Reteplase Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Applies to reteplase: intravenous powder for solution.

Precautions

Reteplase can cause bleeding that usually is not serious. However, serious bleeding may occur in some people. To help prevent serious bleeding, carefully follow any instructions given by your doctor. Move around as little as possible, and do not get out of bed on your own, unless your doctor tells you it is all right to do so.

Watch for any bleeding or oozing on your skin, such as around the place of injection or where blood was drawn from your arm. Also, check for blood in your urine or bowel movements. If you have any bleeding or injuries, tell your doctor or nurse right away .

Serious side effects of reteplase

Along with its needed effects, reteplase may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking reteplase:

For healthcare professionals

Applies to reteplase: intravenous kit.

General adverse events

Fever, a general body side effect, has been reported.^[Ref]

Cardiovascular

Cardiovascular side effects are probably sequelae of myocardial infarction and not due to reteplase. These side effects have included hypotension, cardiogenic shock, arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, premature ventricular depolarizations, supraventricular tachycardia, ventricular tachycardia, and ventricular fibrillation), AV block, pulmonary edema, heart failure, cardiac arrest, recurrent ischemia, reinfarction, myocardial rupture, mitral regurgitation, pericardial effusion, pericarditis, cardiac tamponade, venous thrombosis and embolism, and electromechanical dissociation.^[Ref]

The following incidences were reported from the RAPID-2 trial: myocardial reinfarction 4.7%, congestive heart failure 9.5%, and ischemia or angina in 29.0%.

Cholesterol embolization--sometimes fatal--has been reported rarely in patients treated with thrombolytic agents. The exact incidence is unknown. Its relationship with lytic therapy might be coincidental as there is such risk associated with invasive vascular procedures (e.g., cardiac catheterization, angiography, vascular surgery) and/or anticoagulant therapy.

Reperfusion arrhythmias during thrombolytic therapy can be a sign of successful lytic therapy. These arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular rhythm, ventricular premature depolarizations, ventricular tachycardia) may also be seen during the natural course of acute myocardial infarction, and they should be treated with standard antiarrhythmic measures, as indicated. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular irritability be available during reteplase therapy.^[Ref]

Hypersensitivity

Serious hypersensitivity reactions to reteplase have been rare. Among the 2,965 patients in the INJECT trial, such reactions were noted in 3 patients, with 1 patient experiencing dyspnea and hypotension. No cases of anaphylaxis were reported among the 3,856 patients treated with reteplase in initial clinical trials, but 2 cases of anaphylaxis were associated with the use of reteplase among approximately 2,500 patients in ongoing clinical trials.^[Ref]

There are no data to demonstrate the formation of anti-reteplase antibodies among the approximately 2,400 patients who have been tested for the presence of such antibodies. Nevertheless, the use of reteplase (including the second bolus of reteplase) is not recommended if anaphylaxis has occurred with any prior use of reteplase in a given patient.^[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.^[Ref]

Hematologic

Hematologic side effects have been the most frequently reported side effects. In the INJECT trial, the overall incidence of bleeds from any site was 15.0%, of which 4.6% were clinically significant. Transfusion requirements have ranged from 1.0% (INJECT trial) to 12.4% (RAPID-2 trial). The types of bleeds associated with this drug (and thrombolytic therapy, in general) may be broadly categorized as either intracranial hemorrhage or other types of hemorrhage.

The overall incidence of intracranial hemorrhage has averaged 0.8%. This risk is increased in patients with advanced age or hypertension. The incidence of transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) in the INJECT trial averaged 0.20%, and the incidence of frank stroke in the RAPID-2 trial averaged 1.8%. The average incidence of nonintracranial hemorrhage ranged from 1.9% to 9.0%, depending on the trial, use of arterial catheterization, and whether the study was performed in the US or Europe.

The incidence of IV site bleeding ranged from 4.6% to 48.6%. Arterial and venous punctures should be minimized. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, or pericardial) occur, any concomitant heparin should be terminated immediately, and the second bolus of reteplase should be withheld.^[Ref]

The incidences of bleeding have been reported in the following sites within the following clinical trials, respectively (European INJECT study [n=2965], US RAPID-1 study [n=210], European RAPID-2 study [n=113]: injection site 4.6%, 48.6%, 19.5%; intracranial 1.2% (stroke), 0%, 1.8% (stroke); gastrointestinal 2.5%, 9.0%, 1.8%; genitourinary 1.6%, 9.5%, 0.9%; anemia 2.6%; 1.4%, 0.9%).

Since reteplase causes lysis of the fibrin plug, which is necessary to stop bleeding at puncture sites, careful attention should be paid to potential sites of bleeding during therapy (injection site, arterial puncture sites, catheter insertion sites, etc.).^[Ref]

See also:

Frequently asked questions

• Is Activase the same as tPA?

Further information

Reteplase side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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