Tranexamic acid - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Thromboembolism, including retinal occlusion, has been reported with tranexamic acid USP tablets use.

Concomitant use of tranexamic acid USP tablets with combined hormonal contraceptives, Factor I X complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid (oral tretinoin) may increase the risk of thrombosis.

Visual or ocular adverse reactions may occur with tranexamic acid USP tablets.

Immediately discontinue use if visual or ocular symptoms occur.

In case of severe allergic reaction, discontinue tranexamic acid USP tablets and seek immediate medical attention.

Cerebral edema and cerebral infarction may be caused by use of tranexamic acid USP tablets in patients with subarachnoid hemorrhage.

Ligneous conjunctivitis has been reported in patients taking tranexamic acid.

5.1 Thromboembolic Risk Venous and arterial thrombosis or thromboembolism, as well as cases of retinal artery and retinal vein occlusions, have been reported with tranexamic acid USP tablets.

Retinal venous and arterial occlusion have been reported in patients using tranexamic acid.

Patients should be instructed to report visual and ocular symptoms promptly.

In the event of such symptoms, patients should be instructed to discontinue tranexamic acid USP tablets immediately and should be referred to an ophthalmologist for a complete ophthalmic evaluation, including dilated retinal examination, to exclude the possibility of retinal venous or arterial occlusion.

Concomitant Use of Hormonal Contraceptives Combined hormonal contraceptives are known to increase the risk of venous thromboembolism, as well as arterial thromboses such as stroke and myocardial infarction.

Because tranexamic acid USP tablets are antifibrinolytic, the risk of venous thromboembolism, as well as arterial thromboses such as stroke, may increase further when combined hormonal contraceptives are administered with tranexamic acid USP tablets.

This is of particular concern in women who are obese or smoke cigarettes, especially smokers over 35 years of age.

Women using combined hormonal contraception were excluded from the clinical trials supporting the safety and efficacy of tranexamic acid USP tablets, and there are no clinical trial data on the risk of thrombotic events with the concomitant use of tranexamic acid USP tablets with combined hormonal contraceptives.

However, there have been US postmarketing reports of venous and arterial thrombotic events in women who have used tranexamic acid USP tablets concomitantly with combined hormonal contraceptives.

For this reason, concomitant use of tranexamic acid with combined hormonal contraceptives is contraindicated [see Contraindications and Drug Interactions ].

Concomitant Use with Factor I X Complex Concentrates or Anti-Inhibitor Coagulant Concentrates Tranexamic acid USP tablets are not recommended in patients taking either Factor I X complex concentrates or anti-inhibitor coagulant concentrates because the risk of thrombosis may be increased [see Drug Interactions and Clinical Pharmacology ].

Patients with Acute Promyelocytic Leukemia Taking Concomitant All-Trans Retinoic Acid (Oral Tretinoin) Tranexamic acid USP tablets are not recommended in patients 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 [see Drug Interactions and Clinical Pharmacology ].

5.2 Severe Allergic Reactions A case of severe allergic reaction to tranexamic acid USP tablets was reported in the clinical trials, involving a subject who experienced dyspnea, tightening of her throat, and facial flushing that required emergency medical treatment.

A case of anaphylactic shock has also been reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid.

Tranexamic acid USP tablets are contraindicated in females of reproductive potential with known hypersensitivity to tranexamic acid.

5.3 Subarachnoid Hemorrhage Cerebral edema and cerebral infarction may be caused by use of tranexamic acid USP tablets in patients with subarachnoid hemorrhage.

5.4 Ligneous Conjunctivitis Ligneous conjunctivitis has been reported in patients taking tranexamic acid.

The conjunctivitis resolved following cessation of tranexamic acid USP tablets.