Recomlyse Special Precautions

The decision to treat a patient with AIS with Recomlyse should be taken under the consultation of a physician experienced in the use of thrombolytic treatment and with the facilities to monitor its use. As with other thrombolytics, it is recommended that when Recomlyse is administered standard resuscitation equipment and medication be available in all circumstances.
Traceability: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file.
Coronary intervention: Transfer to a coronary intervention capable facility for adjunctive Percutaneous Coronary Intervention (PCI): Patients receiving Recomlyse as primary coronary recanalization treatment should be transferred without delay to a coronary intervention capable facility for angiography and timely coronary intervention within 6-24 hours or earlier if medically indicated.
Primary Percutaneous Coronary Intervention (PCI): For patients with acute myocardial infarction who are scheduled to undergo primary PCI as reperfusion therapy according to current relevant treatment guidelines, this product should not be used for thrombolytic therapy before primary PCI.
Bleeding: Exceeding recommended doses may increase the risk of bleeding.
In clinical studies, patients were treated with heparin, aspirin, and clopidogrel. Simultaneous use of anticoagulants and antiplatelet aggregation drugs may increase the risk of bleeding from this product. When severe bleeding occurs, anticoagulants and antiplatelet aggregation drugs should be discontinued immediately. Protamine can be used to reverse the effects of heparin. Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration. A target fibrinogen level of 1 g/L is desirable with cryoprecipitate infusion. Antifibrinolytic agents are available as a last alternative.
In clinical studies of Recomlyse, there is no experience with concomitant use of Recomlyse and warfarin or GP IIb/IIIa antagonists. The use of anticoagulants (e.g. vitamin K antagonists) and platelet aggregation inhibitors (e.g. GP IIb/IIIa antagonists) before, during or after treatment with Recomlyse is likely to increase the risk of bleeding.
The use of rigid catheters, intramuscular injections and non-essential handling of the patient should be avoided as bleeding from recent puncture sites may occur during treatment with Recomlyse. The arterial and venous puncture should be avoided after the treatment with Recomlyse. Should an arterial puncture be necessary, it is preferable to use an upper extremity vessel that is accessible to manual compression. Pressure should be applied for at least 30 minutes, a pressure dressing applied, and the puncture site checked frequently for evidence of bleeding. Noncompressible arterial punctures must be avoided. If venipuncture is necessary, venipunctures should be performed and monitored carefully. Puncturing of the internal jugular and subclavian veins should be avoided to reduce bleeding at noncompressible sites.
Each patient being considered for therapy with Recomlyse should be carefully evaluated and anticipated benefits weighed against potential risks associated with therapy. Especially for the following patients: Recent gastrointestinal or genitourinary bleeding within 10 days; Recent minor trauma; Any known recent intramuscular injection; Hypertension: systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg; Haemostatic defects that are not mentioned in Contraindications, including severe renal disease; Pregnancy; Diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions; Septic thrombophlebitis or occluded AV cannula at seriously infected site; Patients currently receiving oral anticoagulants, e.g. warfarin sodium; Recent administration of GP IIb/IIIa inhibitors; Any other condition that may cause bleeding besides conditions mentioned in Contraindications.
Additional considerations when treating acute myocardial infarction: Other situations that require special attention are as follows: High likelihood of left heart thrombus, e.g. mitral stenosis with atrial fibrillation; Recent major surgery, e.g. coronary artery bypass graft, obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels, and resuscitative cardiac compressions; Cerebrovascular disease; Advanced age (>75 years of age); Low body weight <50 kg.
Additional considerations when treating acute ischemic stroke: Intracranial hemorrhage is the main adverse event, but this does not mean that it will increase the overall disability and mortality rates. Compared with other indications, the risk of intracranial hemorrhage is significantly increased when this product is used to treat acute ischemic stroke, because bleeding mainly occurs at the infarction site.
If symptoms have occurred for more than 4.5 hours, patients should not be treated with this product (see Contraindications) due to an unfavorable benefit/risk ratio, mainly based on the following situation: over time, the expected positive therapeutic effect will be reduced. Decreased; increased mortality in patients, especially those pretreated with aspirin; increased risk of symptomatic bleeding.
Other situations that require special attention are as follows: Minor non-disabling stroke; Stroke with rapid improvement in symptoms; Neurologic impairment following a convulsive attack (related to the stroke); Extracranial cervical artery dissection; Severe trauma within the past 2 weeks (no head injury); Have a history of myocardial infarction within the past 3 months.
Arrhythmias: Coronary thrombolysis may result in arrhythmia associated with reperfusion.
Reperfusion arrhythmias may lead to cardiac arrest, can be life-threatening and may require the use of conventional antiarrhythmic therapies.
Such arrhythmias such as sinus bradycardia, accelerated ventricular autonomic rhythm, premature ventricular depolarization, ventricular tachycardia are no different from those seen in usual clinical cases of acute myocardial infarction, and standard antimicrobial therapy can also be used. Arrhythmias are treated with medications. Concomitant antiarrhythmic treatment of bradycardia and/or ventricular excitation is recommended.
Blood pressure monitoring: Blood pressure monitoring up to 24 hours after Recomlyse treatment is necessary; intravenous antihypertensive therapy is recommended if systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg.
Special groups at reduced benefit/risk: The benefit/risk ratio is considered less favourable in patients that had a prior stroke or in those with known uncontrolled diabetes, but still positive in these patients. Patients with extensive infarction are at high risk for poor prognosis, including the possibility of severe bleeding and death. In these patients, the benefit/risk ratio should be carefully weighed.
Patients with atrial fibrillation have certain risks when applying this product for treatment, but they can still benefit from the treatment. The benefit/risk ratio should be carefully weighed before use.
In stroke patients the likelihood of a favourable outcome decreases with longer time from onset of symptoms to thrombolytic treatment, increasing age, increasing stroke severity and increased levels of blood glucose on admission while the likelihood of severe disability and death or symptomatic intracranial bleeding increases, independently of treatment.
Due to the possible increased risk of bleeding, platelet aggregation inhibitors should not be used within 24 hours after thrombolysis with this product.
Hypersensitivity: Immune-mediated hypersensitivity reactions associated with the administration of Recomlyse can be caused by the active substance rhTNK-tPA, gentamicin (a trace residue from the manufacturing process) or any of the excipients.
Anaphylactoid reactions associated with the administration of Recomlyse can be caused byhypersensitivity to the active substance rhTNK-tPA, excipients, or stoppers containing natural rubber (latex derivatives). There is no experience with re-administration of Recomlyse. No sustained antibody formation to the rhTNK-tPA molecule has been observed after treatment, and caution should be exercised when re-administering Recomlyse.
If a severe hypersensitivity reaction occurs, appropriate treatment should be promptly initiated.
Brain edema: Reperfusion of the ischaemic area may induce cerebral oedema in the infarcted zone.
Direct PCI: For patients with acute myocardial infarction who are scheduled to undergo primary PCI as reperfusion therapy according to current relevant treatment guidelines, this product should not be used for thrombolytic therapy before primary PCI.
Effects on ability to drive and use machines: Not relevant.
Use in children: Safety and efficacy data in children below 18 years of age are not available for Recomlyse. Therefore, treatment of such patients is not recommended.
Use in the elderly: Compared with younger patients, patients with acute ischemic stroke over 80 years old have a higher risk of bleeding after thrombolytic treatment, and the benefit/risk ratio should be carefully weighed before use.