Alteplase

DEA Class; Rx

Common Brand Names; Activase, TPA, Cathflo Activase

Acute Ischemic Stroke

• Do not administer to treat acute ischemic stroke in the following situations in which the risk of bleeding is greater than the potential benefit

  • Current or prior intracranial hemorrhage

  • Subarachnoid hemorrhage suspected

  • Active internal bleeding

  • Stroke within 3 months

  • Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma

  • Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms)

  • Bleeding diathesis

  • Current severe uncontrolled hypertension

Acute myocardial infarction or pulmonary embolism

• Do not administer for treatment of AMI or PE in the following situations in which the risk of bleeding is greater than the potential benefit

• Active internal bleeding

• History of recent stroke

• Ischemic stroke within 3 months except when within 4.5 hr

• Recent (within 3 months) intracranial or intraspinal surgery or serious head trauma

• Presence of intracranial conditions that may increase the risk of bleeding (eg, some neoplasms, arteriovenous malformations, aneurysms)

• Significant closed head or facial trauma with radiographic evidence of brain injury or facial trauma within 3 months

• Bleeding diathesis

• Aortic dissection

• Current severe uncontrolled hypertension

• Prior intracranial hemorrhage

Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen; considers these types of conditions before administering treatment

Because of risk of damage to vascular wall or collapse of soft-walled catheters, vigorous suction should not be applied during attempts to determine catheter occlusion

Avoid applying excessive pressure when agent is instilled into catheter; such force could cause rupture of catheter or expulsion of clot into circulation

Use caution in recent major surgery, cerebrovascular disease, HTN, acute pericarditis, hemostatic defects, severe thrombophlebitis, severe hepatic/renal dysfunction

Hypersensitivity, including urticaria, angioedema and anaphylaxis, reported in association with therapy; monitor patients during and for several hours after infusion for hypersensitivity; if signs of hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops, discontinue therapy and promptly institute appropriate therapy

Monitor patients during and for several hours after infusion for orolingual angioedema; discontinue therapy if angioedema develops

Cholesterol embolism reported rarely in patients treated with thrombolytic agents; may present with pancreatitis, cerebral infarction, acute renal failure, gangrenous digits, hypertension, rhabdomyolysis, or retinal artery oclusion

Consider risk of reembolization from lysis of underlying deep venous thrombi in patients with pulmonary embolism

Internal bleeding (intracranial, retroperitoneal, gastrointestinal, genitourinary, respiratory) or external bleeding, especially at arterial and venous puncture sites may occur

Avoid intramuscular injections and trauma to patient while on therapy

Perform venipunctures carefully and only as required

Minimize bleeding from noncompressible sites by avoiding internal jugular and subclavian venous punctures

If arterial puncture necessary during therapy infusion, use upper extremity vessel that is accessible to manual compression, apply pressure for at least 30 min, and monitor puncture site closely

Patients treated for acute ischemic stroke, with high risk of intracranial hemorrhage, should be treated at facilities that can provide timely access to appropriate evaluation and management of intracranial hemorrhage

Coronary thrombolysis may result in reperfusion arrhythmias

Published studies and case reports on alteplase use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes

There are no data on presence of alteplase in human milk, effects on breastfed infant, or on milk production