Dilute argatroban 250mg in either 250ml sodium chloride 0. Comparison of the aptt with alternative tests for monitoring direct. We examined samples containing several concentrations of argatroban or lepirudin. Argatroban therapy is typically monitored using an aptt 1. Mcmaster university department of medicine division of. Initial infusion or organ failure discontinue if patient is currently on heparin wait 1 hour before. Monitoring of direct inhibitors of thrombin dti is critical for their safe and effective use as anticoagulants. The aim of this study was to collect data in france in patients with heparininduced thrombocytopenia who required parenteral anticoagulation and for whom other nonheparin. Argatroban is licensed for patients with heparininduced thrombocytopenia and monitoring is conventionally by activated partial thromboplastin time aptt ratio with a target of 1. Effect of direct thrombin inhibitors, bivalirudin, lepirudin.
In 2000, argatroban was licensed by the food and drug administration fda for prophylaxis or treatment of thrombosis in patients with heparininduced thrombocytopenia hit. Sep 05, 2019 argatroban injection must be diluted 100fold prior to infusion. Final concentration after dilution as recommended is 1 mgml see section 6. Comparison of the aptt with alternative tests for monitoring. Argatroban effects can be described using a variety of coagulation parameters, with a close doseconcentration vs effect relationship harder et al. Monitoring of the anticoagulants argatroban and lepirudin. Nov 11, 2015 while under argatroban therapy we observed a rapid reversal of thrombocytopenia in the majority of patients.
This assay has a therapeutic range of 60 100 seconds for argatroban different for other dtis. Tell your doctor about the allergy and what signs you. The standard nomogram was predominately based on the argatroban911 trial, a prospective analysis of 304 patients with hit and normal hepatic function initiated on an argatroban dosage of 2 gkg. We compared aptt, thrombin time tt, and prothrombin time pt. The aim of this study was to collect data in france in patients with heparininduced thrombocytopenia who required parenteral anticoagulation and for whom other nonheparin anticoagulant therapies were contraindicated including patients with renal failure, crossreactivity to danaparoid or at high hemorrhagic risk. If patients ptt is greater than 100 or inr greater than 2. Initial dose of argatroban based on actual body weight at time of initiation of therapy. Monitoring of direct thrombin inhibitors dtis in patients with. Following the withdrawal of lepirudin in 2012 we needed to establish inhouse therapeutic ranges and dosing schedules for both dti, since their practical handling was not clearly defined.
Exembol multidose 100 mgml concentrate for solution for infusion. Acova argatroban dosing, indications, interactions, adverse. The argatroban administration record will be used to record argatroban therapy similar to heparin and the anticoagulation administration record. An evaluation of monitoring possibilities of argatroban using rotational thromboelastometry and activated. This assay is poorly standardized, reagent dependent, and not dti specific. Argatroban is a univalent and direct inhibitor of fibrinbound thrombin. May 25, 2017 1 with or without thrombosis monitoring therapy. Practical guidelines for argatroban and bivalirudin in. Argatroban is a direct thrombin inhibitor indicated for prophylaxis or treatment of thrombosis in adult patients with heparininduced thrombocytopenia. Argatroban is monitored using the activated partial thromboplastin time aptt. At therapeutic concentrations, argatroban has little or no effect on related serine proteases.
For prophylaxis or treatment of thrombosis in adult patients with heparininduced. Argatroban is a type of blood thinner used instead of heparin to prevent blood clots during certain procedures to open up the blood vessels in the heart e. The goal aptt in seconds has been defined at uwmchmc as 6080 seconds. Effects of argatroban, danaparoid, and fondaparinux on trombin generation in heparininduced thrombocytopenia.
In most clinical studies, argatroban effects have been monitored by act predominantly in highdose therapy, eg, pci setting or aptt activated partial thromboplastin time in preventiontreatment of thrombosis in hit. Nov 09, 2018 argatroban blocks the activity of certain clotting substances in the blood. Acova argatroban dosing, indications, interactions. Monitoring of argatroban and lepirudin anticoagulation in critically ill. Argatroban testing can also be used to verify the results of the apttact monitoring. Guidelines for the use of argatroban in hit anticoagulation. It is used to thin the blood so that clots will not form. Argatroban injection side effects, medical uses, and. In these instances, aptt needs to be monitored closely and frequently, and dose reduction is required.
Argatroban injection side effects, medical uses, and drug. It is used as an alternative anticoagulant in patients with heparininduced thrombocytopenia hit. Argatroban argatroban for injection product monograph page 4 of 30 warnings and precautions general argatroban is intended for use as an anticoagulant in patients with. One ml concentrate for solution for infusion contains 100 mg argatroban monohydrate. While under argatroban therapy we observed a rapid reversal of thrombocytopenia in the majority of patients. It is not a substitute for appropriate clinical evaluation and does not supersede clinical judgment. Laboratory routine data in 37 patients on argatroban and 80 patients on lepirudin therapy were collected in this retrospective study between. Argatroban side effects, dosage, interactions drugs.
Management and monitoring of anticoagulation at the beginning of crrt, all patients re. For argatroban, the eca and dtt were linear within the range of. Monitor fbc daily argatroban should be continued as bridging therapy with oral anticoagulation until the inr is. Argatroban injection should not be mixed with other drugs prior to dilution. At uwmc, bivalirudin is monitored using the direct thrombin inhibitor dti assay plasmadiluted thrombin time. Heparin induced thrombocytopenia hit treatment page 1. Argatroban or lepirudin anticoagulation therapy in patients with heparin.
Shown is the doseresponse relationship between argatroban added to normal pooled plasma and the ecarin chromogenic assay eca a, activated partial thromboplastin time aptt b, dilute thrombin time dtt c, and prothrombinaseinduced clotting time pict d. Argatroban is a synthetic derivative of larginine with antithrombotic activity. Titrate according to corresponding table on page 3. Argatroban fda prescribing information, side effects and. K i for thrombin, 40 nmoll that was associated with a lower thrombotic event rate in two prospective cohort treatment studies 232,233 that used historical control groups.
What is the input of laboratory values in real life. Argatroban and bivalirudin are two direct thrombin inhibitors dti employed to treat heparininduced thrombocytopenia hit. What is the methodology used for the argatroban assay. K i for thrombin, 40 nmoll that was associated with a lower thrombotic. Inr should be measured daily while argatroban and warfarin are. In most clinical studies, argatroban effects have been monitored by act predominantly in highdose therapy, eg, pci setting or aptt activated.
Argatroban is not for use in patients with moderate to severe hepatic insufficiency. Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 15aminoiminomethylamino1oxo2. Indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparininduced thrombocytopenia. During argatroban treatment the aptt assay is commonly used for therapeutic monitoring. Exembol multidose 100 mgml concentrate for solution for. Argatroban fda prescribing information, side effects and uses. Argatroban argatroban injection, solution this product information is intended only for residents of the united states.
Monitoring therapy and dosage adjustments recommendations should be followed 2. Alternatively, it can be monitored with the direct thrombin inhibitor assay available at uwmchmc. Argatroban for anticoagulation in continuous renal. Argatroban is clinically used to treat thrombosis and acute coronary syndrome. Shown is the doseresponse relationship between argatroban added to. For use in hit, therapy with argatroban injection is monitored using the aptt with a target range of 1. This agent reversibly binds to the thrombin active site, thereby preventing the thrombindependent reactions, which include the conversion of. Argatroban suggested guidelines for use university of. To compare the relative effect of each dti on each pt reagent, a median inr was calculated from the inr values obtained from the dti samples table 3. Management and monitoring of anticoagulation at the beginning of crrt, all patients received argatroban at a dose of 100 gkg as a bolus injection followed by a continuous infusion of 1 gkgmin. If you would like additional information about heparin induced thrombocytopenia hit, there is an option nursing ce program available on tracker trainer. Argatroban, a smallmolecule, direct inhibitor of thrombin dti, is used as anticoagulant for prophylaxis and therapy of thromboembolic complications in typeii heparin.
Argatroban anhydrous is the anhydrous form of argatroban, a synthetic derivative of larginine with antithrombotic activity. Argatroban last updated on april 15, 2020 2020 memorial sloan kettering cancer center. During argatroban treatment the aptt assay is commonly used for. The concomitant use of argatroban with warfarin results in prolongation of inr beyond that produced by warfarin alone. No anticoagulation within 24 hours of therapeutic tpa for ischemic stroke. Monitoring of argatroban anticogulation argatroban effects can be described using a variety of coagulation parameters, with a close doseconcentration vs effect relationship harder et al 2004. Pdf an evaluation of monitoring possibilities of argatroban using. Heparin induced thrombocytopenia hit treatment page 1 of 7. Rotem and wholeblood aptt analyses were performed at each argatroban concentration. Argatroban in sodium chloride injection is a direct thrombin inhibitor indicated. Note that argatroban is a nonformulary drug at uw medicine. Adult argatroban drip protocol this protocol reflects current evidence based clinical practice. Infuse using a micropump repeat aptt after start of infusion.
We examined samples containing several concentrations of argatroban or. The molecular formula of argatroban is c 23 h 36 n 6 o 5 sh 2 o. Argatroban can also be considered in patients with hepatic dysfunction even though it is cleared by the hepatobiliary system. Argatroban, a smallmolecule, direct inhibitor of thrombin dti, is used as anticoagulant for prophylaxis and therapy of thromboembolic complications in typeii heparininduced thrombocytopenia hit ii. Argatroban is capable of inhibiting the action of both free and clotassociated thrombin.
Tests of anticoagulant effects including the aptt typically attain steadystate levels within 1 to 3 hours following. Direct thrombin inhibitors dtis such as argatroban, bivalirudin. Monitoring of direct thrombin inhibitors dtis in patients with heparininduced thrombocytopenia hit is primarily performed using the activated partial thromboplastin time aptt. The standard nomogram was predominately based on the argatroban911 trial, a prospective analysis of 304 patients with hit and normal hepatic function initiated on an. Pdf alternative monitoring of argatroban using plasma. No concurrent epidural analgesia, spinal, or lumbar puncture while anticoagulated.
For use in hit, therapy with argatroban in sodium chloride injection is monitored using the aptt with a target range of 1. Argatroban see appendix a for dosing see page 2 for transition to alternate anticoagulant continue current treatment and monitoring 2 thrombocytopenia platelet count fall 50% and nadir. Argatroban is an anticoagulant that is a small molecule direct thrombin inhibitor. Log in to print or send this list to your patient and save. In critically ill patients, coagulation abnormalities are commonly found and may prolong the baseline aptt. Argatroban is used to treat or prevent blood clots in adults who have thrombocytopenia low levels of platelets in the. High doses of argatroban are an option, if needed, with close inhospital monitoring. Argatroban is a a small molecule, synthetic direct thrombin inhibitor.
Argatroban suggested guidelines for use university of washington medical center dept of pharmacy for physician use only this is not intended as a nursemanaged protocol september 2008 background. The clotting time obtained is directly related to the concentration of argatroban in the patient specimen. Vha directive 1033, anticoagulation therapy management. Argatroban is highly selective for thrombin with an inhibitory constant k. A dilute thrombin clotting time method functional assay is used. Argatroban in sodium chloride injection is a sterile, nonpyrogenic, clear, colorless to pale yellow solution. At therapeutic concentrations, argatroban has little or no effect on related serine proteases trypsin, factor xa, plasmin, and kallikrein. Nov 01, 2018 argatroban consists of a mixture of r and s stereoisomers at a ratio of approximately 65.
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