1. WHAT ACTILYSE IS AND WHAT IT IS USED FOR
The active substance in Actilyse is alteplase (see section 6: “Further information”). It belongs to a group of medicines called thrombolytic agents. These medicines act by dissolving blood clots that have formed in blood vessels.
Actilyse is used to treat a number of conditions caused by blood clots forming within blood vessels, including:
- heart attacks caused by blood clots in the arteries of the heart (myocardial infarction)
- blood clots in the arteries of the lungs (pulmonary embolism)
- stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke)
3. HOW IS ACTILYSE ADMINISTERED
Actilyse will be administered to you by your doctor or by a health care professional. It is not for self-administration.
Treatment with Actilyse should be initiated as soon as possible after the start of your symptoms.
There are three different conditions for which this medicine can be given:
Heart attack (myocardial infarction)
The dose you are given depends on your body weight. The maximum dose of Actilyse is 100 mg but will be lower if you weigh less than 65 kg.
It can be administered in two different ways:
a) The 90 minute form of administration, for patients treated within 6 hours after start of their symptoms. This consists of:
- an initial injection of part of the dose of Actilyse into a vein
- infusions of the remainder of the dose over the following 90 minutes
b) The 3 hour form of administration, for patients treated 6 to 12 hours after start of their symptoms. This consists of:
- an initial injection of part of the dose of Actilyse into a vein
- infusions of the remainder of the dose over the following 3 hours
In addition to Actilyse your doctor will give you another medicine to stop the blood clotting. This will be given as soon as possible after your chest pain starts.
Blood clots in the arteries of the lungs (pulmonary embolism)
The dose you are given depends on your body weight. The maximum dose of Actilyse is 100 mg but will be lower if you weigh less than 65 kg. The medicine is usually given as:
- an initial injection of part of the dose into a vein
- an infusion of the remainder of the dose over the following 2 hours.
After the treatment with Actilyse, your doctor will start (or resume) therapy with heparin (a medicine to “thin” the blood).
Stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke)
Actilyse must be given within 3 hours of the first symptoms. The dose you are given depends on your body weight. The maximum dose of this medicine is 90 mg but will be lower if you weigh less than 100 kg.
Actilyse is given as:
- an initial injection of part of the dose into a vein
- an infusion of the remainder of the dose over the following 60 minutes.
You should not take aspirin for the first 24 hours after your treatment with Actilyse for a stroke. Your doctor may give you an injection with heparin if this is necessary.
Method of administration
Actilyse is supplied as a powder and solvent for solution for injection or infusion. This means that each pack contains one vial with powder and one vial with the solvent (water for injections). Before use, the solvent is added to the powder to form a solution ready for administration. This solution is given into a vein (intravenous injection or infusion).
Actilyse should not be mixed with other medicines.
If you have any further questions on the use of Actilyse, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Actilyse can cause side effects, although not everybody gets them. The side effects described below have been experienced by people given Actilyse. Your treatment may be stopped by your doctor if any of the following side effects occur:
- bleeding in the brain (cerebral haemorrhage) after the treatment of a stroke caused by a blood clot in an artery of the brain (acute ischaemic stroke)
- cessation of heartbeat (cardiac arrest)
- shock (a very low blood pressure) due to heart failure
- bleeding in the respiratory tract, such as nosebleeds (epistaxis) or blood stained phlegm (haemoptysis)
- bleeding in the brain (cerebral haemorrhage) after the treatment of heart attacks (myocardial infarction) or blood clots in the arteries of the lungs (pulmonary embolism)
- bleeding into the membranous sac surrounding the heart (haemopericardium)
- internal bleeding into the back part of the abdomen (retroperitoneal bleeding)
- damage to the heart valves (mitral regurgitation) or to the wall dividing the heart chambers (ventricular septal defect)
- bleeding in internal organs, e.g. bleeding in the liver (hepatic haemorrhage) or in the lung (pulmonary haemorrhage)
- formation of blood clots in the blood vessels which can travel to other organs in the body (thrombotic embolisation). The symptoms will depend on the organ affected
- serious allergic reaction (e.g. life-threatening anaphylaxis, difficulty in breathing, bronchospasm), fluid under the skin (angioedema), low blood pressure or shock)
- heart failure
The following are other side effects that may cause your doctor to stop your treatment but, this will depend on how severe the side effects are:
Very common (occurs in more than 1 in 10 patients receiving the medicine)
- fluid on the lungs (pulmonary oedema)
- bleeding or bruising (haematoma) where the injection is given
- low blood pressure (hypotension)
- irregular heart beat after the blood supply to the heart has been restored
- chest pain (angina pectoris)
Common (occurs in less than 1 in 10 patients receiving the medicine)
- further heart attack
- bleeding of the gums
- bleeding in the stomach or gut, including vomiting blood (haematemesis) or blood in the stools (melanea or rectal haemorrhage)
- bleeding into the body tissues causing purplish bruising (ecchymosis)
- bleeding from the urinary tract or the reproductive organs, which may lead to blood in your urine (haematuria)
- bleeding which necessitates a blood transfusion
- feeling sick (nausea)
- vomiting
- fever
Uncommon (occurs in less than 1 in 100 patients receiving the medicine)
- formation of blood clots in the lungs (pulmonary embolism)
- formation of blood clots in the blood vessels which can travel to other organs in the body (thrombotic embolisation). The symptoms will depend on the organ affected.
- allergic reactions, e.g. hives (urticaria) and rash
Very rare (occurs in less than 1 in 10,000 patients receiving the medicine)
- bleeding in the eyes (ocular haemorrhage)
- events which affect the nervous system such as:
- cramps (convulsions, fits)
- speech problems
- confusion or delirium (very severe confusion)
- anxiety accompanied by restlessness (agitation)
- depression
- altered thinking (psychosis)
These disorders often occur in association with a stroke caused by a blood clot or bleeding in the brain.
Tell your doctor immediately if you think you are experiencing any of these side effects listed above your doctor may need to stop your treatment.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
5. HOW TO STORE ACTILYSE
Keep out of the reach and sight of children.
Actilyse should not be used after the expiry date which is stated on the vial label and the carton. The expiry date refers to the last day of that month.
Normally you will not be asked to store Actilyse as it will be given to you by your doctor. Do not store above 25°C. Store in the original package in order to protect from light.
Once the solution is ready for administration, it should be used immediately. The solution may be stored for 24 hours
at 2°C-8°C or for 8 hours at up to 25°C.
