Reteplase

Solution for inj: Reconstitute a vial labelled as containing 10 units with 10 mL of sterile water for inj or the supplied 10 mL syringe of solvent and reconstitution spike.

May result in precipitation with heparin in the same IV line.

Active bleeding, including active internal bleeding; known haemorrhagic diathesis; intracranial neoplasm, arteriovenous malformation or aneurysm, neoplasm with increased bleeding risk; history of CVA; severe uncontrolled hypertension, portal hypertension (oesophageal varices); active peptic ulceration, acute pancreatitis, pericarditis, bacterial endocarditis; within 3 months of severe bleeding, major trauma or major surgery (e.g. CABG, intracranial or intraspinal surgery or trauma); obstetrical delivery, organ biopsy, previous puncture of noncompressible vessels; suspected aortic dissection; ischaemic stroke within 3 months, significant closed head or facial trauma with radiographic evidence of bony fracture or brain injury. Severe renal and hepatic impairment.

Patient with high probability of left heart thrombus (e.g. mitral stenosis, atrial fibrillation); history of chronic, severe, or poorly controlled hypertension; significant hypertension (systolic blood pressure of >180 mmHg or diastolic blood pressure of >110 mmHg); cerebrovascular disease; dementia; traumatic or prolonged CPR (>10 minutes); septic thrombophlebitis or occluded arteriovenous cannula at seriously infected site. Avoid IM inj and internal jugular or subclavian venous punctures. Elderly. Pregnancy and lactation. Concurrent use with anticoagulants.

Significant: Reperfusion arrhythmia (e.g. accelerated idioventricular rhythm, sinus bradycardia, ventricular premature depolarisations, ventricular tachycardia); hypersensitivity reactions (e.g. glossal oedema, hypotension, respiratory distress).
Cardiac disorders: Recurrent ischaemia, angina.
General disorders and administration site conditions: Inj site bleeding (e.g. haematoma), inj site reactions (e.g. burning sensation).
Respiratory, thoracic and mediastinal disorders: Pulmonary oedema.
Potentially Fatal: Internal bleeding (e.g. intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory); external bleeding, particularly at arterial and noncompressible venous puncture sites. Rarely, cholesterol embolisation.

IV/Parenteral: C

Monitor CBC and aPTT. Perform continuous ECG monitoring. Carefully monitor all potential bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cut down sites and needle puncture sites). Assess for signs and symptoms of bleeding and hypersensitivity reactions.

Symptom: Bleeding.

Management: Symptomatic and supportive treatment. Volume replacement should be employed; apply manual pressure to an incompetent vessel. Use of transfusion products may be indicated in patients who fail to respond to conservative measures.

Increased risk of bleeding with heparin, LMWH, oral anticoagulants and antiplatelet agents (e.g. aspirin, dipyridamole, abciximab, ticlopidine, clopidogrel).

Reteplase alters the results of coagulation and fibrinolytic activity tests.

Description:
Overview: Reteplase, a recombinant plasminogen activator, is a thrombolytic agent.
Mechanism of Action: Reteplase catalyses the cleavage of endogenous plasminogen to plasmin. Consequently, plasmin degrades fibrin which is the main component of the matrix of thrombus, thereby exerting its thrombolytic effect.
Onset: Thrombolysis: 30-90 minutes.
Pharmacokinetics:
Excretion: Via urine and faeces. Elimination half-life: 13-16 minutes.

Store between 2-25°C. Protect from light.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AD07 - reteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.

Brayfield A, Cadart C (eds). Reteplase. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/09/2025.

Mirel (Ambica). MIMS Philippines. http://www.mims.com/philippines. Accessed 23/09/2025.

Rapilysin 10 U Powder and Solvent for Solution for Injection (Accord-UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 23/09/2025.

Reteplase. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 23/09/2025.

Reteplase. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 23/09/2025.