Federal law restricts this device to sale by or on the order of a physician. It is a highly specific inhibitor of thrombin and used as an anticoagulant in patients with heparininduced thrombocytopenia. Refludan lepirudin rdna for injection is a highly specific direct inhibitor of thrombin. Lepirudin forms a stable noncovalent stoichometric 1. Lepirudin is a recombinant dna product derived from yeast cells. Lepirudin is used to treat or prevent blood clots that can occur after using heparin, or with certain blood vessel conditions.
Guidelines for the use of lepirudin in the treatment of. Reconstitute two vials each containing 50 mg of lepirudin with 1 ml each using either sterile water for injection usp or 0. The report by tardy et al adds to others suggesting that the standard, approved dosing of lepirudin for treatment of hit is too high. Argatroban package insert pdf store in original package until time of use. In contrast to heparin, lepirudin is a direct thrombin inhibitor and it inhibits not only free but also clotbound thrombin weitz et al 1990.
Storing the test strips store the test strips in their original container, with the cap. Jun 14, 2017 refludan 50 mgvial lepirudin rdna for injection. Lepirudin side effects, dosage, interactions everyday. A comparison of lepirudin and argatroban outcomes maureen a. Discontinuation of refludan lepirudin rdna for injection. Monitoring of argatroban and lepirudin anticoagulation in. Clinical monitoring of direct thrombin inhibitors using the. Aug 19, 2019 argatroban package insert pdf store in original package until time of use. Lepirudin increases your risk of bleeding, which can be severe or lifethreatening. Duexis ibuprofen and famotidine tablets, for oral use. Lepirudin is fdaapproved for the treatment of hit complicated by thrombosis. Because lepirudin is excreted renally, dose adjustment is needed for patients with impaired renal functions. Argatroban is a small molecule with a shorter halflife than lepirudin, fondaparinux, or danaparoid, and its use is preferred in patients who may need. Lepirudin, a direct thrombin inhibitor, has been associated with anaphylactic reaction in a patient, who had received five courses of lepirudin therapy uneventfully.
The specific activity of lepirudin is approximately 16,000 atumg. Angiomax is intended for use with aspirin 300325 mg daily and has been studied only in patients receiving concomitant aspirin. A unique id assigned by the fda when a product is submitted for. It binds both to the substrate binding and catalytic sites of thrombin. Berlex laboratories, wayne, nj, 3 recommended initial dosing for serum creatinine level below 141. The coaguchek xs pt test uses only fresh capillary or nonanticoagulated venous whole blood. Bayer ceased the production of lepirudin refludan effective may 31, 2012. Lepirudin, a recombinant hirudin, is a direct irreversible thrombin inhibitor by binding. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze. Because lepirudin is excreted renally, dose adjustment is needed for. Apr 25, 2019 argatroban package insert pdf store in original package until time of use. Regular iletin ii insulin injection, usp, purified pork762005 eli lilly and company revex nalmefene hcl injection 1mgml, 2 ml ampule and 0.
Patients received additional boluses of lepirudin 5 mg if plasma. Lepirudin was among the first direct thrombin inhibitors approved for use in the united states as an alternative i. Leu1, thr263desulfohirudin is a recombinant hirudin derived from yeast cells. As regards the comparison between argatroban and lepirudin for efficacy and safety, they have been. Here are the answers to the common questions about provocholine and the methacholine challenge test.
Mattson, md clinical and applied thrombosishemostasis 2005 11. The venetoclax dose is increased during a rampup phase as follows. Predictive factors for thrombosis and major bleeding in an observational study in 181 patients with heparininduced thrombocytopenia treated with lepirudin. Healthcare professionals argatroban injection in % sodium chloride mg ml 1 mg1 ml. Argatroban or lepirudin anticoagulation therapy in patients with heparin induced thrombocytopenia hit or hit suspect is typically monitored using the activated partial thromboplastin time aptt.
Lepirudin is a recombinant hirudin derived from yeast cells. Refludan lepirudin rdna for injection is a highly specific direct inhibitor of. Oral vitamin k is preferred for patients without severe bleeding. Lepirudin leu1, thr263desulfohirudin is composed of 65 amino acids and characterised by the two first nterminal aminoacids.
Fda package insert for abcixmab contains no information regarding mechanism of action. The rate of infusion must be reduced in case of known or suspected renal insufficiency see sections 4. Highlights of prescribing information withhold purixan at. Lepirudin side effects, dosage, interactions everyday health. Before you start testing if you are new to the coaguchek xs system, watch the coaguchek xs system. In the national heart, lung and blood institutes cardiac arrhythmia suppression trial cast, a longterm, multicentered, randomized, doubleblind study in patients with asymptomatic nonlifethreatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an excessive mortality or nonfatal cardiac arrest rate 7. Refludan lepirudin rdna for injection is indicated for anticoagulation in patients with heparininduced thrombocytopenia hit and associated thromboembolic disease in order to prevent further thromboembolic complications tec. There is no experience with lepirudin in patients with significant liver impairment. Each vial contains 250 mg bivalirudin, equivalent to an average of 275 mg of bivalirudin trifluoroacetate, 125 mg mannitol, and sodium hydroxide to adjust the ph to 56 equivalent of approximately 12. Several fdaapproved drug labels may be available for ethambutol hydrochloride. Thus, argatroban has to be carefully titrated in patients with reduced liver function. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic. Initial dosage, refludan should not be started in patients presenting with a baseline aptt.
Sep 30, 2019 bivalirudin for injection is supplied as a sterile white lyophilized cake, in singledose vials. The coaguchek xs plus system should not be used for patients being treated with any direct thrombin inhibitors, including hirudin, lepirudin, bivalirudin and argatroban. Lepirudin may also be used for purposes not listed in this medication guide. To evaluate the safety, effectiveness, and dosing of offlabel bivalirudin to argatroban and lepirudin in patients with heparininduced thrombocytopenia hit using a new pharmacist. Coaguchek xs pro pt controls package insert and this entire insert. In contrast, lepirudin, a parenteral recombinant hirudin, is eliminated primarily through the kidneys.
Lepirudin differs from a natural hirudin variant by having the nterminal isoleucine substituted by leucine. Insert test strip as far as you can into the meter. A series of four studies and one metaanalysis evaluated the efficacy of lepirudin for anticoagulation in patients with confirmed hit. U n c m e d i c a l c e n t e r g u i d e l i n e emergent. Sep 01, 2006 the report by tardy et al adds to others suggesting that the standard, approved dosing of lepirudin for treatment of hit is too high. Argatroban package insert pdf admin april 25, 2019 leave a comment. Ethambutol hydrochloride fda label tablet film coated. Product information refludan lepirudin powder for injection. The coaguchek xs pt test uses only fresh capillary or non. Aidsinfo provides the following drug label solely as an example of the labels available for ethambutol hydrochloride. A total of 495 argatroban, n 189 and lepirudin, n 306 patient samples were analyzed under clinical and laboratory routine conditions.
Understanding the misunderstood disease of heparin induced. You have 180 seconds to apply a blood sample to the test strip. Refludan lepirudin rdna for injection is a highly specific direct. Lepirudin in the management of patients with heparininduced ncbi. Package insert protamine sulfate injection, usppiengv1. Although aptt correlates well with plasma levels of argatroban and lepirudin in healthy volunteers, it might not be the method of choice in critically ill patients. Lepirudin leu1, thr263desulfohirudin is a recombinant hirudin derived from yeast cells with the molecular formula c287 h440 n80 o111 s6 and a molecular weight of 6979. Hirudin, recombinant drug information, professional. Prescribing information as of october, 2004 refludan lepirudin. Lepirudin may also be used for purposes not listed in this medication.
Lepirudininduced thrombocytopenia following subcutaneous. Liver cirrhosis may also affect the renal excretion of lepirudin. No further product will be distributed from bayer after may 31, 2012. The dose of lepirudin given as repetitive intravenous boli was titrated based on the activated partial thromboplastin time aptt in order to maintain an aptt value of 7080s 1. Lepirudin is used for treating thrombosisrelated complications due to hit and is given as intravenous infusion with or without bolus. Angiomax bivalirudin for injection is contraindicated in patients with active major bleeding and hypersensitivity e. Bivalirudin for injection is supplied as a sterile white lyophilized cake, in singledose vials.
In hemodialysis patients or in case of acute renal failure, the lepirudin infusion should be avoided or stopped. Antipf4heparin antibody ab may form in up to 8% of patients receiving. May 19, 2019 argatroban package insert pdf store in original package until time of use. Leu 1, thr 263desulfohirudin is a recombinant hirudin derived from yeast cells. Recombinant hirudin lepirudin provides and effective anticoagulation. Highlights of prescribing information these highlights do not include all the information needed to use purixan safely and effectively. To our surprise, we have noticed, for these patients, that the dosage had. April 2010 page 1 of 9 highlights of prescribing information these highlights do not include all the information needed to use elspar safely and effectively. Lepirudin needs to be carefully adapted to those with reduced kidney function. The recommended dose of angiomax is an intravenous iv bolus dose of 0. Lepirudin for prophylaxis of thrombosis in patients with. Lepirudin in the management of patients with heparininduced. Lepirudin, a recombinant hirudin, is a direct thrombin inhibitor approved.
The recommended dose of angiomax is an intravenous iv bolus dose of. Additional intravenous bolus injections at a dose of 0. These facts should be taken into consideration during lepirudin dosage. Provocholine diagnostic bronchoconstrictor agent for the. Discard product if it contains particulate matter, is cloudy, or discolored do not freeze protect from. Pdf comparison of bivalirudin to lepirudin and argatroban. Lepirudin binds to free and clotbound thrombin to block its. The polypeptide composed of 65 amino acids has a molecular weight of 6979. This is usually reversible and appears to be dose dependent. Pdf lepirudin in the management of patients with heparin. Provocholine is the only fda approved methacholine chloride for the diagnosis of bronchial hyperresponsiveness.
Name, dosage, strength, route, labeller, marketing start, marketing end. Heparin sodium injection, usp is a sterile, nonpyrogenic solution of a highly purified sodium salt of heparin, a high molecular weight polysaccharide derived from porcine intestinal mucosa or beef lung. Lepirudin is a heterodetic cyclic peptide composed of 65 amino acids joined in sequence and cyclised by three disulfide bridges between cysteine residues 614, 1628 and 2239. Clinical monitoring of direct thrombin inhibitors using. A new diagnosis of hit was the indication for dti therapy in 44. A comparison is considered statistically significant if the pvalue is lepirudin rdna for injection rx only description refludan lepirudin rdna for injection is a highly specific direct inhibitor of thrombin. Argatroban is a small molecule with a shorter argatgoban than lepirudin, fondaparinux, or danaparoid, and its use is preferred in patients who may need. Leustatin cladribine injection for intravenous infusion. Information for the user bivalirudin 250 mg powder. The listed drug referenced by the applicant is argatroban by sandoz, nda. Leustatin cladribine injection for intravenous infusion only warning leustatin cladribine injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy.
The bleeding risk associated with lepirudin treatment in patients with isolated hit may be reduced by aiming for an aptt of between 1. Lepirudin treatment of heparininduced thrombocytopenia. Refludan fda prescribing information, side effects and uses. Laboratory routine data in 37 patients on argatroban and 80 patients on lepirudin therapy were collected in this retrospective study between march 2008 and february 2011. Renal function must be taken into consideration while decid. Highlights of prescribing information these highlights do not include all the information needed to use angiomax safely and effectively. Highlights of prescribing information these highlights do not. Dailymed bivalirudin injection, powder, lyophilized, for. A negative methacholine challenge test can essentially rule out asthma. If your facility procedures require use of the operator id and patient. It contains 6 cysteine residues which form 3 disulfide bonds 614, 1628 and 2239. Suppression of bone marrow function should be anticipated. The coaguchek xs system uses fresh capillary or nonanticoagulated venous whole blood.
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