TRANEXAMIC ACID IN SODIUM CHLORIDE

TRANEXAMIC ACID IN SODIUM CHLORIDE- tranexamic acid injection, solution
Exela Pharma Sciences, LLC

1 INDICATIONS AND USAGE

Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dose of Tranexamic Acid in Sodium Chloride Injection is 10 mg/kg actual body weight intravenously administered as a single dose, immediately before tooth extractions. Infuse no more than 10 mL/minute to avoid hypotension. Following tooth extraction, Tranexamic Acid in Sodium Chloride Injection may be administered for 2 to 8 days at a dose of 10 mg/kg actual body weight three to four times daily, intravenously.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use Tranexamic Acid in Sodium Chloride Injection if particulate matter or coloration is seen.

Tranexamic Acid in Sodium Chloride Injection should NOT be mixed with blood. The drug is a synthetic amino acid and should NOT be mixed with solutions containing penicillin.

The premix flexible plastic container bag contains no preservative; discard any unused portion.

2.2 Recommended Dosage for Patients with Varying Degrees of Renal Impairment

The recommended dosage of Tranexamic Acid in Sodium Chloride Injection in patients with varying degrees of renal impairment is described in Table 1 [see Use in Specific Populations (8.6)].

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

Serum Creatinine (mg/dL)

Tranexamic Acid in Sodium Chloride Injection 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: 1,000 mg of tranexamic acid in 100 mL (10 mg/mL), colorless solution in a single-dose bag for intravenous use

4 CONTRAINDICATIONS

Tranexamic Acid in Sodium Chloride Injection is contraindicated:

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 (5.1)].
In patients with history of 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 in Sodium Chloride 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. Avoid concomitant use of Tranexamic Acid in Sodium Chloride Injection and medical products that are pro-thrombotic, 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) and Use in Specific Populations (8.3)].

5.2 Seizures

Tranexamic acid 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 in Sodium Chloride Injection is not FDA approved and which uses doses of up to ten-fold higher than the recommended human dose and in patients inadvertently given tranexamic acid into the neuraxial system). Tranexamic Acid in Sodium Chloride 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 EEG monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or show evidence of focal seizures. Discontinue Tranexamic Acid in Sodium Chloride Injection if seizures occur.

5.3 Hypersensitivity Reactions

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

5.4 Visual Disturbances

Although not seen in humans, focal areas of retinal degeneration have been observed in cats, dogs and rats following oral or intravenous tranexamic acid at doses between 250 to 1600 mg/kg/day (6 to 40 times the recommended usual human dose) 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 in Sodium Chloride Injection if changes in ophthalmological examination occurs.

5.5 Dizziness

Tranexamic acid may cause dizziness. Concomitant use of other drugs that may also cause dizziness may worsen this effect. Advise patients to avoid driving or using machines until they know how Tranexamic Acid in Sodium Chloride 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 (5.2)]
Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
Visual Disturbances [see Warnings and Precautions (5.4)]
Dizziness [see Warnings and Precautions (5.5)]

6.1 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of tranexamic acid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur and may resolve with dose-reduction. Allergic dermatitis and giddiness have been reported. Hypotension has been reported when intravenous injection is too rapid.

Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery, vein obstruction and cases associated with concomitant use of combination hormonal contraceptives) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, cromatopsia, and visual impairment have also been reported.

Anaphylaxis or anaphylactoid reactions have been reported that are suggestive of a causal relationship.

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