Bivalirudin 250 mg/1
Bivalirudin · INJECTION · Dr. Reddy's Laboratories Limited
Bivalirudin is a injection containing bivalirudin at 250 mg/1, taken intracavernous. Manufactured by Dr. Reddy's Laboratories Limited.
Key Facts
- Brand Name
- Bivalirudin
- Generic Name
- Bivalirudin
- NDC Code (Product)
55111-652- Manufacturer
- Dr. Reddy's Laboratories Limited
- Strength
- 250 mg/1
- Dosage Form
- INJECTION
- Route
- INTRACAVERNOUS
- Marketing Status
- Application #
- ANDA201577
- Drug Class
- Anti-coagulant [EPC]; Direct Thrombin Inhibitor [EPC]
- Marketing Start
- 05/31/2017
Recall History
Accord Healthcare, Inc.
Presence of Particulate Matter: Particulate matter identified as fiber.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 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 & Administration
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 needed. • Extending duration of infusion post-procedure up to 4 hours should be considered in patients with ST segment elevation MI (STEMI). ( 2.1 ) 2.1 Recommended Dosage Bivalirudin has been studied only in patients receiving concomitant aspirin. The recommended dose of bivalirudin is an intravenous bolus dose of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h 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 of 0.3 mg/kg should be given if needed. Extended duration of infusion following PCI at 1.75 mg/kg/h for up to 4 hours post-procedure should be considered in patients with ST segment elevation MI (STEMI). 2.2 Dose Adjustment in Renal Impairment Bolus Dose No reduction in the bolus dose is nee…
Contraindications
4 CONTRAINDICATIONS Bivalirudin is contraindicated in patients with: • Active major bleeding; • Hypersensitivity (e.g., anaphylaxis) to bivalirudin or its components [see Adverse Reactions (6.1) ] . • Active major bleeding ( 4 ) • Hypersensitivity to bivalirudin or its components ( 4 )
Drug Interactions
7 DRUG INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), coadministration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications. Heparin, warfarin, thrombolytics, or GPIs: Increased major bleeding risk with concomitant use. ( 7 )
Adverse Reactions
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the BAT trials, 79 of the 2161 (3.7%) patients undergoing PCI for treatment of unstable angina and randomized to bivalirudin experienced major bleeding events, which consisted of intracranial bleeding, retroperitoneal bleeding, and clinically overt bleeding with a decrease in hemoglobin greater than 3 g/dL or leading to a transfusion of greater than 2 units of blood. 6.2 Immunogenicity As with all peptides, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors …
Frequently Asked Questions
What is Bivalirudin used for?
Bivalirudin contains Bivalirudin. It is a injection taken intracavernous. Consult your doctor for specific uses.
Is Bivalirudin a controlled substance?
Bivalirudin is not classified as a controlled substance by the DEA.
What is the generic name for Bivalirudin?
The generic name for Bivalirudin is Bivalirudin. There are 4 other brand versions of Bivalirudin.
What is the NDC code for Bivalirudin 250 mg/1?
The NDC (National Drug Code) for Bivalirudin 250 mg/1 is 55111-652, listed by Dr. Reddy's Laboratories Limited.