bivalirudin for injection - ADD-VANTAGE How Supplied/Storage and Handling | Pfizer Medical Information - US

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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 vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate.3

Unit of Sale	Concentration
NDC 0409-8300-15 Tray containing 10 Single-dose ADD-Vantage™ vials	250 mg/vial

3: The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.7 to 2.6 equivalents.

16.2 Storage

Store Bivalirudin for Injection dosage units at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]

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bivalirudin for injection - ADD-VANTAGE Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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 Adverse Reactions (6.1)]...

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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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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), 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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

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.