BIVALIRUDIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

Bivalirudin

Composition:

Bivalirudin 250 mg

Administration route:

INTRACAVERNOUS

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 for injection is contraindicated in patients with: - Active major bleeding; - Hypersensitivity (e.g., anaphylaxis) to bivalirudin for injection or its components [see Adverse Reactions (6.3)]. Risk Summary There are no data available on use of bivalirudin for injection 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 bir

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. Package of 10 Single-dose Vials NDC 55111-652-37 Store bivalirudin for injection dosage units at 20 to 25°C (68 to 77°F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BIVALIRUDIN- BIVALIRUDIN INJECTION
DR. REDDY'S LABORATORIES LIMITED
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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
• 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
beconsidered 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 vial for reconstitution. (3)
CONTRAINDICATIONS
Active major bleeding (4)
Hypersensitivity to bivalirudin or its components (4)
WARNINGS AND PRECAUTIONS
Bleeding Events: Bivaluridin 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 THE DR. REDDY’S
LABORATORIES INC. AT 1-888-375-3784OR
THE FDA AT 1-800-FDA-1088 OR _www.fda.gov/medwatch_
DRUG INTERACTIONS
Hep