Tranexamic Acid

SECTION 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.

(1)

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 injection 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)

5.1Risk of Medication Errors Due to Incorrect Route of Administration

Tranexamic acid injection is for intravenous use only. Serious, including fatal, adverse reactions including seizures and cardiac arrythmias have occurred when tranexamic acid injection was inadvertently administered via the neuraxial route. Confirm the correct route of administration for tranexamic acid injection and avoid confusion with other injectable solutions that might be administered at the same time as tranexamic acid injection.