Data from FDA - Curated by EPG Health - Last updated 23 March 2017

Indication(s)

INDICATIONS & USAGE Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.

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Advisory information

contraindications
CONTRAINDICATIONS Tranexamic Acid Injection is contraindicated: 1. In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity (see WARNINGS). 2. In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by Tranexamic Acid Injection in such patients. 3. In patients with active intravascular clotting. 4. In patients with hypersensitivity to tranexamic acid or any of the ingredients.
Special warnings and precautions
PRECAUTIONS GENERAL PRECAUTIONS The dose of Tranexamic Acid Injection should be reduced in patients with renal insufficiency because of the risk of accumulation. (See DOSAGE AND ADMINISTRATION.) Ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported in patients treated with Tranexamic Acid Injection. Venous and arterial thrombosis or thromboembolism has been reported in patients treated with Tranexamic Acid Injection. In addition, cases of central retinal artery and central retinal vein obstruction have been reported. Patients with a previous history of thromboembolic disease may be at increased risk for venous or arterial thrombosis. Tranexamic Acid Injection should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased. Patients with disseminated intravascular coagulation (DIC), who require treatment with Tranexamic Acid Injection, must be under strict supervision of a physician experienced in treating this disorder. Tranexamic acid may cause dizziness and therefore may influence the ability to drive or use machines. DRUG INTERACTIONS No studies of interactions between Tranexamic Acid Injection and other drugs have been conducted. CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY An increased incidence of leukemia in male mice receiving tranexamic acid in food at a concentration of 4.8% (equivalent to doses as high as 5 g/kg/day) may have been related to treatment. Female mice were not included in this experiment. Hyperplasia of the biliary tract and cholangioma and adenocarcinoma of the intrahepatic biliary system have been reported in one strain of rats after dietary administration of doses exceeding the maximum tolerated dose for 22 months. Hyperplastic, but not neoplastic, lesions were reported at lower doses. Subsequent long-term dietary administration studies in a different strain of rat, each with an exposure level equal to the maximum level employed in the earlier experiment, have failed to show such hyperplastic / neoplastic changes in the liver. No mutagenic activity has been demonstrated in several in vitro and in vivo test systems. There are no clinical data to assess the effects of tranexamic acid on fertility. PREGNANCY (Category B) Reproduction studies performed in mice, rats, and rabbits have not revealed any evidence of impaired fertility or adverse effects on the fetus due to tranexamic acid. There are no adequate and well-controlled studies in pregnant women. However, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. LABOR & DELIVERY See above under Pregnancy. NURSING MOTHERS Tranexamic acid is present in the mother’s milk at a concentration of about a hundredth of the corresponding serum levels. Caution should be exercised when Tranexamic Acid Injection is administered to a nursing woman. PEDIATRIC USE The drug has had limited use in pediatric patients, principally in connection with tooth extraction. The limited data suggest that dosing instructions for adults can be used for pediatric patients needing Tranexamic Acid Injection therapy. GERIATRIC USE Clinical studies of Tranexamic Acid Injection 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. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 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 CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Adverse reactions
ADVERSE REACTIONS Gastrointestinal disturbances (nausea, vomiting, diarrhea) may occur but disappear when the dosage is reduced. Allergic dermatitis, giddiness, and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. To avoid this response, the solution should not be injected more rapidly than 1 mL per minute. Worldwide Postmarketing Reports: Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. Convulsion, chromatopsia, and visual impairment have also been reported. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined.

Usage information

Dosing and administration
DOSAGE & ADMINISTRATION Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexamic Acid Injection intravenously together with replacement therapy (see PRECAUTIONS). Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days. Note: For patients with moderate to severe impaired renal function, the following dosages are recommended: Serum Creatinine (µmol/L) Tranexamic Acid Intravenous Dosage 120 to 250 (1.36 to 2.83 mg/dL) 10 mg/kg twice daily 250 to 500 (2.83 to 5.66 mg/dL) 10 mg/kg daily 10 mg/kg every 48 hours >500 (>5.66 mg/dL) or 5 mg/kg every 24 hours 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 Tranexamic Acid Injection vial and any remaining portion in the vial after single use. The diluted mixture may be stored for up to 4 hours at room temperature prior to patient administration.
Pregnancy and lactation
NURSING MOTHERS Tranexamic acid is present in the mother’s milk at a concentration of about a hundredth of the corresponding serum levels. Caution should be exercised when Tranexamic Acid Injection is administered to a nursing woman.

Interactions

DRUG INTERACTIONS No studies of interactions between Tranexamic Acid Injection and other drugs have been conducted.

More information

Category Value
Authorisation number ANDA207239
Agency product number 6T84R30KC1
Orphan designation No
Product NDC 68083-160
Date Last Revised 21-02-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 238720
Marketing authorisation holder Gland Pharma Limited