Recomlyse Adverse Reactions

Summary of the safety profile: Haemorrhage is the most common undesirable effect associated with the use of Recomlyse. The type of haemorrhage can be superficial at the injection site or internal at any site or body cavity. Death and permanent disability are reported in patients who have experienced bleeding episodes.
Tabulated list of adverse reactions: Adverse reactions related to treatment of acute myocardial infarction: The most common adverse reaction in clinical studies of this product is bleeding, including intracranial hemorrhage and other minor bleeding adverse events. The specific data are shown in Table 4. (See Table 4.)

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If a potential for massive bleeding, especially intracranial hemorrhage, is detected, thrombolytic therapy should be stopped.
Allergic Reaction: In clinical trials of this product, no allergic reactions were seen in patients after using this product. Once an allergic reaction occurs, anti-allergic treatment is required.
Other adverse events: The following adverse events were seen in patients treated with Recomlyse in clinical trials, and the impact of Recomlyse on their incidence is unclear. These adverse events include cardiogenic shock, heart failure, cardiac rupture and electromechanical dissociation, ventricular fibrillation and cardiac rupture, with an incidence rate of 3.23%; increases in aminotransferases, cardiac enzymes, blood lipids, blood sugar, and nausea, vomiting, fever, and cough etc., all to a lesser degree. Researchers judged that most of these adverse events were not related to the experimental drugs, but were related to underlying diseases and/or accompanying diseases, as well as concomitant medications.
In the ASSENT-2 study, the following non-ICH bleeding events were reported (Table 5). (See Table 5.)

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Non-intracranial major bleeding and the need for blood transfusions were lower in patients treated with TNKase.
Types of major bleeding reported in 1% or more of the patients were haematoma (1.7%) and gastrointestinal tract (1%). Types of major bleeding reported in less than 1% of the patients were urinary tract, puncture site (including cardiac catheterisation site), retroperitoneal, respiratory tract, and unspecified. Types of minor bleeding reported in 1% or more of the patients were haematoma (12.3%), urinary tract (3.7%), puncture site (including cardiac catheterisation site) (3.6%), pharyngeal (3.1%), gastrointestinal tract (1.9%), epistaxis (1.5%), and unspecified (1.3%).
Allergic Reactions: Rarely (<1%) allergic reactions (e.g., allergic symptoms, angioedema, laryngeal edema, rash, urticaria) have been reported in patients treated with TNKase. <0.1% of patients treated with TNKase have experienced allergic reactions, but causality is uncertain. When an allergic reaction occurs, conventional treatments are usually used.
Other adverse reactions: The following adverse reactions were seen in patients treated with TNKase in clinical trials. These reactions are often sequelae of the underlying disease, and the contribution of TNKase to their incidence is unknown.
These adverse reactions include cardiogenic shock, arrhythmias, atrioventricular block, pulmonary edema, heart failure, cardiac arrest, cyclic myocardial ischemia, recurrence of myocardial infarction, cardiac rupture, cardiac tamponade, pericarditis, and pericardium. fluid, mitral regurgitation, thrombosis, embolism and cardiac electromechanical dissociation. These events can be life-threatening and may result in death. Nausea and/or vomiting, hypotension, and fever have also been reported.
Adverse reactions related to treatment of acute ischemic stroke: Adverse reactions are classified according to frequency. Frequency groupings are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Adverse reactions in clinical studies are as follows: Bleeding: (See Table 6.)

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When a potential tendency for massive bleeding occurs, especially intracranial hemorrhage, it needs to be treated according to clinical treatment standards. Antiplatelet aggregation drugs and anticoagulants (if any) being used should be stopped immediately, blood pressure should be controlled, and symptomatic treatment should be given promptly. Currently, the most commonly used treatment methods include hemostatic drugs (vitamin K, prothrombin complex concentrate, anti-Fibrinolytic agents, etc.), if severe bleeding occurs, alternative treatments (such as transfusion of fresh frozen plasma, whole blood, platelets, or cryoprecipitate) may be considered. If intracranial hemorrhage is evaluated by neurosurgery and surgery (decompressive craniotomy or hematoma evacuation) is required, treatment will be based on specialist advice.
Other adverse reactions: (See Table 7.)

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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.