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What is Activase (alteplase)?
- heart attacks (acute myocardial infarctions),
- chest pain at rest (unstable angina),
- blood clots in the lungs (pulmonary thrombosis or embolus),
- and other less common conditions involving blood clots.
Activase is also used for clearing blood clots from blocked venous catheters.
Common side effects of Activase include:
Serious side effects of Activase include:
- significant bleeding such as into the brain (intracranial hemorrhage) or fatal bleeding,
- pulmonary embolism (PE),
- cholesterol embolism,
- abnormal heartbeats,
- allergic reactions,
- re-embolization of deep venous thrombi (DVT) during treatment of acute massive pulmonary embolism,
- and angioedema.
Drug interactions of Activase include drugs that also interfere with the body's ability to form blood clots (or the clot-promoting effects of platelets), which increase the risk of bleeding in patients receiving Activase.
Such drugs include:
Activase has been shown to cause damage to embryos of rabbits. No damage has been reported in humans. Doctors must carefully balance potential risks and possible benefits when prescribing Activase to pregnant women. It is not known whether Activase passes into breast milk. Consult your doctor before breastfeeding.
What are the important side effects of Activase (alteplase)?
The most common and serious side effect of alteplase is bleeding. Minor bleeding is more common, but significant bleeding such as into the brain (intracranial hemorrhage) or fatal bleeding also occurs.
Other important side effects include:
Other possible serious side effects include:
Activase (alteplase) side effects list for healthcare professionals
The following adverse reactions are discussed in greater detail in the other sections of the label:
- Orolingual Angioedema
- Cholesterol Embolization
- Reembolization of Deep Venous Thrombi during Treatment for Acute Massive Pulmonary Embolism
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most frequent adverse reaction associated with Activase in all approved indications is bleeding.
Acute Ischemic Stroke (AIS)
In clinical studies in patients with AIS (Studies 1 and 2) the incidence of intracranial hemorrhage, especially symptomatic intracranial hemorrhage, was higher in Activase-treated patients than in placebo patients. A dose-finding study of Activase suggested that doses greater than 0.9 mg/kg may be associated with an increased incidence of intracranial hemorrhage.
The incidence of all-cause 90-day mortality, intracranial hemorrhage, and new ischemic stroke following Activase treatment compared to placebo are presented in Table 3 as a combined safety analysis (n=624) for Studies 1 and 2.
These data indicate a significant increase in intracranial hemorrhage following Activase treatment, particularly symptomatic intracranial hemorrhage within 36 hours. There was no increase in the incidences of 90-day mortality or severe disability in Activasetreated patients compared to placebo.
Table 3 : Combined Safety Outcomes for Studies 1 and 2
|All-Cause 90-day Mortality||64 (20.5%)||54 (17.3%)||0.36|
|Total ICH†||20 (6.4%)||48 (15.4%)||<0.01|
|Symptomatic||4 (1.3%)||25 (8.0%)||<0.01|
|Asymptomatic||16 (5.1%)||23 (7.4%)||0.32|
|Symptomatic Intracranial Hemorrhage within 36 hours||2 (0.6%)||20 (6.4%)||<0.01|
|New Ischemic Stroke (3-months)||17 (5.4%)||18 (5.8%)||1.00|
|*Fisher's Exact Test.|
†Within trial follow-up period. Symptomatic intracranial hemorrhage was defined as the occurrence of sudden clinical worsening followed by subsequent verification of intracranial hemorrhage on CT scan. Asymptomatic intracranial hemorrhage was defined as intracranial hemorrhage detected on a routine repeat CT scan without preceding clinical worsening.
Bleeding events other than intracranial hemorrhage were noted in the studies of AIS and were consistent with the general safety profile of Activase. In Studies 1 and 2, the frequency of bleeding requiring red blood cell transfusions was 6.4% for Activase-treated patients compared to 3.8% for placebo (p = 0.19).
Although exploratory analyses of Studies 1 and 2 suggest that severe neurological deficit (National Institutes of Health Stroke Scale [NIHSS > 22]) at presentation was associated with an increased risk of intracranial hemorrhage, efficacy results suggest a reduced but still favorable clinical outcome for these patients.
Acute Myocardial Infarction (AMI)
For the 3-hour infusion regimen in the treatment of AMI, the incidence of significant internal bleeding (estimated as > 250 mL blood loss) has been reported in studies in over 800 patients (Table 4). These data do not include patients treated with the Activase accelerated infusion.
Table 4 : Incidence of Bleeding in 3-Hour Infusion in AMI Patients
|Total Dose ≤100 mg|
The incidence of intracranial hemorrhage in AMI patients treated with Activase is presented in Table 5.
Table 5 : Incidence of Intracranial Hemorrhage in AMI Patients
|Dose||Number of Patients||Intracranial Hemorrhage (%)|
|100 mg, 3-hour||3272||0.4|
|≤ 100 mg, accelerated||10,396||0.7|
A dose of 150 mg or greater should not be used in the treatment of AMI because it has been associated with an increase in intracranial bleeding.
Pulmonary Embolism (PE)
For acute massive pulmonary embolism, bleeding events were consistent with the general safety profile observed with Activase treatment of AMI patients receiving the 3-hour infusion regimen.
Allergic-type reactions, e.g., anaphylactoid reaction, laryngeal edema, orolingual angioedema, rash, and urticaria have been reported. When such reactions occur, they usually respond to conventional therapy.
The following adverse reactions have been identified during post-approval use of Activase. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions are frequent sequelae of the underlying disease, and the effect of Activase on the incidence of these events is unknown.
Acute Ischemic Stroke
Acute Myocardial Infarction
Arrhythmias, AV block, cardiogenic shock, heart failure, cardiac arrest, recurrent ischemia, myocardial reinfarction, myocardial rupture, electromechanical dissociation, pericardial effusion, pericarditis, mitral regurgitation, cardiac tamponade, thromboembolism, pulmonary edema. These events may be life threatening and may lead to death. Nausea and/or vomiting, hypotension and fever have also been reported.
What drugs interact with Activase (alteplase)?
The interaction of Activase with other cardioactive or cerebroactive drugs has not been studied. Anticoagulants and antiplatelet drugs increase the risk of bleeding if administered prior to, during, or after Activase therapy.
In the post-marketing setting, there have been reports of orolingual angioedema in patients (primarily patients with AIS) receiving concomitant angiotensin-converting enzyme inhibitors.
Activase (alteplase) is an enzyme used to treat conditions caused by arterial blood clots including heart attacks (acute myocardial infarctions), strokes, chest pain at rest (unstable angina), blood clots in the lungs (pulmonary thrombosis or embolus), and other less common conditions involving blood clots. Activase is also used for clearing blood clots from blocked venous catheters. Common side effects of Activase include bleeding, nausea, and vomiting. Activase has been shown to cause damage to embryos of rabbits. No damage has been reported in humans. Doctors must carefully balance potential risks and possible benefits when prescribing Activase to pregnant women. It is not known whether Activase passes into breast milk. Consult your doctor before breastfeeding.
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Related Disease Conditions
Blood Clots (in the Leg)
Blood clots can form in the heart, legs, arteries, veins, bladder, urinary tract, and uterus. Risk factors include high blood pressure and cholesterol, diabetes, smoking, and family history. Symptoms and treatment depend on the location of the clot.
Congestive Heart Failure (CHF)
Congestive heart failure (CHF) refers to a condition in which the heart loses the ability to function properly. Heart disease, high blood pressure, diabetes, myocarditis, and cardiomyopathies are just a few potential causes of congestive heart failure. Signs and symptoms of congestive heart failure may include fatigue, breathlessness, palpitations, angina, and edema. Physical examination, patient history, blood tests, and imaging tests are used to diagnose congestive heart failure. Treatment of heart failure consists of lifestyle modification and taking medications to decrease fluid in the body and ease the strain on the heart. The prognosis of a patient with congestive heart failure depends on the stage of the heart failure and the overall condition of the individual.
Heart Attack Symptoms and Early Warning Signs
Recognizing heart attack symptoms and signs can help save your life or that of someone you love. Some heart attack symptoms, including left arm pain and chest pain, are well known but other, more nonspecific symptoms may be associated with a heart attack. Nausea, vomiting, malaise, indigestion, sweating, shortness of breath, and fatigue may signal a heart attack. Heart attack symptoms and signs in women may differ from those in men.
Pulmonary Embolism (Blood Clot in the Lung)
A pulmonary embolism (PE) occurs when a piece of a blood clot from deep vein thrombosis (DVT) breaks off and travels to an artery in the lung where it blocks the artery and damages the lung. The most common symptoms of a pulmonary embolism are shortness of breath, chest pain, and a rapid heart rate. Causes of pulmonary embolism include prolonged immobilization, certain medications, smoking, cancer, pregnancy, and surgery. Pulmonary embolism can cause death if not treated promptly.
Heart Attack (Myocardial Infarction)
A heart attack occurs when a blood clot completely obstructs a coronary artery supplying blood to the heart muscle. Learn about warning signs, causes, complications, risk factors, and treatment.
Heart failure (congestive) is caused by many conditions including coronary artery disease, heart attack, cardiomyopathy, and conditions that overwork the heart. Symptoms of heart failure include congested lungs, fluid and water retention, dizziness, fatigue and weakness, and rapid or irregular heartbeats. There are two types of congestive heart failure, systolic or left-sided heart failure; and diastolic or right-sided heart failure. Treatment, prognosis, and life-expectancy for a person with congestive heart failure depends upon the stage of the disease.
Angina is chest pain due to inadequate blood supply to the heart. Angina symptoms may include chest tightness, burning, squeezing, and aching. Coronary artery disease is the main cause of angina but there are other causes. Angina is diagnosed by taking the patient's medical history and performing tests such as an electrocardiogram (EKG), blood test, stress test, echocardiogram, cardiac CT scan, and heart catheterization. Treatment of angina usually includes lifestyle modification, medication, and sometimes, surgery. The risk of angina can be reduced by following a heart healthy lifestyle.
Herpangina is a contagious illness often seen in children. It is caused by a Coxsackievirus or an enterovirus. Symptoms and signs include mouth sores, fever, and sore throat. Treatment focuses on alleviating fever and pain with acetaminophen and ibuprofen. It is important for children to stay well hydrated, as children may be resistant to eating or drinking.
The lungs are primarily responsible for the exchange of oxygen and carbon dioxide between the air we breathe and the blood. Eliminating carbon dioxide from the blood is important, because as it builds up in the blood, headaches, drowsiness, coma, and eventually death may occur. The air we breathe in (inhalation) is warmed, humidified, and cleaned by the nose and the lungs.
Heart Attack vs. Stroke Symptoms, Differences, and Similarities
Heart attack usually is caused by a clot that stops blood flow supplying oxygen to an area of heart muscle, which results in heart muscle death. Stroke or "brain attack" is caused by a loss of blood supply to the brain (usually a blood clot) or by hemorrhagic stroke (bleeding within the brain), which results in brain tissue death. Both heart attack and stroke usually come on suddenly, produce similar symptoms, can be disabling, and can be fatal. The classic symptoms and warning signs of heart attack are different. Classic heart attack warning signs are chest pain or discomfort, shortness of breath, pain that radiates to the shoulders, back, arms, belly, jaw, or teeth, sweating, fainting, and nausea and vomiting. Moreover, woman having a heart attack may have additional symptoms like abdominal pain or discomfort, dizziness, clammy skin, and moderate to severe fatigue. The classic symptoms and warning signs that a person is having a stroke are confusion or loss of consciousness, sudden severe headache, speech problems, problems seeing out of one or both eyes, and numbness or weakness of only one side of the body. Moreover, a woman having a stroke may have additional warning symptom and signs like shortness of breath, disorientation, agitation, behavioral changes, weakness, nausea, vomiting, seizures, and hiccups. Recognition of stroke symptoms is vital for emergency treatment. The acronym "FAST" stands for recognition of Facial drooping, Arm weakness, Speech difficulty, and a Time for action. If you experience the symptoms heart attack or stroke (FAST) or see them develop in another person, then contact 911 immediately.
Heart Attack vs. Heartburn
Heartburn is a symptom of another disease or medical problem and can be described as a feeling of burning in the chest accompanied by symptoms of nausea, vomiting, or a sour taste or food stuck in the back of the throat. Heart attack occurs when an artery in the heart is completely blocked by a blood clot, which causes that portion of heart muscle to die. Heart attack also has symptoms of chest pain, nausea, and vomiting, however, other warning signs and symptoms of a heart attack are unusual weakness or fatigue, and persistent and/or increased severity of symptoms over a few minutes. Heart attack is a life threatening emergency. If you think you or someone you are with is having a heart attack, call 911 immediately for urgent medical treatment. It may save your life.
Heart Attack Treatment
A heart attack involves damage or death of part of the heart muscle due to a blood clot. The aim of heart attack treatment is to prevent or stop this damage to the heart muscle. Heart attack treatments included medications, procedures, and surgeries to protect the heart muscle against injury.
Heart Attack Pathology: Photo Essay
A heart attack is a layperson's term for a sudden blockage of a coronary artery. This photo essay includes graphics, pictures, and illustrations of diseased heart tissue and the mechanisms that lead to coronary artery disease, and possible heart attack. A coronary artery occlusion may be fatal, but most patients survive it. Death can occur when the occlusion leads to an abnormal heartbeat (severe arrhythmia) or death of heart muscle (extensive myocardial infarction).
Heart Attack Prevention
Heart disease and heart attacks can be prevented by leading a healthy lifestyle with diet, exercise, and stress management. Symptoms of heart attack in men and women include chest discomfort and pain in the shoulder, neck, jaw, stomach, or back.
Heart Attack Prevention Overview
Heart attacks are the major causes of unexpected, sudden death among men and women. A heart attack also is a significant cause of heart failure. The process of developing atherosclerosis (hardening of the arteries) begins early in life. Heart attack prevention should begin in childhood because the atherosclerosis process can not be reversed. The risk of having a heart attack increases if you have diseases or conditions such as high blood pressure, diabetes, and other heart conditions.
Vitamins & Exercise: Heart Attack Prevention Series
Vitamins and exercise can lower your risk for heart attack and heart disease. Folic acid, vitamins, and homocysteine levels are interconnected and affect your risk for heart disease or heart attack. For better heart health, avoid the following fried foods, hard margarine, commercial baked goods, most packaged and processed snack foods, high fat dairy, and processed meats such as bacon, sausage, and deli meats.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.