Embedded Files
Pharmacologic Category
Antifibrinolytic Agent; Antihemophilic Agent; Hemostatic Agent; Lysine Analog
Dosing: Adult
Note: Safety: Higher total IV doses (eg, ≥50 mg/kg), such as those given perioperatively, may be associated with an increased risk of seizures; lower doses (eg, 1 or 2 g given in the first 8 hours of trauma) do not appear to increase the risk of seizure or venous thromboembolism (CRASH-3 Trial Collaborators 2019; Fillingham 2018a; Lecker 2016; Myles 2017; Sigaut 2014).
Dental procedures in patients on oral anticoagulant therapy (off-label use):
Oral rinse: 5% solution (extemporaneously prepared): Administer 5 to 10 minutes prior to the procedure; hold 5 to 10 mL in mouth and rinse for 2 minutes; drain gently, being careful not to forcibly spit and dislodge clots; do not eat or drink for 1 hour after using oral rinse. Repeat 3 to 4 times daily for 1 to 2 days after the procedure (ACCP [Douketis 2012]; Borea 1993; Gaspar 1997; Lam 2011; Patatanian 2006).
Hemoptysis (nonmassive), treatment (off-label use):
Inhalation for nebulization: 500 mg (using injectable solution) 3 times daily for up to 5 days (Segrelles 2016; Wand 2018).
Hereditary angioedema, long-term prophylaxis (alternative agent) (off-label use):
Note: May be used when other agents (eg, C1-inhibitor, androgens) are not available or contraindicated (WAO/EEACI [Maurer 2018]). The recommended dosage range is based on use of 500 mg tablets available internationally, but not in the United States.
Oral: Initial: 1 to 1.5 g two to three times daily; reduce to 500 mg once or twice daily when frequency of attacks decreases (Gompels 2005; Levy 2010); maximum total daily dose: 4 to 6 g/day (Bowen 2010; WAO/EEACI [Maurer 2018]).
Hereditary hemorrhagic telangiectasia, epistaxis or other bleeding sites (alternative agent) (off-label use):
Note: May be used in carefully selected patients in whom local therapy and other management options are insufficient. The recommended dosage range is based on use of 500 mg tablets available internationally, but not in the United States.
Oral: Initial: 1.5 g twice daily or 1 g three times daily for 4 to 10 days; adjust dose as needed based on response and tolerability to a usual daily dose of 2 to 4.5 g in 2 or 3 divided doses (Gaillard 2014; Geisthoff 2014; Pabinger 2017).
Intracranial hemorrhage associated with thrombolytic treatment (alternative therapy) (off-label use):
Note: Consider for use in addition to cryoprecipitate or when cryoprecipitate is contraindicated in patients who have a symptomatic intracranial hemorrhage after receiving thrombolytic within the past 24 hours (NCS/SCCM [Frontera 2016]).
IV: 1 g (or 10 to 15 mg/kg) once; administer at a rate not to exceed 100 mg/minute (generally over 10 to 20 minutes) (AHA/ASA [Powers 2018]; NCS/SCCM [Frontera 2016]).
Menstrual bleeding, heavy (alternative agent):
Note: Consider for use in women who decline or should not use hormonal therapy. Start once heavy menstrual bleeding has begun.
Oral:
Lysteda: 1.3 g three times daily for up to 5 days during monthly menstruation.
Cyklokapron [Canadian product]: 1 to 1.5 g three to four times daily for several days during menstruation.
Perioperative prevention of blood loss and transfusion (eg, cardiac surgery, other surgeries with significant blood loss):
Note: There is wide variety in doses and routes of administration (IV, oral, and/or topical). Dosing and timing of administration are procedure and institution specific. Recommendations provided below are examples of IV regimens for use in selected surgeries; refer to institutional protocols.
Usual dose and range: IV: 1 g (or 10 to 30 mg/kg) prior to procedure; administer at a rate not to exceed 100 mg/minute (generally over 10 to 30 minutes). Depending upon type of procedure, a continuous infusion may be given intraoperatively after the initial bolus dose, or the bolus dose may be repeated at the end of procedure and/or during the postoperative period.
Cardiac surgery (off-label use):
Note: Optimal regimen is uncertain; refer to institutional protocol.
IV: Loading dose: 10 to 30 mg/kg administered at a rate not to exceed 100 mg/minute (generally over 10 to 20 minutes), followed by 1 to 16 mg/kg/hour (Fergusson 2008; Nuttall 2008; Sigaut 2014). Alternatively, some centers administer a single loading dose of 50 mg/kg (Myles 2017).
Orthopedic surgery (hip or knee arthroplasty) (off-label use):
Note: Optimal regimen is uncertain; refer to institutional protocol. Use in patients without a baseline high risk of thromboembolism. For patients with risk factors for thromboembolism, consider risk of thromboembolism vs benefit of reduced blood loss (Amundson 2019).
IV: 1 g (or 10 to 15 mg/kg) administered before skin incision at a rate not to exceed 100 mg/minute (generally over 10 to 20 minutes); repeat dose at skin closure or up to 12 hours later; some experts recommend a third dose during the postoperative period if needed (AAHKS/ASRA/AAOS [Fillingham 2018b]; Erens 2019; Kim 2014; MacGillivray 2011; Maniar 2012; Martin 2019; Xiao 2019; Zufferey 2010). Note: Some experts use intra-articular tranexamic acid (ie, 1 g per 50 mL of NS applied topically into the wound at the end of the procedure) (AAHKS/ASRA/AAOS [Fillingham 2018b]; Alshryda 2013a; Alshryda 2013b).
Spinal surgery (eg, spinal fusion) (off-label use):
Note: Optimal regimen is uncertain; refer to institutional protocol.
IV: 10 to 15 mg/kg administered prior to incision at a rate not to exceed 100 mg/minute (generally over 10 to 20 minutes), followed by 1 to 2 mg/kg/hour as a continuous infusion for the remainder of the surgery; discontinue at the end of the procedure (Brown 2019; Lu 2018; Wong 2008).
Postpartum hemorrhage, prevention (adjunctive therapy) (off-label use):
Note: For use in women in high–bleeding risk situations in conjunction with standard prophylactic uterotonics (eg, oxytocin) (Berghella 2019; Muñoz 2019).
IV: 1 g over 10 to 20 minutes (Berghella 2019; Saccone 2019).
Postpartum hemorrhage, treatment (off-label use):
Note: For continued bleeding despite oxytocin; used in conjunction with other therapies/procedures.
IV: 1 g over 10 to 20 minutes given within 3 hours of vaginal birth or cesarean delivery. If bleeding continues after 30 minutes, may repeat the dose in conjunction with thorough re-evaluation for cause of continued or recurrent bleeding (WOMAN Trial Collaborators 2017).
Subarachnoid hemorrhage, prevention of early aneurysmal rebleeding (off-label use):
Note: Consider for use to prevent early rebleeding when surgical treatment (eg, surgical clipping, endovascular coiling) is delayed (AHA/ASA [Connolly 2012]; Singer 2019; Suarez 2015). Optimal regimen has not been established; refer to institutional protocol.
IV: 1 g over 10 minutes immediately after diagnosis, followed by 1 g every 6 hours for no more than 72 hours (Hillman 2002). Some experts recommend 1 g, followed by 1 g over 8 hours as a continuous infusion, for no more than 36 hours (Post 2019).
Tooth extraction in patients with hemostatic defects (eg, hemophilia, von Willebrand disease, other factor deficiencies associated with bleeding) (adjunctive therapy):
Note: Generally used in conjunction with (and not as a substitute for) replacement of the appropriate clotting factor, especially in individuals with hemophilia. Do not give simultaneously with an activated prothrombin complex concentrate, as this can increase the risk of thromboembolism; if used concurrently, they should be separated by ≥12 hours (WFH [Srivastava 2013]). Consultation with a hemophilia treatment center is advised.
IV: 10 mg/kg (usual dose range: 500 mg to 1 g) administered ~2 hours before procedure at a rate not to exceed 100 mg/minute (generally over 10 to 20 minutes), then 10 mg/kg 3 to 4 times daily for 2 to 8 days. Alternatively, 10 mg/kg as a single dose 2 hours prior to procedure; following procedure, transition to oral tranexamic acid depending on individual patient characteristics, type of procedure, other therapies, and degree of bleeding (Cyklokapron Canadian product monograph; van Galen 2019).
Oral: 25 mg/kg (usual dose range: 1 to 1.5 g) given 2 hours prior to procedure, then 25 mg/kg (usual dose range: 1 to 1.5 g) 3 to 4 times daily for up to 7 to 10 days (Cyklokapron Canadian product monograph; Hoots 2019; van Galen 2019). The recommended oral dosage range is based on use of 500 mg tablets available internationally, but not in the United States.
Trauma-associated hemorrhage or traumatic brain injury (off-label use):
Note: Consider for use in patients with significant hemorrhage, at risk of significant hemorrhage, or in moderate traumatic brain injury (TBI) (Glasgow Coma Scale [GCS] score >8 and <13); patients with severe TBI (GCS score 3 to 8) may not demonstrate benefit (CRASH-2 Trial Collaborators 2010; CRASH-3 Trial Collaborators 2019; Rajajee 2020).
IV: Loading dose: 1 g over 10 minutes started within 3 hours of injury, followed by 1 g over the next 8 hours as a continuous infusion. Note: Some experts suggest using thromboelastogram or rotational thromboelastometry to guide repeat dosing (Callum 2019; CRASH-2 Trial Collaborators 2010; CRASH-2 Trial Collaborators 2011; CRASH-3 Trial Collaborators 2019; Galvagno 2019).
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
IV formulation:
Tooth extraction in patients with hemophilia:
Serum creatinine 1.36 to 2.83 mg/dL: Maintenance dose of 10 mg/kg/dose twice daily
Serum creatinine 2.83 to 5.66 mg/dL: Maintenance dose of 10 mg/kg/dose once daily
Serum creatinine >5.66 mg/dL: Maintenance dose of 10 mg/kg/dose every 48 hours or 5 mg/kg/dose once daily
Cardiac surgery (the following dose adjustments have been recommended [Nuttall 2008]):
Serum creatinine 1.6 to 3.3 mg/dL: Reduce maintenance infusion to 1.5 mg/kg/hour (based on a 25% reduction from 2 mg/kg/hour)
Serum creatinine 3.3 to 6.6 mg/dL: Reduce maintenance infusion to 1 mg/kg/hour (based on a 50% reduction from 2 mg/kg/hour)
Serum creatinine >6.6 mg/dL: Reduce maintenance infusion to 0.5 mg/kg/hour (based on a 75% reduction from 2 mg/kg/hour)
Oral formulation:
Lysteda:
Serum creatinine >1.4 to 2.8 mg/dL: 1,300 mg twice daily (2,600 mg/day) for up to 5 days
Serum creatinine 2.9 to 5.7 mg/dL: 1,300 mg once daily for up to 5 days
Serum creatinine >5.7 mg/dL: 650 mg once daily for up to 5 days
Cyklokapron [Canadian product]:
Serum creatinine 1.4 to 2.8 mg/dL (120 to 250 micromol/L): 15 mg/kg twice daily
Serum creatinine 2.8 to 5.7 mg/dL (250 to 500 micromol/L): 15 mg/kg every 24 hours
Serum creatinine ≥5.7 mg/dL (≥500 micromol/L): 15 mg/kg every 48 hours
Dosing: Hepatic Impairment: Adult
No dosage adjustment is necessary.
Dosing: Pediatric
Menorrhagia: Female Children ≥12 years and Adolescents: Oral: Tablet: 1,300 mg 3 times daily; maximum daily dose: 3900 mg/day for up to 5 days during monthly menstruation
Prevention of bleeding associated with tooth extraction in hemophilic patients (in combination with replacement therapy): Infants, Children, and Adolescents: IV: 10 mg/kg immediately before surgery, then 10 mg/kg/dose 3 to 4 times daily; may be used for 2 to 8 days
Prevention of bleeding associated with cardiac surgery: Limited data available; reported regimens variable and ideal dose-response not established: Infants, Children, and Adolescents ≤15 years: IV: 10 mg/kg into the by-pass circuit after induction, during cardiopulmonary bypass, and after protamine reversal of heparin for a total of 3 doses; regimen used in two separate trials (n=80, age range: 2 months to 15 years) (Chauhan, 2004; Chauhan, 2004a). Also reported in the younger patients undergoing cardiac surgery (typically <2 years or 20 kg): Loading dose: 100 mg/kg, followed by 10 mg/kg/hour IV infusion (continued until ICU transport) and 100 mg/kg priming dose into the circuit when by-pass initiated (Reid, 1997; Schindler, 2011). In children 1 to 12 years and weighing 5 to 40 kg, a pharmacokinetic analysis proposed the following regimen to achieve a target serum concentration range of 20 to 30 mcg/mL: IV: Loading dose: 6.4 mg/kg over 5 minutes followed by a weight-adjusted continuous infusion in the range of 2 to 3.1 mg/kg/hour; the pharmacokinetic data showed that patients weighing less should receive an initial infusion rate at the higher end of the range (ie, if patient weight =5 kg then initial infusion rate: 3.1 mg/kg/hour; or if patient weight =40 kg then initial infusion rate: 2 mg/kg/hour) (Grassin-Deyle, 2013)
Prevention of perioperative bleeding associated with spinal surgery (eg, idiopathic scoliosis): Limited data available; reported dosing regimens variable; ideal dose response not established: Children ≥8 years and Adolescents: IV: Loading dose: 100 mg/kg, followed by infusion at 10 mg/kg/hour until skin closure (Sethna, 2005; Shapiro 2007). Other reported regimens with positive results: Loading dose: 20 mg/kg, followed by 10 mg/kg/hour infusion (Grant, 2009) or loading dose: 10 mg/kg and 1 mg/kg/hour infusion (Grant, 2009; Neilipovitz, 2001)
Prevention of perioperative bleeding associated with craniosyntosis surgery: Limited data available; reported dosing regimens variable; ideal dose-response not established: Infants ≥2 months and Children ≤6 years: IV: Loading dose of 50 mg/kg over 15 minutes prior to incision, followed by infusion at 5 mg/kg/hour until skin closure (Goobie, 2011) or 15 mg/kg over 15 minutes prior to incision, followed by infusion at 10 mg/kg/hour until skin closure (Dadure, 2011)
Hereditary angioedema (HAE), prophylaxis: Limited data available: Children and Adolescents:
Long-term prophylaxis: Oral: 20 to 75 mg/kg/day in 2 to 3 divided doses; maximum daily dose range: 3,000 to 6,000 mg/day (Bowen, 2010; Farkas, 2007; Gompels, 2005; Zuraw, 2013) or 1,000 to 2,000 mg daily (~50 mg/kg/day; depending on age and size of patient); may consider alternate-day regimen or twice-weekly regimen when frequency of attacks reduces; diarrhea may be a dose-limiting side effect (Gompels, 2005)
Short-term prophylaxis (eg, prior to surgical or diagnostic interventions in head/neck region): Oral:
Weight-directed: 20 to 40 mg/kg/day in 2 to 3 divided doses; maximum daily dose: 6,000 mg/day (Bowen, 2010; Farkas, 2007); other guidelines suggest 50 to 75 mg/kg/day in 2 to 3 divided doses (Craig [WAO], 2012)
Fixed dosing: Patients with an adequate weight (eg, ≥50 kg): 500 mg 4 times daily (Gompels, 2005); therapy usually initiated 2 to 5 days before dental work and continue for 2 days after the procedure (Bowen, 2004; Gompels, 2005)
Traumatic hyphema: Limited data available: Children and Adolescents: Oral: 25 mg/kg/dose every 8 hours for 5 to 7 days (Rahmani, 1999; Vangsted, 1983). Note: This same regimen may also be used for secondary hemorrhage after an initial traumatic hyphema event.
Dosing: Renal Impairment: Pediatric
Note: Recommendations are dependent on use and route.
Oral: Menorrhagia: Female Children ≥12 years and Adolescents:
Scr >1.4 to 2.8 mg/dL: 1,300 mg twice daily (2,600 mg/day) for up to 5 days
Scr 2.9 to 5.7 mg/dL: 1,300 mg once daily for up to 5 days
Scr >5.7 mg/dL: 650 mg once daily for up to 5 days
IV: Tooth extraction in patients with hemophilia: Infants, Children, and Adolescents:
Scr 1.36 to 2.83 mg/dL: Maintenance dose of 10 mg/kg/dose twice daily
Scr >2.83 to 5.66 mg/dL: Maintenance dose of 10 mg/kg/dose once daily
Scr >5.66 mg/dL: Maintenance dose of 10 mg/kg/dose every 48 hours or 5 mg/kg/dose once daily
Dosing: Hepatic Impairment: Pediatric
All patients: No adjustment is necessary.
Use: Labeled Indications
Menstrual bleeding, heavy (oral): Treatment of cyclic heavy menstrual bleeding.
Tooth extraction in patients with hemostatic defects (injection, oral [Cyklokapron; Canadian product]): Short-term use in hemophilia patients to reduce or prevent hemorrhage and reduce need for replacement therapy during and following tooth extraction.
Use: Off-Label: Adult
Dental procedures in patients on oral anticoagulant therapyLevel of Evidence [G]
Based on the American College of Chest Physicians guidelines for perioperative management of antithrombotic therapy, tranexamic acid is recommended to use, when needed, in combination with the continuation of oral anticoagulant therapy for the perioperative management of patients who require minor procedures.
Hemoptysis (nonmassive), treatmentLevel of Evidence [C]
Data from a small, single-center, prospective, randomized, double-blind, placebo-controlled trial suggest that nebulized tranexamic acid may be beneficial for the control of nonmassive hemoptysis by reducing the duration and volume of bleeding, with a low risk for side effects Ref. In addition, data from a small case series suggest that nebulized tranexamic acid may be beneficial for the control of moderate hemoptysis (without severe hypotension, tachycardia, or shock) Ref.
Hereditary angioedema, long-term prophylaxisLevel of Evidence [G]
Based on the International World Allergy Organization/European Academy of Allergy and Clinical Immunology guideline for the management of hereditary angioedema, tranexamic acid may be considered as a third-line agent for long-term prophylaxis of hereditary angioedema (HAE) when a C1-inhibitor (human or recombinant) is not available and androgens are contraindicated. Efficacy in suppressing attacks appears low but may benefit some patients. Tranexamic acid is not recommended for treatment of acute HAE attacks.
Hereditary hemorrhagic telangiectasia, epistaxis or other bleeding sitesLevel of Evidence [B]
Data from two randomized, double-blind, crossover trials suggest that oral tranexamic acid is beneficial to reduce epistaxis and duration of epistaxis in patients with hereditary hemorrhagic telangiectasia Ref.
Intracranial hemorrhage associated with thrombolytic treatmentLevel of Evidence [G]
Based on the Neurocritical Care Society and the Society of Critical Care Medicine guideline for reversal of antithrombotics in intracranial hemorrhage and the American Heart Association/American Stroke Association (AHA/ASA) guidelines for the early management of patients with acute ischemic stroke, tranexamic acid is suggested as a reversal agent for use in patients with intracranial hemorrhage due to thrombolytics (plasminogen-activator) (eg, alteplase, reteplase, tenecteplase) in addition to cryoprecipitate or when cryoprecipitate is contraindicated or not available in a timely manner.
Perioperative prevention of blood loss and transfusion, cardiac surgeryLevel of Evidence [A]
Data from multicenter, blinded, randomized, controlled trials support the use of tranexamic acid in the prevention of perioperative bleeding associated with cardiac surgery Ref. Tranexamic acid was associated with a lower risk of bleeding, without a higher risk of death or thrombotic complications within 30 days after surgery compared to placebo Ref. Additional clinical data also support the use of tranexamic acid for the prevention of perioperative bleeding associated with cardiac surgery Ref.
Perioperative prevention of blood loss and transfusion, orthopedic surgery (hip or knee arthroplasty)Level of Evidence [A, G]
Data from numerous randomized controlled trials and a meta-analysis demonstrate efficacy of IV tranexamic acid for the reduction of bleeding and transfusion-related complications in patients undergoing orthopedic surgery (eg, hip or knee arthroplasty). Total blood loss, number of transfusions required, and units of blood transfused were significantly reduced, and hematological indices were significantly improved with administration of tranexamic acid Ref.
Based on the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society guidelines on tranexamic acid use in total joint arthroplasty, tranexamic acid is recommended for reducing blood loss and the need for transfusions during hip or knee arthroplasty.
Perioperative prevention of blood loss and transfusion, spinal surgeryLevel of Evidence [B]
Data from numerous prospective, blinded, randomized, controlled trials that were analyzed in a meta-analysis support the use of tranexamic acid to reduce blood loss and the need for transfusions during spinal surgery Ref.
Postpartum hemorrhage, preventionLevel of Evidence [G]
Based on the Network for the Advancement of Patient Blood Management, Haemostasis, and Thrombosis consensus statement on patient blood management in obstetrics: prevention and treatment of postpartum haemorrhage, tranexamic acid, in addition to uterotonics, is recommended for the prevention of postpartum hemorrhage during caesarean delivery. Additionally, expert opinion suggests tranexamic acid is effective for the prevention of primary postpartum hemorrhage during vaginal deliveries Ref.
Postpartum hemorrhage, treatmentLevel of Evidence [A, G]
Data from a large international, randomized, double-blind, placebo-controlled trial evaluating the early administration of IV tranexamic acid in women (≥16 years of age) with postpartum hemorrhage following vaginal birth or cesarean delivery support the use of tranexamic acid for treatment of postpartum hemorrhage. A significant reduction in risk of death due to bleeding was observed when treatment was started within 3 hours of birth whereas no apparent risk reduction was seen when given after 3 hours Ref.
Based on the American College of Obstetricians and Gynecologists practice bulletin on postpartum hemorrhage, IV tranexamic acid is recommended for the treatment of obstetric hemorrhage when initial therapy fails Ref. In addition, the World Health Organization recommends IV tranexamic acid be administered within 3 hours of birth, along with standard care, to women diagnosed with postpartum hemorrhage Ref.
Subarachnoid hemorrhage, prevention of early aneurysmal rebleedingLevel of Evidence [C, G]
Data from a randomized, prospective, multicenter, controlled study in patients who suffered aneurysmal subarachnoid hemorrhage suggest that short-term use of tranexamic acid may be beneficial for the prevention of early rebleeding Ref.
Based on the AHA/ASA guidelines for the management of aneurysmal subarachnoid hemorrhage, the short-term use (<72 hours) of an antifibrinolytic is reasonable to reduce the risk of early aneurysm rebleeding.
Trauma-associated hemorrhage or traumatic brain injuryLevel of Evidence [A]
Data from a large, randomized, placebo-controlled trial evaluating the effects of early administration (ie, within 8 hours, ideally within 3 hours) of tranexamic acid in adult trauma patients with significant hemorrhage or at risk of hemorrhage support the use of tranexamic acid to reduce the risk of death from bleeding in this patient population Ref. In a post-hoc analysis, treatment beyond 3 hours was shown to be significantly less effective and possibly associated with harm Ref. In a subsequent retrospective observational study in patients suffering combat-related injury, the use of tranexamic acid resulted in improved measures of coagulopathy and survival, especially in patients requiring massive transfusion Ref.
Data from a large, randomized, placebo-controlled trial evaluating the effects of early administration (ie, within 3 hours) of tranexamic acid in adult patients with acute traumatic brain injury support the use of tranexamic acid to reduce the risk of head injury–related death in this population Ref.
Level of Evidence Definitions
Level of Evidence Scale
Clinical Practice Guidelines
Coronary Artery Bypass Graft Surgery:
“2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery,” November 2011
"2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines," March 2011
Dental Procedures in Patients on Oral Anticoagulant Therapy:
2012 ACCP, "Perioperative Management of Antithrombotic Therapy," February 2012
Hereditary Angioedema:
2017 WAO/EAACI, "The International WAO/EAACI Guideline for the Management of Hereditary Angioedema – the 2017 Revision and Update," January 2018
Life-Threatening Hemorrhage:
NCS/SCCM, “Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage,” December 2015
Perioperative Prevention of Blood Loss and Transfusion, Orthopedic Surgery:
AAHKS/ASRAPM, AAOSHIKS, "Tranexamic Acid use in Total Joint Arthroplasty: The Clinical Practice Guidelines Endorsed by the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society," October 2018
Postpartum Hemorrhage:
"NATA Consensus Statement on Patient Blood Management in Obstetrics: Prevention and Treatment of Postpartum Haemorrhage," March 2019
"WHO Recommendation on Tranexamic Acid for the Treatment of Postpartum Haemorrhage," 2017
Administration: IV
May be administered by direct IV injection at a maximum rate of 100 mg/minute (Crash-trial collaborators 2010; Elwatidy 2008; WOMAN Trial Collaborators 2017); faster rates may cause hypotension.
Administration: Oral
Administer without regard to meals. Swallow tablet whole; do not break, chew, or crush.
Administration: Inhalation
Inhalation via nebulization (off-label use/route): Administer over 15 minutes via jet nebulizer (Segrelles 2016; Wand 2018).
Administration: Pediatric
Oral: Administer without regard to meals; tablets should be swallowed whole; do not break, split, chew, or crush.
Parenteral:
Intermittent IV doses: May be administered undiluted (100 mg/mL) by direct IV injection; use plastic syringe only for IV push; or may further dilute dose and infuse over 5 to 30 minutes; maximum administration rate: 100 mg/minute
Continuous IV infusion:
Loading doses: In perioperative pediatric trials, loading doses were administered either undiluted or diluted and infused over 15 minutes (Dadure 2011; Goobie 2011; Neilipovitz 2001; Reid 1997; Sethna 2005).
IV infusion: After dilution, administer by continuous IV infusion at a rate not to exceed 100 mg/minute.
Storage/Stability
IV:
Ampules and vials: Diluted mixture may be stored for up to 4 hours at room temperature. However, solutions prepared in NS are chemically stable for up to 180 days at room temperature (McCluskey 2014). In another study, tranexamic acid (undiluted) was shown to be chemically stable for up to 12 weeks when stored at -20°C, 4°C, 22°C, and 50°C; freezing tranexamic acid in original ampules is unacceptable due to cracking of the ampules (de Guzman 2013). Freezing tranexamic acid in original vials has not been evaluated.
Premixed solution: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Preparation for Administration: Adult
Tranexamic acid doses using ampules/vials may be diluted in 50 to 250 mL of NS or D5W (CRASH-2 Trial Collaborators 2010; Ducloy-Bouthors 2011; Elwatidy 2008; Fergusson 2008). According to the manufacturer, tranexamic acid may be mixed with most solutions for infusion such as electrolyte solutions, carbohydrate solutions, amino acid solutions, and dextran solutions. Note: A 10 mg/mL premixed solution formulation is also available.
Preparation for Administration: Pediatric
Parenteral: Continuous IV infusion: In perioperative pediatric trials, loading doses may be further diluted in 1 mL/kg or 20 mL of NS (Goobie 2011; Grassin-Deyle 2013; Reid 1997; Schindler 2011). For intravenous infusion, tranexamic acid may be further diluted with D5W, NS, or other compatible solutions to a concentration <100 mg/mL.
Compatibility
See Trissel’s IV Compatibility Database
Open Trissel's IV Compatibility
Extemporaneously Prepared
A 5% (50 mg/mL) oral solution may be prepared by diluting 5 mL of 10% (100 mg/mL) tranexamic acid injection with 5 mL sterile water. Label “refrigerate”. Stable for 5 days refrigerated.
A 25 mg/mL oral suspension may be prepared with tablets. Place one 500 mg tablet (strength not available in U.S.) into 20 mL water and let stand ~2 to 5 minutes. Begin stirring and continue until the tablet is completely disintegrated, forming a fine particulate suspension (dispersion time for each 500 mg tablet is ~2 to 5 minutes). Administer immediately after preparation.
Lam MS, "Extemporaneous Compounding of Oral Liquid Dosage Formulations and Alternative Drug Delivery Methods for Anticancer Drugs," Pharmacotherapy 2011, 31(2):164-92.[PubMed 21275495]
Medication Patient Education with HCAHPS Considerations
What is this drug used for?
• It is used to treat or prevent bleeding in patients with hemophilia after having a tooth removed.
• It is used to treat heavy bleeding during monthly periods (menstruation).
• It may be given to you for other reasons. Talk with the doctor.
Frequently reported side effects of this drug
• Abdominal pain
• Back pain
• Muscle pain
• Joint pain
• Stuffy nose
• Muscle cramps
• Nausea
• Vomiting
• Diarrhea
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood
• Severe cerebrovascular disease like change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or vision changes
• Flushing
• Severe headache
• Vision changes
• Eye pain
• Severe eye irritation
• Severe loss of strength and energy
• Seizures
• Severe dizziness
• Passing out
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Medication Safety Issues
Sound-alike/look-alike issues:
Administration issues:
Contraindications
Hypersensitivity to tranexamic acid or any component of the formulation
Injection: Acquired defective color vision; active intravascular clotting; subarachnoid hemorrhage. Note: Although subarachnoid hemorrhage (SAH) is listed in the manufacturer’s labeling as a contraindication due to risk of cerebral edema and cerebral infarction, use has been described in the literature for aneurysmal SAH (Roos 2000; Roos 2003). When definitive treatment of the aneurysm is unavoidably delayed and no other contraindications exist, short-term use (<72 hours) of tranexamic acid is a reasonable treatment option to reduce the risk of early rebleeding without an increased risk of vasospasm and delayed ischemia; however, clinical trial data regarding improved outcomes are not conclusive at this time and an increased risk of deep venous thrombosis has been reported (ASA [Connolly 2012]; Chwajol 2008; Starke 2011;).
Oral: Active thromboembolic disease (eg, cerebral thrombosis, DVT, or PE); history of thrombosis or thromboembolism, including retinal vein or retinal artery occlusion; intrinsic risk of thrombosis or thromboembolism (eg, hypercoagulopathy, thrombogenic cardiac rhythm disease, thrombogenic valvular disease); concurrent use of combination hormonal contraception
Canadian labeling: Additional contraindications (not in the US labeling): Injection, oral: History or risk of thrombosis (unless concurrent anticoagulation therapy is possible); hematuria
Warnings/Precautions
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis or anaphylactoid reaction have been reported. Discontinue use if serious reactions occur; do not reinitiate treatment.
• Ocular effects: Visual defects (eg, color vision change, visual loss) and retinal venous and arterial occlusions have been reported; discontinue treatment if ocular changes occur; prompt ophthalmic examination should be performed by an ophthalmologist. Use of the injection is contraindicated in patients with acquired defective color vision. Ligneous conjunctivitis has been reported with the oral formulation but resolved upon discontinuation of therapy.
• Seizure: Seizures have been reported with use; most often with intraoperative use (eg, open chamber cardiac surgery and in patients inadvertently administered into the neuraxial system) and in older patients (Murkin 2010). The mechanism by which tranexamic acid use results in seizures may be secondary to neuronal GABA and glycine inhibition or cerebral emboli (Levy 2018). Consider EEG monitoring for patients with history of seizures or who experience myoclonic movements, twitching, or evidence of focal seizures. Discontinue use if seizures occur.
• Thrombotic events: Venous and arterial thrombosis or thromboembolism, including central retinal artery/vein obstruction, has been reported. Use the injection with caution in patients with thromboembolic disease; oral formulation is contraindicated in patients with a history of or active thromboembolic disease or with an intrinsic risk of thromboembolic events (eg, thrombogenic valvular disease, thrombogenic cardiac rhythm disease, hypercoagulopathy). Concomitant use with certain procoagulant agents (eg, anti-inhibitor coagulant complex/factor IX complex concentrates, oral tretinoin, hormonal contraceptives) may further increase the risk of thrombosis; concurrent use with either the oral or injectable formulation may be contraindicated, not recommended, or to be used with caution.
• Ureteral obstruction: Use the injection with caution in patients with upper urinary tract bleeding, ureteral obstruction due to clot formation has been reported.
Disease-related concerns:
• Disseminated intravascular coagulation: Use with extreme caution in patients with disseminated intravascular coagulation requiring antifibrinolytic therapy; patients should be under strict supervision of a health care provider experienced in treating this disorder.
• Renal impairment: Use with caution in patients with renal impairment; dosage modification necessary.
• Subarachnoid hemorrhage: Use with caution in patients with subarachnoid hemorrhage (SAH); cerebral edema and infarction may occur. According to the manufacturer's labeling, use of the injection is contraindicated in patients with SAH; however, use has been described in the literature for aneurysmal SAH and is considered a reasonable treatment option in select patients (ASA [Connolly 2012]).
• Vascular disease: Use with caution in patients with uncorrected cardiovascular or cerebrovascular disease due to the complications of thrombosis.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Pregnancy Considerations
Tranexamic acid crosses the placenta; concentrations within cord blood are similar to maternal serum.
Use of oral tranexamic acid for the long-term prophylaxis of HAE in pregnant females has been reported (González-Quevedo 2016; Machado 2017; Milingos 2009). Tranexamic acid may be considered for long-term prophylaxis when preferred treatment is not available (WAO/EEACI [Maurer 2018]).
Intravenous tranexamic acid has been evaluated for the treatment of postpartum hemorrhage (Ducloy-Bouthors 2011; WOMAN Trial Collaborators 2017). A significant reduction in risk of death due to bleeding was observed when treatment was started within 3 hours of vaginal birth or cesarean section (WOMAN Trial Collaborators 2017). Tranexamic acid is recommended for the treatment of obstetric hemorrhage when initial therapy fails (ACOG 183 2017; WHO 2017). IV tranexamic acid has also been studied for prophylaxis of postpartum hemorrhage in low-risk females prior to vaginal or cesarean delivery (Novikova 2015; Sentilhes 2018; Simonazzi 2016). However, available data related to prophylactic use is insufficient and use for routine prophylaxis against postpartum hemorrhage is not currently recommended outside of the context of clinical research (ACOG 183 2017).
Breast-Feeding Considerations
Tranexamic acid is present in breast milk.
Breast milk concentrations of tranexamic acid in lactating women were ~1% of the maximum maternal serum concentration when measured 1 hour after the last dose following 2 days of treatment (maternal dose and actual milk concentrations not provided) (Verstraete 1985).
Thromboembolic disorders were not observed in breastfed infants following maternal use of tranexamic acid for the treatment of postpartum hemorrhage (WOMAN Trial Collaborators 2017). An increased risk of adverse events was not observed in 21 breastfed infants exposed to tranexamic acid following maternal use for coagulation disorders (maternal dose range: 1.5 to 4 g/day). Authors of this study suggest taking the maternal dose immediately after breastfeeding to minimize infant exposure and monitor the infant for adverse events (Gilad 2014). Breastfeeding is not recommended by the manufacturer.
Although other agents are preferred, breastfeeding is considered acceptable during use of tranexamic acid for prophylaxis of HAE (WAO/EEACI [Maurer 2018]).
Briggs' Drugs in Pregnancy & Lactation
Adverse Reactions
>10%:
Gastrointestinal: Abdominal pain (oral: 20%)
Nervous system: Headache (oral: 50%)
Neuromuscular & skeletal: Back pain (oral: 21%), musculoskeletal pain (oral: 11%)
Respiratory: Nasal signs and symptoms (oral: 25%; including sinus symptoms)
1% to 10%:
Hematologic & oncologic: Anemia (oral: 6%)
Nervous system: Fatigue (oral: 5%)
Neuromuscular & skeletal: Arthralgia (oral: 7%), muscle cramps (oral: ≤7%), muscle spasm (oral: ≤7%)
Postmarketing:
Cardiovascular: Cerebral thrombosis, deep vein thrombosis, hypotension (with rapid IV injection), pulmonary embolism
Dermatologic: Allergic dermatitis, allergic skin reaction
Gastrointestinal: Diarrhea, nausea, vomiting
Genitourinary: Ureteral obstruction
Hypersensitivity: Anaphylactic shock, anaphylaxis, hypersensitivity reaction, nonimmune anaphylaxis, severe hypersensitivity reaction
Nervous system: Dizziness, seizure (Lecker 2016)
Ophthalmic: Chromatopsia, conjunctivitis (ligneous), retinal artery occlusion, retinal vein occlusion, visual disturbance
Renal: Renal cortical necrosis
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
Anti-inhibitor Coagulant Complex (Human): Antifibrinolytic Agents may enhance the thrombogenic effect of Anti-inhibitor Coagulant Complex (Human). Risk X: Avoid combination
Estrogen Derivatives (Contraceptive): May enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination
Progestins (Contraceptive): May enhance the thrombogenic effect of Tranexamic Acid. Risk X: Avoid combination
Tretinoin (Systemic): May enhance the thrombogenic effect of Antifibrinolytic Agents. Risk C: Monitor therapy
Monitoring Parameters
Ophthalmic examination (visual acuity, color vision, eye-ground, and visual fields) at baseline and regular intervals during the course of therapy in patients being treated for longer than several days; signs/symptoms of hypersensitivity reactions, seizures, thrombotic events, and ureteral obstruction
Advanced Practitioners Physical Assessment/Monitoring
Obtain ophthalmic examination at baseline and regular intervals if infusion formulation is used longer than several days. Obtain baseline renal function; dosage adjustment may be needed in patients with renal impairment. Assess for signs and symptoms of hypersensitivity, seizures, thrombotic events, and ureteral obstruction.
Nursing Physical Assessment/Monitoring
Check ordered labs and report abnormalities. Educate patient on importance of ophthalmic exams. Monitor for signs of hypersensitivity, seizure activity, or thrombosis; instruct patient to report.
Dosage Forms: US
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Generic: 1000 mg/10 mL (10 mL)
Solution, Intravenous [preservative free]:
Cyklokapron: 1000 mg/10 mL (10 mL)
Generic: 1000 mg/10 mL (10 mL); 1000 mg/100 mL in NaCl 0.7% (100 mL)
Tablet, Oral:
Lysteda: 650 mg
Generic: 650 mg
Dosage Forms: Canada
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Cyklokapron: 100 mg/mL (5 mL, 10 mL)
Generic: 100 mg/mL (5 mL, 10 mL, 50 mL)
Tablet, Oral:
Cyklokapron: 500 mg
Generic: 500 mg
Anatomic Therapeutic Chemical (ATC) Classification
- B02AA02
Generic Available (US)
Yes
Pricing: US
Solution (Cyklokapron Intravenous)
1000 mg/10 mL (per mL): $3.60
Solution (Tranexamic Acid Intravenous)
1000 mg/10 mL (per mL): $0.87 - $8.68
Solution (Tranexamic Acid-NaCl Intravenous)
1000MG/100ML 0.7% (per mL): $0.25
Tablets (Lysteda Oral)
650 mg (per each): $6.52
Tablets (Tranexamic Acid Oral)
650 mg (per each): $5.21 - $5.22
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Mechanism of Action
Forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis; it also inhibits the proteolytic activity of plasmin
With reduction in plasmin activity, tranexamic acid also reduces activation of complement and consumption of C1 esterase inhibitor (C1-INH), thereby decreasing inflammation associated with hereditary angioedema.
Pharmacodynamics/Kinetics
Distribution: Vd: 9 to 12 L; CSF levels are 10% of plasma
Protein binding: ~3%, primarily to plasminogen
Bioavailability: Oral: ~45%
Half-life elimination: ~2 to 11 hours
Time to peak: Oral: 2.5 hours (range: 1 to 5 hours)
Excretion: Urine (>95% as unchanged drug)
Pharmacodynamics/Kinetics: Additional Considerations
Renal function impairment: Following administration of a single IV injection, urinary excretion declines as renal function decreases.
Pediatric: The Cmax and AUC values after a single oral dose of 1,300 mg in adolescent females were 20% to 25% less than those in adult females given the same dose.
In vitro data suggests that neonates require a lower serum tranexamic acid concentration than adults (6.54 mcg/mL vs 17.5 mcg/mL) to completely prevent fibrinolysis (Yee 2013). In pediatric patients weighing 5 to 40 kg undergoing cardiac surgery with by-pass, a target serum concentration range of 20 to 30 mcg/mL has been used in pharmacokinetic analysis (Dowd 2002; Grassin-Delyle 2013).
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Dental Health Professional Considerations
Antifibrinolytic drugs are useful for the control of bleeding after dental extractions in patients with hemophilia because the oral mucosa and saliva are rich in plasminogen activators.
Effects on Dental Treatment
No significant effects or complications reported. See Effects on Bleeding and Dental Health Professional Considerations.
Effects on Bleeding
General dental procedures and simple restorative procedures are not associated with bleeding; therefore, there is no contraindication to general dental treatment for most patients with bleeding disorders. However, after dental extractions and other dental surgeries including deep scaling, block anesthesia, and large fillings, in patients with hemophilia, antifibrinolytic drugs such as tranexamic acid are useful in controlling bleeding. A carefully coordinated strategy between the dental and medical team may be required to ensure adequate procedures for hemostasis. As preparation for selected dental procedures tranexamic acid may be required.
Immediately before dental extraction in hemophilic patients, administer 10 mg/kg tranexamic acid IV together with replacement therapy.
Related Information
Pharmacotherapy Pearls
Tranexamic acid is 6 to 10 times more potent in plasminogen/plasmin binding compared to epsilon-aminocaproic acid.
Index Terms
Cyklokapron
FDA Approval Date
December 30, 1986
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