Retavase (reteplase)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Reteplase, a biosynthetic (recombinant DNA origin) form of the enzyme human tissue-type plasminogen activator (t-PA), is a thrombolytic agent.
Reteplase, a biosynthetic (recombinant DNA origin) form of the enzyme human tissue-type plasminogen activator (t-PA), is a thrombolytic agent. Although structurally and pharmacologically related to alteplase, reteplase lacks the finger, kringle-1, and epidermal growth factor domains of alteplase and has no glycosidic side chains. Reteplase has a decreased fibrin affinity, a longer plasma half-life, and a lower plasma clearance than alteplase, which allows reteplase to be administered as a direct IV injection.
Reteplase is prepared from cultures of genetically modified Escherichia coli using recombinant DNA technology. The thrombolytic effect of reteplase results when the drug binds to fibrin and converts plasminogen to plasmin; plasmin then degrades the fibrin matrix of the thrombus. Potency of reteplase using an in vitro clot lysis assay is expressed in reteplase-specific units; each mg of reteplase has a potency of 0.575 (about 0.6) reteplase-specific units.
It is not known whether reteplase is distributed into human milk. Reteplase is cleared primarily by the liver and kidney and has an effective half-life of 13-16 minutes.
Generic name: reteplase
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Retavase
Indications
The following indications are listed for Retavase:
- Acute Myocardial Infarction
Also known as: Acute Mi, Cardiac Infarction, Myocardial Infarct.
Dosing
Dosage of reteplase is expressed in reteplase-specific units.
Reteplase is administered by IV injection. The drug is supplied in a kit containing 2 single-use reteplase vials, 2 single-use prefilled syringes with Sterile Water for Injection diluent for reconstitution, 2 syringe plungers, 2 sterile 10 mL graduated syringes, and 2 sterile reconstitution spikes. A half-kit is also available that contains only 1 each of the components in the full kit.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Active internal bleeding.
*Recent stroke.
*Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma.
*Intracranial conditions that increase bleeding risk (e.g., neoplasms, arteriovenous malformation, aneurysm).
*Bleeding diathesis.
*Current severe uncontrolled hypertension.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
The most frequent adverse effect occurring in >5% of patients receiving reteplase was bleeding.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy not established in pediatric patients <18 years of age.
Data on use of reteplase in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, administration of reteplase to pregnant rabbits at doses equivalent to 3 times the human dose resulted in hemorrhaging in the genital tract, leading to abortions; however, there was no evidence of fetal anomalies in rats administered doses of up to 15 times the human dose.
Pregnancy may increase the risk of bleeding associated with thrombolytic therapy.
It is unknown whether reteplase is distributed into human milk; potential effects on the breast-fed infant or on milk production also are not known.
Based on results of a trial with tenecteplase showing that an excess of intracranial hemorrhage in patients >=75 years of age with acute MI was reduced after reducing the tenecteplase dosage by 50%, some clinicians suggest considering a 50% reduction in the dosage of reteplase in patients >=75 years of age receiving the drug for acute MI.
In the INJECT clinical trial, the risk of intracranial hemorrhage with reteplase was increased in geriatric patients >70 years of age.
Some clinicians suggest considering a 50% reduction in the dosage of reteplase in patients >=75 years of age receiving the drug for acute MI.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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