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bivalirudin for injection - ADD-VANTAGE
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
bivalirudin for injection - ADD-VANTAGE Quick Finder
Highlights
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Bleeding Events
Bivalirudin increases the risk of bleeding [see Adverse Reactions (6.1)]...
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Adverse Reactions
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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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no data...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
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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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
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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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.