FDA Hemlibra · 2.1FDA Hemlibra · Boxed WarningFDA Hemlibra · 5.4FDA Hemlibra · SPL approval / marketing categoryFDA Hemlibra · 8.1FDA Hemlibra · 8.2FDA Hemlibra · 8.4FDA Hemlibra · 8.5FDA Hemlibra · 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-5488/Emicizumab
- Clinical review⚠ Unverified