Medically reviewed by Drugs.com. Last updated on Nov 19, 2020.
(RE ta plase)
- Recombinant Plasminogen Activator
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Intravenous [preservative free]:
Retavase: 2 X 10 UNIT [contains polysorbate 80]
Retavase Half-Kit: 1 X 10 UNIT [contains polysorbate 80]
Brand Names: U.S.
- Retavase Half-Kit
- Thrombolytic Agent
Reteplase 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.
Feces and urine
Clearance: Plasma: 250 to 450 mL/minute
Onset of Action
Thrombolysis: 30 to 90 minutes
13 to 16 minutes
Use: Labeled Indications
ST-elevation myocardial infarction, acute: Use in acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure
Limitation 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.
Active internal bleeding; recent stroke; intracranial or intraspinal surgery or serious head trauma within 3 months; intracranial conditions that increase the risk of bleeding (eg, neoplasm, arteriovenous malformations, or aneurysm); bleeding diathesis; severe uncontrolled hypertension
Additional contraindications (ACCF/AHA [O’Gara 2013]): Ischemic stroke within 3 months; any prior intracranial hemorrhage; active bleeding (excluding menses); suspected aortic dissection; significant closed head or facial trauma within 3 months with radiographic evidence of bony fracture or brain injury
ST-elevation myocardial infarction (STEMI), acute: IV: 10 units IV over 2 minutes, followed by a second dose 30 minutes later of 10 units IV over 2 minutes
Note: Thrombolytic should be administered within 30 minutes of hospital arrival. Generally, there is only a small trend for benefit of therapy after a delay of 12 to 24 hours from symptom onset, but thrombolysis may be considered for selected patients with ongoing ischemic pain and extensive ST elevation; however, primary PCI is preferred in these patients. Administer concurrent aspirin, clopidogrel, and anticoagulant therapy (ie, unfractionated heparin, enoxaparin, or fondaparinux) with reteplase (ACCF/AHA [O’Gara 2013]).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information
Refer to adult dosing.
Reconstitute using the supplied 10 mL syringe and 10 mL SWFI. Do not shake when reconstituting. Slight foaming is normal and will dissipate if left standing for several minutes. The reconstituted solution is 1 unit/mL. Use immediately after reconstitution.
IV: For IV use only; do not administer IM. Administer reconstituted dose over 2 minutes; no other medication should be added to the injection solution.
Store at 2°C to 25°C (36°F to 77°F); keep sealed until use to protect from light.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy
Anticoagulants: Thrombolytic Agents may enhance the anticoagulant effect of Anticoagulants. Management: See full drug monograph for guidelines for the use of alteplase for acute ischemic stroke during treatment with oral anticoagulants. Monitor therapy
Aprotinin: May diminish the therapeutic effect of Thrombolytic Agents. Monitor therapy
Dabigatran Etexilate: Thrombolytic Agents may enhance the anticoagulant effect of Dabigatran Etexilate. Management: Carefully monitor for bleeding. Dabigatran Canadian labeling recommends avoiding use with thrombolytic agents. Consider avoiding alteplase treatment of acute ischemic stroke in patients receiving dabigatran (see full drug monograph for details). Monitor therapy
Desirudin: Thrombolytic Agents may enhance the anticoagulant effect of Desirudin. Management: Discontinue treatment with thrombolytic agents prior to desirudin initiation. If concomitant use cannot be avoided, monitor patients receiving these combinations closely for clinical and laboratory evidence of excessive anticoagulation. Consider therapy modification
Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Thrombolytic Agents. Bleeding may occur. Management: Avoid coadministration of herbs possessing anticoagulant/antiplatelet properties and thrombolytic agents. If coadministered, monitor for bleeding. Discontinue anticoagulant/antiplatelet herbs 2 weeks prior to surgical, dental or invasive procedures. Consider therapy modification
Limaprost: May enhance the adverse/toxic effect of Thrombolytic Agents. The risk for bleeding may be increased. Monitor therapy
Prostacyclin Analogues: Thrombolytic Agents may enhance the adverse/toxic effect of Prostacyclin Analogues. Specifically, the antiplatelet effects of prostacyclin analogues may lead to an increased risk of bleeding when combined with thrombolytic agents. Monitor therapy
Salicylates: May enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Monitor therapy
Altered results of coagulation and fibrinolytic activity tests
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Local: Bleeding at injection site (49%)
1% to 10%:
Gastrointestinal: Gastrointestinal hemorrhage (9%)
Hematologic & oncologic: Hemorrhage (genitourinary: 10%), anemia (1%)
<1%, postmarketing, and/or case reports: Anaphylactoid shock, hypersensitivity reaction, intracranial hemorrhage
Concerns related to adverse effects:
• Arrhythmias: Coronary thrombolysis may result in reperfusion arrhythmias (eg, sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, ventricular tachycardia). Antiarrhythmic therapy should be available during therapy (Miller 1986).
• Bleeding: Internal bleeding (intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory) or external bleeding (especially at arterial and noncompressible venous puncture sites) may occur (may be fatal). Monitor all potential bleeding sites. If serious bleeding occurs, the infusion of reteplase and any other concurrent anticoagulants (eg, heparin) should be stopped and the patient should be treated appropriately.
• Cholesterol embolization: Has been reported rarely in patients treated with thrombolytic agents; may present as livedo reticularis, "purple toe" syndrome, acute renal failure, gangrenous digits, hypertension, pancreatitis, myocardial infarction, cerebral infarction, spinal cord infarction, retinal artery occlusion, bowel infarction, or rhabdomyolysis and can be fatal.
• Hypersensitivity reactions: Have been reported, including glossal edema, hypotension, and respiratory distress. If anaphylactoid reaction occurs, withhold second dose of reteplase and initiate appropriate therapy.
• Thromboembolic events: Use may increase risk of thromboembolic events in patients with high probability of left heart thrombus (eg, patients with mitral stenosis or atrial fibrillation).
• Conditions that increase bleeding risk: For the following conditions the risk of bleeding is higher with use of thrombolytics and should be weighed against the benefits of therapy: History of chronic, severe, poorly controlled hypertension; significant hypertension on presentation (systolic BP >180 mm Hg or diastolic BP >110 mm Hg); history of prior ischemic stroke >3 months; dementia; traumatic or prolonged CPR (>10 minutes); major surgery (<3 weeks); recent internal bleeding (within 2 to 4 weeks); noncompressible vascular punctures; active peptic ulcer; oral anticoagulant therapy (ACC/AHA [O’Gara 2013]); lumbar puncture within 10 days (ASRA [Horlocker 2010]).
• STEMI: Appropriate use: Follow standard management for STEMI while infusing reteplase.
• Elderly: Use with caution in patients with advanced age (eg, >75 years); increased risk of bleeding.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Administration: Intramuscular injections and nonessential handling of the patient should be avoided. Venipunctures should be performed carefully and only when necessary. Avoid internal jugular and subclavian venous punctures. If arterial puncture is necessary, use an upper extremity vessel that can be manually compressed.
CBC, aPTT; signs/symptoms of bleeding; ECG monitoring
Adverse events have been observed in some animal reproduction studies. The risk of bleeding may be increased in pregnant women.
What is this drug used for?
• It is used to treat a heart attack.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Bleeding like vomiting blood or vomit that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
• Blue/black/purple skin discoloration
• Change in amount of urine passed
• Severe headache
• Severe dizziness
• Passing out
• Chest pain
• Vision changes
• Muscle pain
• Dark urine
• Severe abdominal pain
• Back pain
• Severe loss of strength and energy
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about reteplase
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
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- Drug class: thrombolytics
Other brands: Retavase