Tranexamic acid

Method of Administration:

Abnormal uterine bleeding, nonacute: Alternative for patients who decline or should not use hormonal therapy. Start at onset of heavy menstrual bleeding.

Oral: 1.3 g 3 times daily for up to 5 days during monthly menstruation.

Perioperative prevention of blood loss and transfusion:

Usual dose and range: IV: 1 g (or 10 to 30 mg/kg) prior to procedure; administer at a rate not to

exceed 100 mg/minute (generally over 10 to 30 minutes). Depending upon type of procedure, a

continuous infusion may be given intraoperatively after the initial bolus dose, or the bolus dose may be repeated at the end of procedure and/or during the postoperative period

Contraindications

Hypersensitivity to tranexamic acid or any component of the formulation.

Injection: Active intravascular clotting; subarachnoid hemorrhage.

Oral: Active thromboembolic disease (eg, cerebral thrombosis, DVT, or pulmonary embolism); history of thrombosis or thromboembolism, including retinal vein or retinal artery occlusion

Interactions

Anti-inhibitor Coagulant Complex (Human): Antifibrinolytic Agents may enhance the thrombogenic effect of Anti-inhibitor Coagulant Complex (Human). Risk X: Avoid combination

Estrogen Derivatives: May enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination

Factor IX Complex (Human) [(Factors II, IX, X)]: Antifibrinolytic Agents may enhance the adverse/toxic effect of Factor IX Complex (Human) [(Factors II, IX, X)]. Specifically, the risk for thrombosis may be increased. Risk X: Avoid combination

Hormonal Contraceptives: May enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination

Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, and Protein S]: Antifibrinolytic Agents may enhance the adverse/toxic effect of Prothrombin Complex Concentrate (Human) [(Factors II, VII, IX, X), Protein C, and Protein S]. Specifically, the risk for thrombosis may be increased. Risk X: Avoid combination

Thrombolytic Agents: Tranexamic Acid may diminish the therapeutic effect of Thrombolytic Agents. Thrombolytic Agents may diminish the therapeutic effect of Tranexamic Acid. Risk X: Avoid combination

Tretinoin (Systemic): May enhance the thrombogenic effect of Antifibrinolytic Agents. Management: Concomitant use of antifibrinolytics and tretinoin is not recommended. If combined, monitor patients closely for any signs of thrombotic complications. Risk D: Consider therapy modification

Pregnancy and Lactation

Tranexamic acid crosses the placenta; concentrations within cord blood are similar to maternal serum.

Tranexamic acid is present in breast milk. The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Warning and Precaution

• Disseminated intravascular coagulation: Use with extreme caution in patients with disseminated intravascular coagulation requiring antifibrinolytic therapy; patients should be under strict supervision of a health care provider experienced in treating this disorder.
• Renal impairment: Use with caution in patients with renal impairment; dosage modification necessary.
• Subarachnoid hemorrhage: Use with caution in patients with subarachnoid hemorrhage; cerebral edema and infarction may occur.
• Vascular disease: Use with caution in patients with uncorrected cardiovascular or cerebrovascular disease due to the complications of thrombosis.

Adverse Reactions

>10%:

Gastrointestinal: Abdominal pain (20%)

Nervous system: Headache (50%)

Neuromuscular & skeletal: Back pain (21%), musculoskeletal pain (11%)

Respiratory: Nasal signs and symptoms (25%; including sinus symptoms)

Storage

Store below 30ºC and protect from light and moisture.