andexxa package insert

The effects of Andexxa can be measured using assays for its anti-FXa activity, free fraction of FXa inhibitor, and thrombin generation. Select one or more newsletters to continue. No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with Andexxa. Upon reconstitution, the parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA. To date, safety data are available for 352 subjects. Symptoms were mild to moderate in severity, and 90% (35/39) did not require treatment. A total of 33% of subjects with thromboembolic events (21/63) experienced the thromboembolic event during the first three days. From Table 14.2.1.2A of Clinical Study Report 16-512. These highlights do not include all the information needed to use SAVAYSA ™ safely and effectively. Follow the same procedure outlined above for IV bolus preparation. Four 200 mg single-dose vials. The results of Study 1 and Study 2 are provided below (see Table 4). The package insert recommends to monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Forty-eight of the 71 apixaban-treated subjects (68%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA. 9. An agent to reverse the anti-factor Xa activity of apixaban is available. The sustained elevation of thrombin generation over the baseline range and the sustained elevation over placebo were not observed in a contact-activated thrombin generation assay (an assay that is not affected by TF-TFPI interaction). Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the Andexxa bolus. This decrease was sustained through the end of the ANDEXXA continuous infusion. Carton and vial label have a red to blue transition colored stripe across the front. Please visit www.andexxa… A summary of the pharmacokinetic (PK) properties of Andexxa in healthy subjects is shown in the table below (see Table 3). The safety and efficacy of an additional dose have not been established. In an ongoing multinational, prospective, single-arm, open-label study, Andexxa was administered to 352 subjects taking FXa inhibitors who presented with acute major bleeding. Twenty (37%) subjects died within ten days after the Andexxa infusion. An improvement in hemostasis has not been established. Management of factor Xa inhibitor-associated life-threatening major hemorrhage: a retrospective multi-center analysis. Overview. An agent to reverse the anti-factor Xa activity of apixaban is available. Circulation. 5.1 Thromboembolic Risk . 7. Do not shake (B); shaking could lead to foaming. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Kaatz S, Bhansali H, Gibbs J, Lavender R, Mahan CE, Paje DG. Use of Heparin Following Administration of ANDEXXA. Also, monitor for symptoms and signs that precede … FDA Approved: Yes (First approved May 3, 2018) Brand name: Andexxa Generic name: coagulation factor Xa (recombinant), inactivated-zhzo Company: Portola Pharmaceuticals, Inc. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Mean ng/mL (± SD) change from baseline at the nadir, Mean % (± SD) change from baseline at the nadir, 4 single use vials in a carton, each vial containing 200 mg of Andexxa. Of the 352 subjects who received Andexxa, 223 received at least one anticoagulation dose within 30 days after treatment. The safety and efficacy of Andexxa were evaluated in two prospective, randomized, placebo-controlled studies, conducted in healthy volunteers (Study 1 ANNEXA-A; Study 2 ANNEXA-R). The most common adverse reactions (≥ 5%) in bleeding subjects receiving Andexxa were urinary tract infections and pneumonia. All subjects died prior to Day 45. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Administer ANDEXXA intravenously, using a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter. Inform patients that reversing FXa inhibitor therapy increases the risk of thromboembolic events. FULL PRESCRIBING INFORMATION 1 . ANDEXXA is a Factor Xa reversal agent that is FDA approved for the {{{indicationType}}} of ANDEXXA, coagulation factor Xa (recombinant), inactivated-zhzo is a recombinant modified human … Andexxa is not made with natural rubber latex. By clicking “Continue” below, you will transfer to another Alexion website. STN BL 125586/0 coagulation factor Xa (recombinant), inactivated-zhzo Page 5 Hamster Ovary (CHO) cell line. Andexxa; Available Dosage Forms: Powder for Solution; Therapeutic Class: Blood Modifier Agent. Boston, Ma 02210 USA Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. If dissolution is incomplete, discard the vial, and do not use the product. 10. Patients being treated with dabigatran therapy have underlying disease states that predispose them to … By using this site without changing your cookie settings, you agree to our use of cookies. Andexxa® The manufacturing process incorporates two validated virus clearance steps. Andexxa is available as a white to off-white lyophilized powder in single-use vials of 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo. Data month ending November 2018. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption [see Warnings and Precautions (5.1)]. Praxbind® Package Insert: 2015 October Coagulation Factor Xa (Andexxa®) Recombinant modified human factor Xa protein ApprovedMay 2018 Indicationis reversal of apixabanand rivaroxabanif needed … Discard the vials, including any unused portion. Monitor patients treated with ANDEXXA for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. Using an electrochemiluminescence (ECL)-based assay, 145 ANDEXXA-treated healthy subjects were tested for antibodies to ANDEXXA as well as antibodies cross-reacting with Factor X (FX) and FXa. Dosage Form: injection, powder, lyophilized, for solution. Study 1 ANNEXA-A (NCT02207725) – apixaban reversal. Low titers of anti-ANDEXXA antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (Days 44 to 48). Animal reproductive and developmental studies have not been conducted with Andexxa. HIGHLIGHTS OF PRESCRIBING INFORMATION . Patients treated with FXa inhibitor therapy have underlying disease states that predispose them to thromboembolic events. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa. ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. Safety of ANDEXXA also has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event. Contains no preservative. One subject with a history of hives prematurely discontinued Andexxa after developing mild hives. Drug class: anticoagulant reversal agents, Determine total number of vials required (see. This study examined the percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus up until the end of the infusion and the rate of effective hemostasis within 12 hours after infusion, as rated by an independent endpoint adjudication committee. To reduce the risk of thrombosis, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa. Low titers of anti-Andexxa antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30, with 20 subjects (14%) still having titers at the last time point (Days 44 to 48). In Study 1 and Study 2, the percent change from baseline in anti-FXa activity at its nadir was statistically significant (p < 0.0001) in favor of the Andexxa groups compared to placebo in both Studies 1 and 2. The primary endpoint of both studies was mean percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion. Infusion-related adverse reactions occurred in 18% (39/223) of the Andexxa-treated group and were the only type of adverse reaction that occurred more frequently than in the placebo group. Peled et al. To stay on the current website, click "Cancel." Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. In the ongoing ANNEXA-4 study, of the 352 subjects completing 30-day safety follow-up, there were 54 deaths (15%) occurring prior to the Day 30 visit. The median time to event was seven days. 4. WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS, See full prescribing information for complete boxed warning. There are no adequate and well-controlled studies of Andexxa in pregnant women to inform patients of associated risks. A total of 63 (18%) experienced 88 thromboembolic or ischemic events. No neutralizing antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding subjects (0/209) to date. Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials. The pharmacokinetics of Andexxa in healthy older (≥ 65 years; n=10) subjects were not different compared to younger (18-45 years; n=10) subjects. The pharmacokinetics of Andexxa were not affected by apixaban (5 mg orally BID for six days) or rivaroxaban (20 mg orally once daily for six days). Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Elevation of TF-initiated thrombin generation above the baseline range (prior to anticoagulation) occurred within two minutes following a bolus administration of Andexxa and was maintained throughout the duration of the continuous infusion. Please visit www.andexxa… The ANNEXA-4 study is an ongoing multinational, prospective, open-label study using Andexxa in subjects presenting with acute major bleeding and who have recently received an FXa inhibitor. The recombinant protein is produced in a genetically engineered Chinese Hamster Ovary (CHO) cell expression system and has a molecular weight of approximately 41 kDa. These reactions were characterized by a range of symptoms, including flushing, feeling hot, cough, dysgeusia, and dyspnea. Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. There are two dosing regimens (see Table 1). Introduction. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors. Dosing of Andexxa, as a bolus followed by a two-hour continuous infusion, resulted in a rapid decrease in anti-FXa activity (within two minutes after the completion of the bolus administration) followed by reduced anti-FXa activity that was maintained throughout the duration of the continuous infusion [see Clinical Studies (14)]. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. Andexxa [prescribing information]. J Blood Med. Uses for Andexxa. Infusion will require a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter. Coagulation factor Xa (recombinant), inactivated-zhzo injection is used to … August 16, 2016. U.S. License No. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The co-primary endpoints are: (a) percent change in anti-FXa activity from baseline to the nadir between five minutes after the end of the bolus up until the end of the infusion; and (b) rate of effective hemostasis within 12 hours after infusion, as rated by an independent endpoint adjudication committee. Current commercial clinical anti-FXa-activity assays are unsuitable for measuring FXa activity following administration of Andexxa. No neutralizing antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding patients (0/209) to date. J Thromb Thrombolysis (2016) 41:187–205 * If patient is unable to tolerate PO, Vitamin K via IV route may be substituted for PO above 1. In August 2018, the UIC Drug Information Group reviewed the literature related to the use of andexanet alfa for the reversal of factor Xa inhibitors. Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors. Eur Heart J. Andexxa vials are provided as follows (see Table 5): Unopened vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). It … Using an electrochemiluminescence (ECL)-based assay, 145 Andexxa-treated healthy subjects were tested for antibodies to Andexxa as well as for antibodies cross-reacting with factor X (FX) and FXa. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. © 2021 Alexion Pharmaceulicals, Inc.All rights reserved. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption. No animal studies were performed to evaluate the effects of Andexxa on carcinogenesis, mutagenesis, or impairment of fertility. Please see full Prescribing Information including Boxed Warning on thromboembolic risks, ischemic risks, cardiac arrest, and sudden death. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience. A break in the x-axis is added to better visualize the immediate, short-term dynamics of anti-FXa activity following Andexxa treatment. The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received ANDEXXA. The reconstituted solution contains coagulation factor Xa (recombinant), inactivated-zhzo at a concentration of 10 mg/mL. Please see our Privacy Notice to learn more. As with all therapeutic proteins, there is the potential for immunogenicity. 2014;35(28):1873-1880. Alexion Pharmaceuticals, Inc. Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Click "Continue" if you wish to continue on to the website you clicked on. The points on the graph represent the mean anti-FXa activity level; error bars illustrate standard error. Infuse TEPADINA via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin. Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation. Click "Continue" if you wish to continue on to the website you clicked on. Carton and label have "200 mg/vial" in a blue graphic on the front panel. 6.2 Postmarketing Experience KCentra Package Insert, CSL Behring, 2013 Witt. Avoid use of ANDEXXA for the reversal of direct FXa inhibitors (apixaban and rivaroxaban) prior to heparinization as ANDEXXA may cause unresponsiveness to heparin. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on expert consensus decision pathways. Truven Health Analytics, DOAC Market Data Report. In Study 2, healthy subjects (median age: 57 years; range: 50 to 68 years) received rivaroxaban 20 mg once per day for four days to achieve steady-state. Infusion-related reactions occurred in 18% (39/223) of Andexxa-treated healthy volunteers vs. 6% (6/94) of placebo-treated subjects. The safety and efficacy of Andexxa in the pediatric population have not been studied. In adults with potentially life-threatening acute major bleeding, what is the efficacy and safety of andexanet alfa for reversing the anticoagulant effects of the factor Xa inhibitors apixaban, rivaroxaban, edoxaban, or enoxaparin? 1743. Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors Andexxa (coagulation factor Xa (recombinant), … Reversing factor Xa inhibitors–clinical utility of andexanet alfa. Available for Android and iOS devices. Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. The most common adverse reactions (≥ 5%) in bleeding patients receiving ANDEXXA were urinary tract infections and pneumonia. For intravenous use only. Methergine® (methylergonovine maleate) Tablets, USP (methylergonovine maleate) Injection, USP . Excipient information presented when available (limited, particularly for generics); consult specific product labeling.Solution Reconstituted, Intravenous [preservative free]: Andexxa: 100 mg (1 ea); 200 mg (1 ea) [contains polysorbate 80] Contains no preservative. The safety of ANDEXXA has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with ANDEXXA. Please note that the privacy policy and security practices may differ from those of the Andexxa.com site. 2015;36(20):1264-1272. An agent to reverse the anti-factor Xa activity of apixaban is available. Ten of the 19 rivaroxaban subjects (53%) experienced a > 90% decrease from baseline anti-FXa activity after administration of ANDEXXA. Anti-FXa activity was measured prior to and after Andexxa or placebo administration. The frequency of adverse reactions was similar in the Andexxa-treated group (120/223; 54%) and in the placebo-treated group (54/94; 57%). Raval AN, Cigarroa JE, Chung MK, et al. Andexxa is a registered trademark of Alexion Pharmaceuticals, Inc. 8. This website is intended only for residents of the United States. If anticoagulation is needed, use an alternative anticoagulant to heparin. Management of patients on non-vitamin K antagonist oral anticoagulants in the acute care and periprocedural setting: a scientific statement from the American Heart Association. Methergine ® (methylergonovine maleate) is a semi-synthetic ergot alkaloid … Thirteen subjects received placebo, and 26 received Andexxa, administered as an 800 mg IV bolus followed by an 8 mg per minute continuous infusion for 120 minutes (total 960 mg). Medically reviewed by Drugs.com. The number of cardiovascular deaths, including three with unknown causes and two that were unadjudicated, was 42 of 352 (12%), and the number of non-cardiovascular deaths was 12 (3%). Each 200 mg vial delivers 200 mg of … Of the 352 subjects who received ANDEXXA, 223 received at least one anticoagulation dose within 30 days after treatment. Annotated Package Insert Version 13.0 CONFIDENTIAL Page 2 of 28 5.3 Transmissible Infectious Agents. Of the 352 subjects in the ANNEXA-4 study of Andexxa, 314 were 65 years of age or older, and 231 were 75 years of age or older. Piccini JP, Garg J, Patel MR, et al; for the ROCKET AF Investigators. Monitor subjects treated with Andexxa for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To report SUSPECTED ADVERSE REACTIONS, call 1-866-777-5947 or contact the FDA by visiting www.fda.gov/medwatch, or calling 1-800-FDA-1088. Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials. No serious or severe adverse reactions were reported. To date, the pattern of antibody response in subjects in the ongoing ANNEXA-4 study has been similar to that observed in healthy volunteers. DESCRIPTION . The safety and effectiveness of Andexxa during labor and delivery have not been evaluated. Reconstitute the total number of vials needed based on the dose requirements. Of the 236 subjects with available samples, 6.8% (16/236) had antibodies against Andexxa. Generic Name: andexanet alfa An improvement in hemostasis has not been established. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). No additives of human or animal origin are used in the manufacture of Andexxa. Sixty-three percent of the 352 subjects were 75 years or older. The time courses of anti-FXa activity before and after Andexxa administration are shown in Figure 1. Prior to and following each infusion, flush the catheter with approximately 5 ml … Dashed lines indicate the end of the bolus or infusion. Andexxa FDA Approval History. The active ingredient in Andexxa is a genetically modified variant of human FXa. The dose and dosing regimen of Andexxa that are required to reverse anti-FXa activity and to restore thrombin generation were determined in dose-ranging studies on healthy volunteers. See full prescribing information for Use of ANDEXXA as an antidote for heparin has not been established. 2017;8:141-149. Portola Pharmaceuticals, Inc. INDICATIONS AND USAGE . Tomaselli GF, Mahaffey KW, Cuker A, et al. Andexanet alfa, sold under the trade name Andexxa among others, is an antidote for the medications rivaroxaban and apixaban, when reversal of anticoagulation is needed due to uncontrolled bleeding. The most common adverse reactions (≥ 3%) in healthy subjects treated with Andexxa were infusion-related reactions. South San Francisco, CA: Portola Pharmaceuticals Inc.; 2020. Steffel J, Verhamme P, Potpara TS, et al; for the ESC Scientific Document Group. Interim results of the study include data for 352 subjects dosed with Andexxa, of which 234 were efficacy-evaluable defined as subjects (1) on treatment with apixaban or rivaroxaban; (2) who had a baseline anti-FXa activity above 75 ng/mL; and (3) were adjudicated as meeting eligibility criteria for acute major bleeding [also see Adverse Reactions (6)]. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.1, Limitations of Use: ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.1, Intracranial Hemorrhageintracerebral, subdural, subarachnoid, There is an urgent need for a specific reversal agent for FXa inhibitor-treated patients hospitalized with a major bleed.5,6, patients each day were hospitalized with an apixaban- or rivaroxaban-related bleed in 20189, patients die each day following hospitalization from apixaban- or rivaroxaban-related bleeds9-11. The most common adverse reactions (≥ 3%) in healthy subjects treated with ANDEXXA were infusion-related reactions. 3. 5. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. The gamma-carboxyglutamic acid (Gla) domain was removed to eliminate the protein's ability to assemble into the prothrombinase complex, thus removing the potential anticoagulant effects. Of the 54 subjects who died, the bleeding type was intracranial bleeding in 37 (69%), gastrointestinal bleeding in 12 (22%), and other bleeding types in 5 (9%) subjects. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Andexxa and any potential adverse effects on the breastfed child from Andexxa or from the underlying maternal condition. Alexion assumes no responsibility for nor does it control, endorse, or guarantee any aspect of your use of this linked site. Effective with date of service April 4, 2019, the North Carolina Medicaid and NC Health Choice programs cover coagulation factor Xa (recombinant), inactivated-zhzo lyophilized powder for solution for intravenous injection (Andexxa… © 2021 Alexion Pharmaceuticals, Inc. All rights reserved. Start the bolus at a target rate of approximately 30 mg/min. After reconstitution of the lyophilized powder with SWFI for IV administration, the product is a clear, colorless to slightly yellow solution. Of the 352 subjects who received Andexxa, 223 received at least one anticoagulation dose within 30 days after treatment. Andexxa is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. To ensure dissolution of the cake or powder, gently swirl each vial until complete dissolution of powder occurs (A). The recommended dosing of Andexxa is based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor (see Table 2). 2017;70(24):3042-3067. KANUMA ™ is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase Nineteen subjects who were anticoagulated with rivaroxaban had elevated baseline anti-FXa activity levels >300 ng/mL. Start the bolus at a target rate of approximately 30 mg/min. Re-elevation or Incomplete Reversal of Anti-FXa Activity. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. Lyophilized powder for solution. Laboratory assessment of coagulation does not necessarily correlate with or predict the hemostatic effectiveness of Andexxa. 11. For these reasons, comparison of the incidence of antibodies to Andexxa with the incidence of antibodies to other products may be misleading. Note the total volume withdrawn into the syringe. Detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. 2017;135(10):e604-e633. Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. 2018;39(16):1330-1393. Rx only . Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a white to off-white lyophilized cake or powder supplied as 4 single-use vials in a carton. J Am Coll Cardiol. Truven Bleeding Events Report: Commercial, Medicare, & Medicaid Populations. Use of Andexxa as an antidote for heparin has not been established. Each 200 mg vial delivers 200 mg of coagulation factor Xa formulated with the inactive ingredients tromethamine (Tris base), Tris hydrochloride, L-arginine hydrochloride, sucrose (1% w/v), mannitol (2.5% w/v), and polysorbate 80 (0.01% w/v) at pH 7.8. following bolus and sustained throughout the 2-hour IV infusion*1, ANDEXXA® is the first and only FDA-approved specific reversal agent for ELIQUIS® (apixaban) or XARELTO® (rivaroxaban) related life-threatening or uncontrolled bleeding.1, *ANNEXA-A and ANNEXA-R were two Phase 3 studies designed to establish the efficacy and safety of ANDEXXA for the reversal of anticoagulation with apixaban or rivaroxaban in older, healthy volunteers vs placebo. In Study 1, healthy subjects (median age: 57 years; range: 50 to 73 years) received apixaban 5 mg twice daily for three and a half days to achieve steady-state. Study 2 ANNEXA-R (NCT02220725) – rivaroxaban reversal. The safety of Andexxa has not been evaluated in subjects who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with Andexxa. ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 6. As with all therapeutic proteins, there is the potential for immunogenicity. 2. ANDEXXA was designed to bind small-molecule In addition to its ability to sequester the FXa inhibitors, rivaroxaban and apixaban, Andexxa has been shown to inhibit TFPI activity. 16.3 Appendix C: Eliquis® Package Insert .....93. In the ANNEXA-4 study, 63/352 (18%) subjects experienced one or more of the following overall thromboembolic events: cerebrovascular accident (CVA) (16/63; 25%), deep venous thrombosis (16/63; 25%), acute myocardial infarction (10/63; 16%), pulmonary embolism (5/63; 8%), and transient ischemic attack (1/63; 2%). To stay on the current website, click "Cancel." The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Andexxa has not been shown to be effective for bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. Andexanet alfa is a recombinant modified human factor Xa decoy protein that has the ability to bind to factor Xa inhibitors in the active site with high affinity. Eur Heart J. Andexanet alfa, a recombinant modified human "decoy" factor Xa (FXa) protein, is the first and only available antidote approved by the Food and Drug Administration to manage life-threatening or … In ANNEXA-A and ANNEXA-R, 23/31 and 26/39 patients received ANDEXXA respectively.1, ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.1, This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers.

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