Metalyse Solution

METALYSE belongs to a group of medicines called thrombolytic agents. These medicines help to dissolve blood clots.

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.

METALYSE treatment should be carried out by a doctor who is experienced in the use of this type of medicine.

Your doctor will not use METALYSE if you have, or have recently had any illness, medicine or medical procedure which is associated with a high risk of haemorrhage (bleeding).

METALYSE should not be administered to you

• if you are hypersensitive (allergic) to the active ingredient (tenecteplase), gentamicin (a trace residue from the manufacturing process) or any of the other ingredients of METALYSE listed in section 6.
• if you have, or have recently had, a situation that increases your risk of bleeding (haemorrhage), including:
• a bleeding disorder or tendency to bleed (haemorrhage)
• stroke (cerebrovascular event)
• very high, uncontrolled blood pressure
• a head injury
• severe liver disease
• an ulcer in the stomach or intestinal tract
• varicose veins in the gullet (oesophageal varices)
• known 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)
• if you are taking tablets/capsules called vitamin K antagonists used to “thin” the blood, such as warfarin or coumarin (anticoagulants)
• if you have an inflamed pancreas (pancreatitis)
• if you have recently had major surgery including surgery to your brain or spine
• if you gave birth within the previous 3 days
• if you are pregnant or breastfeeding (see below)
• if you had previous treatment with tenecteplase
• if you are older than 80 years or younger than 18 years of age.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection:

• if you have high blood pressure
• if you have problems with circulation of blood in the brain (cerebrovascular disease) or a history of previous stroke or transient ischaemic attack (TIA)
• if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration
• 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 or small recent traumas, such as biopsies, puncture of major blood vessels
• if you are 75 years or older
• if you weigh less than 50 kg.

Thromboembolism

The use of METALYSE can increase your risk of thromboembolic events if you have existing conditions which could cause clots, e.g. left heart thrombus (mitral stenosis or atrial fibrillation).

Children and adolescents

The use of METALYSE in children and adolescents up to 18 years is not recommended.

Other medicines and METALYSE

Always tell your healthcare provider if you are taking any other medicines. (This includes all complementary or traditional medicines.) Medicines that affect coagulation (clotting) or those that alter platelet function may increase the risk of bleeding prior to, during or after METALYSE therapy.

Pregnancy and breastfeeding

Safety in using METALYSE in pregnant and breastfeeding women has not been established. METALYSE may contain gentamicin as a trace residue from the manufacturing process.

METALYSE contains polysorbate 20. This medicine contains 3,2 mg of polysorbate 20 in each vial of METALYSE 8 000 U and 4,0 mg in each vial of METALYSE 10 000 U. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

You will not be expected to give yourself METALYSE. It will be given to you by a person who is qualified to do so.

The doctor calculates your dose of METALYSE according to your bodyweight, based on the following scheme:

Bodyweight (kg)

• less than 60: 6 000 U
• 60 to 70: 7 000 U
• 70 to 80: 8 000 U
• 80 to 90: 9 000 U
• above 90: 10 000 U

Your doctor will give you medication 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 medicine. Your doctor will give METALYSE as soon as possible after your chest pain starts as a single dose. Repetition is not recommended.

If you are given more METALYSE than you should have received Since a healthcare provider will administer METALYSE, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

METALYSE can cause side effects. Not all side effects reported for METALYSE are included in this leaflet. Should your general health worsen, or if you experience untoward effects after receiving METALYSE, please consult your healthcare provider for advice.

Tell your doctor if you notice any of the following:

Frequent side effects

• low blood pressure (hypotension)
• irregular heart beat
• chest pain (angina pectoris)
• bleeding where the injection is given
• nosebleeds
• further heart attack or chest pain (recurrent ischaemia, reinfarction)
• heart failure
• shock due to heart failure
• inflammation of the lining around the heart (pericarditis)
• fluid in the lungs (pulmonary oedema)
• genitourinary bleeding (you may notice blood in your urine)
• bruising
• gastrointestinal bleeding (bleeding from the stomach or bowel)

Less frequent side effects

• cardiac arrest
• problem with the heart valve or heart lining (mitral insufficiency, pericardial effusion)
• blood clot in the vein (venous thrombosis)
• blood clot in the blood vessel (thrombotic embolisation)
• fluid between heart lining and the heart (cardiac tamponade)
• rupture in heart muscle
• 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 lungs (pulmonary haemorrhage)
• hypersensitivity (anaphylactoid reactions) e.g. rash, hives (urticaria), swelling of the throat
• bleeding into the area surrounding the heart (pericardial haemorrhage)
• blood clot in the lung (pulmonary embolism)
• bleeding in the eyes (eye haemorrhage).

Side effects where frequency is not known

• clot consisting of fat
• nausea
• vomiting
• fever
• bleedings requiring blood transfusion

As with other thrombolytic agents, the following side effects have been reported as consequences of myocardial infarction and/or thrombolytic administration:

Frequent side effects

• Low blood pressure (hypotension)
• Irregular heart beat
• Chest pain (angina pectoris), which can be recurrent
• Heart attack
• Heart failure
• Shock due to heart failure
• Inflammation of the lining around the heart
• Fluid in the lungs (pulmonary oedema)

Less frequent side effects

• 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)
• 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 (inability to move one side of the body) and fits (convulsions).

Tell your doctor immediately if you think you are experiencing any of these side effects. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of METALYSE.

Suspected adverse reactions can also be reported directly to the holder of the certificate of registration using the email address [email protected].

Store all medicines out of reach of children. Both the vials and the solvent should be stored at or below 30 °C. Keep the glass vial containing METALYSE powder 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 for 8 hours at 30 °C. However, for microbiological reasons your doctor will normally use the reconstituted solution for injection immediately. Do not use METALYSE after the expiry date which is stated on the label/carton.