Bivalirudin

What is Bivalirudin?

• Bivalirudin (Angiomax; Angiomax rtu) is a direct thrombin inhibitor, used as an anticoagulant.

Bivalirudin

What are the uses of this medicine?

• Bivalirudin (Angiomax; Angiomax rtu) is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.

How does this medicine work?

• Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion binding exosite of circulating and clot-bound thrombin.
• Thrombin is a serine proteinase that plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently cross-linked framework which stabilizes the thrombus; thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.
• The binding of bivalirudin to thrombin is reversible as thrombin slowly cleaves the bivalirudin-Arg3-Pro4 bond, resulting in recovery of thrombin active site functions.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Active major bleeding.
• Hypersensitivity to bivalirudin or its components.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• heparin, warfarin, thrombolytics, or GPIs

Is this medicine FDA approved?

• Initial U.S. Approval: 2000

How should this medicine be used?

Recommended dosage:

• The recommended dose of Bivalirudin for Injection is an intravenous (IV) bolus dose of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h for the duration of the procedure.
• Five minutes after the bolus dose has been administered, an activated clotting time (ACT) should be performed and an additional bolus of 0.3 mg/kg should be given if needed.
• Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI).
• Bivalirudin for Injection has been studied only in patients receiving concomitant aspirin.

• In patients with creatinine clearance less than 30mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h.
• In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h.

Administration:

• Bivalirudin for Injection is for intravenous administration only.
• Bivalirudin for Injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of Bivalirudin for Injection containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 250 mg of bivalirudin in a single-dose vial for reconstitution.

This medicine is available in fallowing brand namesː

• Angiomax; Angiomax rtu

What side effects can this medication cause?

The most common side effects of this medicine include:

• bleeding

Less common side effects may include:

• fatal bleeding; hypersensitivity and allergic reactions including reports of anaphylaxis; lack of anticoagulant effect; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes; pulmonary hemorrhage; cardiac tamponade; and INR increased.

What special precautions should I follow?

• Bivalirudin for Injection increases the risk of bleeding. Monitor patients receiving Bivalirudin for Injection for signs and symptoms of bleeding. Monitor patients with disease states associated with an increased risk of bleeding more frequently for bleeding.
• Acute stent thrombosis (AST) (<4 hours) has been observed. Increased incidence of acute stent thrombosis in STEMI patients undergoing primary PCI.
• An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Bivalirudin for Injection in gamma brachytherapy.
• Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider when they occur.
• It is not known whether bivalirudin is present in human milk. No data are available on the effects on the breastfed child or on milk production.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Bleeding, as well as deaths due to hemorrhage, have been observed in some reports of overdose

Management of overdosage:

• In cases of suspected overdosage, discontinue bivalirudin immediately and monitor the patient closely for signs of bleeding.
• There is no known antidote to bivalirudin.
• Bivalirudin is hemodialyzable.

Can this medicine be used in pregnancy?

• There are no data available on use of Bivalirudin for Injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of bivalirudin in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BIVALIRUDIN

Inactive ingredients:

• MANNITOL
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• fresenius-kabi
• Lake Zurich, IL

What should I know about storage and disposal of this medication?

• Store Bivalirudin for Injection dosage units at 20° to 25°C (68° to 77°F).
• The container closure is not made with natural rubber latex.

Storage after Reconstitution:

• Do not freeze reconstituted or diluted Bivalirudin for Injection.
• Reconstituted material may be stored at 2 to 8ºC for up to 24 hours.
• Diluted Bivalirudin for Injection with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours.
• Discard any unused portion of reconstituted solution remaining in the vial.

• Dailymed label info on Bivalirudin
• FDA Bivalirudin

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