No

Thrombolytic Agent

Management of acute myocardial infarction (AMI); improvement of ventricular function; reduction of the incidence of CHF and the reduction of mortality following AMI

C

Hypersensitivity to reteplase or any component; active internal bleeding; history of cerebrovascular accident; recent intracranial or intraspinal surgery or trauma; intracranial neoplasm, arteriovenous malformations, or aneurysm; known bleeding diathesis; severe uncontrolled hypertension

Concurrent heparin anticoagulation can contribute to bleeding; careful attention to all potential bleeding sites. I.M. injections and nonessential handling of the patient should be avoided. Venipunctures should be performed carefully and only when necessary. If arterial puncture is necessary, use an upper extremity vessel that can be manually compressed. If serious bleeding occurs then the infusion of anistreplase and heparin should be stopped.

Coronary thrombolysis may result in reperfusion arrhythmias. Follow standard MI management. Rare anaphylactic reactions can occur. Safety and efficacy in pediatric patients have not been established.

Bleeding is the most frequent adverse effect associated with reteplase. Heparin and aspirin have been administered concurrently with reteplase in clinical trials. The incidence of adverse events is a reflection of these combined therapies, and are comparable with comparison thrombolytics.

1% to 10%:

Hematologic: Anemia (0.9% to 2.6%)

Gastrointestinal: Bleeding (1.8% to 9.0%)

Genitourinary: Bleeding (0.9% to 9.5%)

<1% (Limited to important or life-threatening symptoms): Intracranial hemorrhage (0.8%), allergic/anaphylactoid reactions, cholesterol embolization

Other adverse effects noted are frequently associated with myocardial infarction (and therefore may or may not be attributable to Retavase™) and include arrhythmias, hypotension, cardiogenic shock, pulmonary edema, cardiac arrest, reinfarction, pericarditis, tamponade, thrombosis, and embolism.

Symptoms of overdose include increased incidence of intracranial bleeding

Aminocaproic acid (antifibrinolytic agent) may decrease effectiveness.

Drugs which affect platelet function (eg, NSAIDs, dipyridamole, ticlopidine, clopidogrel, IIb/IIIa antagonists) may potentiate the risk of hemorrhage; use with caution.

Heparin and aspirin: Use with aspirin and heparin may increase bleeding. However, aspirin and heparin were used concomitantly with reteplase in the majority of patients in clinical studies.

Warfarin or oral anticoagulants: Risk of bleeding may be increased during concurrent therapy.

Dosage kits should be stored at 2°C to 25°C (36°F to 77°F) and remain sealed until use in order to protect from light

Reteplase is a nonglycosylated form of tPA produced by recombinant DNA technology using E. coli; it initiates local fibrinolysis by binding to fibrin in a thrombus (clot) and converts entrapped plasminogen to plasmin

Onset: 30-90 minutes

Half-life: 13-16 minutes

Elimination: Hepatic and renal, cleared from the plasma at a rate of 250-450 mL/minute

Children: Not recommended

Adults: 10 units I.V. over 2 minutes, followed by a second dose 30 minutes later of 10 units I.V. over 2 minutes

Withhold second dose if serious bleeding or anaphylaxis occurs

Monitor for signs of bleeding (hematuria, GI bleeding, gingival bleeding)

It is important that in using thrombolytic therapy in an institution, that the protocol for that institution be followed closely, particularly in terms of dosage, adjunctive heparin therapy, and standard myocardial infarction therapy (aspirin, beta-blocker, ACE inhibitor).

None reported

None reported

No information available to require special precautions

No effects or complications reported

This medication can only be administered I.V. You will have a tendency to bleed easily following this medication; use caution to prevent injury (use electric razor, use soft toothbrush, use caution with sharps). If bleeding occurs, apply pressure to bleeding spot until bleeding stops completely. Report unusual bruising or bleeding (eg, blood in urine, stool, or vomitus; bleeding gums; vaginal bleeding; nosebleeds); dizziness or changes in vision; back pain; skin rash; swelling of face, mouth, or throat; or difficulty breathing. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Consult prescriber if breast-feeding.

Injection: Powder in vials, each vial contains reteplase 10.8 units; supplied with 2 mL diluent (preservative free)