Bivalirudin Injection 250 mg

Bivalirudin  is a specific and reversible direct thrombin inhibitor (DTI). It is a synthetic congener of the naturally occurring drug hirudin (found in the saliva of the medicinal leech Hirudo medicinalis).Bivalirudin is a DTI that overcomes many limitations seen with indirect thrombin inhibitors, such as heparin. Bivalirudin is a short, synthetic peptide that is potent, highly specific, and a reversible inhibitor of thrombin.It inhibits both circulating and clot-bound thrombin.It does not require a binding cofactor such as antithrombin and does not activate platelets. These characteristics make bivalirudin an ideal alternative to heparin.

Bivalirudin is intended for IV use only and is supplied as a sterile, lyophilized product in single-use, glass vials. After reconstitution, each vial delivers 250 mg of bivalirudin.

Very common: More than 1 in 10 people who have Bivalirudin

  • minor bleeding from various sites of the body

Common: More than 1 in 100 people who have Bivalirudin

  • abnormal laboratory test results
  • bruising
  • injection site problems such as bleeding, pain, discomfort or collection of blood under the skin
  • major bleeding from various sites of the body – certain types of bleeding may be fatal. Seek medical advice if you develop any unusual bleeding
  • thrombosis – this may be fatal

Uncommon: More than 1 in 1000 people who have Bivalirudin

  • blood and bone marrow problems
  • blood in the urine
  • collection of blood under the skin
  • coughing blood
  • headaches
  • hypersensitivity reactions such as tightness of chest, wheezing, anaphylaxis or anaphylactic shock. Anaphylaxis or anaphylactic shock may be fatal
  • lowered blood pressure
  • melaena
  • nausea
  • nose bleed
  • vomiting blood

Rare: More than 1 in 10,000 people who have Bivalirudin

  • back pain
  • breathing difficulties
  • chest pain
  • circulation problems
  • fistula
  • groin pain
  • irregular heart rate
  • other heart problems or a heart attack
  • skin rash or rashes
  • urticaria
  • vomiting

Very rare: Fewer than 1 in 10,000 people who have Bivalirudin

  • compartment syndrome