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Includes the arterial catheterization site all patients in the RAPID studies underwent arterial catheterization ; . In these studies the severity and sites of bleeding events were comparable for Retavase and the comparison thrombolytic agents. 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. 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 ; . Allergic Reactions: 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. Other Adverse Reactions: 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. DOSAGE AND ADMINISTRATION Retavase Reteplase ; is for intravenous administration only. Retavase is administered as a 10 unit double-bolus injection. Two 10 unit bolus injections are required for a complete treatment. Each bolus is administered as an intravenous injection over 2 minutes. The second bolus is given 30 minutes after initiation of the first bolus injection. Each bolus injection should be given via an intravenous line in which no other medication is being simultaneously injected or infused. No other medication should be added to the injection solution containing Retavase. There is no experience with patients receiving repeat courses of therapy with Retavase. Heparin and Retavase are incompatible when combined in solution. Do not administer heparin and Retavase simultaneously in the same intravenous line. If Retavase is to be injected through an intravenous line containing heparin, a normal saline or 5% dextrose D5W ; solution should be flushed through the line prior to and following the Retavase injection. Although the value of anticoagulants and antiplatelet drugs during and following administration of Retavase has not been studied, heparin has been administered concomitantly in more than 99% of patients. Aspirin has been given either during and or following heparin treatment. Studies assessing the safety and efficacy of Retavase without adjunctive therapy with heparin and aspirin have not been performed. Reconstitution Retavase Kit and Retavase Half-Kit: Reconstitution should be carried out using the diluent and dispensing pin provided with Retavase. It is important that Retavase be reconstituted only with the supplied Sterile Water for Injection, USP without preservatives ; . The reconstituted preparation results in a colorless solution containing Retavase 1 unit mL. Slight foaming upon reconstitution is not unusual; allowing the vial to stand undisturbed for several minutes is usually sufficient to allow dissipation of any large bubbles.
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