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Drug overview for TRANEXAMIC ACID (tranexamic acid):
Generic name: TRANEXAMIC ACID
Drug class: Antifibrinolytics
Therapeutic class: Hematological Agents
Tranexamic acid, a synthetic derivative of lysine, is an antifibrinolytic agent.
No enhanced Uses information available for this drug.
Generic name: TRANEXAMIC ACID
Drug class: Antifibrinolytics
Therapeutic class: Hematological Agents
Tranexamic acid, a synthetic derivative of lysine, is an antifibrinolytic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
TRANEXAMIC ACID 1,000 MG/10 ML
The following indications for TRANEXAMIC ACID (tranexamic acid) have been approved by the FDA:
Indications:
Bleeding prevention in hemophilia
Hemorrhaging in hemophilia
Professional Synonyms:
Bleeding prophylaxis in hemophilia
Hemorrhage prophylaxis in hemophilia
Indications:
Bleeding prevention in hemophilia
Hemorrhaging in hemophilia
Professional Synonyms:
Bleeding prophylaxis in hemophilia
Hemorrhage prophylaxis in hemophilia
The following dosing information is available for TRANEXAMIC ACID (tranexamic acid):
No enhanced Dosing information available for this drug.
Tranexamic acid is administered orally or by slow IV injection or IV infusion. The drug also has been administered topically+ (as a solution via irrigation, mouthwash, or gauze pad) for local application such as during dental procedures.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TRANEXAMIC ACID 1,000 MG/10 ML | Maintenance | Adults infuse 10 mg/kg by intravenous route every 6 hours |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TRANEXAMIC ACID 1,000 MG/10 ML | Maintenance | Adults infuse 10 mg/kg by intravenous route every 6 hours |
The following drug interaction information is available for TRANEXAMIC ACID (tranexamic acid):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Antifibrinolytics/Factor IX; Anti-Inhibitor Coagulant Conc SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Concurrent use may result in additive or synergistic effects on the coagulation pathways.(1-3) CLINICAL EFFECTS: Concurrent use may result in thrombosis.(1-3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of aminocaproic acid states that aminocaproic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(1) The manufacturer of tranexamic acid states that tranexamic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(2,3) Concurrent use may be warranted in select patients with hemophilia A or hemophilia B. Monitor patients closely for signs of thrombosis, disseminated intravascular coagulation, and hypercoagulability if concurrent use is deemed necessary.(4-6) DISCUSSION: Because of the increased risk of thrombosis, the manufacturer of aminocaproic acid states that aminocaproic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(1) Because of the increased risk of thrombosis, the manufacturer of tranexamic acid states that tranexamic acid should not be administered concomitantly with Factor IX Complex concentrates or with Anti-inhibitor Coagulant concentrates.(2,3) In a study, eight hemophilia B patients undergoing dental extraction procedures received combination therapy with aminocaproic acid or tranexamic acid and monoclonal antibody purified factor IX for bleeding prophylaxis. All patients achieved hemostasis without clinical evidence of thrombosis as well as no changes were seen in hemoglobin, hematocrit, or in markers of hemostatic system activation.(4) In a study, seven hemophilia A patients with inhibitors and one with acquired hemophilia patient received activated prothrombin complex concentrate (APCC) and tranexamic acid for management of bleeding episodes and prevention of hemorrhage during surgery. Hemostatic outcomes were rated excellent or good in 10 out of 11 (91%) treatment episodes. No episodes of thrombosis or disseminated intravascular coagulation occurred during treatment.(5) A study in six hemophilia A patients and five healthy volunteers evaluated the use of tranexamic acid as an adjunct to APCC to control bleeding. Patients who received tranexamic acid had a significant increase in maximum clot firmness compared to healthy controls. No clinical or laboratory signs of thromboembolic events, disseminated intravascular coagulation, or hypercoagulability were observed.(6) |
ALPHANINE SD, ALPROLIX, BENEFIX, FEIBA, IDELVION, IXINITY, KCENTRA, PROFILNINE, REBINYN, RIXUBIS |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Tranexamic Acid; Aminocaproic Acid; Aprotinin/Tretinoin, Oral SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tranexamic acid, aminocaproic acid, or aprotinin may increase the procoagulant effect of all-trans retinoic acid (tretinoin).(1) CLINICAL EFFECTS: Concurrent use of tranexamic acid, aminocaproic acid, or aprotinin in patients taking tretinoin may increase the risk of embolisms.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Tranexamic acid, aminocaproic acid, and aprotinin should be used with caution in patients taking oral tretinoin for acute promyelocytic leukemia.(1) DISCUSSION: In a small study of 28 patients with acute promyelocytic leukemia, patients were administered oral tretinoin with intravenous tranexamic acid, oral tretinoin with chemotherapy, or oral tretinoin with intravenous tranexamic acid and chemotherapy. All four patients who received oral tretinoin with tranexamic acid died. Three of these deaths involved thrombotic complications.(1) There is a case report of fatal thromboembolism in a patient with acute promyelocytic leukemia who was administered oral tretinoin and tranexamic acid concurrently.(2) There are two case reports of thrombosis in patients with acute promyelocytic leukemia who were administered oral tretinoin and aprotinin concurrently.(2-4) Ones of the cases resulted in fatal thromboembolism.(4) |
RETINOIC ACID, TRETINOIN, TRETINOIN ACID |
| Tranexamic Acid (Injectable)/Estrogenic Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tranexamic acid is an antifibrinolytic and estrogen-containing hormonal contraceptives are known to increase the risk of venous thromboembolism and arterial thromboses, including stroke and myocardial infarction. Concurrent use may increase the risk of these events.(1,2) CLINICAL EFFECTS: Concurrent use of tranexamic acid in patients taking estrogen-containing agents or hormonal contraceptives may increase the risk of embolisms.(1,2) PREDISPOSING FACTORS: The risk of thrombosis may be even greater in women who are obese or smoke, especially smokers over age 35.(1) PATIENT MANAGEMENT: The concurrent use of injectable tranexamic and and estrogen-containing hormonal contraception or estrogen replacement therapy should be approached with caution.(1) DISCUSSION: There are no clinical trial data on the risk of concurrent therapy with tranexamic acid and hormonal contraceptives. There have been postmarketing reports of venous and arterial thrombotic events in women receiving combination therapy with oral tranexamic acid.(2) Women taking hormonal contraception were excluded from safety and efficacy trials of oral tranexamic acid.(2) |
2-METHOXYESTRADIOL, ACTIVELLA, AFIRMELLE, ALTAVERA, ALYACEN, AMETHIA, AMETHYST, ANGELIQ, ANNOVERA, APRI, ARANELLE, ASHLYNA, AUBRA, AUBRA EQ, AUROVELA, AUROVELA 24 FE, AUROVELA FE, AVIANE, AYUNA, AZURETTE, BALCOLTRA, BALZIVA, BEYAZ, BIJUVA, BLISOVI 24 FE, BLISOVI FE, BRIELLYN, CAMRESE, CAMRESE LO, CAZIANT, CHARLOTTE 24 FE, CHATEAL EQ, CLIMARA, CLIMARA PRO, COMBIPATCH, CRYSELLE, CYRED, CYRED EQ, DASETTA, DAYSEE, DELESTROGEN, DEPO-ESTRADIOL, DESOGESTR-ETH ESTRAD ETH ESTRA, DIETHYLSTILBESTROL, DIVIGEL, DOLISHALE, DOTTI, DROSPIRENONE-ETH ESTRA-LEVOMEF, DROSPIRENONE-ETHINYL ESTRADIOL, DUAVEE, ELESTRIN, ELINEST, ELURYNG, ENILLORING, ENPRESSE, ENSKYCE, ESTARYLLA, ESTRACE, ESTRADIOL, ESTRADIOL (ONCE WEEKLY), ESTRADIOL (TWICE WEEKLY), ESTRADIOL BENZOATE, ESTRADIOL CYPIONATE, ESTRADIOL HEMIHYDRATE, ESTRADIOL HEMIHYDRATE MICRO, ESTRADIOL MICRONIZED, ESTRADIOL VALERATE, ESTRADIOL-NORETHINDRONE ACETAT, ESTRIOL, ESTRIOL MICRONIZED, ESTROGEL, ESTRONE, ETHINYL ESTRADIOL, ETHYNODIOL-ETHINYL ESTRADIOL, ETONOGESTREL-ETHINYL ESTRADIOL, EVAMIST, FALMINA, FEIRZA, FEMLYV, FINZALA, FYAVOLV, GEMMILY, HAILEY, HAILEY 24 FE, HAILEY FE, HALOETTE, ICLEVIA, ISIBLOOM, JAIMIESS, JASMIEL, JINTELI, JOLESSA, JOYEAUX, JULEBER, JUNEL, JUNEL FE, JUNEL FE 24, KAITLIB FE, KALLIGA, KARIVA, KELNOR 1-35, KELNOR 1-50, KURVELO, LARIN, LARIN 24 FE, LARIN FE, LAYOLIS FE, LEENA, LESSINA, LEVONEST, LEVONORG-ETH ESTRAD ETH ESTRAD, LEVONORG-ETH ESTRAD-FE BISGLYC, LEVONORGESTREL-ETH ESTRADIOL, LEVORA-28, LO LOESTRIN FE, LO-ZUMANDIMINE, LOESTRIN, LOESTRIN FE, LOJAIMIESS, LORYNA, LOW-OGESTREL, LUTERA, LYLLANA, MARLISSA, MENOSTAR, MERZEE, MIBELAS 24 FE, MICROGESTIN, MICROGESTIN FE, MILI, MIMVEY, MINIVELLE, MINZOYA, MONO-LINYAH, MYFEMBREE, NATAZIA, NECON, NIKKI, NORELGESTROMIN-ETH ESTRADIOL, NORETHIN-ETH ESTRA-FERROUS FUM, NORETHINDRON-ETHINYL ESTRADIOL, NORETHINDRONE-E.ESTRADIOL-IRON, NORGESTIMATE-ETHINYL ESTRADIOL, NORTREL, NUVARING, NYLIA, OCELLA, ORIAHNN, ORTHO TRI-CYCLEN, ORTHO-NOVUM, PHILITH, PIMTREA, PORTIA, PREMARIN, PREMPHASE, PREMPRO, RECLIPSEN, RIVELSA, SAFYRAL, SETLAKIN, SIMLIYA, SIMPESSE, SPRINTEC, SRONYX, SYEDA, TARINA 24 FE, TARINA FE, TARINA FE 1-20 EQ, TAYTULLA, TILIA FE, TRI-ESTARYLLA, TRI-LEGEST FE, TRI-LINYAH, TRI-LO-ESTARYLLA, TRI-LO-MARZIA, TRI-LO-MILI, TRI-LO-SPRINTEC, TRI-MILI, TRI-SPRINTEC, TRI-VYLIBRA, TRI-VYLIBRA LO, TRIVORA-28, TURQOZ, TWIRLA, TYBLUME, VALTYA, VELIVET, VESTURA, VIENVA, VIORELE, VIVELLE-DOT, VOLNEA, VYFEMLA, VYLIBRA, WERA, WYMZYA FE, XARAH FE, XELRIA FE, XULANE, YASMIN 28, YAZ, ZAFEMY, ZARAH, ZOVIA 1-35, ZUMANDIMINE |
There are 0 moderate interactions.
The following contraindication information is available for TRANEXAMIC ACID (tranexamic acid):
Drug contraindication overview.
*Patients with acquired defective color vision. (See Ocular Toxicity under Cautions.) *Patients with subarachnoid hemorrhage; cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. *Patients with active thromboembolic disease (e.g., deep-vein thrombosis, pulmonary embolism, cerebral thrombosis, active intravascular clotting) or a history or risk of thromboembolism (including retinal vein or artery occlusion).
*Concomitant use with combination hormonal contraceptives. *Hypersensitivity reactions to tranexamic acid or any other ingredients in the preparation.
*Patients with acquired defective color vision. (See Ocular Toxicity under Cautions.) *Patients with subarachnoid hemorrhage; cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients. *Patients with active thromboembolic disease (e.g., deep-vein thrombosis, pulmonary embolism, cerebral thrombosis, active intravascular clotting) or a history or risk of thromboembolism (including retinal vein or artery occlusion).
*Concomitant use with combination hormonal contraceptives. *Hypersensitivity reactions to tranexamic acid or any other ingredients in the preparation.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Subarachnoid intracranial hemorrhage |
There are 14 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
| Acute pulmonary thromboembolism |
| Cerebral thrombosis |
| Cerebrovascular accident |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Deep venous thrombosis |
| Retinal thrombosis |
| Thromboembolic disorder |
| Thrombophilia |
| Thrombotic disorder |
| Valvular heart disease |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Ligneous conjunctivitis |
The following adverse reaction information is available for TRANEXAMIC ACID (tranexamic acid):
Adverse reaction overview.
The manufacturer states that the most common adverse effects of IV tranexamic acid include nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. The manufacturer states that the most common adverse effects of oral tranexamic acid include headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia, and fatigue.
The manufacturer states that the most common adverse effects of IV tranexamic acid include nausea, vomiting, diarrhea, allergic dermatitis, giddiness, hypotension, and thromboembolic events. The manufacturer states that the most common adverse effects of oral tranexamic acid include headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, joint pain, muscle cramps, migraine, anemia, and fatigue.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypotension Thromboembolic disorder |
None. |
| Rare/Very Rare |
|---|
|
Anaphylaxis Hypersensitivity drug reaction Renal infarction Retinal vascular occlusion Seizure disorder Thrombotic disorder Visual changes |
There are 6 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Dizziness Nausea Vomiting |
Allergic dermatitis |
| Rare/Very Rare |
|---|
|
Acquired chromatopsia |
The following precautions are available for TRANEXAMIC ACID (tranexamic acid):
There are limited data on the use of tranexamic acid in pediatric patients with hemophilia undergoing tooth extraction. The manufacturer of tranexamic acid tablets states that the drug is indicated for use in women of reproductive age and is not intended for premenarchal girls. Tranexamic acid also has been used for other indications in pediatric patients (e.g., cardiac surgery+, spinal surgery+, trauma+), although evidence for these uses in children is more limited compared with the adult population.
The available information suggests that there are no significant pharmacokinetic differences between adults and pediatric patients. Adverse effects of tranexamic acid in children are rare, but can include GI effects, hypotension following rapid IV administration, muscle pain, and seizures in patients receiving high doses during cardiac surgery.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The available information suggests that there are no significant pharmacokinetic differences between adults and pediatric patients. Adverse effects of tranexamic acid in children are rare, but can include GI effects, hypotension following rapid IV administration, muscle pain, and seizures in patients receiving high doses during cardiac surgery.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
It is not known whether tranexamic acid is associated with a risk of adverse maternal or fetal outcomes; however, the drug is known to cross the placenta and appears in cord blood in concentrations similar to maternal concentrations. The potential risks to the fetus should be considered along with potential benefits of the drug and the mother's clinical need for tranexamic acid. There are no adequate and well-controlled studies of tranexamic acid in pregnant women.
Fatal structural abnormalities have been reported in 2 cases when tranexamic acid was used during conception or the first trimester of pregnancy; however, it is not clear whether these effects were related to the drug or other factors. Animal reproduction studies have not revealed any evidence of adverse fetal or developmental effects from in utero exposure to tranexamic acid.
Fatal structural abnormalities have been reported in 2 cases when tranexamic acid was used during conception or the first trimester of pregnancy; however, it is not clear whether these effects were related to the drug or other factors. Animal reproduction studies have not revealed any evidence of adverse fetal or developmental effects from in utero exposure to tranexamic acid.
Tranexamic acid is distributed into human milk. It is not known whether the drug has any effects on the breastfed infant or on milk production. One manufacturer states that tranexamic acid should be used during lactation only when clearly needed. The known benefits of breast-feeding should be considered along with the mother's clinical need for tranexamic acid and the potential adverse effects on the infant from the drug or underlying maternal condition.
Clinical studies of tranexamic acid injection did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between geriatric and younger patients. Tranexamic acid is substantially excreted by the kidneys; because geriatric patients are more likely to have decreased renal function, dosage should be selected carefully and renal function monitoring should be considered in such patients.
The following prioritized warning is available for TRANEXAMIC ACID (tranexamic acid):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for TRANEXAMIC ACID (tranexamic acid)'s list of indications:
| Bleeding prevention in hemophilia | |
| D66 | Hereditary factor VIII deficiency |
| D67 | Hereditary factor IX deficiency |
| D68.311 | Acquired hemophilia |
| Z14.02 | Symptomatic hemophilia A carrier |
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