TRANEXAMIC ACID

TRANEXAMIC ACID- tranexamic acid injection, solution
HF Acquisition Co LLC, DBA HealthFirst

HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use TRANEXAMIC ACID INJECTION safely and effectively. See full prescribing information for TRANEXAMIC ACID INJECTION.
TRANEXAMIC ACID injection, for intravenous use
Initial U.S. Approval: 1986

RECENT MAJOR CHANGES

Warnings and Precautions, Risk of Medication Errors Due to Incorrect Route of Administration. ( 5.2) 12/2020

INDICATIONS AND USAGE

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 )

DOSAGE AND ADMINISTRATION

Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy. ( 2.1)
After Extraction: Administer 10 mg/kg actual body weight 3 to 4 times daily for 2 to 8 days. Infuse no more than 1 mL/minute to avoid hypotension. ( 2.1).
Reduce the dosage for patients with renal impairment. ( 2.2, 8.6)

DOSAGE FORMS AND STRENGTHS

Injection: 1,000 mg tranexamic acid (100 mg/mL) in 10 mL single-dose vials ( 3)

CONTRAINDICATIONS

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)

ADVERSE REACTIONS

Most common adverse reactions are nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact AuroMedics Pharma LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Prothrombotic Medical Products: Avoid concomitant use, can further increase the risk of thromboembolic adverse reactions associated with tranexamic acid. ( 5.1, 7.1, 8.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2021

TABLE OF CONTENTS

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Recommended Dosage for Patients With Varying Degrees of Renal Impairment*
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Risk
5.2 Risk of Medication Errors Due to Incorrect Route of Administration
5.3 Seizures
5.4 Hypersensitivity Reactions
5.5 Visual Disturbances
5.6 Dizziness
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Prothrombotic Medical Products
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & 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 & 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:

DOSAGE
(click image for full-size original)

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

3 DOSAGE FORMS & STRENGTHS

Injection: 1,000 mg tranexamic acid, USP (100 mg/mL) clear and colorless solution in 10 mL single-dose vials

4 CONTRAINDICATIONS

Tranexamic acid 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 hypersensitivity to tranexamic acid or any of the ingredients [see WARNINGS AND PRECAUTIONS (5.4)].

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