RETAVASE Dosage & Rx Info | Uses, Side Effects

Retavase Generic Name & Formulations

Legal Class

General Description

Reteplase 10 units; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free.

Pharmacological Class

Tissue plasminogen activator (tPA).

How Supplied

Kit—1 (2 vials w. diluents, supplies); Half-Kit—1 (1 vial w. diluent, supplies)

Manufacturer

Chiesi USA, Inc.

Mechanism of Action

Reteplase is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.

Retavase Indications

Indications

Treatment of acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure.

Limitations of Use

The risk of stroke may outweigh the benefit produced by thrombolytic
therapy in patients whose STEMI puts them at low risk for death or heart failure.

Retavase Dosage and Administration

Adult

Start as soon as possible after onset of STEMI. 10 units IV over 2mins; repeat with 10 units 30mins after the first dose.

Children

Not established.

Retavase Contraindications

Contraindications

Active internal bleeding. Recent stroke. Intracranial or intraspinal surgery or serious head trauma within 3 months. Intracranial neoplasm, arteriovenous malformation, or aneurysm. Bleeding diathesis. Severe uncontrolled hypertension.

Retavase Boxed Warnings

Not Applicable

Retavase Warnings/Precautions

Warnings/Precautions

Avoid noncompressible arterial puncture, internal jugular and subclavian venous punctures, IM inj, nonessential handling of patient to minimize risk of bleeding. Withhold second dose if serious bleeding or anaphylactoid reaction occurs. Discontinue concomitant anticoagulant therapy if severe bleeding occurs. Cholesterol embolization. Pregnancy. Nursing mothers: not studied.

Retavase Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life: 13–16 minutes.

Retavase Interactions

Interactions

Increased bleeding risk with concomitant anticoagulant therapy. Incompatible with heparin; do not administer through an IV line together. Coagulation tests may be unreliable during therapy.

Retavase Adverse Reactions

Adverse Reactions

Bleeding, hypersensitivity reactions, cholesterol embolism.

Retavase Clinical Trials

See Literature

Retavase Note