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| __NOTOC__
| | #REDIRECT [[Desirudin#Adverse Reactions]] |
| {{Desirudin}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Adverse Reactions==
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| In the Phase II and III clinical studies, desirudin was administered to 2159 patients undergoing elective[[ hip replacement surgery]] to determine the safety and efficacy of Iprivask in preventing VTE in this population. Below is the safety profile of the Iprivask 15 mg (q12h) regimen from these 5 multicenter clinical trials.
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| ===Hemorrhagic Events===
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| The following rates of hemorrhagic events have been reported during clinical trials.
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| <sup>a</sup> Includes hematomas which occurred at an incidence of 6% in the Iprivask and enoxaparin treatment groups and 5% in the heparin treatment group.
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| <sup>b</sup> Bleeding complications were considered serious if perioperative transfusion requirements exceeded 5 units of whole blood or packed red cells, or if total transfusion requirements up to postoperative Day 6 inclusive exceeded 7 units of whole blood or packed red cells, or total blood loss up to postoperative Day 6 inclusive exceeded 3500 mL.
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| <sub>c</sub> Bleeding complications were considered major if the hemorrhage was: (1) overt and it produced a fall in hemoglobin of ≥2g/dL or if it lead to a transfusion of 2 or more units of whole or packed cells outside the perioperative period (the time from start of surgery until up to 12 hours after); (2) Retroperitoneal, intracranial, intraocular, intraspinal, or occurred in a major prosthetic joint.
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| == ===Non-hemorrhagic Events===
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| Non-hemorrhagic adverse events occurring at ≥2% incidence in patients treated with Iprivask 15 mg (q 12h) during elective[[ hip replacement surgery]] and considered to be remotely, possibly, or probably related to desirudin are provided below. ==
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| <div>
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| <sup>a</sup> Represents events reported while on treatment, excluding unrelated adverse events
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| <sup>b</sup> All hemorrhages that occurred are included in ADVERSE REACTIONS, Hemorrhagic Events.
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| '''Related Adverse Events with a Frequency of <2% and >0.2% (in decreasing order of frequency)''': thrombosis, hypotension, leg edema, fever, decreased hemoglobin, hematuria, dizziness, epistaxis, vomiting, impaired healing, cerebrovascular disorder, leg pain, hematemesis.
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| '''Allergic Reactions'''. In clinical studies, allergic events were reported <2% overall and in 2% of patients who were administered 15 mg desirudin. (See PRECAUTIONS, General,Antibodies/ Re-exposure).
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| ===Post Marketing===
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| In addition to adverse events reported from clinical trials the following adverse events have been identified during post approval use of Iprivask. These events were reported voluntarily from a population of unknown size and the frequency of occurrence cannot be determined precisely: rare reports of major hemorrhages, some of which were fatal, and anaphylactic/anaphylactoid reactions.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = IPRIVASK (DESIRUDIN) KIT [MARATHON PHARMACEUTICALS, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=d768eca6-b25d-4aec-905f-b6a89e89ff29 | publisher = | date = | accessdate = 3 February 2014 }}</ref>
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| </div>
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| ==References==
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| {{Reflist|2}}
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| {{Antithrombotics}}
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| [[Category:Direct thrombin (II) inhibitors]]
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| [[Category:Anticoagulants]]
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| [[Category:Cardiovascular Drugs]]
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