Mirel Adverse Reactions

The most commonly reported adverse drug reaction associated with reteplase treatment is hemorrhage, predominantly at the injection site.
Intracranial bleeding has been seen with reteplase therapy, which may be fatal in some cases. Systolic blood pressure over 160 mm Hg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding. As age increases the risk of intracranial bleeding and fatal intracranial bleeding increases.
Patients administered Reteplase as treatment for myocardial infarction have experienced many events which are frequent sequelae of myocardial infarction and may or may not be attributable to Reteplase therapy. These events include cardiogenic shock, arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarization, 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. Allergic reactions were noted in clinical studies in a small number of patients.
Clinical study with Reteplase (MIREL) demonstrated it to be safe, well tolerated and easy to administer. The safety profile was comparable with earlier reported Reteplase studies. Bleeding events with Reteplase (MIREL) therapy were in 7.50%, which is comparable to earlier reported studies and only 2.50% patients, required blood transfusion. No stroke event was reported in this study. Other cardiac complications reported in the study were hypotension (12.50%), hypertension (10.00%), pericarditis (2.50%), bradycardia (8.75%) and thrombosis (2.50%).