Tranexamic Acid

TRANEXAMIC ACID- tranexamic acid injection, solution
XGen Pharmaceuticals DJB, Inc.

BOXED WARNING

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of Tranexamic Acid Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 1 mL/minute to avoid hypotension [see Warnings and Precautions (5.1)]. Following tooth extraction, Tranexamic Acid Injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight 3 to 4 times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For intravenous infusion, Tranexamic Acid Injection may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and Dextran solutions. Heparin may be added to Tranexamic Acid Injection. Tranexamic Acid Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.

Discard any unused portion.

The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.

2.2 Recommended Dosage for Patients with Varying Degrees of Renal Impairment*

For patients with moderate to severe impaired renal function, the following dosages are recommended:

Table 1. Recommended Dosage in Patients with Varying Degrees of Renal Impairment

Serum Creatinine (mg/dL)

Tranexamic Acid Intravenous Dosage

1.36 to 2.83 (120 to 250 micromol/L)

10 mg/kg twice daily

2.83 to 5.66 (250 to 500 micromol/L)

10 mg/kg daily

>5.66 (>500 micromol/L)

10 mg/kg every 48 hours

or 5 mg/kg every 24 hours

*Dose reduction is recommended for all doses, both before and after tooth extraction.

3 DOSAGE FORMS AND STRENGTHS

Injection: 1000 mg tranexamic acid (100 mg/mL) clear and colorless solution in 10 mL single-dose vials

4 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 (5.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic 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 prothrombotic, as the risk of thrombosis may be increased. These medications include but are not limited to, Factor IX Complex concentrates, Anti-inhibitor Coagulant concentrates, and hormonal contraceptives [see Drug Interactions (7.1), Use in Specific Populations (8.3)].

5.2 Risk of Medication Errors Due to Incorrect Route of Administration

Tranexamic Acid Injection is for intravenous use only. Serious adverse reactions including seizures and cardiac arrhythmias have occurred when Tranexamic Acid Injection was inadvertently administered intrathecally instead of intravenously.

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. Syringes containing Tranexamic Acid Injection should be clearly labeled with the intravenous route of administration.

5.3 Seizures

Tranexamic Acid Injection may cause seizures, including focal and generalized seizures. The most common setting for tranexamic acid-induced seizures has been during cardiovascular surgery (a setting in which Tranexamic Acid Injection is not FDA-approved and which uses doses of up to 10-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system). Tranexamic Acid Injection is not approved and not recommended for neuraxial administration. Consider dose reduction during surgery and dose adjustments for patients with clinical conditions such as renal dysfunction. Closely monitor the patient during surgery. Consider electroencephalogram (EEG) monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue Tranexamic Acid Injection if seizures occur.

5.4 Hypersensitivity Reactions

Cases of hypersensitivity reactions, including anaphylactic reactions, have occurred with use of intravenous tranexamic acid. Discontinue treatment with Tranexamic Acid Injection if serious reaction occurs, provide appropriate medical management, and do not restart treatment. Tranexamic Acid Injection is contraindicated in patients with a history of hypersensitivity to tranexamic acid.

5.5 Visual Disturbances

Although not seen in humans, focal areas of retinal degeneration have been observed in cats and dogs following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (1.6 to 22 times the recommended usual human dose based on body surface area) from 6 days to 1 year. No retinal changes have been observed in eye examinations of patients treated with tranexamic acid for up to 8 years. Patients expected to be treated for greater than 3 months may consider ophthalmic monitoring including visual acuity and optical coherence tomography at regular intervals.

Discontinue Tranexamic Acid Injection if changes in ophthalmological examination occurs.

5.6 Dizziness

Tranexamic Acid Injection may cause dizziness. Concomitant use of other drugs that may also cause dizziness may women this effect. Advise patients to avoid driving or using machines until they know how Tranexamic Acid Injection affects them.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Thromboembolic Risk [see Warnings and Precautions (5.1)]

• Seizures [see Warnings and Precautions (5.3)]

• Hypersensitivity Reactions [see Warnings and Precautions (5.4)]

• Visual Disturbances [see Warnings and Precautions (5.5)]

• Dizziness [ see Warnings and Precautions (5.6)]

Page 1 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.