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Tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Tranexamic acid injection is an antifibrinolytic indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

Tranexamic acid injection is contraindicated: As a neuraxial (i.e., intrathecal, epidural) injection [see Warnings and Precautions (5.1) ] . In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. In patients with active intravascular clotting [see Warnings and Precautions (5.2) ] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [see Warnings and Precautions (5.4) ] . As a neuraxial (i.e., intrathecal, epidural) injection. (4) In patients with subarachnoid hemorrhage, due to risk of cerebral edema and cerebral infarction. (4) In patients with active intravascular clotting. (4) In patients with severe hypersensitivity reactions to tranexamic acid or any of the ingredients. (4)

Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. (5.2) Seizures: Inadvertent injection into neuraxial system may result in seizures. ( 5.3 ) Hypersensitivity Reactions: In case of severe reaction, discontinue use and seek immediate medical attention. ( 5.4 ) Visual Disturbances: Visual or ocular adverse effects may occur. Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. ( 5.6 ) 5.1 Risk of Medication Errors Due to Incorrect Route of Administration Tranexamic acid is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid was inadvertently administered via the neuraxial route. Confirm the correct route of administration for tranexamic acid and avoid confusion with other injectable solutions that might be administered at the same time as tranexamic acid. Clearly label syringes containing tranexamic acid with the intravenous route of administration. 5.2 Thromboembolic Risk Tranexamic acid is contraindicated in patients with active intravascular clotting. Tranexamic acid is an antifibrinolytic and may increase the risk of thromboembolic events. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with tranexamic acid. Avoid concomitant use of tranexamic acid and medical products that are pro-thrombotic, as the risk of thrombosis may be increased. These …

8.1 Pregnancy Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear. Tranexamic acid is known to pass the placenta and appears in cord blood at …