Reteplase

What is Reteplase?

• Reteplase (Retavase) is a tissue plasminogen activator (tPA), used to treat heart attacks by breaking up the clots that cause them.
• Reteplase is a recombinant non-glycosylated form of human tissue plasminogen activator, which has been modified to contain 357 of the 527 amino acids of the original protein.
• It is produced in the bacterium Escherichia coli.

What are the uses of this medicine?

• Reteplase (Retavase) is indicated for use in 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.

How does this medicine work?

• Reteplase (Retavase) 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Active internal bleeding.
• Recent stroke.
• Recent intracranial or intraspinal surgery or serious head trauma.
• Intracranial neoplasm, arteriovenous malformation, or aneurysm.
• Known bleeding diathesis.
• Severe uncontrolled hypertension.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Reteplase was approved for use in 1996.

How should this medicine be used?

Recommended dosage:

• Two 10 unit intravenous injections, each administered over 2 minutes, 30 minutes apart.

Administration:

• Administer 10 units intravenously over 2 minutes.
• Reconstitute Retavase immediately before administration.
• Reconstitute Retavase only with the supplied Sterile Water for Injection.
• Slight foaming upon reconstitution may occur; if necessary allow the vial to stand undisturbed for several minutes to allow dissipation of any large bubbles. Prior to administration, inspect the product for particulate matter and discoloration.
• Use aseptic technique throughout.
• No other medication should be injected or infused simultaneously via the same intravenous line or added to the injection solution.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 10 units as a lyophilized powder in single-use vials for reconstitution co-packaged with Sterile Water for Injection, USP in 10 mL prefilled syringe.

This medicine is available in fallowing brand namesː

• Retavase

What side effects can this medication cause?

The most common side effects of this medicine include:

• bleeding

Less common, but serious side effects may include:

• Intracranial hemorrhage
• Other types of hemorrhage

Allergic Reactions:

• Signs and symptoms observed included rash, pruritis, erythema, glossal (tongue) edema, hypotension, and respiratory distress.

What special precautions should I follow?

• Retavase can cause significant and sometimes fatal bleeding. Avoid intramuscular injections and other trauma to a patient administered Retavase. If serious bleeding (not controllable by local pressure) occur, terminate concomitant anticoagulant therapy. Withhold the second Retavase dose if serious bleeding occurs before it is administered.
• Hypersensitivity reactions have been reported with Retavase administration. If an anaphylactoid reaction occurs, withhold the second dose of Retavase and initiate appropriate therapy.
• Cholesterol embolism has been reported in patients treated with thrombolytic agents.
• Coagulation tests and measures of fibrinolytic activity are unreliable during Retavase therapy unless specific precautions are taken.
• There are no data on the presence of reteplase in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. RETEVASE has not been studied in nursing mothers.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Limited published data with Retavase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.
• The most common complication of thrombolytic therapy is bleeding and pregnancy may increase this risk.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredient:

• RETEPLASE

Inactive ingredients:

• DIBASIC POTASSIUM PHOSPHATE
• PHOSPHORIC ACID
• POLYSORBATE 80
• SUCROSE
• TRANEXAMIC ACID

Who manufactures and distributes this medicine?

Manufactured by:

• Chiesi USA, Inc.
• Cary, NC

• Retavase® manufactured at Patheon Italia, S.p.A., Monza, Italy
• Retavase® is a registered trademark of Chiesi USA, Inc.

What should I know about storage and disposal of this medication?

• Store Retavase at 2°C to 25°C (36°F to 77°F).
• The box should remain sealed until use to protect the lyophilisate from exposure to light.

• Dailymed label info on Reteplase
• FDA Reteplase