Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor.
1. Why am I being given Metalyse?
Metalyse contains the active ingredient tenecteplase. Metalyse is given during the
early stages of a heart attack.
2. What should I know before I am given Metalyse?
You should not be given Metalyse if you have ever had an allergic reaction to Metalyse
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,
have a planned heart procedure, blood vessel problems, high blood pressure, have had
a stroke or 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 Metalyse and affect how it works.
Tell your healthcare professional if you are taking any blood-thinning medicines or
any other medicines.
4. How will I be given Metalyse?
Metalyse will be prepared and administered to you by your doctor or by a healthcare
professional as soon as possible after the start of your symptoms.
5. What should I know while being given Metalyse?
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Things you should do
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Follow all instructions given to you by your healthcare professionals
Avoid moving unnecessarily after receiving Metalyse to prevent bleeding or bruising
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6. Are there any side effects?
There is an increased probability of getting side effects if you are over 75 years
of age.
The most common side effect is bleeding more easily than usual, either inside the
body, on the surface, or at the injection site.
Side effects that require urgent medical attention include: bleeding or blood clot
within the head or brain which includes symptoms such as difficult or slurred speech,
weakness in arms or legs, loss of memory or seizures; bleeding from the skin, nose,
eyes or back passage; nausea; vomiting; blood in the urine; coughing up blood; low
blood pressure; irregular heartbeat; allergic reaction which includes symptoms such
as 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: tenecteplase
Full Consumer Medicine Information (CMI)
This leaflet provides important information about Metalyse. You should also speak to your doctor if you would like further information or if you
have any concerns or questions about being given Metalyse.
Where to find information in this leaflet:
1. Why am I being given Metalyse?
Metalyse contains the active ingredient tenecteplase. It belongs to a group of medicines called tissue plasminogen activators (t-PA).
Metalyse is used during the early stages of a heart attack.
It 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 Metalyse?
Warnings
You must not be given Metalyse if you:
are allergic to tenecteplase, gentamicin (a trace residue from the manufacturing process)
or any of the ingredients listed at the end of this leaflet
have a percutaneous coronary intervention (PCI) planned. PCI is an interventional
procedure in which blocked blood vessels in the heart are unblocked. Examples of PCI
procedures include balloon angioplasty, atherectomy and stent placement. Receiving
Metalyse treatment prior to a planned PCI procedure may increase your risk of having
side effects
are under 18 years of age. The safety and effectiveness in this age group has not
been established.
Because of the risk of bleeding, Metalyse must 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
treatment with an anti-clotting agent (anticoagulant), such as warfarin, unless its
effect has had time to wear off
major surgery, biopsy or significant trauma in the past 2 months
a stroke due to bleeding in the brain or a stroke of unknown origin at any time
a stroke caused by a blood clot or a transient ischaemic attack (TIA) in the past
6 months
severe and uncontrolled high blood pressure (hypertension)
tumours in which the risk of bleeding is increased
any blood clotting defect
current treatment with a thrombolytic agent (medicine used to dissolve blood clots)
previous or current aneurysms (swelling and weakening of a part of a blood vessel)
in your brain or spinal cord, or arteries in other parts of your body
previous brain or spinal cord surgery
previous or current tumours in your brain or spinal cord
recent trauma to your head or skull
heart and lung resuscitation (CPR) in the past 2 weeks
structural abnormalities in your arteries or veins
severe liver disease
inflammation, infection or swelling of your heart or pancreas
childbirth, organ biopsy or any invasive medical procedure in the past 10 days
recent severe bleeding, particularly in your stomach, gut or from your genitals
problems with your blood, especially if you also have severe liver or kidney disease
stomach ulcers in the past 3 months.
Check with your doctor if you have or have had any of the following medical conditions:
allergies to any other medicines, foods, preservatives or dyes
recent major trauma, medical procedure (such as a biopsy or injection) or surgery
to any part of your body
problems with blood supply to the brain
a previous stroke caused by a blood clot or a transient ischaemic attack (TIA) more
than 6 months previously
recent bleeding from your stomach, gut or genitals
high blood pressure
any heart conditions or infections
severe problems with your pancreas
severe liver disease
problems with your blood, especially if you also have severe liver or kidney disease
diabetes mellitus
bleeding from inside or around your eyes
if your body weight is less than 60 kg
if you are elderly (75 years of age or older).
Speak to your doctor if you are uncertain as to whether any of these conditions apply
to you.
In addition, before starting treatment, your doctor will assess other factors which
may increase the risks of using Metalyse. These include infected veins and cannula
sites or any condition in which bleeding is a significant risk or would be particularly
difficult to manage because of its location.
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.
3. What if I am taking other medicines?
Tell your doctor if you are taking any other medicines, including any vitamins or
supplements that you buy without a prescription from your pharmacy, supermarket or
health food shop.
Some medicines may interfere with Metalyse 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.
Check with your doctor if you are not sure about what medicines, vitamins or supplements
you are taking and if these affect Metalyse.
4. How will I be given Metalyse?
How much you will be given
The recommended dose is based on your body weight and ranges between 30 mg and 50
mg. The dose is given as a single injection over about 10 seconds.
Your doctor may prescribe a different dose or duration of treatment to that described
here.
Ask your doctor if you want more information.
How will you be given Metalyse
Metalyse will be given under the supervision of a doctor and in a setting where appropriate
equipment is readily available for diagnosis and patient monitoring.
Metalyse is a powder which is mixed with sterile water for injections before being
given into a vein through a drip line.
At the same time or soon after treatment with Metalyse, you may also receive other
medications such as heparin to help prevent the blood vessel(s) becoming blocked again
after treatment.
When you will be given Metalyse
You should be treated with Metalyse as soon as possible after the onset of your symptoms.
If you are given too much Metalyse
An overdose is unlikely because Metalyse is administered under medical supervision.
Symptoms of an overdose may include bleeding.
If you have serious bleeding, your doctor will immediately stop treatment with Metalyse
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 Metalyse?
Things you should be careful of
Metalyse increases the risk of bleeding and bruising. After treatment with Metalyse,
medical staff will avoid giving you injections or moving you unless absolutely necessary.
Your doctor will probably continue to treat you with other medications after treatment
with Metalyse. This is to reduce the risk of more blood clots forming.
You should only receive one injection of Metalyse. Any leftover solution that was
prepared to treat you should be thrown away and not injected into anyone else.
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 75 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 if you have any further
questions about side effects.
Serious side effects
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Serious side effects
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What to do
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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, nose or eyes
bruising
bleeding or bruising where the injection is given
nausea, vomiting or 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:
low blood pressure
irregular heartbeat
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
low blood pressure
Other side effects:
nausea and vomiting
high body temperature (fever)
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Tell your doctor immediately if you notice any of these serious side effects.
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There have also been reports of blockages of blood vessels following treatment with
Metalyse. This can lead to organ failure (e.g. kidney failure). These serious effects
are rare.
Tell your doctor or nurse if you notice anything 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 Metalyse contains
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Active ingredient
(main ingredient)
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Tenecteplase (40 mg or 50 mg)
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Other ingredients
(inactive ingredients)
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arginine
phosphoric acid
polysorbate 20
sterilised water for injections
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You should not be given this medicine if you are allergic to any of these ingredients.
What Metalyse looks like
Metalyse is the brand name of your medicine.
It comes as a sterile, white to off-white powder in a clear glass vial. Metalyse powder
must be mixed with sterile water for injections before use. When mixed, the resulting
solution is clear, and colourless to pale yellow.
Metalyse is sold as a pack containing one vial of powder and one pre-filled syringe
of sterile water for injections.
Metalyse is available in two strengths:
Metalyse 40 mg: One vial of powder with 40 mg tenecteplase and one pre-filled syringe
containing 8 mL of sterilised Water for Injections (AUST R 75012)
Metalyse 50 mg: One vial of powder with 50 mg tenecteplase and one pre-filled syringe
containing 10 mL of sterilised Water for Injections (AUST R 75013)
The reconstituted solution contains 5 mg of tenecteplase per mL.
Who distributes Metalyse
Metalyse is supplied in Australia by:
Boehringer Ingelheim Pty Limited
ABN 52 000 452 308
Sydney NSW
This Consumer Medicine Information was prepared in December 2023.
®Metalyse is a registered trademark of Boehringer Ingelheim
© Boehringer Ingelheim Pty Limited 2023.