Mirel Special Precautions

Bleeding is the most common complication encountered during Reteplase therapy. The sites of bleeding include both internal bleeding sites (intracranial, retroperitoneal, gastrointestinal, genitourinary, or respiratory) and superficial bleeding sites (venous cut downs, arterial punctures, sites of recent surgical intervention). The concomitant use of heparin and other anticoagulation may contribute to bleeding.
Thrombolytic therapy requires careful attention to all potential bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites, and needle puncture sites).
Should an arterial puncture be necessary during the administration of Reteplase, it is preferable to use an upper extremity vessel that is accessible to manual compression. Pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding.
Other venipunctures should be performed carefully and only as required. In case of serious bleeding which is not controllable by local pressure, concomitant anticoagulant therapy should be terminated immediately. In addition, the second bolus of Reteplase should not be given if serious bleeding occurs before it is administered.
Each patient considered for therapy with Reteplase should be carefully evaluated and anticipated benefits weighed against the potential risks associated with therapy. In the following conditions, the potential risks of Reteplase therapy may be increased and should be weighed against the anticipated benefits: Recent major surgery, e.g., coronary artery bypass graft, obstetrical delivery, organ biopsy; Previous puncture of noncompressible vessels; Cerebrovascular disease; Recent gastrointestinal or genitourinary bleeding; Hypertension: systolic BP ≥180 mm Hg and/or diastolic BP ≥ 110 mm Hg; Subacute bacterial endocarditis; Hemostatic defects including those secondary to severe hepatic or renal disease; Severe hepatic or renal dysfunction; Diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions; Septic thrombophlebitis or occluded AV cannula at a seriously infected site; Age over 75 years; Patients currently receiving oral anticoagulants, e.g., warfarin sodium; Any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location.
Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular irritability be available when Reteplase is administered.
Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown.
Use in Pregnancy & Lactation: Pregnancy Category C: Reteplase has been shown to have an abortifacient effect in rabbits when given in doses 3 times the human dose. Reproduction studies performed in rats at doses up to 15 times the human dose revealed no evidence of fetal anomalies; however, Reteplase administered to pregnant rabbits resulted in hemorrhage in the genital tract, leading to abortions in mid-gestation. There are no adequate and well controlled studies in pregnant women. Reteplase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Reteplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Reteplase is administered to a nursing woman.