bivalirudin for injection - VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.

BIVALIRUDIN for injection, for intravenous use
Initial U.S. Approval: 2000

INDICATIONS AND USAGE

Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).(1)

DOSAGE AND ADMINISTRATION

  • The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion 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 dose of 0.3 mg/kg should be given if needed.
  • Extending duration of infusion post-procedure up to 4 hours should be considered in patients with ST segment elevation MI (STEMI).(2.1)

DOSAGE FORMS AND STRENGTHS

For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose glass vial for reconstitution.(3)

CONTRAINDICATIONS

  • Active major bleeding (4)
  • Hypersensitivity to bivalirudin or its components (4)

WARNINGS AND PRECAUTIONS

  • Bleeding Events: Bivalirudin increases the risk of bleeding.(5.1, 6.1, 12.2)
  • Acute Stent Thrombosis: Increased incidence of acute stent thrombosis in STEMI patients undergoing primary PCI. (2.1, 5.2)
  • Thrombotic Risk with Coronary Artery Brachytherapy: An increased risk of thrombus formation, including fatal outcomes, in gamma brachytherapy.(5.3)

ADVERSE REACTIONS

Most common adverse reaction (>2%) was bleeding.(6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use.(7)

USE IN SPECIFIC POPULATIONS

  • Geriatric Use: Increased bleeding risk possible.(8.5)
  • Renal impairment: Reduce infusion dose and monitor ACT.(2.2, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BIVALIRUDIN FOR INJECTION safely and effectively. See full prescribing information for BIVALIRUDIN FOR INJECTION.

BIVALIRUDIN for injection, for intravenous use
Initial U.S. Approval: 2000

INDICATIONS AND USAGE

Bivalirudin is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).(1)

DOSAGE AND ADMINISTRATION

  • The recommended dosage is a 0.75 mg/kg intravenous bolus dose followed immediately by a 1.75 mg/kg/h intravenous infusion 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 dose of 0.3 mg/kg should be given if needed.
  • Extending duration of infusion post-procedure up to 4 hours should be considered in patients with ST segment elevation MI (STEMI).(2.1)

DOSAGE FORMS AND STRENGTHS

For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose glass vial for reconstitution.(3)

CONTRAINDICATIONS

  • Active major bleeding (4)
  • Hypersensitivity to bivalirudin or its components (4)

WARNINGS AND PRECAUTIONS

  • Bleeding Events: Bivalirudin increases the risk of bleeding.(5.1, 6.1, 12.2)
  • Acute Stent Thrombosis: Increased incidence of acute stent thrombosis in STEMI patients undergoing primary PCI. (2.1, 5.2)
  • Thrombotic Risk with Coronary Artery Brachytherapy: An increased risk of thrombus formation, including fatal outcomes, in gamma brachytherapy.(5.3)

ADVERSE REACTIONS

Most common adverse reaction (>2%) was bleeding.(6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use.(7)

USE IN SPECIFIC POPULATIONS

  • Geriatric Use: Increased bleeding risk possible.(8.5)
  • Renal impairment: Reduce infusion dose and monitor ACT.(2.2, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2019
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