APO-TRANEXAMIC

What it is

APO-TRANEXAMIC is tranexamic acid 500 mg per 5 mL presented as a solution for injection. The solution is sterile, clear and colourless, free from visible particles, presented in glass ampoules. APO-TRANEXAMIC is intended for intravenous administration (intravenous injection and infusion).

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 undergoing cardiac surgery.

Dosing overview

For adult cardiac surgery, after induction of anaesthesia and prior to skin incision, a pre-surgical loading dose of 15 mg/kg tranexamic acid is administered, 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, 15 mg/kg tranexamic acid is administered prior to release of the tourniquet, followed by repeat bolus injection of 15 mg/kg at 8 hourly intervals after the initial dose, with the last bolus dose administered 16 hours after the initial dose. For adult total hip arthroplasty, 15 mg/kg tranexamic acid is administered immediately prior to skin incision, followed by a repeat bolus of 15 mg/kg at 8 hourly intervals after the initial dose, with the last bolus dose administered 16 hours after the initial dose. For paediatric cardiac surgery in patients ≥ 2 years old, after induction of anaesthesia and prior to skin incision, an initial pre-surgical bolus dose of 10 mg/kg is administered followed by a repeat bolus dose of 10 mg/kg during surgery or as an infusion during surgery. APO-TRANEXAMIC should only be used in the paediatric population ≥ 2 years old. The recommended rate of administration is 50 mg/min. Rapid intravenous injection may cause dizziness and/or hypotension.

Key safety warnings

The dose of tranexamic acid should be reduced in patients with renal impairment because of the risk of accumulation. Isolated cases of obstruction of the urinary tract due to blood clots have been observed when tranexamic acid has been used to treat severe bleeding from the upper urinary tract. 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. A few patients have developed intracranial thrombosis with tranexamic acid but further investigation is needed to assess the significance of this potential hazard. Patients with a high risk for thrombosis (a previous thromboembolic event and a family history of thromboembolic disease) should use tranexamic acid only if there is a strong medical indication and under strict medical supervision. Focal areas of retinal degeneration have developed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) from 6 days to 1 year. The incidence of such lesions has varied from 25% to 100% of animals treated and was dose related. 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. Convulsions have been reported in association with tranexamic acid treatment. Serious events including death and cardiac arrythmias were reported in patients erroneously treated with tranexamic acid via intrathecal or epidural injection.

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. APO-TRANEXAMIC 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 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

APO-TRANEXAMIC was first registered on the ARTG on 2017-01-30.