Patient leaflet - Metalyse 10 000 units powder and solvent for solution for injection
1. What Metalyse is and what it is used for
Metalyse is a powder and solvent for solution for injection.
Metalyse belongs to a group of
medicines called thrombolytic agents. These medicines help to dissolve blood clots. Tenecteplase is a recombinant fibrin-specific plasminogen activator.
Metalyse is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart. This helps to prevent the damage caused by heart attacks and has been shown to save lives.
2. What you need to know before you receive Metalyse
Metalyse will not be prescribed and given by your doctor
if you have previously had a sudden
life-threatening allergic reaction (severe hypersensitivity) to tenecteplase, to any of the other ingredients of this medicine (listed in section 6) or to gentamicin (a trace residue from the manufacturing process). If treatment with Metalyse is nevertheless considered to be necessary, facilities for reanimation should be immediately available in case of need;
if you have, or have recently had,
an illness that increases your risk of bleeding (haemorrhage), including:
a bleeding disorder or tendency to
bleed (haemorrhage)
stroke caused by bleeding in the
brain (haemorrhagic stroke) or stroke of unknown cause
stroke caused by a blood clot in an
artery of the brain (ischaemic stroke) in the preceding 6 months
- very high, uncontrolled blood pressure
- a head injury
- severe liver disease
- gastric ulcer or ulcers in the gut
varicose veins in the gullet
(oesophageal varices)
abnormality of the blood vessels
(e.g. an aneurysm)
- certain tumours
inflammation of the lining around
the heart (pericarditis); inflammation or infection of the heart valves (endocarditis)
- dementia;
if you are taking tablets/capsules used
to “thin” the blood, such as coumarin derivatives like warfarin
(anti-coagulants);
if you have an inflamed pancreas
(pancreatitis);
if you have recently had major surgery
including surgery to your brain or spine.
Warnings and precautions
Your doctor will take special care with Metalyse
if you have had any allergic reaction
other than a sudden life-threatening allergic reaction (severe hypersensitive) to tenecteplase, to any of the other ingredients of this medicine (listed in section 6) or to gentamicin (a trace residue from the manufacturing process);
- if you have high blood pressure;
if you have had gastrointestinal (gut) or
genitourinary bleeding within the last ten days (this may cause blood in stools or urine);
if you have a heart valve abnormality
(e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation);
if you have recently had an intramuscular
injection;
- if you are aged 75 years or older;
- if you weigh less than 50 kg;
if you have been given cardiopulmonary
resuscitation (chest compressions) for more than 2 minutes duration;
- if you have ever received Metalyse before.
Children and adolescents
The use of Metalyse in children and adolescents up to the age of 18 years is not recommended.
Other medicines and Metalyse
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Metalyse contains polysorbate 20
This medicine contains 4.0 mg of polysorbate 20 in each 50 mg vial. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
3. How is Metalyse administered
The doctor calculates your dose of Metalyse according to your bodyweight, based on the following scheme:
Bodyweight (kg) Metalyse (U)
less than 60 6 000 60 to 70 7 000 70 to 80 8 000 80 to 90 9 000 above 90 10 000
Your doctor will give you the medicinal product to prevent blood clotting in addition to Metalyse, as soon as possible after your chest pain starts.
Metalyse is given by a single injection into a vein by a doctor who is experienced in the use of this type of medicinal product.
Your doctor will give Metalyse as soon as possible after your chest pain starts as a single dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects described below have been experienced by people given Metalyse:
Very common (may affect more than 1 in 10 people):
- Bleeding
Common (may affect up to 1 in 10 people):
- Bleeding at the injection or puncture site
- Nosebleeds
- Genitourinary bleeding (you may notice blood in your urine)
- Bruising
- Gastro-intestinal bleeding (e.g. bleeding from the stomach or bowel)
Uncommon (may affect up to 1 in 100 people):
- Irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest. Cardiac (heart) arrest can be life threatening.
Internal bleeding in the abdomen
(retroperitoneal bleeding)
- Bleeding in the brain (cerebral haemorrhage). Death or permanent disability may occur following bleeding in the brain or other serious bleeding events
- Bleeding in the eyes (eye haemorrhage)
Rare (may affect up to 1 in 1 000 people):
- Low blood pressure (hypotension)
- Bleeding in the lungs (pulmonary haemorrhage)
- Hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), difficulty breathing (bronchospasm)
- Bleeding into the area surrounding the heart (haemopericardium)
Blood clot in the lung (pulmonary embolism)
and in the vessels of other organ systems (thrombotic embolisation)
Not known (frequency cannot be estimated from the available data):
- Fat embolism (clots consisting of fat)
- Nausea
- Vomiting
- Body temperature increased (fever)
- Blood transfusions as consequence of bleedings
Package leaflet: Information for the user
Metalyse®
10 000 units (50 mg) powder and solvent for solution for injection
tenecteplase
abcd As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Very common (may affect more than 1 in 10 people):
- Low blood pressure (hypotension)
- Irregular heart beat
- Chest pain (angina pectoris)
Common (may affect up to 1 in 10 people):
Further chest pain/angina (recurrent
ischaemia)
- Heart attack
- Heart failure
- Shock due to heart failure
Inflammation of the lining around the
heart
- Fluid in the lungs (pulmonary oedema)
Uncommon (may affect up to 1 in 100 people):
- Heart arrest
Problem with the heart valve or heart
lining (mitral valve incompetence, pericardial effusion)
Blood clot in the veins (venous
thrombosis)
Fluid between the heart lining and the
heart (cardiac tamponade)
Rupture of the heart muscle (myocardial
rupture)
Rare (may affect up to 1 in 1 000 people):
Blood clot in the lung (pulmonary
embolism)
These cardiovascular events can be life-threatening and may lead to death.
In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Metalyse
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Do not store above 30 °C.
Keep the container in the outer carton in order to protect from light.
Once Metalyse has been reconstituted it may be stored for 24 hours at 2-8 °C and 8 hours at 30 °C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Metalyse contains
- The active substance is tenecteplase.
- Each vial contains 10 000 units (50 mg) of tenecteplase. Each pre-filled syringe contains 10 mL of solvent. When reconstituted with 10 mL solvent each mL contains 1 000 U tenecteplase.
- The other ingredients are arginine, concentrated phosphoric acid (E 338) and polysorbate 20 (E 432).
- The solvent is water for injections.
- Gentamicin is contained as trace residue from the manufacturing process
What Metalyse looks like and contents of the pack
The carton contains:
one vial with a lyophilised powder with
50 mg tenecteplase, one ready for use pre-filled syringe with 10 mL solvent and one vial adapter.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Boehringer Ingelheim International GmbH Binger Strasse 173
55216 Ingelheim am Rhein
Germany
Manufacturer
Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
88397 Biberach/Riss
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
Boehringer Ingelheim Ltd.
Tel: +44 1344 424 600
This leaflet was last revised in 07/2025.
P053698-006