Tranexamic-AFT

What it is

Tranexamic-AFT is tranexamic acid 500 mg/5 mL solution for injection. It is presented as a solution for injection—a sterile, clear, colourless solution free from visible particles in glass ampoules.

Approved indications —

Reduction of peri- and post-operative blood loss and the need for blood transfusion in adult patients undergoing cardiac surgery. — Reduction of peri- and post-operative blood loss and the need for blood transfusion in adult patients undergoing total knee arthroplasty. — Reduction of peri- and post-operative blood loss and the need for blood transfusion in adult patients undergoing total hip arthroplasty. — Reduction of peri- and post-operative blood loss and the need for blood transfusion in paediatric patients aged 2 years and older undergoing cardiac surgery.

Dosing overview

For adult cardiac surgery, after induction of anaesthesia and prior to skin incision, administer a pre-surgical loading dose of 15 mg/kg tranexamic acid, followed by infusion of 4.5 mg/kg/h for the duration of surgery. 0.6 mg/kg of this infusion dose may be added in the priming volume of the heart lung machine. For adult total knee arthroplasty, administration of 15 mg/kg tranexamic acid prior to release of the tourniquet followed by repeat bolus injection of 15 mg/kg at 8 hourly intervals after the initial dose. The last bolus dose is to be administered 16 hours after the initial dose. For adult total hip arthroplasty, administration of 15 mg/kg tranexamic acid immediately prior to skin incision, followed by a repeat bolus of 15 mg/kg at 8 hourly intervals after the initial dose. The last bolus dose is to be administered 16 hours after the initial dose. For paediatric cardiac surgery in patients aged 2 years and older, after induction of anaesthesia and prior to skin incision, administration of 10 mg/kg as an initial pre-surgical bolus dose followed by a repeat bolus dose of 10 mg/kg during surgery or as an infusion during surgery. No reduction in dosage is necessary in elderly patients, unless there is evidence of renal failure.

Key safety warnings

The dose of tranexamic acid should be reduced in patients with renal impairment because of the risk of accumulation. Rapid intravenous injection of Tranexamic-AFT may cause dizziness and/or hypotension. The recommended rate of administration is 50 mg/min. Although clinical evidence shows no significant increase in thrombosis, possible risk of thrombotic complications cannot be ruled out. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid. In addition, cases of central retinal artery and central retinal vein obstruction have been reported. No retinal changes have been reported or noted in eye examinations in patients treated with tranexamic acid for weeks to months in clinical trials. However, visual abnormalities, often poorly characterised, represent the most frequently reported post-marketing adverse event in Sweden. For patients who are to be treated continually for longer than several days, an ophthalmological examination, including visual acuity, colour vision, eye-ground and visual fields, is advised before commencing and at regular intervals during the course of treatment. Tranexamic acid should be discontinued if changes in examination results are found. Convulsions have been reported in association with tranexamic acid treatment.

Contraindications

Intrathecal and epidural administration of tranexamic acid is contraindicated. Patients with a history or risk of thrombosis should not be given tranexamic acid, unless at the same time it is possible to give treatment with anticoagulants. Active thromboembolic disease such as deep vein thrombosis (DVT), pulmonary embolism and cerebral thrombosis is contraindicated. The preparation should not be given to patients with acquired disturbances of colour vision. If disturbances of colour vision arise during the course of treatment the administration of the preparation should be discontinued. Patients with subarachnoid haemorrhage should not be given tranexamic acid as anecdotal experience indicates that cerebral oedema and cerebral infarction may be caused in such cases. Hypersensitivity to tranexamic acid or any of its excipients is contraindicated.

Regulatory history

Tranexamic-AFT 500 mg/5 mL solution for injection ampoule was first listed on the ARTG on 9 November 2015.