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BIVALIRUDIN is a brand name for Bivalirudin, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BIVALIRUDIN INJECTION (bivalirudin) is indicated for: use as an anticoagulant in patients undergoing percutaneous coronary intervention and in the treatment of patients with moderate to high risk acute coronary syndromes due to unstable angina or non-ST-segment elevation in whom early percutaneous coronary…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations BIVALIRUDIN INJECTION (bivalirudin) should be administered with ASA. Clopidogrel can also be administered. Patients can be started with BIVALIRUDIN INJECTION 30 minutes after discontinuation of UFH given intravenously, or 8 hours after discontinuation of LMWH given subcutaneously.
25 mg/kg/h prior to angiography and continued through angiography and as long as needed. The dose should be administered before assignment to a procedure (PCI, CABG, or drug therapy management). 25 mg/kg/h for up to 72 hours. No dosage adjustment is needed for these patients.
75 mg/kg/h for the duration of the procedure. 25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary. For patients who proceed to CABG surgery off-pump, the IV infusion of BIVALIRUDIN INJECTION should be continued until the time of surgery.
75 mg/kg/h infusion for the duration of the surgery. For patients who proceed to CABG surgery on-pump, the IV infusion of BIVALIRUDIN INJECTION should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin.
75 mg/kg. 75 mg/kg/h for the duration of the PCI procedure (see Table 1). 3 mg/kg should be given if needed. GPI administration should be considered in the event that any of the conditions listed in “CLINICAL TRIALS – REPLACE-2” is present.
Continuation of the infusion following PCI for up to 4 hours post-procedure is optional, at the discretion of the treating physician. 25 mg/kg/h may be continued for 4-12 hours as clinically necessary. BIVALIRUDIN INJECTION is intended for use with ASA (300 – 325 mg daily) and has only been studied in patients receiving concomitant ASA.
BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 6 of 41 In STEMI patients undergoing primary PCI, standard pre-PCI adjunctive therapy should include clopidogrel and may include the early administration of UFH (see CLINICAL TRIALS – HORIZONS).
Patients should be carefully monitored following PCI for signs and symptoms consistent with myocardial ischemia. 5 mg/kg/h IV infusion. BIVALIRUDIN INJECTION infusion may be terminated approximately 15 minutes prior to the anticipated end of cardiopulmonary bypass (CPB).
The ACT may be used to check that the patient is anticoagulated following administration of BIVALIRUDIN INJECTION. Infusion dose adjustment should not be necessary. For patients in whom hemofiltration is required during bypass, periodic ACT monitoring may be used (see Dosing Pre- and Post-Cardiac Surgery, Medical Management Guidelines for Cardiac Surgery).
1 Adverse Reaction Overview As with any antithrombotic treatment, hemorrhagic manifestations can occur. Risk factors for bleeding identified with the use of bivalirudin include elderly status, female gender, and the concomitant use of drugs known to cause bleeding, such as heparin, warfarin and thrombolytics.
These risks are comparable to those seen in heparin-treated patients. Petechiae or easy bruising may precede frank hemorrhage. The early signs of bleeding may include epistaxis, hematuria, or melena. Bleeding may occur at any site and be difficult to detect, for example, retroperitoneal bleeding.
Bleeding may also occur at surgical sites. Major hemorrhage, including retroperitoneal or intracranial bleeding, has been associated with bivalirudin use, in some cases leading to a fatal outcome. ACUITY (UA/NSTEMI) The type and severity of adverse events observed in the ACS trials were similar between the bivalirudin and other treatment groups, and were typical of ACS trials.
Few patients discontinued due to an adverse event, and the overall incidence and types of events that led to discontinuation were balanced between treatment groups. Very few of these events were associated with bleeding. 6% of heparin patients reported a serious adverse event leading to study discontinuation.
1% of patients in either treatment arm was cardiogenic shock. BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 13 of 41 REPLACE-2 (PCI) Adverse events observed in clinical trials are similar between the bivalirudin-treated patients and the control groups.
Adverse events seen are those typical of PCI trials. In clinical trials, adverse events leading to discontinuation occurred in 2% of bivalirudin patients and 7% of heparin patients. CHOOSE and EVOLUTION (Cardiac Surgery) Pleural effusion, atelectasis and atrial fibrillation were the most frequent adverse events observed in the clinical trials in both the bivalirudin group and the control group; these events are common following cardiac surgery.
General BIVALIRUDIN INJECTION (bivalirudin) should not be administered intramuscularly. There is no known antidote to bivalirudin. Bivalirudin is hemodialysable (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). Acute Stent Thrombosis Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see ADVERSE REACTIONS, HORIZONS; and CLINICAL TRIALS, HORIZONS).
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. An increased incidence of acute stent thrombosis has been mainly observed in STEMI patients undergoing primary PCI.
The majority of these cases were non-fatal. 25 mg/kg/hour. BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 11 of 41 Brachytherapy To date, no formal clinical trials have been conducted with bivalirudin as the principal anticoagulant when performing catheter-based brachytherapy (beta or gamma) to reduce the risk of in-stent restenosis.
Therefore, BIVALIRUDIN INJECTION is not recommended for use in brachytherapy procedures. An increased risk of thrombus formation has been associated with the use of bivalirudin in gamma brachytherapy, including fatal outcomes. Cardiac Surgery When bivalirudin is used in cardiac surgery, techniques that allow blood or blood-based solutions to lie stagnant should be avoided.
Local bivalirudin levels may decrease due to metabolism by proteases from blood exposed to wound or foreign surfaces, potentially leading to local clot formation. During surgery, blood should not be allowed to stand in grafts, and grafts should preferably be stored and tested for flow and leakage with saline, instead of blood.
Care should be taken to avoid stasis in the internal mammary artery after harvest. Circulation throughout the cardiopulmonary bypass (CPB) circuit must be ensured with particular attention paid to bypass lines that are blood-filled and then clamped off, or lines that are intermittently used for perfusion.
BIVALIRUDIN INJECTION (bivalirudin) is contraindicated in patients with: Hypersensitivity to this drug or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Uncontrollable active bleeding Major blood clotting disorders Acute gastric or duodenal ulcer Cerebral hemorrhage Severe cerebro-spinal trauma Bacterial endocarditis Severe uncontrolled hypertension Diabetic or hemorrhagic retinopathy Proximal use of spinal/epidural anesthesia BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 5 of 41
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg/kg/h IV infusion restarted and continued until 15 minutes prior to the anticipated end of CPB (see DOSAGE AND ADMINISTRATION, Dosing Pre- and Post- Cardiac Surgery, Medical Management Guidelines for Cardiac Surgery for dosing of the CPB pump with BIVALIRUDIN INJECTION).
75 mg/kg/h IV infusion for the duration of the procedure. The ACT may be used to check that the patient is anticoagulated following administration of Bivalirudin Injection. 25 mg/kg/h increments if a higher level of anticoagulation was desired.
The data suggest that infusion dose adjustments should not be necessary. 5 mg/kg/h. In addition, see Dosing Pre- and Post-Cardiac Surgery, Medical Management Guidelines for Cardiac Surgery for dosing of the pump. Dosing Pre- and Post-cardiac Surgery BIVALIRUDIN INJECTION may be used for anticoagulation up to 48 hours prior to surgery or in the postoperative phase up to 14 days after the procedure.
5 times the baseline value.
Medical Management Guidelines for Cardiac Surgery:
CPB Use of BIVALIRUDIN INJECTION for anticoagulation during CPB requires little modification to the conventional bypass circuit setup. Before initiation of CPB, a bolus dose of 50 mg BIVALIRUDIN INJECTION should be added to the circuit regardless of patient weight or volume of the prime.
Either an open system or a closed system may be used for venous drainage. A closed system with venous reservoir bags generally has better flow characteristics with […]
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Bleeding ACUITY (UA/NSTEMI) In 13,819 patients with ACS treated in the ACUITY trial, patients administered bivalirudin monotherapy exhibited statistically significantly lower rates of bleeding, and transfusions when compared to those patients who received heparin+GPI (Glycoprotein IIb/IIIa Inhibitor).
There was no statistical difference in bleeding rates when bivalirudin+GPI was compared to heparin + GPI (Table 3). 7% 1 GPIs were administered to <7% of patients in the bivalirudin group for procedural complications. 2 Defined as the occurrence of any of the following: intracranial bleeding, retroperitoneal bleeding, intraocular bleeding, a transfusion of any units of blood/blood products, a fall in haemoglobin (Hgb) ≥4 g/dL, whether or not bleeding site is identified, spontaneous or non-spontaneous blood loss with a decrease in Hgb ≥3 g/dL, reoperation for bleeding, access site bleeding requiring surgical or radiological intervention, or a hematoma ≥5 cm at puncture site.
3 Defined as observed bleeding that does not meet the criteria for major bleeding. 4 Thrombolysis in Myocardial Infarction (TIMI) major bleeding is defined as: intracranial, or a fall in adjusted Hgb >5 g/dL or hematocrit (Hct) of >15%; TIMI minor bleeding is defined as a fall in adjusted Hgb of 3 to <5 g/dL or a fall in adjusted Hct of 9 to <15%, with a bleeding site such as hematuria, hematemesis, hematomas, retroperitoneal bleeding or a decrease in Hgb of >4 g/dL with no bleeding site.
* Heparin was either unfractionated heparin (UFH) or enoxaparin. BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 14 of 41 HORIZONS (STEMI undergoing primary PCI) The following adverse reaction data are based on a clinical study of bivalirudin in patients with STEMI undergoing PCI; 1,800 patients were randomized to receive bivalirudin alone, 1,802 were randomized to unfractionated heparin plus GP IIb/IIIa inhibitor.
0001) (Table 4). Major bleeding occurred most frequently at the sheath puncture site. The most frequent event was a haematoma <5 cm at puncture site. 9%) of patients treated with unfractionated heparin + GP IIb/IIIa inhibitor. 8% 1 Defined as the occurrence of any of the following: intracranial bleeding, intraocular bleeding, retroperitoneal bleeding, access site haemorrhage requiring surgery or a radiologic or interventional procedure, haematoma ≥5 cm in diameter at the puncture site, reduction in haemoglobin concentration of ≥4 g/dL without an overt source of bleeding, […]
Hematologic Hemorrhage Bleeding may occur in conjunction with use of any anticoagulant drug. As with other anticoagulants, bivalirudin should be used with extreme caution in patients at increased risk of hemorrhage. Bleeding can occur at any site during therapy with BIVALIRUDIN INJECTION.
An unexpected drop in hematocrit or blood pressure should lead to a search for a bleeding site (see DRUG INTERACTIONS; and ADVERSE REACTIONS, Bleeding). Immune Immunogenicity/Re-exposure In in vitro studies, bivalirudin exhibited no platelet aggregation response against sera from patients with a history of HIT/TS.
Among 494 patients who received bivalirudin in clinical trials and were tested for antibodies, two had treatment-emergent positive bivalirudin antibody tests. Neither patient demonstrated clinical evidence of allergic or anaphylactic reactions, and repeat testing was not performed.
Nine other patients who had initial positive tests were negative on repeat testing. Of fifteen healthy volunteers who were exposed to bivalirudin twice, none developed antibodies. Laboratory Test Interference Bivalirudin affects International Normalized Ratio (INR), therefore INR measurements made in patients who have been treated with BIVALIRUDIN INJECTION may not be useful for determining the appropriate dose of warfarin.
1 Pregnant Women There are no studies available evaluating bivalirudin in pregnant women. BIVALIRUDIN INJECTION (bivalirudin) Product Monograph Page 12 of 41 Studies in rats and rabbits have demonstrated no evidence of impaired fertility or harm to the fetus attributable to bivalirudin at clinically relevant doses.
Because animal reproduction studies are not always predictive of human response, bivalirudin should be used during pregnancy only if clearly indicated. In PCI, bivalirudin is intended for use with ASA (see INDICATIONS). Because of possible adverse effects on the neonate and the potential for increased maternal bleeding, particularly during the third trimester, bivalirudin and ASA should be used together during pregnancy only with caution and if benefit is thought to outweigh risk.
2 Breast-feeding It is not known whether bivalirudin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BIVALIRUDIN INJECTION is administered to a nursing woman. 3 Pediatrics The safety and efficacy of bivalirudin in children have not been established.
4 Geriatrics Across studies approximately 45% of patients were ≥65 years of age and 18% of patients were ≥75 years old. Elderly patients experienced more bleeding events than younger patients.