In patients with acute ST-elevation myocardial infarction (STEMI), the most effective management strategies are percutaneous transluminal coronary angiography (PTCA) and thrombolytic therapy.1 In the U.S., about 50% of patients with STEMI present to hospitals that do not have PTCA capability.2 Clinical trials have unequivocally shown that thrombolytic therapy results in preserved left ventricular function and decreased mortality in acute myocardial infarction.3
RETAVASE® (reteplase) is indicated for use in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms.
Important Safety Information
Because thrombolytic therapy increases the risk of bleeding, RETAVASE is contraindicated in the following situations:
The most common complication during RETAVASE therapy is bleeding, which may involve internal and/or superficial sites.
Avoid non-compressible arterial puncture. If arterial or venous puncture is required, an upper extremity compressible site should be used. Avoid internal jugular and subclavian venous punctures.
If serious bleeding occurs, concomitant anticoagulant therapy should be terminated immediately and a second bolus of RETAVASE should not be administered.
Each patient being considered for therapy with RETAVASE should be carefully evaluated and anticipated benefits weighed against the potential risks associated with therapy.
Cholesterol embolization has been reported rarely in patients treated with thrombolytic therapy.
Coronary thrombolysis may result in arrhythmias associated with reperfusion and antiarrhythmic therapy for bradycardia and/or ventricular irritability should be available when RETAVASE is administered.
The most frequent adverse reaction associated with RETAVASE treatment is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, RETAVASE treatment and anticoagulants should be discontinued immediately.
Life-threatening and fatal complications are not uncommon in patients with acute myocardial infarction and may or may not be attributable to RETAVASE therapy.
Intracranial hemorrhage (in-hospital) occurred in 0.8% of patients treated with RETAVASE; the risk is increased in patients with advanced age or with elevated blood pressure.
In clinical studies, the overall incidence of bleeding events was 21.1%.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
1. van de Werf F, Bax J, Betriu A, et al. Eur Heart J.2008; 29: 2909-45.
2. Waters RE 2nd, Singh KP, Roe MT, et al. J Am Coll Cardiology. 2004; 43: 2153-9.
3. The Reperfusion Therapy Consensus Group. Eur Heart J. 1997; 18: 1371-81
RETAVASE® is a registered trademark of Chiesi USA, Inc.