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