Reteplase, Recombinant

Pronunciation: (REH-tuh-place)
Class: Tissue plasminogen activator

Trade Names

Retavase
- Powder for injection, lyophilized 10.4 U (18.1 mg)

Pharmacology

Aids in dissolution of blood clots.

Pharmacokinetics

Elimination

Cleared primarily by liver and kidneys. Plasma Cl is 250 to 450 mL/min. The t _½ is 13 to 16 min.

Indications and Usage

Management of acute MI, to reduce incidence of CHF and mortality associated with an acute MI.

Contraindications

Active internal bleeding; history of cerebrovascular accident; recent intracranial or intraspinal surgery or trauma; intracranial neoplasm, arteriovenous malformation or aneurysm; bleeding diathesis or severe uncontrolled hypertension because thrombolytic therapy increases the risk of bleeding.

Dosage and Administration

Adults

IV 10 + 10 unit double-bolus injection, each bolus given over 2 min. The second bolus given 30 min after initiation of the first.

General Advice

• Administer only by IV bolus injection. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
• Reconstitute lyophilized powder following manufacturer's recommendations using supplied diluent (sterile water for injection) and dispensing pin. Do not reconstitute with bacteriostatic water for injection.
• Mix by gentle swirling. Avoid excessive agitation during reconstitution.
• Use reconstituted solution immediately or within 4 h if stored properly.
• Do not administer if particulate matter or discoloration noted.
• Administer reconstituted solution as IV bolus injection over 2 min via IV line in which no other medication, including heparin, is being administered. If administration through an IV line containing heparin is necessary, flush line with normal saline or dextrose 5% in water prior to and following reteplase administration.
• Discard any unused solution.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F) or at controlled room temperature (less than 77°F). Protect from exposure to light. Reconstituted solution may be stored for up to 4 h in refrigerator (36° to 46°F) or at controlled room temperature (less than 86°F).

Drug Interactions

Abciximab, aspirin, dipyridamole, heparin, vitamin K antagonists

May increase the risk of bleeding.

Incompatibility

Heparin

Do not add other medications to the same IV.

Laboratory Test Interactions

Results of coagulation tests may be unreliable if precautions are not taken to prevent in vitro artifacts.

Adverse Reactions

Hematologic

Bleeding, both superficial (eg, venous cutdowns, arterial punctures, sites of surgical intervention) and internal (eg, GI tract, GU tract, intracranial, pericardial, retroperitoneal sites).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Antithrombotic use

Heparin and aspirin have been administered concomitantly with reteplase.

Arrhythmias

Antiarrhythmic therapy should be available because coronary reperfusion may result in arrhythmias.

Bleeding

Most frequent and serious side effect.

Cholesterol embolism

May occur rarely in patients treated with thrombolytic agents.

Readministration

There is no experience with readministration of reteplase.

Overdosage

Symptoms

Bleeding.

Patient Information

• Advise patient, family, or caregiver that medication will be prepared and administered by a health care professional in a medical setting.
• Instruct patient, family, or caregiver to report any unusual symptoms or feelings, signs of bleeding, or allergic reaction immediately.
• Caution patient to avoid getting out of bed without assistance during treatment.

Copyright © 2009 Wolters Kluwer Health.