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At a glance

Bivalirudin is an anticoagulant (blood thinner) medicine used to prevent and treat blood clots. It is used as an anticoagulant in patients undergoing PTCA/PCI, unstable angina, heart attack, and heparin-induced thrombocytopenia (HIT/HITTS).

Indications
  • Anticoagulant in patients undergoing PTCA/PCI
  • PCI with HIT/HITTS (heparin-induced thrombocytopenia/thrombosis syndrome)
  • Unstable angina/Non-ST-Elevation MI (off-label)
  • STEMI undergoing primary PCI (off-label)
  • Heparin-induced thrombocytopenia
Pharmacology

Bivalirudin is a synthetic 20-amino acid analogue of the naturally occurring hirudin. It specifically and reversibly inhibits thrombin by binding to the catalytic site and anion-binding exosite of circulating and clot-bound thrombin. Thrombin converts fibrinogen to fibrin and activates Factor XIII, stabilizing the thrombus. Bivalirudin inhibits these thrombin-mediated actions, preventing blood clot formation.

Dosage

PCI/PTCA: IV Bolus: 0.75 mg/kg, then infusion: 1.75 mg/kg/h for the duration of the PCI procedure. Obtain ACT 5 minutes after bolus and administer additional 0.3 mg/kg bolus if indicated.

HIT/HITTS: IV Bolus: 0.75 mg/kg, followed by continuous infusion at 1.75 mg/kg/h for the duration of the procedure.

Post-procedure: Infusion may be continued for up to 4 hours post-procedure as indicated. After 4 hours, an additional infusion of 0.2 mg/kg/h for up to 20 hours may be given if needed.

Concomitant Therapy: Intended for use with aspirin (300-325 mg/day).

Renal Impairment:
CrCl 30-50 mL/min: Infusion rate 1.75 mg/kg/h
CrCl <30 mL/min: Reduce infusion rate to 1 mg/kg/h
Hemodialysis: Reduce infusion rate to 0.25 mg/kg/h (no reduction in bolus dose needed)

Hepatic impairment: No dosage adjustment needed.

Side effects

Common: Bleeding (bruising), hypotension, nausea, headache, fever, infection, sepsis.

Cardiovascular: Hypotension, syncope, vascular anomaly, ventricular fibrillation.

Nervous: Cerebral ischemia, confusion, facial paralysis.

Respiratory: Lung edema.

Urogenital: Kidney failure, oliguria.

Elderly patients experienced more bleeding events than younger patients.

Use in pregnancy

Pregnancy Category B. No adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Due to potential for increased maternal bleeding, especially during the third trimester, use with aspirin only if clearly needed.

Pregnancy Category: B — always consult a doctor before taking during pregnancy.

Precautions & warnings
  • Bleeding events: Most bleeding occurs at the arterial puncture site, but hemorrhage can occur at any site. An unexplained fall in blood pressure or hematocrit should lead to consideration of a hemorrhagic event and cessation of bivalirudin.
  • Use with caution in patients with conditions associated with increased bleeding risk.
  • Coronary artery brachytherapy: Increased risk of thrombus formation with bivalirudin use in gamma brachytherapy.
  • Notify your doctor if you see blood in vomit, urine, or stool (black, tarry stools or bright red blood).
  • Caution with other anticoagulants.
Overdose effects

Cases of overdose up to 10 times the recommended bolus or infusion dose have been reported. Many overdoses were due to failure to adjust infusion dose in renal dysfunction including hemodialysis. In suspected overdose, discontinue bivalirudin immediately and monitor for signs of bleeding. No known antidote. Bivalirudin is hemodialyzable.

Storage conditions

Store below 30°C in a dry place. Do not freeze. Keep out of reach of children. Do not freeze reconstituted or diluted bivalirudin. Reconstituted material may be stored at 2-8°C for up to 24 hours. Diluted bivalirudin (0.5-5 mg/mL) is stable at room temperature for up to 24 hours.

Bivalirudin — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.