API- Bivalirudin

Packaging- Single-Use Vial

Strength- 250mg

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Bivalirudin specifically is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing:

  • Percutaneous Transluminal Coronary Angioplasty (PTCA)
  • Percutaneous Coronary Intervention (PCI)
  • Also indicated for the treatment of adult patients with unstable angina/ non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.

Dosage and Side Effects

The recommended dose of Bivalirudin is for intravenous administration only. It is intended for use together with the aspirin (300-325 mg daily) and has been studied only in patients taking concomitant aspirin.

The most common adverse reactions include bleeding. Other adverse reactions include thrombocytopenia, fever and headache.

Warning and Precautions

  • Use of bivalirudin 250 mg injection is contraindicated in patients with active major bleeding and hypersensitivity.
  • Patients should be carefully monitored after primary PCI for signs/symptoms consistent with myocardial ischemia.
  • An increased risk of the thrombus formation, including fatal outcomes, may occur with the use of bivalirudin 250 mg injection in gamma brachytherapy.
  • This medication should be used with caution in patients with disease states associated with an increased risk of bleeding.
  • The infusion dose of bivasave may require to be decreased, and status of anticoagulant should be monitored in patients with renal impairment.
  • Use of bivalirudin injection and aspirin during pregnancy needs to be avoided.
  • Caution must be exercised when this medication is administered to a nursing woman.


What are the alternate Brands of Bivalirudin Injection?

  • Bivastat 250mg Injection (Cipla Ltd) 
  • Gennomax 250mg Injection (Emcure Pharmaceuticals Ltd) 
  • Nubimax 250mg Injection (Emcure Pharmaceuticals Ltd) 
  • Bivacard 250mg Injection (Biocon Ltd) 

From which class of drug Bivalirudin belongs?

Bivalirudin specifically belongs to the class of drugs named anticoagulants. 

What are commonly reported side effects?

Thrombocytopenia, fever and headache.

How should Bivalirudin be administered?

The recommended dose of bivalirudin 250 mg injection is intended for the intravenous bolus injection and continuous infusion.