Actilyse

Actilyse IV Infusion

• Alteplase
• 50 mg/vial
• Radiant Pharmaceuticals Ltd.
• 50 mg vial: ৳ 48,000.00

Indications

Alteplase 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)

Therapeutic Class

Anti-platelet drugs, Fibrinolytics (Thrombolytics)

Pharmacology

Alteplase works by dissolving clots in the blood vessels. Alteplase binds to fibrin rich clots via the fibronectin finger-like domain and the Kringle 2 domain. The protease domain then cleaves the Arg/Val bond in plasminogen to form plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.

Dosage

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. If you want more information, ask your doctor.

Administration

Alteplase will be prepared and administered to you by your doctor or by a healthcare professional. It is not for self-administration.

Treatment with Alteplase should be initiated as soon as possible after the start of your symptoms.

Alteplase 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.

Interaction

Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. Some medicines and Alteplase may interfere with each other. These include:

• Aspirin, heparin, warfarin or any other medicines used to “thin” the blood and prevent blood clots
• ACE inhibitors, a group of medicines used to treat high blood pressure

Contraindications

You should not be given Alteplase if you have an allergy to:

• Any medicine containing alteplase (the active ingredient in Alteplase)
• Gentamicin (an antibiotic)
• Natural rubber (also called latex which is part of the packaging material)
• Any of the ingredients listed here.

Side Effects

• 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;
• 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
• Changes in heart rate (fast, slow or irregular), extra heartbeats, weak pulse
• Chest pain, pain behind the breastbone, sometimes spreading to the neck and shoulders
• Shortness of breath, tiring easily after light physical activity such as walking, waking up short of breath at night
• Rapid, shallow breathing
• 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
• Any symptoms of an allergic reaction (e.g. rash, itching, 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)
• High body temperature

Pregnancy & Lactation

Pregnancy category B1. Studies with Alteplase have not been performed to determine effect on fertility or reproduction.

Use in Lactation: It is not known whether Alteplase is excreted in human milk. Because many drugs are excreted by this route, caution should be exercised when Alteplase is administered to breastfeeding women.

Precautions & Warnings

Alteplase increases the risk of bleeding and bruising. After treatment with Alteplase medical staff will avoid giving you injections or moving you unless absolutely necessary.

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.

Use in Special Populations

Use in the Elderly: The risks of therapy may be increased in the elderly. In a pooled analysis of randomised controlled clinical trials, patients over 80 years was associated with an increased risk of haemorrhage (both ICH and symptomatic ICH), mortality and decreased efficacy compared to younger patients

Paediatric use: Safety and effectiveness of Alteplase in children has not been established. Therefore treatment of such patients is not recommended. Alteplase is not indicated for treatment of acute stroke in patients less than 18 years of age.

Storage Conditions

Alteplase will be stored in the pharmacy or on the ward below 30°C and protected from light.