There are no adequate data on the use of reteplase in pregnant women. The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions. The potential risk for humans is unknown. Except in life-threatening situations, Rapilysin should not be used in pregnant women.
It is not known whether reteplase is excreted into breast milk. Breast milk should be discarded within the first 24 hours after thrombolytic therapy.
Not relevant.
The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site. Local reactions at injection site can also occur.
As with other thrombolytic agents, recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema have been reported frequently as sequelae of myocardial infarction and/or thrombolytic administration.
The most frequent adverse drug reaction associated with reteplase treatment is haemorrhage.
Reports of intracranial bleeding, many of which are fatal, are of particular concern.
Systolic blood pressure over 160 mmHg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding. The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age. Blood transfusions were rarely required. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.
The frequency of adverse reactions reported is listed below. Frequencies are defined as 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) and not known (cannot be estimated from the available data).
Uncommon: Hypersensitivity reactions (e.g. allergic reactions)1
Very rare: Serious anaphylaxis/anaphylactoid reactions1
Uncommon: Cerebral haemorrhage2
Very rare: Events related to the nervous system (e.g. epileptic seizure, convulsion, aphasia, speech disorder, delirium, acute brain syndrome, agitation, confusion, depression, psychosis)
Very common: Recurrent ischaemia/angina, hypotension and heart failure/pulmonary oedema
Common: Arrhythmias (e.g. AV block, atrial fibrillation/flutter, ventricular tachycardia/fibrillation, electromechanical dissociation (EMD)), cardiac arrest, cardiogenic shock and reinfarction
Uncommon: Mitral regurgitation, pulmonary embolism, other systemic embolism/cerebral embolism and ventricular septal defect
Common: Gastrointestinal haemorrhage (haematemesis, melena), gingival or genitourinary bleeding
Uncommon: Haemopericardium, retroperitoneal bleeding, cerebral haemorrhage, epistaxis, haemoptysis, eye haemorrhage and ecchymosis
Very common: Haemorrhage at the injection site (e.g. haematoma), a local reaction at injection site, for example a burning sensation
Not known: Fat embolism, which may lead to corresponding consequences in the organs concerned4
1 Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
2 Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions.
3 As with other thrombolytic agents these cardiovascular events have been reported as sequelae of myocardial infarction and/or thrombolytic administration. These events can be life-threatening and may lead to death.
4 This event has been reported for the therapeutic class of thrombolytic agents.
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