Reteplase

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Reteplase
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alejandro Lemor, M.D. [2]

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Overview

Reteplase is a tissue plasminogen activator that is FDA approved for the {{{indicationType}}} of acute myocardial infarction. Common adverse reactions include bleeding.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Myocardial Infarction
  • 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
  • Dosing Information
  • First dose: 10 unit IV bolus' over 2 minutes
  • Second dose (30 minutes after first bolus): 10 unit IV bolus' over 2 minutes

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Reteplase in adult patients.

Non–Guideline-Supported Use

Vascular Graft Thrombosis
  • Dosing Information
  • (Dosage)
Pulmonary Embolism
  • Dosing Information
  • (Dosage)
Acute Peripheral Ischemia
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Reteplase FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Reteplase in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Reteplase in pediatric patients.

Contraindications

  • Recent intracranial or intraspinal surgery or trauma

Warnings

Bleeding

  • The most common complication encountered during reteplase 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 reteplase had dissipated, but while heparin therapy was continuing.
  • As fibrin is lysed during reteplase 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 andinternal jugular and subclavian venous punctures should be avoided to minimize bleeding from noncompressible sites.
  • Should an arterial puncture be necessary during the administration of reteplase, 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 reteplase.
  • 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 reteplase should not be given if serious bleeding occurs before it is administered.
  • Each patient being considered for therapy with reteplase should be carefully evaluated and anticipated benefits weighed against the potential risks associated with therapy.
  • In the following conditions, the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits:

Cholesterol Embolization

Arrhythmias

Adverse Reactions

Clinical Trials Experience

Bleeding

  • The most frequent adverse reaction associated with reteplase is bleeding.
  • The types of bleeding events associated with thrombolytic therapy may be broadly categorized as either intracranial hemorrhage or other types of hemorrhage.

Intracranial hemorrhage

  • In the INJECT clinical trial the rate of in-hospital, intracranial hemorrhage among all patients treated with reteplase was 0.8% (23 of 2,965 patients).
  • As seen with reteplase and other thrombolytic agents, the risk for intracranial hemorrhage is increased in patients with advanced age or with elevated blood pressure.

Other types of hemorrhage

  • The incidence of other types of bleeding events in clinical studies of reteplase varied depending upon the use of arterial catheterization or other invasive procedures and whether the study was performed in Europe or the USA.
  • The overall incidence of any bleeding event in patients treated with reteplase in clinical studies (n = 3,805) was 21.1%.
  • The rates for bleeding events, regardless of severity, for the 10 + 10 unit reteplase regimen from controlled clinical studies are summarized in Table 3.

  • In these studies the severity and sites of bleeding events were comparable for reteplase and the comparison thrombolytic agents.
  • Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, any concomitant heparin should be terminated immediately.
  • In addition, the second bolus of reteplase should not be given if the serious bleeding occurs before it is administered.
  • Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
  • Fibrin which is part of the hemostatic plug formed at needle puncture sites will be lysed during reteplase therapy.
  • Therefore, reteplasetherapy requires careful attention to potential bleeding sites (e.g., catheter insertion sites, arterial puncture sites).

Allergic Reactions

  • Among the 2,965 patients receiving reteplase in the INJECT trial, serious allergic reactions were noted in 3 patients, with one patient experiencing dyspnea and hypotension.
  • No anaphylactoid reactions were observed among the 3,856 patients treated with reteplase in initial clinical trials.
  • In an ongoing clinical trial two anaphylactoid reactions have been reported among approximately 2,500 patients receiving reteplase.

Other Adverse Reactions

Postmarketing Experience

(Description)

Drug Interactions

  • The interaction of reteplase with other cardioactive drugs has not been studied.
  • In addition to bleeding associated with heparin and vitamin K antagonists, drugs that alter platelet function (such as aspirin, dipyridamole, and abciximab) may increase the risk of bleeding if administered prior to or after retaplase therapy.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Reteplase has been shown to have an abortifacient effect in rabbits when given in doses 3 times the human dose (0.86 units/kg). Reproduction studies performed in rats at doses up to 15 times the human dose (4.31 units/kg) revealed no evidence of fetal anomalies; however, Reteplase administered to pregnant rabbits resulted in hemorrhaging in the genital tract, leading to abortions in mid-gestation. There are no adequate and well-controlled studies in pregnant women. The most common complication of thrombolytic therapy is bleeding and certain conditions, including pregnancy, can increase this risk. Reteplase should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS): C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

Labor and Delivery

There is no FDA guidance on use of Reteplase during labor and delivery.

Nursing Mothers

It is not known whether reteplase is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Retavase® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of reteplase in pediatric patients have not been established.

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

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Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Reteplase
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Mechanism of Action

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Pharmacodynamics

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Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

  • Long-term studies in animals have not been performed to evaluate the carcinogenic potential of retaplase.
  • Studies to determine mutagenicity, chromosomal aberrations, gene mutations, and micronuclei induction were negative at all concentrations tested.
  • Reproductive toxicity studies in rats revealed no effects on fertility at doses up to 15 times the human dose (4.31 units/kg).

Clinical Studies

Condition 1

(Description)

Condition 2

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Condition 3

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How Supplied

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Storage

There is limited information regarding Reteplase Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Reteplase Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Reteplase interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Retavase

Look-Alike Drug Names

There is limited information regarding Reteplase Look-Alike Drug Names in the drug label.

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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