Idarucizumab
ایداروسیزوماب
🧪 VariousSpecific dabigatran reversal agent
Market / country: 🇺🇸 USA
Praxbind (US)
🧮 Dose calculator
Life-threatening bleeding on anticoagulants (reversal) · Regimen source: FDA Praxbind · 2.1
- • Two 2.5 g vials consecutively (infusions or bolus). Limited data for a second 5 g. Restart anticoagulation as soon as medically appropriate; dabigatran after 24 h. FDA Praxbind · 2.1FDA Praxbind · 2.3FDA Praxbind · 2.4
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Formulations
- 2.5 g/50 mL vial (dose = 2 vials) — injection 🇺🇸 USA FDA Praxbind · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Praxbind · 8.1
“Risk Summary There are no available data on PRAXBIND 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 Praxbind · 8.2
“Because many drugs are excreted in human milk, caution should be exercised when PRAXBIND is administered to a nursing woman.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Praxbind · 8.4
“Safety and effectiveness have not 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 Praxbind · 8.5
“A total of 454 (90%) patients treated with idarucizumab in the case series trial were 65 years of age and older, and 318 (63%) were 75 years of age and older.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA761025
- DailyMed (FDA label)FDA Praxbind
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDV03AB37
- Darooyab (Iran)Idarucizumab
🇮🇷 Registered in Iran Darooyab · G-5494/Idarucizumab
Dosage forms with Iranian generic codes, per Darooyab.
- 52463 · IDARUCIZUMAB INJECTION, SOLUTION PARENTERAL 2.5 g/50mL · محلول تزریقی ایداروسیزومب ۲٫۵ گرم / ۵۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Praxbind · 3FDA Praxbind · 2.1FDA Praxbind · 2.3FDA Praxbind · 2.4FDA Praxbind · SPL approval / marketing categoryFDA Praxbind · 8.1FDA Praxbind · 8.2FDA Praxbind · 8.4FDA Praxbind · 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-5494/Idarucizumab
- Clinical review⚠ Unverified