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Questions & Answers
Side Effects & Adverse Reactions
Bleeding: The most common complication encountered during Retavase® therapy is bleeding. The sites of bleeding include both internal bleeding sites (intracranial, retroperitoneal, gastrointestinal, genitourinary, or respiratory) and superficial bleeding sites (venous cutdowns, arterial punctures, sites of recent surgical intervention). The concomitant use of heparin anticoagulation may contribute to bleeding. In clinical trials some of the hemorrhage episodes occurred one or more days after the effects of Retavase® had dissipated, but while heparin therapy was continuing.
As fibrin is lysed during Retavase® therapy, bleeding from recent puncture sites may occur. Therefore, 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). Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from noncompressible sites.
Should an arterial puncture be necessary during the administration of Retavase®, 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.
Intramuscular injections and nonessential handling of the patient should be avoided during treatment with Retavase®. Venipunctures should be performed carefully and only as required.
Should serious bleeding (not controllable by local pressure) occur, concomitant anticoagulant therapy should be terminated immediately. In addition, the second bolus of Retavase® should not be given if serious bleeding occurs before it is administered.
Each patient being considered for therapy with Retavase® should be carefully evaluated and anticipated benefits weighed against the potential risks associated with therapy. In the following conditions, the risks of Retavase® 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
- Recent trauma
- Hypertension: systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg
- High likelihood of left heart thrombus, e.g., mitral stenosis with atrial fibrillation
- Acute pericarditis
- 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
- Advanced age
- 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
Cholesterol Embolization: Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. This serious condition, which can be lethal, is also associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy. Clinical features of cholesterol embolism may include livedo reticularis, “purple toe” syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, and rhabdomyolysis.
Arrhythmias: Coronary thrombolysis may result in arrhythmias associated with reperfusion. These arrhythmias (such as sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) are not different from those often seen in the ordinary course of acute myocardial infarction and should be managed with standard antiarrhythmic measures. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular irritability be available when Retavase® is administered.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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 (see CLINICAL PHARMACOLOGY).
There is currently no drug history available for this drug.
Retavase® (Reteplase) is a non-glycosylated deletion mutein of tissue plasminogen activator (tPA), containing the kringle 2 and the protease domains of human tPA. Retavase® contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527). Retavase® is produced by recombinant DNA technology in E. coli. The protein is isolated as inactive inclusion bodies from E. coli, converted into its active form by an in vitro folding process and purified by chromatographic separation. The molecular weight of Reteplase is 39,571 daltons.
Potency is expressed in units (U) using a reference standard which is specific for Retavase® and is not comparable with units used for other thrombolytic agents.
Retavase® is a sterile, white, lyophilized powder for intravenous bolus injection after reconstitution with Sterile Water for Injection, USP (without preservatives). Following reconstitution, the pH is 6.0 ± 0.3. Retavase® is supplied as a 10.4 unit vial to ensure sufficient drug for administration of each 10 unit injection. Each single-use vial contains:
Reteplase 18.1 mg
Tranexamic Acid 8.32 mg
Dipotassium Hydrogen Phosphate 136.24 mg
Phosphoric Acid 51.27 mg
Sucrose 364.0 mg
Polysorbate 80 5.20 mg