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| __NOTOC__
| | #REDIRECT [[Reteplase#Adverse Reactions]] |
| {{Reteplase}}
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| {{CMG}}; {{AE}} {{AZ}}
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| ==ADVERSE REACTIONS==
| | [[Category: Cardiovascular Drugs]] |
| | | [[Category: Drug]] |
| ===Bleeding===
| | [[Category: Anticoagulants]] |
| The most frequent adverse reaction associated with Retavase® is bleeding (see [[Reteplase warnings and precautions|WARNINGS]]). The types of bleeding events associated with [[thrombolytic therapy]] may be broadly categorized as either [[intracranial hemorrhage]] or other types of hemorrhage.
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| ===Intracranial hemorrhage===
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| In the INJECT clinical trial the rate of in-hospital, [[intracranial hemorrhage]] among all patients treated with Retavase® was 0.8% (23 of 2,965 patients). As seen with Retavase® and other thrombolytic agents, the risk for [[intracranial hemorrhage]] is increased in patients with advanced age or with elevated blood pressure.
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| ===Other types of hemorrhage===
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| The incidence of other types of bleeding events in clinical studies of Retavase® varied depending upon the use of arterial [[catheterization ]]or other invasive procedures and whether the study was performed in Europe or the USA. The overall incidence of any bleeding event in patients treated with Retavase® in clinical studies (n = 3,805) was 21.1%. The rates for bleeding events, regardless of severity, for the 10 + 10 unit Retavase® regimen from controlled clinical studies are summarized in Table 3.
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| [[File:Retavase hemorrahge rates.JPG|900px]]
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| In these studies the severity and sites of bleeding events were comparable for Retavase® and the comparison thrombolytic agents.
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| Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, any concomitant [[heparin ]]should be terminated immediately. In addition, the second bolus of Retavase® should not be given if the serious bleeding occurs before it is administered. Death and permanent disability are not uncommonly reported in patients who have experienced [[stroke ]](including intracranial bleeding) and other serious bleeding episodes.
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| [[Fibrin ]]which is part of the [[hemostatic ]]plug formed at needle puncture sites will be lysed during Retavase® therapy. Therefore, Retavase®therapy requires careful attention to potential bleeding sites (e.g., catheter insertion sites, arterial puncture sites).
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| ===Allergic Reactions===
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| Among the 2,965 patients receiving Retavase® in the INJECT trial, serious allergic reactions were noted in 3 patients, with one patient experiencing [[dyspnea ]]and [[hypotension]]. No [[anaphylactoid reactions ]]were observed among the 3,856 patients treated with Retavase® in initial clinical trials. In an ongoing clinical trial two [[anaphylactoid reactions]] have been reported among approximately 2,500 patients receiving Retavase®.
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| ===Other Adverse Reactions===
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| Patients administered Retavase® as treatment for [[myocardial infarction]] have experienced many events which are frequent sequelae of [[myocardial infarction]] and may or may not be attributable to Retavase® therapy. These events include[[ cardiogenic shock]], [[arrhythmias ]](e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, [[supraventricular tachycardia]], [[ventricular tachycardia]], [[ventricular fibrillation]]), [[AV block]], [[pulmonary edema]],[[ heart failure]], [[cardiac arrest]], [[recurrent ischemia]], reinfarction, [[myocardial rupture]], [[mitral regurgitation]], [[pericardial effusion]], [[pericarditis]], [[cardiac tamponade]], [[venous thrombosis]]and [[embolism]], and electromechanical dissociation. These events can be life-threatening and may lead to death. Other adverse events have been reported, including [[nausea ]]and/or [[vomiting]], [[hypotension]], and fever.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = RETAVASE (RETEPLASE) KIT [EKR THERAPEUTICS, INC.] | url =http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e9ae6656-977c-4105-8528-bee664aab27a | publisher = | date = | accessdate = }}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]] | |
| [[Category:Drugs]] | |