TRANEXAMIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1)

Available from:

Athenex Pharmaceutical Division, LLC.

INN (International Name):

tranexamic acid

Composition:

tranexamic acid 100 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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)] . 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 to 4% and 15 to 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 during pregnancy, the potential risk of tranexamic acid administration on the fetus should always be considered along with the mother's clinical need for tranexamic acid; 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 to 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. Risk Summary Published literature reports the presence of tranexamic acid in human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tranexamic acid and any potential adverse effects on the breastfed child from tranexamic acid or from the underlying maternal condition. Contraception Concomitant use of tranexamic acid, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions. Advise patients to use an effective alternative (nonhormonal) contraceptive method [see Warnings and Precautions ( 5.1), Drug Interactions ( 7.1)] . There are limited data concerning the use of tranexamic acid in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients. Clinical studies of tranexamic acid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration ( 2.2), Clinical Pharmacology ( 12.3)] . Reduce the dosage of tranexamic acid in patients with renal impairment, based on the patient's serum creatinine [see Dosage and Administration ( 2.2), Clinical Pharmacology ( 12.3)] .

Product summary:

Tranexamic Acid Injection, USP is a clear, colorless solution supplied as follows: Storage Conditions Store at 20º to 25°C (68º to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRANEXAMIC ACID- TRANEXAMIC ACID INJECTION, SOLUTION
ATHENEX PHARMACEUTICAL DIVISION, LLC.
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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 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 per 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 o