Argatroban warnings and precautions: Difference between revisions
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====5.1 Risk of Hemorrhage==== | ====5.1 Risk of Hemorrhage==== | ||
Hemorrhage can occur at any site in the body in patients receiving argatroban. An unexplained fall in hematocrit or hemoglobin or a fall in blood pressure should lead to consideration of a hemorrhagic event. Argatroban Injection should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. These include severe hypertension; immediately following lumbar puncture; spinal anesthesia; major surgery, especially involving the brain, spinal cord or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations. | Hemorrhage can occur at any site in the body in patients receiving argatroban. An unexplained fall in [[hematocrit]] or [[hemoglobin]] or a fall in blood pressure should lead to consideration of a hemorrhagic event. Argatroban Injection should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. These include [[severe hypertension]]; immediately following [[lumbar puncture]]; spinal anesthesia; major surgery, especially involving the brain, spinal cord or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as [[ulcerations]]. | ||
Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding. | Concomitant use of argatroban with [[antiplatelet agents]], thrombolytics, and other anticoagulants may increase the risk of bleeding. | ||
====5.2 Use in Hepatic Impairment==== | ====5.2 Use in Hepatic Impairment==== | ||
Use caution when administering argatroban to patients with hepatic impairment by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal should be avoided. | Use caution when administering argatroban to patients with hepatic impairment by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Use of argatroban in PCI patients with clinically significant hepatic disease or [[AST/ALT]] levels ≥3 times the upper limit of normal should be avoided. | ||
====5.3 Laboratory Tests==== | ====5.3 Laboratory Tests==== | ||
Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT). Although other global clot-based tests including prothrombin time (PT), the International Normalized Ratio (INR), and thrombin time (TT) are affected by argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy. In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure. The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone [see Dosage and Administration (2.5) and Clinical Pharmacology (12.2)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = }}</ref> | Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT). Although other global clot-based tests including prothrombin time (PT), the [[International Normalized Ratio]] (INR), and [[thrombin time]] (TT) are affected by argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy. In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure. The concomitant use of argatroban and [[warfarin]] results in prolongation of the [[PT]] and [[INR]] beyond that produced by [[warfarin]] alone [see Dosage and Administration (2.5) and Clinical Pharmacology (12.2)].<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ARGATROBAN INJECTION, SOLUTION [GLAXOSMITHKLINE LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c9616c0-a299-4fd5-c8ae-79e6db453595 | publisher = | date = | accessdate = }}</ref> | ||
==Reference== | ==Reference== | ||
Revision as of 12:39, 6 March 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]
Warnings and Precautions
5.1 Risk of Hemorrhage
Hemorrhage can occur at any site in the body in patients receiving argatroban. An unexplained fall in hematocrit or hemoglobin or a fall in blood pressure should lead to consideration of a hemorrhagic event. Argatroban Injection should be used with extreme caution in disease states and other circumstances in which there is an increased danger of hemorrhage. These include severe hypertension; immediately following lumbar puncture; spinal anesthesia; major surgery, especially involving the brain, spinal cord or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.
Concomitant use of argatroban with antiplatelet agents, thrombolytics, and other anticoagulants may increase the risk of bleeding.
5.2 Use in Hepatic Impairment
Use caution when administering argatroban to patients with hepatic impairment by starting with a lower dose and carefully titrating until the desired level of anticoagulation is achieved. Upon cessation of argatroban infusion in the hepatically impaired patient, full reversal of anticoagulant effects may require longer than 4 hours due to decreased clearance and increased elimination half-life of argatroban [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Use of argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal should be avoided.
5.3 Laboratory Tests
Anticoagulation effects associated with argatroban infusion at doses up to 40 mcg/kg/min correlate with increases of the activated partial thromboplastin time (aPTT). Although other global clot-based tests including prothrombin time (PT), the International Normalized Ratio (INR), and thrombin time (TT) are affected by argatroban, the therapeutic ranges for these tests have not been identified for argatroban therapy. In clinical trials in PCI, the activated clotting time (ACT) was used for monitoring argatroban anticoagulant activity during the procedure. The concomitant use of argatroban and warfarin results in prolongation of the PT and INR beyond that produced by warfarin alone [see Dosage and Administration (2.5) and Clinical Pharmacology (12.2)].[1]
Reference
Adapted from the FDA Package Insert.