2. What should I know before I am given Actilyse?
You should not be given Actilyse if you have ever had an allergic reaction to Actilyse
or any of the ingredients listed at the end of the CMI.
Tell your doctor or nurse if you have any current or previous medical conditions including
recent bleeding, are at increased risk of bleeding or have blood clotting problems,
blood vessel problems, high blood pressure, serious liver problems or have had recent
surgery or injury.
Talk to your doctor if you take any other medicines, are pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Actilyse and affect how it works.
Tell your healthcare professional if you are taking any blood-thinning medicines,
medicines used to treat high blood pressure, or any other medicines.
4. How will I be given Actilyse?
Actilyse will be prepared and administered to you by your doctor or by a healthcare
professional as soon as possible after the start of symptoms.
5. What should I know while being given Actilyse?
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Things you should do
|
Follow all instructions given to you by your healthcare professionals
Avoid moving unnecessarily to prevent bleeding or bruising
|
|
Things you should not do
|
You should not take aspirin for the first 24 hours after treatment with Actilyse
|
6. Are there any side effects?
If you are over 80 years of age, there is an increased probability of getting side
effects.
Side effects that require urgent medical attention include: bleeding or blood clot
within the head or brain which includes difficult or slurred speech, weakness in arms
or legs, loss of memory or seizures; bleeding from the skin, mouth, gums, nose, eyes
or back passage; nausea; vomiting; blood in the urine; coughing up blood; changes
in heart rate; chest pain; shortness of breath; rapid shallow breathing; cold, clammy
or white skin; light-headedness; fluid retention; allergic reaction which includes
shortness of breath, wheezing or difficulty breathing, swelling of the face, lips,
tongue or other parts of the body, rash, itching or hives on the skin; fever.
Active ingredient(s):
alteplase
Full Consumer Medicine Information (CMI)
This leaflet provides important information about being given Actilyse. You should also speak to your doctor if you would like further information or if you
have any concerns or questions about being given Actilyse.
Where to find information in this leaflet:
1. Why am I being given Actilyse?
Actilyse contains the active ingredient alteplase. It belongs to a group of medicines called thrombolytic agents.
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).
Actilyse works by dissolving clots in the blood vessels. These clots cause disease
by interfering with normal blood flow.
2. What should I know before I am given Actilyse?
Warnings
You must not be given Actilyse if you:
are allergic to alteplase, or any of the ingredients listed at the end of this leaflet
are under 18 years of age.
Because of the risk of bleeding, Actilyse should not be given to you if you have or
have had:
current bleeding or severe bleeding in the past 6 months
a family history of bleeding disorders or a tendency to bleed
a previous condition resulting in bleeding or suspected bleeding in the brain
heart and lung resuscitation, childbirth, organ biopsy or an invasive medical procedure
in the past 10 days
major surgery, including heart, head or spinal surgery, or significant trauma (including
trauma to the head) in the past 3 months
severe and uncontrolled high blood pressure
tumours in which the risk of bleeding is increased
any blood clotting defect
current treatment with other thrombolytic agents (medicines used for dissolving blood
clots) or an anti-clotting agent (anticoagulant), such as warfarin
certain diseases of the blood vessels, heart, brain, oesophagus, stomach/intestine,
liver, kidney or pancreas in which the risk of bleeding is increased
serious liver problems.
In addition to the above medical conditions, Actilyse should not be used for the treatment
of heart attack or pulmonary embolism if you have, or have had:
a stroke caused by bleeding in the brain (condition known as haemorrhagic stroke)
or a stroke of unknown origin at any time
a stroke caused by a blood clot in the artery of the brain (condition known as ischaemic
stroke) or a transient ischaemic attack (TIA) in the past 6 months, unless the symptoms
of your stroke occurred within the past 4.5 hours and you are about to be treated
for it.
Actilyse should not be used for the treatment of acute ischaemic stroke if you have,
or have had:
experienced the symptoms of your stroke for more than 4.5 hours or if you do not know
when they began
mild neurological symptoms or when the symptoms are rapidly improving before receiving
Actilyse
a very severe stroke
any signs of bleeding in the brain or any condition that increases the risk of bleeding
in the brain
fits or seizures at the onset of stroke
treatment with heparin in the past 48 hours (and your bleeding time is abnormal)
previous stroke or serious head injury/trauma within the last 3 months
previous stroke and you are diabetic
a low platelet count (platelets are blood cells involved in blood clotting)
severe high blood pressure (over 185/110 mmHg)
very low sugar (glucose) level in your blood (under 50 mg/dL or under 2.8 mmol/L)
or very high sugar level in your blood (over 400 mg/dL or over 22.2 mmol/L).
Check with your doctor if you:
have or have had any of the following conditions:
allergies to any other medicines, foods, preservatives or dyes
a previous heart attack or any other heart condition
a previous stroke caused by a blood clot in the brain or a transient ischaemic attack
(TIA) more than 6 months previously (this only applies if you are being treated for
heart attack or pulmonary embolism)
diabetes mellitus
bleeding from inside or around your eyes or visual disturbances
high blood pressure
severe liver disease
any recent medical procedure such as a biopsy or injection
any condition in which bleeding is a significant risk or would be particularly difficult
to manage because of its location
any infected veins and cannula sites
ever received Actilyse before
Tell your doctor if you are over the age of 70 years.
The risks of treatment with Actilyse may be increased in patients over 70 years if
they have, or have had, high blood pressure, or in any patient over 80 years of age.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or are breastfeeding.
Your doctor can discuss with you the risks and benefits involved.
Children
Actilyse must not be given to a child under the age of 18 years. The safety and effectiveness in this age group has not been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Actilyse and affect how it works.
Medicines that may
increase
the risk of bleeding include:
aspirin, heparin, warfarin or any other medicines used to "thin" the blood and prevent
blood clots.
Medicines that may
increase
the risk of a serious allergic reaction include:
ACE inhibitors, a group of medicines used to treat high blood pressure.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Actilyse.
4. How will I be given Actilyse?
How much you will be given
The recommended dose is 100 mg given over 90 or 180 minutes for a heart attack, or
over 120 minutes for pulmonary embolism. A lower dose (1.5 mg/kg) is recommended for
patients weighing less than 65 kg. No more than 100 mg should be given because it
is associated with a higher risk of bleeding (especially in the brain)
For treatment of acute ischaemic stroke, a dose equivalent to 0.9 mg/kg body weight
is given over 60 minutes. The maximum dosage should not exceed 90 mg.
Your doctor might prescribe a different dose or duration of treatment to that described
here.
Ask your doctor if you want more information.
How you will be given Actilyse
Actilyse will be prepared and administered to you by your doctor or by a healthcare
professional. It is not for self-administration.
Actilyse is supplied as a powder and sterilised water for injections. Before use,
the water for injections is added to the powder to form a solution ready for administration.
This solution is given into a vein through a drip line.
When you will be given Actilyse
You should be treated with Actilyse as soon as possible after the onset of your symptoms.
If you are given too much Actilyse
An overdose is unlikely because Actilyse is administered under medical supervision.
Symptoms of an overdose may include bleeding.
In the case of serious bleeding, your doctor will immediately stop treatment with
Actilyse and heparin. Your doctor will start appropriate treatment to control the
bleeding and, if necessary, replace the lost blood.
5. What should I know while being given Actilyse?
Things you should be careful of
Actilyse increases the risk of bleeding and bruising. After treatment with Actilyse,
medical staff will avoid giving you injections or moving you unless absolutely necessary.
Your doctor will probably continue to treat you with heparin and aspirin after treatment
with Actilyse. This is to reduce the risk of more blood clots forming.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Things you should not do
You should not take aspirin for the first 24 hours after treatment with Actilyse.
Your doctor may give you an injection with heparin if this is necessary.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 80 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
|
Serious side effects
|
What to do
|
|
Bleeding-related problems:
bleeding or blood clot within the head or brain. Symptoms may include collapse, sleepiness,
difficulty in speaking or slurred speech, numbness or weakness of the arms or legs,
headache, dizziness, visual disturbance, confusion, loss of memory, agitation, depression,
weakness on one side of the body, convulsions, fits or seizures, psychosis (a severe
mental condition in which the person loses contact with reality and is unable to think
and judge clearly), difficulty swallowing
bleeding from the skin, mouth, gums, nose, or eyes
bruising
bleeding or bruising where the injection is given
vomiting blood or material that looks like coffee grounds
bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
blood in the urine
coughing up blood
Signs of heart problems:
changes in heart rate (fast, slow or irregular), extra heart beats, weak pulse
chest pain, pain behind the breastbone, sometimes spreading to the neck and shoulders
cold, clammy or white skin
light-headedness
weakness
fluid retention in different parts of the body, often first noticed as swollen ankles
and feet
restlessness
Breathing problems:
shortness of breath, tiring easily after light physical activity such as walking,
waking up short of breath at night
rapid, shallow breathing
Signs of an allergic reaction:
rash, itching or hives on the skin
swelling of the face, lips, mouth, tongue, throat or other parts of the body
shortness of breath
wheezing or difficulty swallowing or breathing
Other side effects:
nausea and vomiting
high body temperature (fever)
|
Tell your doctor immediately if you notice any of these serious side effects.
Tell your doctor immediately if you notice any of these serious side effects.
|
Due to the life-threatening nature of the diseases for which Actilyse is used, some
deaths have occurred after treatment. However, use of Actilyse in large numbers of
patients has shown that when used as recommended, the benefits outweigh the risks.
There have also been reports of blockages of blood vessels following treatment with
Actilyse. This can lead to organ failure (e.g. kidney failure).
Tell your doctor if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
What Actilyse contains
|
Active ingredient
(main ingredient)
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alteplase (10 mg, 20 mg or 50 mg)
|
|
Other ingredients
(inactive ingredients)
|
arginine
phosphoric acid
polysorbate 80
nitrogen
|
You should not be given this medicine if you are allergic to any of these ingredients.
What Actilyse looks like
Actilyse is the brand name of your medicine.
It comes as a sterile white to off-white powder in a clear glass vial. Actilyse powder
must be mixed with sterile Water for Injections before use. When mixed, the resulting
solution is clear, and colourless to pale yellow.
The reconstituted solution contains 1 mg of alteplase per mL.
Actilyse is available as a pack containing one vial of powder and one vial of sterilised
Water for Injections.
Actilyse is available in three strengths:
Actilyse 10 mg: One vial of powder with 10 mg alteplase and one vial with 10 mL of
sterilised Water for Injections (AUST R 64240)
Actilyse 20 mg: One vial of powder with 20 mg alteplase and one vial with 20 mL of
sterilised Water for Injections (AUST R 43375)*
Actilyse 50 mg: One vial of powder with 50 mg alteplase and one vial with 50 mL of
sterilised Water for Injections (AUST R 17905)
*Not distributed in Australia
Who distributes Actilyse
Actilyse is supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney NSW
This leaflet was prepared in December 2025.
®Actilyse is a registered trademark of Boehringer Ingelheim