Antifibrinolytic Agent

Tranexamic Acid

Approved 10 Aug 2011InjectionInjectable

The FDA lists this product in 32 strengths and forms.

Indications

Tranexamic acid injection, USP 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, USP 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 )

Contraindications

Tranexamic Acid injection is contraindicated: 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 (5.1) ] . In patients with hypersensitivity to tranexamic acid or any of the ingredients [ see Warnings and Precautions (5.4) ] .

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 )

Warnings and precautions

Risk of Thrombosis with Concomitant Use of Factor IX: Avoid concomitant use. ( 5.1 ) Risk of Medication Errors Due to Incorrect Route of Administration: FOR INTRAVENOUS USE ONLY. ( 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 ).

5.1Thromboembolic Risk

Tranexamic acid injection 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 injection. Avoid concomitant use of tranexamic acid injection and medical products that are pro-thrombotic, as the risk of thrombosis may be increased.

Indications

( 1 )

Contraindications

Warnings and precautions

Discontinue use if visual or ocular symptoms occur. ( 5.5 ) Dizziness: Advise patients not to drive if dizziness occurs. ( 5.6 ).

5.1Thromboembolic Risk

Pregnancy and breastfeeding

8.1Pregnancy 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 concentrations approximately equal to maternal concentration (see Data ) . Reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fetus due to tranexamic acid administered during organogenesis. Doses examined were multiples of up to 3 times (mouse), 6 times (rat), and 3 times (rabbit) the maximum human dose based on body surface area in the mouse, rat, and rabbit, respectively (see Data ) .

The estimated background risk for major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2–4% and 15–20%, respectively. It is not known whether tranexamic acid use in pregnant women may cause a drug-associated risk of miscarriage or adverse maternal or fetal outcomes.

For decisions regarding the use of tranexamic acid injection during pregnancy, the potential risk of tranexamic acid injection administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid injection; an accurate risk-benefit evaluation should drive the treating physician's decision. Data Human Data Tranexamic acid passes through the placenta. The concentration in cord blood after an intravenous injection of 10 mg/kg to pregnant women is about 30 mg/L, as high as in the maternal blood.

There were 13 clinical studies that described fetal and/or neonatal functional issues such as low Apgar score, neonatal sepsis, cephalohematoma and 9 clinical studies that discussed alterations to growth including low birth weight and preterm birth at 22–36 weeks of gestation in fetuses and infants exposed to tranexamic acid in-utero. Animal Data In embryo-fetal development studies, tranexamic acid was administered to pregnant mice from Gestation day (GD) 6 through GD 12 and rats from GD 9 through GD 14 at daily doses of 0.3 or 1.5 g/kg.

There was no evidence of adverse developmental outcomes in mice and rats at multiple of 3 and 6 times the maximum recommended human dose based on body surface area in the mouse and rat, respectively. In rabbits, tranexamic acid was administered intravenously at doses of 50, 100, or 200 mg/kg/day or orally at doses of 100, 200, or 400 mg/kg/day from GD 6 through GD 18. There was no evidence of adverse developmental outcomes at dose multiples of 2 or 3 times, respectively, the maximum recommended human dose based on body surface area.

Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits.

Tranexamic Acid

Indications

Contraindications

Warnings and precautions

5.1Thromboembolic Risk

Two medicines in one question?

Tranexamic Acid

Indications

Contraindications

Warnings and precautions

5.1Thromboembolic Risk

Two medicines in one question?

5.2Risk of Medication Errors Due to Incorrect Route of Administration

5.3Seizures

5.4Hypersensitivity Reactions Cases

5.5Visual Disturbances Although

5.6Dizziness

Interactions

7.1Prothrombotic Medical Products

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance