Angioedema has been observed during and up to 2 hours after Activase infusion in patients treated for acute ischemic stroke and acute myocardial infarction. Rare fatal outcome for hypersensitivity was reported. Hypersensitivity, including urticarial / anaphylactic reactions, have been reported after administration of Activase. In the following conditions, the risks of bleeding with Activase are increased and should be weighed against the anticipated benefits: recent major surgery or procedure cerebrovascular disease recent intracranial hemorrhage recent gastrointestinal or genitourinary bleeding recent trauma hypertension acute pericarditis subacute bacterial endocarditis hemostatic defects including those secondary to severe hepatic or renal disease significant hepatic dysfunction pregnancy diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions septic thrombophlebitis or occluded AV cannula at seriously infected site advanced age and patients currently receiving oral anticoagulants, or any other condition in which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location. If serious bleeding occurs, terminate the Activase infusion, and treat appropriately. Hemorrhage can occur 1 or more days after administration of Activase, while patients are still receiving anticoagulant therapy. Because heparin, aspirin, or Activase may cause bleeding complications, carefully monitor for bleeding, especially at arterial puncture sites. The concomitant administration of heparin and aspirin with and following infusions of Activase for the treatment of acute ischemic stroke during the first 24 hours after symptom onset has not been investigated. Aspirin and heparin have been administered concomitantly with and following infusion with Activase in the management of acute myocardial infarction and pulmonary embolism. Fatal cases of hemorrhage associated with traumatic intubation in patients administered Activase have been reported. Perform venipunctures carefully and only as required. Avoid intramuscular injections and trauma to the patient. Important Safety Information Contraindicationsĭo not administer Activase to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit: current intracranial hemorrhage (ICH) subarachnoid hemorrhage active internal bleeding recent (within 3 months) intracranial or intraspinal surgery or serious head trauma presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms) bleeding diathesis and current severe uncontrolled hypertension.ĭo not administer Activase to treat acute myocardial infarction or pulmonary embolism in the following situations in which the risk of bleeding is greater than the potential benefit: active internal bleeding history of recent stroke recent (within 3 months) intracranial or intraspinal surgery or serious head trauma presence of intracranial conditions that may increase the risk of bleeding bleeding diathesis and current severe uncontrolled hypertension.Īctivase can cause significant, sometimes fatal internal or external bleeding, especially at arterial and venous puncture sites. Who are taking direct thrombin inhibitors or direct Xa inhibitors, unless the laboratory tests are normal or the patient has not received a dose of these agents for >48 hours.Who have received a treatment dose of low-molecular-weight heparin within the previous 24 hours.Who have a history of warfarin use and an INR >1.7 and/or a PT >15 seconds.With a platelet count 1.7, activated partial thromboplastin time (aPTT) >40 seconds, or prothrombin time (PT) >15 seconds.In the post-marketing setting, there have been reports of angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors.ĪThe 2019 American Heart Association/American Stroke Association (AHA/ASA) scientific guidelines for the inclusion and exclusion criteria for IV alteplase in AIS also advises against treatment with IV alteplase in patients: 2.Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy.The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied.
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