Metalyse Adverse Reactions

Summary of the safety profile: Haemorrhage is a very common undesirable effect associated with the use of tenecteplase. The type of haemorrhage is predominantly superficial at the injection site. Ecchymoses are observed commonly but usually do not require any specific action. Death and permanent disability are reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
Tabulated list of adverse reactions: Adverse reactions listed as follows are classified according to frequency and system organ class. 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), not known (cannot be estimated from the available data).
Table 5 displays the frequency of adverse reactions. (See Table 5.)

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As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration: Very common: hypotension, heart rate and rhythm disorders, angina pectoris.
Common: recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock, pericarditis, pulmonary oedema.
Uncommon: cardiac arrest, mitral valve incompetence, pericardial effusion, venous thrombosis, cardiac tamponade, myocardial rupture.
Rare: pulmonary embolism.
These cardiovascular events can be life-threatening and may lead to death.
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.