Considering Activase® (alteplase)
for treatment of acute ischemic stroke
A DISCUSSION GUIDE FOR PATIENTS AND CAREGIVERS
Indication
Activase is indicated for treating patients with acute ischemic stroke (AIS), which is caused by a blood clot in the brain’s
blood vessels. Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and
only after bleeding in the brain has been ruled out.
Important Safety Information
Activase can cause bleeding and should not be used in patients who have: current bleeding
in the brain; bleeding in the area between the brain and the thin tissues that cover the brain;
active internal bleeding; recent (within 3 months) brain or spinal surgery or trauma; brain
tumor, an abnormal connection between veins and arteries in the brain, or an abnormal
bulge in the wall of an artery that supplies blood to the brain; problems with blood clotting;
or current severe uncontrolled high blood pressure.
Please see select Important Safety Information throughout
and the accompanying full Prescribing Information.
What you should know about treatment with
Activase® (alteplase) for acute ischemic stroke
1,2
Results of treatment with Activase
in acute ischemic stroke patients
2,3
What is acute ischemic stroke?1
Activase
• This blockage in the brain prevents brain cells from getting the oxygencarrying blood they need to function, and causes these cells to start dying
Placebo
Patients treated with Activase
• Acute ischemic stroke is a sudden loss of brain function caused by a
blood clot in an artery/vessel of the brain. Symptoms may include severe
headache without known cause; sudden weakness or numbness of the
face, arm, or leg, usually on one side of the body; difficulty walking, seeing,
or speaking; and confusion and trouble understanding speech
Patients NOT treated with Activase
Minimal or no disability
31%
20%
Blood clot in an artery/vessel of the brain.
• Brain cell death can result in disabilities
Who is Activase for?2
Moderate to severe disability
• Activase, a tissue plasminogen activator, or tPA, can be used to treat certain patients with acute ischemic stroke
• Patients can receive Activase only if they begin treatment within 3 hours after their stroke symptoms start and
only after they have had a scan to rule out bleeding in the brain
How does Activase work?2
52%
59%
• Activase works by helping to dissolve the blood clot that is blocking the vessel in the brain and causing the stroke
What are the potential benefits of treatment with Activase?2
• In a major clinical study, patients who received Activase were more likely to recover from their strokes with minimal
or no disability than patients who did not receive Activase (see illustration on facing page)
Death
17%
21%
What are the potential risks of treatment with Activase?2
• There are risks involved with Activase treatment. Because Activase works to help dissolve a clot, the most common
side effect is bleeding, including bleeding in the brain; this is called intracranial hemorrhage
• Activase can cause significant, sometimes fatal, bleeding and should not be used in patients who have:
current bleeding in the brain; bleeding in the area between the brain and the thin tissues that cover the
brain; active internal bleeding; recent (within 3 months) brain or spinal surgery or trauma; brain tumor, an
abnormal connection between veins and arteries in the brain, or an abnormal bulge in the wall of an artery
that supplies blood to the brain; problems with blood clotting; or uncontrolled high blood pressure
• Please see Activase full Prescribing Information for additional Important Safety Information
What to expect after receiving Activase2
• Immediately after Activase treatment for acute ischemic stroke, patients are closely monitored for 24 to 48 hours
Important Safety Information (cont'd)
Some patients may or may not benefit from Activase because of an increased risk of bleeding, which may be serious or
sometimes fatal, including those with the following conditions: recent major surgery; disease of blood vessels in the brain;
recent bleeding in the brain; recent internal bleeding; recent trauma; uncontrolled high blood pressure; high likelihood of
developing a blood clot in the left chamber of the heart; inflammation of the sac around the heart; infection of the inner lining
of the heart and the heart valves; increased bleeding risk associated with liver or kidney problems; liver problems; pregnancy;
bleeding in the eyes; swelling and infection associated with blood clots; elderly patients; patients on blood thinning drugs.
Please see select Important Safety Information throughout and the accompanying full Prescribing Information.
These figures represent 3-month outcomes from Part 2 of the National Institute of Neurological Disorders
and Stroke study (N=333), in which patients were treated with Activase within 3 hours of stroke symptom onset.2
Patient response was measured with 4 scales, including the Barthel Index, National Institutes of Health Stroke
Scale (NIHSS), modified Rankin Scale, and the Glasgow Outcome Scale, which assess neurologic function in
stroke patients; Activase showed statistically significant improvement on all 4 stroke scales (global odds ratio
for favorable outcome: 1.71 [95% CI: 1.15-2.56, P=0.02)]. The response rates in the chart are derived from the
NIHSS. Part 1 of the trial demonstrated no significant difference between the Activase and placebo groups in the
primary outcome measure (NIHSS) at 24 hours after treatment.3
The most common side effect of treatment with Activase is bleeding, including bleeding in the brain
that causes symptoms2,3:
• Among patients treated with Activase, 6.4% experienced bleeding within the brain that caused symptoms
• Among patients treated with placebo, 0.6% experienced bleeding within the brain that caused symptoms
Important Safety Information (cont'd)
Swelling of the mouth and throat (orolingual angioedema) has been observed in patients treated for acute ischemic stroke
and acute myocardial infarction. This occurred during and up to 2 hours after infusion of Activase® (alteplase). In many cases,
patients were also taking angiotensin-converting enzyme inhibitors. Patients treated with Activase should be monitored during
and for several hours after infusion for signs of orolingual angioedema. If orolingual angioedema develops, stop the infusion
and immediately give appropriate therapy.
A plug of cholesterol that blocks an artery (cholesterol embolism) has been reported rarely in patients treated with all types of
clot dissolving agents. This is a serious condition, which can be lethal, and is also associated with invasive medical procedures
involving the arteries and veins.
Patients and their caregivers are encouraged to report side effects to Genentech and the FDA.
They may contact Genentech by calling 1-888-835-2555. They may contact the FDA by visiting
www.fda.gov/medwatch or calling 1-800-FDA-1088.
More information about acute ischemic stroke and Activase
is available at www.activase.com
References: 1. National Institute of Neurological Disorders and Stroke. Know Stroke.
http://www.ninds.nih.gov/disorders/stroke/knowstroke.htm#whatis. Accessed May 6, 2015.
2. Activase [prescribing information]. South San Francisco, CA: Genentech, Inc; 2017.
3. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue
plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
© 2017 Genentech USA, Inc. All rights reserved.
ACI/050815/0081(1) Printed in USA.
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