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bivalirudin for injection - ADD-VANTAGE

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bivalirudin for injection - ADD-VANTAGE Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

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

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Bivalirudin has been studied only in patients receiving concomitant aspirin.

The recommended dose of...

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3 DOSAGE FORMS AND STRENGTHS

For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose, ADD-Vantage™ vial for reconstitution. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg...

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4 CONTRAINDICATIONS

Bivalirudin is contraindicated in patients with:

  • Active major bleeding;
  • Hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see ...
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5 WARNINGS AND PRECAUTIONS

5.1 Bleeding Events

Bivalirudin increases the risk of bleeding [see

5.2 Acute Stent Thrombosis in Patients with...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

In clinical trials in patients undergoing PCI/percutaneous transluminal coronary angioplasty (PTCA), co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no data...

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10 OVERDOSAGE

Cases of overdose of up to 10 times the recommended bolus or continuous infusion dose of bivalirudin have been reported in clinical trials and in postmarketing reports. A number of the reported overdoses were...

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11 DESCRIPTION

Bivalirudin is a specific and reversible direct thrombin inhibitor. Bivalirudin is a synthetic, 20 amino acid peptide, with the chemical name of D-phenylalanyl-L-prolyl-L-arginyl-L-prolyl-glycyl-glycyl-glycyl-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bivalirudin directly inhibits thrombin by specifically binding both to the catalytic site and to the anion-binding...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed to evaluate the carcinogenic...

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14 CLINICAL STUDIES

Bivalirudin Angioplasty Trial (BAT)

In the BAT studies, patients with unstable angina undergoing PCI were randomized 1:1 to a 1 mg/kg bolus of...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Bivalirudin for Injection is supplied as a sterile, lyophilized powder in single-dose, ADD-Vantage™ vials. Each...

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17 PATIENT COUNSELING INFORMATION

Advise patients to watch carefully for any signs of bleeding or bruising and to report these to their health care provider when they occur.

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