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:

Hainan Shuangcheng Pharmaceuticals Co., Ltd.

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: - Active major bleeding; - Hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see Adverse Reactions (6.3)] . 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 indic

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 1.9 to 2.6 equivalents. NDC 52958-034-01 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:

Abbreviated New Drug Application

Summary of Product characteristics

BIVALIRUDIN- BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.
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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 be
considered 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: Bivalirudin 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 HAINAN SHUANGCHENG
PHARMACEUTICALS CO., LTD. AT 1-
732-346-6655 OR THE FDA AT 1-800-F