Hemanex Special Precautions

For patients on prolonged treatment with tranexamic acid, perform an ophthalmological examination (including visual acuity, color vision, eyeground, and visual field) before and at regular intervals during treatment, since visual abnormalities are the most frequently reported adverse reactions in some postmarketing studies. Discontinue tranexamic acid if changes are found.
In clinical trials, no retinal changes have been reported in patients treated with tranexamic acid for weeks and months. However, focal areas of retinal degeneration have developed in cats, dogs, rabbits, and rats following oral or IV tranexamic acid at doses between 126 and 1600 mg/kg/day (3 to 40 times the recommended human dose) from six days to one year.
Reduce dose in patients with renal insufficiency because of the risk of drug accumulation.
Treatment with tranexamic acid is not indicated in hematuria caused by diseases of the renal parenchyma. Intravascular precipitation of fibrin frequently occurs and may aggravate the disease. Furthermore, antifibrinolytic treatment carries the risk of clot retention in the renal pelvis in cases of massive renal hemorrhage of any cause.
Urinary tract obstruction due to clot formation in patients with severe bleeding from the upper urinary tract has been reported in patients taking tranexamic acid.
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.
Although clinical evidence shows no significant increase in thrombosis, the possible risk of thrombosis cannot be ruled out. Venous and arterial thrombosis or thromboembolism have been reported in patients given tranexamic acid. Also, cases of central retinal artery and central retinal vein obstruction have been observed. A few patients have developed intracranial thrombosis with tranexamic acid but further observation is needed to assess the significance of this potential hazard.
Combination hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction. Since tranexamic acid is antifibrinolytic, the concomitant use of hormonal contraception and tranexamic acid may further exacerbate this increased thrombotic risk. There are no data on the risk of thrombotic events with the concomitant use of tranexamic acid with hormonal contraceptives. Thus, women using hormonal contraception should use tranexamic acid only if there is a strong medical need and the benefit of treatment will outweigh the potential increased risk of a thrombotic event.
Patients with disseminated intravascular coagulation who require treatment with tranexamic acid must be under the strict supervision of a physician experienced in treating this disorder.
Patients with irregular menstrual bleeding should not use tranexamic acid until the cause of irregular bleeding has been established. Consider an alternative treatment if menstrual bleeding is not adequately reduced by tranexamic acid.
Indissoluble dots may develop in body cavities such as pleural space and joint spaces due to extravascular clots which may be resistant to physiological fibrinolysis.
A case of severe allergic reaction to tranexamic acid was reported in a clinical trial, involving a subject who experienced dyspnea, tightening of throat, and facial flushing that required emergency medical treatment. A case of anaphylactic shock has also been reported involving a patient who received an intravenous bolus of tranexamic acid.
Tranexamic acid is not recommended for women taking either Factor IX complex concentrates or anti-inhibitor coagulant concentrates because of increased risk of thrombosis.
Cerebral edema and cerebral infarction may be caused by tranexamic acid use in women with subarachnoid hemorrhage.
Exercise caution when prescribing tranexamic acid to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.
Convulsions have been reported in association with tranexamic acid treatment.
Use in Children: Tranexamic acid has had limited use in children, principally in tooth extraction.
Use in Elderly: Since elderly patients often have reduced physiological function, careful supervision and dosage reduction are recommended.