Bivalirudin
بیوالیرودین
🩸 Blood And Blood Forming OrgansDirect thrombin inhibitor
Market / country: 🇺🇸 USA
Angiomax (US)
🧮 Dose calculator
Acute coronary syndrome / post-MI · Regimen source: FDA Bivalirudin · 2.1
- • The calculator gives the BOLUS. Check ACT after 5 min; extra 0.3 mg/kg bolus if needed. Studied only with aspirin. Infusion may continue up to 4 h after PCI. FDA Bivalirudin · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Active major bleeding; hypersensitivity to bivalirudin. FDA Bivalirudin · 4
Renal adjustment
- • eGFR < 30: CrCl <30: infusion 1 mg/kg/h; haemodialysis: 0.25 mg/kg/h. No change to the bolus. FDA Bivalirudin · 2
Formulations
- 250 mg vial — powder for injection 🇺🇸 USA FDA Bivalirudin · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Bivalirudin · 8.1
“Risk Summary There are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Bivalirudin · 8.2
“No data are available on the effects on the breastfed child or on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Bivalirudin · 8.4
“The safety and effectiveness of bivalirudin in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Bivalirudin · 8.5
“In studies of patients undergoing PCI, 44% were ≥65 years of age and 12% of patients were ≥75 years old.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA210031
- DailyMed (FDA label)FDA Bivalirudin
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDB01AE06
- Darooyab (Iran)Bivalirudin
🇮🇷 Registered in Iran Darooyab · G-1561/Bivalirudin
Dosage forms with Iranian generic codes, per Darooyab.
- 52515 · BIVALIRUDIN 250 mg Powder For Injection · پودر تزریقی بیوالیرودین ۲۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Bivalirudin · 3FDA Bivalirudin · 2.1FDA Bivalirudin · 4FDA Bivalirudin · 2FDA Bivalirudin · SPL approval / marketing categoryFDA Bivalirudin · 8.1FDA Bivalirudin · 8.2FDA Bivalirudin · 8.4FDA Bivalirudin · 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-1561/Bivalirudin
- Clinical review⚠ Unverified