BIVALIRUDIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BIVALIRUDIN (UNII: TN9BEX005G) (BIVALIRUDIN - UNII:TN9BEX005G)

Available from:

Sandoz Inc

INN (International Name):

BIVALIRUDIN

Composition:

BIVALIRUDIN 250 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bivalirudin for injection 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. Bivalirudin is contraindicated in patients with: Risk Summary There are no data available on use of bivalirudin in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Reproduction studies in rats and rabbits administered subcutaneously doses up to 1.6 times and 3.2 times the maximum recommended human dose (MRHD) of 15 mg/kg/day based on body surface area (BSA) during organogenesis, respectively, revealed no evidence of fetal harm. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage

Product summary:

Bivalirudin for injection is supplied as a sterile, lyophilized powder in single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate*. *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. NDC 0781-3158-95 – Package of 10 – 250 mg Single-Dose Vials Store bivalirudin for injection dosage units at 20° to 25°C (68° to 77°F); excursions to 15° to 30°C permitted [see USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BIVALIRUDIN- BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
SANDOZ INC
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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 for injection 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
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DOSAGE FORMS AND STRENGTHS
For injection: 250 mg of bivalirudin as a lyophilized powder in a
single dose vial for reconstitution. (3)
CONTRAINDICATIONS
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•
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Most common adverse reaction (>2%) was bleeding. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 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
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•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 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
ne e de d.
Extending duration of infusion post-procedure up to 4 hours should be
considered in patients with ST segment
elevation MI (STEMI). (2.1)
Active major bleeding (4)
Hypersensitivity to bivalirudin or its components (4)
Bleeding Events: Bivalirudin increases the risk of ble