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Andexanet alfa

آندگزانت آلفا

⚠ Unverified

🧪 VariousFactor Xa inhibitor reversal agent

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution 🇮🇷 Not found in Iran list 🇺🇸 FDA approved (BLA) BLA125586 ATC V03AB38

Market / country: 🇺🇸 USA

Andexxa (US)

🧮 Dose calculator

Disease / regimen

Life-threatening bleeding on anticoagulants (reversal) · Regimen source: FDA Andexxa · 2.1

⛔ Low dose: 400 mg bolus (30 mg/min) then 4 mg/min for 120 min. High dose: 800 mg then 8 mg/min for 120 min. Choice per label table. More than one dose not studied. FDA Andexxa · 2.1

🛡️ Safety & information

Warnings

• Boxed warning: thromboembolic and ischaemic events, cardiac arrest and sudden death. FDA Andexxa · Boxed Warning

Formulations

200 mg vial (10 mg/mL after reconstitution) — powder for injection 🇺🇸 USA FDA Andexxa · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Andexxa · 8.1
“Risk Summary There are no adequate and well-controlled studies of ANDEXXA in pregnant women to inform patients of associated risks.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Andexxa · 8.2
“Risk Summary There is no information regarding the presence of ANDEXXA 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 Andexxa · 8.4
“The safety and efficacy of ANDEXXA in the pediatric population have not been studied.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Andexxa · 8.5
“Of the 419 patients in the ANNEXA-4 study of ANDEXXA, 381 (91%) were 65 years of age or older, and 278 (66%) were older than 75 years of age.”
⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.

🔗 Reference links

FDA (approval record)BLA125586
DailyMed (FDA label)FDA Andexxa
MedlinePlus (NIH)❌ None
WHO ATC/DDDV03AB38
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 Andexxa · 3 FDA Andexxa · 2.1 FDA Andexxa · Boxed Warning FDA Andexxa · SPL approval / marketing category FDA Andexxa · 8.1 FDA Andexxa · 8.2 FDA Andexxa · 8.4 FDA Andexxa · 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

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