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Alteplase Injection for Acute Ischemic Stroke


Alteplase Injection for Acute Ischemic Stroke

Alteplase (tissue plasminogen activator, recombinant; tPA) is approved by the U.S. FDA for intravenous thrombolysis in acute ischemic stroke within 3 hours of the onset of stroke symptoms. Use the following drug information to increase your understanding of this agent and provide safe patient care.


Inclusion criteria (Powers, et al., 2018)

  • Diagnosis of ischemic stroke causing measurable neurological deficit
  • 18 years of age or older
  • Onset of symptoms < 3 hours
    • Includes patients with severe stroke and patients with mild but disabling stroke symptoms
    • Equally effective in patients < 80 and > 80 years of age
  • For select patients with symptom onset 3- to 4.5- hours:
    • 80 years of age or less
    • No history of diabetes mellitus and prior stroke, no current oral anticoagulant use, NIHSS score ≤ 25, no anticoagulants, cerebral imaging showing ischemia involving less than one third of middle cerebral artery (MCA) territory
  • Blood pressure (BP) that can be lowered safely (< 185/110 mm Hg) with antihypertensive agents.
  • Initial glucose > 50 mg/dL
  • Non-contrast computed tomography (NCCT) showing early mild-moderate ischemic changes.
  • Patients taking mono-antiplatelet therapy or combination therapy (i.e. aspirin and clopidogrel) and patients with end-stage renal disease on hemodialysis and normal aPTT are eligible for therapy.

Contraindications (Powers, et al., 2018)

  • Unclear time and/or unwitnessed symptom onset and last known baseline state > 3 or 4.5 hours
  • Current or history of intracranial hemorrhage
  • CT scan showing hypoattenuation or hypoperfusion representing irreversible injury
  • Recent (within 3 months) ischemic stroke, severe head trauma, or intracranial/intraspinal surgery
  • Subarachnoid hemorrhage
  • Gastrointestinal (GI) malignancy or GI bleed within 21 days of stroke event
  • Intracranial conditions that may increase the risk of bleeding such as intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Coagulopathy: Platelet count < 100,000/mm3, INR > 1.7, aPTT > 40 seconds, or PT > 15 seconds
  • Low molecular weight heparin (LMWH) treatment doses within the previous 24 hours
  • Current use of anticoagulant with INR > 1.7 or PT > 15 seconds
  • Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated laboratory tests
  • Concurrent use of glycoprotein IIb/IIIa receptor inhibitors
  • Infective endocarditis
  • Aortic arch dissection
  • Intra-axial intracranial neoplasm – lesions located within the brain tissue

Note: See current clinical practice guidelines for complete list of recommendations for treatment with parenteral alteplase and relative indications.

Pregnancy Risk Category: C

Dosage and Administration

Available forms: 50-mg vial, 100-mg vial

Dosage: Dose is calculated based on patient weight (0.9 mg/kg) with a maximum total of 90 mg over 60 minutes. Ten percent of total dose given as an IV bolus over 1 minute, followed by an IV infusion of the remainder of the dose over 1 hour.


  • May be administered IV or intra-arterially (intra-arterial administration is an off-label route).
  • May be given to eligible patients even if endovascular therapies (EVTs) are being considered.
  • Consult package insert for complete instructions on medication preparation, reconstitution and administration.

Nursing Considerations

  • BEFORE administration:
    • Carefully lower blood pressure (BP) to maintain systolic BP < 185 mmHg and diastolic BP < 110 mmHg before initiating fibrinolytic therapy (Powers, et al., 2018).
    • Due to an increased risk of intracranial bleeding, check INR, PTT and blood glucose prior to administration.
    • Assess for exclusion criteria/contraindications.
    • Explain use and administration of the drug to the patient and the family; tell them to report adverse reactions immediately.
    • Admit to the intensive care unit (ICU) for monitoring.
  • DURING administration:
    • Maintain strict bedrest during treatment.
    • Measure BP and perform neurological assessment every 15 minutes during infusion for 2 hours, then every 30 minutes for 6 hours, then hourly until 24 hours after treatment.
      • Increase frequency of BP measurements if SBP > 180 mm Hg or if DPB > 105 mm Hg; administer antihypertensive as needed to maintain these levels.
    • If any change in neurological status or symptoms occurs, such as severe headache, acute hypertension, nausea or vomiting, or worsening neurological examination, the alteplase administration should be stopped and a CT scan obtained.
    • Avoid invasive procedures and I.M. injections, and perform venipunctures carefully and only as required, avoiding internal jugular and subclavian venous punctures.
    • Closely monitor the patient for internal bleeding and frequently assess all puncture sites.
      • If serious bleeding occurs, stop the alteplase infusion immediately.
  • AFTER administration:
    • Measure BP and perform neurologic assessment every 15 minutes during infusion for 2 hours, then every 30 minutes for 6 hours, then hourly until 24 hours after treatment. After the initial 24 hours, monitor vital signs, control blood pressure, and perform neurological assessments frequently per your facility’s policy.
    • Maintain BP < 180/105 mmHg for at least 24 hours after treatment.
    • Hold antiplatelet or anticoagulation therapy and invasive procedures for 24 hours following administration.
    • Monitor for serious adverse events, such as bleeding and angioedema.
      • Concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase the risk of orolingual angioedema.
      • Concomitant use of anticoagulants and drugs that inhibit platelet function increase the risk of bleeding.
    • Delay insertion of nasogastric tubes, indwelling bladder catheters, or intra-arterial pressure catheters if patient can be managed without them.
    • Obtain follow-up CT or MRI scan 24 hours after treatment before starting anticoagulants or antiplatelet agents.

Adverse reactions

  • Bleeding (most common)
  • Orolingual angioedema
  • Arrhythmias
  • Hypotension
  • Edema 
  • Cholesterol embolization
  • Venous thrombosis
  • Re-embolization of deep venous thrombi (DVT) in patients with pulmonary embolism
  • Nausea
  • Vomiting
  • Hypersensitivity reactions

Management of Symptomatic Bleeding Within 24 Hours After Administration of IV Alteplase (Powers, et al., 2018)

  • Stop alteplase infusion.
  • Obtain CBC, PT (INR), aPTT, fibrinogen level, and type and cross-match.
  • Obtain emergent nonenhanced head CT.
  • Per order, administer cryoprecipitate (includes factor VIII): 10 U infused over 10-30 minutes (onset in 1 hour, peaks in 12 hour); administer additional dose for fibrinogen level < 200 mg/dL. 
  • Per order, administer tranexamic acid 1000 mg IV infused over 10 min OR Ɛ-aminocaproic acid 4-5 g over 1 hour, followed by 1 g IV until bleeding is controlled.
  • Obtain hematology and neurosurgery consult.
  • Manage BP, intracranial pressure (ICP), cerebral perfusion pressure (CPP), mean arterial pressure (MAP), temperature, and glucose.

Management of Orolingual Angioedema Associated with IV Alteplase (Powers, et al., 2018)

  • Maintain airway.
    • Intubation may not be needed if edema is limited to anterior tongue and lips.
    • Edema involving larynx, palate, floor of mouth, oropharynx with rapid progression (within 30 minutes) poses higher risk of respiratory compromise requiring intubation.
    • Awake fiberoptic intubation is preferred.
  • As ordered, perform the following:
    • Discontinue IV alteplase infusion and hold ACE-inhibitors.
    • Administer IV methylprednisolone 125 mg.
    • Administer IV diphenhydramine 50 mg.
    • Administer ranitidine 50 mg IV or famotidine 20 mg IV.
    • If there is an increase in angioedema, administer epinephrine (0.1%) 0.3 mL subcutaneously or by nebulizer 0.5 mL.
    • Administer icatibant (selective bradykinin B2 receptor antagonist), 3 mL (30 mg) subcutaneously in abdomen.


Demaerschalk, B., Kleindorfer, D., Adeoye, O., Demchuk, A., Fugate, J., Grotta, J. … Smith, E. (2016). Scientific rationale for the inclusion and exclusion criteria for intravenous alteplase in acute ischemic stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke, (47), 581-641.

Genetech. (2017, September). Activase Prescribing Information. Retrieved from

Powers, W.J., Rabinstein, A.A., Ackerson, T., Adeoye, O.M., Bambakidis, N.C., Becker, K.,…Tirschwell, D. L., (2018). 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Stroke, 49, e46-e99.

Wolters Kluwer Health. (2018, August). Alteplase Recombinant Injection. Retrieved from Facts & Comparisons: