BIVALIRUDIN- bivalirudin injection
Dr. Reddy’s Laboratories Limited
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
Bivalirudin for injection has been studied only in patients receiving concomitant aspirin.
The recommended dose of bivalirudin for injection 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 afterthe bolus dose has been administered, an activated clotting time (ACT) should be performed andan 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
No reduction in the bolus dose is needed for any degree of renal impairment.
In patients with creatinine clearance less than 30mL/min (by Cockcroft Gault equation), reduce the infusion rate to 1 mg/kg/h. Monitor anticoagulant status in patients with renal impairment.
In patients on hemodialysis, reduce the infusion rate to 0.25 mg/kg/h [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.3 Instructions for Preparation and Administration
Bivalirudin for injection is intended for intravenous bolus injection and continuous infusion after reconstitution and dilution.
Preparation Instructions for Bolus Injection and Continuous Infusion
• To each 250 mg vial, add 5 mL of Sterile Water for Injection, USP.
• Gently swirl until all material is dissolved.
• Withdraw and discard 5 mL from a 50 mL infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection.
• Add the contents of the reconstituted vial to the infusion bag containing 5% Dextrose in Water or 0.9% Sodium Chloride for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50 mL; 2 vials in 100 mL; 5 vials in 250 mL).
• Adjust the dose to be administered according to the patient’s weight (see Table 1).
Table 1 . Dosing Table
|Weight (kg)||Using 5 mg/mL Concentration|
| Bolus |
0.75 mg/kg ( mL)
| Infusion |
1.75 mg/kg/h( mL/h)
No incompatibilities have been observed with administration sets.
Do not be administer the drugs listed in Table 2 in the same intravenous line with bivalirudin for injection.
|Table 2. Drugs Not for Administration in the Same Intravenous Line with Bivalirudin for Injection.|
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Preparations of bivalirudin for injection containing particulate matter should not be used. Reconstituted material will be a clear to slightly opalescent, colorless to slightly yellow solution.
2.4 Storage after Reconstitution
Do not freeze reconstituted or diluted bivalirudin for injection. Reconstituted material may be stored at 2 to 8º C for up to 24 hours. Diluted bivalirudin for injection with a concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature for up to 24 hours. Discard any unused portion of reconstituted solution remaining in the vial.
3 DOSAGE FORMS AND STRENGTHS
For injection: 250 mg of bivalirudinas a lyophilized power in a single-dose vial for reconstitution. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg 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.
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)].
5 WARNINGS AND PRECAUTIONS
5.1 Bleeding Events
Bivalirudin for injection increases the risk of bleeding [see Adverse Reactions (6.1)]. An unexplained fall in blood pressure or hematocrit should lead to serious consideration of a hemorrhagic event and cessation of bivalirudin for injection administration. Monitor patients receiving bivalirudin for injection for signs and symptoms of bleeding. Monitor patients with disease states associated with an increased risk of bleeding more frequently for bleeding.
5.2 Acute Stent Thrombosis in Patients with STEMI Undergoing PCI
Acute stent thrombosis (AST) (<4 hours) has been observed at a greater frequency in bivalirudin for injection treated patients (1.2%, 36/2889) compared to heparin treated patients (0.2%, 6/2911) with STEMI undergoing primary PCI. Among patients who experienced an AST, one fatality (0.03%) occurred in a bivalirudin for injection treated patient and one fatality (0.03%) in a heparin treated patient. These patients have been managed by Target Vessel Revascularization (TVR). Patients should remain for at least 24 hours in a facility capable of managing ischemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischemia.
5.3 Thrombotic Risk with Coronary Artery Brachytherapy
An increased risk of thrombus formation, including fatal outcomes, has been associated with the use of bivalirudin for injection in gamma brachytherapy.
If a decision is made to use bivalirudin for injection during brachytherapy procedures, maintain meticulous catheter technique, with frequent aspiration and flushing, paying special attention to minimizing conditions of stasis within the catheter or vessels [see Adverse Reactions (6.1)] .
6 ADVERSE REACTIONS
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