andexxa package insert

6.2 Postmarketing Experience Subsequently, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors. By clicking “Continue” below, you will transfer to another Alexion website. 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). 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. 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). This site uses cookies to give you the best online experience. A total of 63 (18%) experienced 88 thromboembolic or ischemic events. Please see full Prescribing Information including Boxed Warning on thromboembolic risks, ischemic risks, cardiac arrest, and sudden death. Andexxa; Available Dosage Forms: Powder for Solution; Therapeutic Class: Blood Modifier Agent. 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] Available for Android and iOS devices. 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). There is no information regarding the presence of Andexxa in human milk, the effects on the breastfed child, or the effects on milk production. Twenty (37%) subjects died within ten days after the Andexxa infusion. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Select one or more newsletters to continue. It … Infusion will require a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter. An agent to reverse the anti-factor Xa activity of apixaban is available. A. Apixaban – with Andexxa 400 mg IV bolus plus 4 mg/min infusion for 120 minutes. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion, whereas TFPI activity in plasma returned to the pretreatment levels approximately 96 hours following Andexxa administration. Within two minutes following the bolus dose, administer the continuous IV infusion for up to 120 minutes. No serious or severe adverse reactions were reported. Andexxa [prescribing information]. Administer ANDEXXA intravenously, using a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter. 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. 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). 2017;135(10):e604-e633. Current commercial clinical anti-FXa-activity assays are unsuitable for measuring FXa activity following administration of Andexxa. Ten of the 19 rivaroxaban subjects (53%) experienced a > 90% decrease from baseline anti-FXa activity after administration of Andexxa. In addition to its ability to sequester the FXa inhibitors, rivaroxaban and apixaban, Andexxa has been shown to inhibit TFPI activity. Study 1 ANNEXA-A (NCT02207725) – apixaban reversal. 2017;8:141-149. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate prothrombin. Key Points to Consider When Evaluating Andexxa for Formulary Addition. A total of 33% of subjects with thromboembolic events (21/63) experienced the thromboembolic event during the first three days. Eight subjects received placebo, and 24 received Andexxa, administered as a 400 mg IV bolus followed by a 4 mg per minute continuous infusion for 120 minutes (total 480 mg). Peled et al. The points on the graph represent the mean anti-FXa activity level; error bars illustrate standard error. The results of Study 1 and Study 2 are provided below (see Table 4). ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, … Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. 8. The effects of Andexxa can be measured using assays for its anti-FXa activity, free fraction of FXa inhibitor, and thrombin generation. FDA Approved: Yes (First approved May 3, 2018) Brand name: Andexxa Generic name: coagulation factor Xa (recombinant), inactivated-zhzo Company: Portola Pharmaceuticals, Inc. 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). Sixty-three percent of the 352 subjects were 75 years or older. 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. The thromboembolic and ischemic risks were assessed in 352 bleeding subjects who received Andexxa. 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). What is the difference between Andexxa and Praxbind? Typical dissolution time for each vial is approximately three to five minutes. 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. 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. 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%). 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. Neurocrit Care 10.1007/s12028-019-00866-6; Dr. Harry Peled is the medical director of Cardiology and … 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 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 … B. Rivaroxaban – with Andexxa 800 mg IV bolus plus 8 mg/min infusion for 120 minutes. Reversing factor Xa inhibitors–clinical utility of andexanet alfa. Please note that the third party’s privacy policy and security practices apply and may differ from those of the Andexxa site. 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 … 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. 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. Animal reproductive and developmental studies have not been conducted with Andexxa. Laboratory assessment of coagulation does not necessarily correlate with or predict the hemostatic effectiveness of Andexxa. Tomaselli GF, Mahaffey KW, Cuker A, et al. Methergine® (methylergonovine maleate) Tablets, USP (methylergonovine maleate) Injection, USP . Data month ending September 2019. 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. 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 … 4. In the pooled safety analysis of clinical trials of Andexxa, 223 healthy volunteers received FXa inhibitors, followed by treatment with Andexxa. Piccini JP, Garg J, Patel MR, et al; for the ROCKET AF Investigators. At four hours after the last rivaroxaban dose (~ Cmax), Andexxa or placebo was administered. WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS, See full prescribing information for complete boxed warning. Prior to and following each infusion, flush the catheter with approximately 5 ml … An improvement in hemostasis has not been established. Circulation. Seventy-one subjects were anticoagulated with apixaban and had baseline levels of anti-FXa activity > 150 ng/mL. 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%). Last updated on Feb 1, 2021. 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. Use 60-mL (or larger) syringe with a 20-gauge (or higher) needle to withdraw the reconstituted Andexxa solution from each of the vials until the required dosing volume is achieved. Carton and label have "200 mg/vial" in a blue graphic on the front panel. 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). This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. Andexxa FDA Approval History. Additional … DO NOT FREEZE. 2. The most common adverse reactions (≥ 3%) in healthy subjects treated with ANDEXXA were infusion-related reactions. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption [see Warnings and Precautions (5.1)]. Another observed procoagulant effect of the Andexxa protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Eur Heart J. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and 21 subjects experienced the event within the first three days. To date, the pattern of antibody response in patients in the ongoing ANNEXA-4 study has been similar to that observed in healthy volunteers. Of the 352 subjects who received Andexxa, 223 received at least one anticoagulation dose within 30 days after treatment. 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. 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. There was a statistically significant difference (p < 0.05) in the percent change of anti-FXa activity normalized to pre-bolus between Andexxa and placebo until two hours after administration of infusion. To stay on the current website, click "Cancel." Of the 236 subjects with available samples, 6.8% (16/236) had antibodies against ANDEXXA. 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). The package insert recommends to monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. 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. Of these 223, 18 subjects (8%) had a thrombotic event and/or ischemic event after resumption. Held C, Hylek EM, Alexander JH, et al. 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. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed. DailyMed is the official provider of FDA label information (package inserts). References:1. Andexxa is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. 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. Arterial and venous thromboembolic events, ischemic events, cardiac events, and sudden death were observed within 30 days following Andexxa administration [see Warnings and Precautions (5.1)]. This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts. The safety and efficacy of Andexxa were evaluated in an ongoing, prospective, single-arm, open-label study (Study 3 ANNEXA-4) in subjects presenting with acute major bleeding and who have recently received an FXa inhibitor. This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers [see Clinical Studies (14)]. 3. An improvement in hemostasis has not been established. From Table 14.2.1.2A of Clinical Study Report 16-512. Each 200 mg vial delivers 200 mg of … Treatment with Andexxa has been associated with serious and life-threatening adverse events, including: (5.1). Use of Heparin Following Administration of ANDEXXA. South San Francisco, CA: Portola Pharmaceuticals Inc.; 2020. Of the 236 subjects with available samples, 6.8% (16/236) had antibodies against Andexxa. © 2021 Alexion Pharmaceulicals, Inc.All rights reserved. August 16, 2016. The safety and effectiveness of Andexxa during labor and delivery have not been evaluated. 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. There are no adequate and well-controlled studies of Andexxa in pregnant women to inform patients of associated risks. Carton and vial label have a red to blue transition colored stripe across the front. These highlights do not include all the information needed to use SAVAYSA ™ safely and effectively. Please note that the privacy policy and security practices may differ from those of the Andexxa.com site. KANUMA ™ is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase Reconstituted Andexxa in vials is stable at room temperature for up to eight hours, or may be stored for up to 24 hours at 2°C to 8°C. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or 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). Other brands noted are the property of their respective owners. Avoid use of Andexxa for the reversal of direct FXa inhibitors (apixaban and rivaroxaban) prior to heparinization as Andexxa may cause unresponsiveness to heparin. If anticoagulation is needed, use an alternative anticoagulant to heparin. Portola Pharmaceuticals, Inc. J Am Coll Cardiol. 2015;36(20):1264-1272. Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo) is a sterile, white to off-white lyophilized powder available in single-use vials. Safety of Andexxa also has not been evaluated in subjects who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood products within seven days prior to the bleeding event. 9. Symptoms were mild to moderate in severity, and 90% (35/39) did not require treatment. These reactions were characterized by a range of symptoms, including flushing, feeling hot, cough, dysgeusia, and dyspnea. 2017;70(24):3042-3067. Four 100 mg single-dose vials. Study 2 ANNEXA-R (NCT02220725) – rivaroxaban reversal. Andexxa contains no preservatives. Andexxa is not made with natural rubber latex. 2018;39(16):1330-1393. Two of 352 (0.6%) subjects in the ANNEXA-4 study experienced an infusion-related reaction. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the Andexxa bolus. No thromboembolic events were observed in 223 healthy volunteers who received FXa inhibitors and were treated with Andexxa. 5. None of these anti-ANDEXXA antibodies were neutralizing. HIGHLIGHTS OF PRESCRIBING INFORMATION . Anti-FXa activity was measured prior to and after Andexxa or placebo administration. Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors Andexxa (coagulation factor Xa (recombinant), … As with all therapeutic proteins, there is the potential for immunogenicity. An improvement in hemostasis has not been established. Raval AN, Cigarroa JE, Chung MK, et al. Patients being treated with dabigatran therapy have underlying disease states that predispose them to … The pharmacokinetics of Andexxa in healthy older (≥ 65 years; n=10) subjects were not different compared to younger (18-45 years; n=10) subjects. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the ANDEXXA bolus. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Click "Continue" if you wish to continue on to the website you clicked on. Do not shake (B); shaking could lead to foaming. Am J Emerg Med. Nadir is defined as the smallest value measured within five minutes after the end of the continuous infusion. Reconstituted Andexxa in IV bags is stable at room temperature for up to eight hours. The median time to event was seven days. 2018;36(3):396-402. Of the 63 subjects who experienced a thrombotic event, the median time to first event was 7 days, and 21 subjects experienced the event within the first three days. 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. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa. All subjects died prior to Day 45. 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… WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS, Treatment with Andexxa has been associated with serious and life-threatening adverse events, including: (, Arterial and venous thromboembolic events, Ischemic events, including myocardial infarction and ischemic stroke, andexanet alfa injection, powder, lyophilized, for solution, We comply with the HONcode standard for trustworthy health information -. 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. Eur Heart J. Avoid use of ANDEXXA for the reversal of direct FXa inhibitors (apixaban and rivaroxaban) prior to heparinization as ANDEXXA may cause unresponsiveness to heparin. To reduce the risk of thrombosis, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa. Andexxa has not been shown to be effective for bleeding related to any FXa inhibitors other than apixaban or rivaroxaban. Overview. 6. Detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Both studies examined the percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion. Annotated Package Insert Version 13.0 CONFIDENTIAL Page 2 of 28 5.3 Transmissible Infectious Agents. Medically reviewed by Drugs.com. The anti-FXa activity returned to the placebo levels approximately two hours after completion of a bolus or continuous infusion. Infuse TEPADINA via a central venous catheter over 3 hours using an infusion set equipped with a 0.2 micron in-line filter. Generic Name: andexanet alfa 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.

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