Actilyse: what is the indication for the package leaflet? See side effects

Diseases that affect organs such as the brain and heart are, in general, of concern. Therefore, it is necessary to pay attention to any type of symptom.

For cases in which there are emergencies, there are medications that reduce physical discomfort or help control the condition.

This is the case of Actilyse, a drug that helps in the treatment of conditions such as a heart attack and stroke, for example. Keep reading and learn more about the medication!


What is Actilyse medicine?

Actilyse is the commercial name of the active ingredient Alteplase, a type of enzyme used in the treatment of myocardial acute infarction (heart attack), pulmonary embolism and stroke (CVA).

It is a medicine for hospital use, manufactured by Boehringer Ingelheim – pharmaceutical company – and its administration is intravenous (in the vein).

It works by stimulating the dissolution of the clots that cause the diseases listed, which restores blood flow in the affected pathways.

What is Actilyse for?

The drug Actilyse is used to treat problems such as acute myocardial infarction – heart attack -, acute pulmonary embolism and acute ischemic stroke, popularly known as stroke. The drug acts to combat clots that cause disease. Specifically, it serves to:

Acute myocardial infarction

Acute myocardial infarction, popularly called a heart attack, occurs when there is an obstruction of blood flow to the heart muscle, caused, in general, by the formation of a clot in the coronary artery.

This interruption of blood flow causes the death (necrosis) of the cardiac tissue, due to lack of oxygen.

Acute pulmonary embolism

Pulmonary embolism, also known as pulmonary thrombosis , is a disease that occurs, in general, when clots cause partial or total obstruction of the arteries of the lungs.

This obstruction can make it difficult and even interrupt the passage of air to the organ.

Acute ischemic stroke

Stroke, known as a stroke, is a disease caused by an obstruction of the artery that carries oxygen to brain cells.

The problem is caused by the formation of clots and, when it occurs, causes a lack of oxygen in the brain, culminating in the death of cells.

Action: How does the active ingredient Alteplase act according to the package insert?

The active ingredient Alteplase acts by binding with fibrin molecules. This then leads to a process of converting plasminogen to plasmin, which results in the dissolution of fibrin from the clot.

The drug promotes the reduction of fibrinogen, which is a protein that assists in the control of normal blood clotting. When it is present in high levels, it causes the appearance of clots.

Thus, the drug works by preventing the appearance of new clots, in addition to dissolving the existing ones.

According to the package leaflet, 100mg of the substance reduces this protein to 60% in the first 4 hours after using the medication. However, after approximately 24 hours, fibrinogen levels rise again to more than 80%.

In general, the prolonged reduction in fibrinogen levels is seen only in some patients.

How to use Actilyse?

Actilyse is a medication to be applied intravenously (into the vein) that must be administered in a hospital environment, by a trained professional. According to the package insert, there is a dosage for each clinical condition treated by the drug and it should be administered as soon as possible after the first symptoms.

Acute myocardial infarction

For cases of heart attack, doses may vary according to the length of time, after the infarction, for the administration of the medication. It might be:

Up to 6 hours after myocardial infarction

These values ​​are valid for patients with a body weight of 65 kg or more. For cases in which the medication is applied within 6 hours after the infarction, administration for a full 90 minutes is indicated. The recommendations are:

During the first 30 minutes:

  • 15mg dose of Actilyse followed by 50mg.

During the next 60 minutes:

  • 35mg dose of the drug, up to a maximum of 100mg.

Below 65kg, the dose should be adjusted according to the weight. A dose of 15mg should be used as an intravenous bolus, followed by an infusion of 0.75 mg / kg up to a maximum of 50mg during the first 30 minutes. Then, an infusion of 0.5 mg / kg of body weight (up to a maximum of 35 mg) during the next 60 minutes.

Between 6 and 12 hours after myocardial infarction

For application in a period of time between 6 to 12 hours after the infarction, the administration of the drug for 3 full hours is indicated. The steps are:

During the first hour:

  • Dosage of 10mg and, in sequence, the application of 50mg.

During the next 2 hours:

  • 40mg, up to the maximum dose of 100mg.

Values ​​refer to patients who weigh 65 kg or less. Values ​​may vary according to the person’s physical characteristics.

Pulmonary embolism

For the treatment of pulmonary embolism, the indication, according to the package insert, is:

For patients with a body weight of 65 kg or less, it is recommended to administer 100mg of Actilyse in 2 hours, divided into:

For 1 to 2 minutes:

  • Administration of 10mg.

For 2 hours:

  • 90mg to the total dose of 100mg.

Values ​​may vary according to the patient’s body weight.


In patients who have suffered a stroke, the dose recommended by the package insert is 0.9mg / kg body weight, with the maximum dose being 90mg.

The recommendation is:

For 60 minutes:

  • Start the administration with 10% of the total dose;
  • Immediately afterwards, apply the remainder of the total dose.

The drug must be used within 4.5 hours after the stroke.

What are the side effects of Actilyse?

Like other medicines, Actilyse can have side effects in some people.

According to the package insert, there are general drug reactions and there may also be some specific ones according to the use for each clinical picture.

Among the most common for all treatments, is hemorrhage.

Common reactions , on the other hand , are:

  • Bleeding in the throat;
  • Gastrointestinal bleeding;
  • Gastric bleeding;
  • Rectal hemorrhage;
  • Oral bleeding;
  • Hemorrhage from the urinary tract;
  • Hemorrhage at the application site;
  • Stomach ulcer;
  • Hematemesis (vomiting with blood);
  • Melena (bloody stools);
  • Gingival bleeding;
  • Hematuria (blood in the urine);
  • Bruise (purple spot on the skin).

The unusual reactions , which can occur in either case, are:

  • Bleeding from the nose;
  • Sputum with blood;
  • Hypotension.

Among the specific reactions of clinical conditions, there are:

The very common ones specific to stroke treatment are:

  • Hemorrhage in the brain;
  • Hematoma in the brain;
  • Bleeding in strokes that do not involve bleeding.

The specific common reactions of patients who have suffered from acute myocardial infarction or pulmonary embolism are:

  • Hemorrhage in the brain;
  • Bleeding in a stroke that does not involve bleeding;
  • Hemorrhagic stroke (rupture of cerebral vessel).

The unusual ones specific to the treatment of acute myocardial infarction that can occur:

  • Alteration of the heart rhythm.

Despite the reactions listed, it is worth remembering that each organism reacts differently to the use of the medication. That way, not all people will necessarily suffer from side effects.

Value: what is the price of Actilyse and where to buy cheaper?

The price of Actilyse may vary according to the geographic region and establishment of purchase.

It can be found in physical and online pharmacies and its value is approximately *:

  • Actilyse 10mg — R$660;
  • Actilyse 20mg — R$1249;
  • Actilyse 50mg — R$2599.

If there is a need to compare prices, it is possible to use the website of Consulta Remédios , which indicates the values ​​of medicines in different pharmacies in each region.

* Prices consulted in March 2020. Prices may change.

Free treatment: Do you have Alteplase in the SUS?

-Yeah . The active ingredient Alteplase is part of the National List of Essential Medicines (Rename), that is, the list of drugs distributed directly by SUS.

If, for any reason, the SUS cannot provide the medication, patients who need the medication and cannot afford the costs of treatment can request coverage by the State.

For this, it is necessary to file a lawsuit, presenting some documents such as medical report and budget in 3 different pharmacies.

Is Actilyse approved in Brazil by ANVISA?

-Yeah . The drug Actilyse was registered with the National Health Surveillance Agency (ANVISA) in 1998.

It is part of the therapeutic class of fibrinolytic anticoagulants, that is, they decrease the levels of fibrinogen in the body and fight blood clots.

How to budget Actilyse?

For cases in which the SUS, for some reason, is unable to provide Actilyse, there is the possibility of requesting in court the coverage by the State.

For that, it is necessary to file a lawsuit and present some documents. Between them:

  • Medical report;
  • Exams;
  • Standard requirement;
  • Budget in 3 different pharmacies.

For the realization of the budget, it is possible to obtain assistance in advising on the quotation of high-cost medications, which provides personalized quotes.

Just access the link , fill in the requested data and wait for the return.

Diseases related to important organs such as the brain and heart can be common.

To treat this type of problem, there are specific medications and, among them, Actilyse.

Want to know more about remedies and treatments? The Healthy Minute has other complete content for you! Read more and stay informed!