Andexanet alfa is administered via two different dosing regimens, standard and high dose, based on the specific FXa inhibitor, dose, and time since the patient's last dose of FXa inhibitor. Andexanet alfa – Erroneous assay results for levels of anti-factor Xa activity (EPITT no 19493) Summary of product characteristics. 26 The US FDA prescribing information for andexanet alfa includes a black box warning regarding the risk of venous and arterial thromboembolic events. A sustained decrease in free apixaban occurred in cohort 6. Includes Andexanet Alfa indications, dosage/administration, pharmacology, mechanism/onset/duration of action, half-life, dosage forms, interactions, warnings, adverse reactions, off-label uses and more. Post‐andexanet, pre‐operative anti‐Xa levels were available for two patients, one taken 19 hours after andexanet alfa administration, and one taken 8.75 hours after administration, with levels ranging from 1.37 to 3.26 units/mL. Labeler Name: Alexion Pharmaceuticals, Inc. Andexanet alfa is a genetically modified variant of human factor Xa (alanine is substituted for serine) produced in the Chinese hamster ovary cell line. between PCCs and andexanet alfa (coagulation factor Xa-[recombinant], inactivated-zhzo). Andexanet alfa ist ein rekombinantes humanes FXa-Protein. Results from the first two dosing cohorts of the study demonstrated that andexanet alfa is able to dose-dependently reverse the anticoagulant effects of XARELTO ®. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa is a recombinant factor Xa decoy molecule capable of reversing direct and indirect factor Xa-inhibiting anticoagulants. Andexanet alfa for the reversal of factor Xa inhibitor activity. The non-proprietary name is sometimes called the generic name. Andexanet Alfa What is the Non-Proprietary Name? Despite these advantages, the risk of bleeding remains a concern. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. Dosing and Administration There are two dosing regimens (Low or High dose) of andexanet alfa based on the last dose and timing of rivaroxaban or apixaban. The generic name of Andexxa is andexanet alfa. These agents unfortunately do not have any specific reversal agents. Andexanet alfa ist ein O-Glycoprotein und wird in CHO-Zellen exprimiert. In addition, no serious adverse events were reported. The results presented here are from a pre-planned analysis of patients treated with PCCs for FXa inhib- itor–related ICH. The reason for this is the ease of use, standard dosing with no levels to check and no injections needed. Andexanet alfa is administered as an intravenous bolus at a target rate of approximately 30 mg/min over 15 minutes (low dose) or 30 minutes (high dose), followed by administration of a continuous infusion of 4 mg/min (low dose) or 8 mg/min (high dose) for 120 minutes (see table 1). Dosing of ANDEXXA, as a bolus followed by a two-hour continuous infusion, resulted in a rapid decrease in anti-FXa activity ... andexanet alfa (UNII: BI009E452R) (andexanet alfa - UNII:BI009E452R) andexanet alfa: 200 mg in 20 mL: Packaging # Item Code Package Description Marketing Start Date Marketing End Date; 1: NDC:69853-0102-1: 4 in 1 CARTON: 01/08/2019: 1: 20 mL … 4.4. Andexanet alfa is a modified recombinant inactive form of human factor Xa de-veloped for reversal of factor Xa inhibitors. Use for edoxaban- or enoxaparin-reversal is not recommended due to lack of data. The dosing strategy for andexanet alfa is different and requires knowledge of the type of Xai and time from last ingestion, basing the dose on the anticipated blood concentrations achieved by the different DOACs. Portola Pharmaceuticals' CEO William Lis on Q3 2017 Results – Earnings Call Transcript. ANDEXXA is available as a white to off-white lyophilized powder in single-use vials of 100 mg or 200 mg of coagulation factor Xa (recombinant), inactivated-zhzo. METHODS We evaluated 352 patients who had acute major bleeding within 18 hours after administration of a factor Xa inhibitor. Andexanet alfa is administered via two different dosing regimens, standard and high dose, based on the specific FXa inhibitor, dose, and time since the patient’s last dose of FXa inhibitor. … 13 Patients receive a bolus followed by a 2-hour continuous infusion because of the short half-life of andexanet alfa. Dosage in the marketing authorisation 2.2 The dosage schedule is available in the summary of product characteristics. Andexanet alfa is a recombinant human coagulation Factor Xa that promotes blood coagulation. Andexanet alfa Accession Number DB14562 Description. Price 2.3 The list price for andexanet alfa is £11,100 per 4-vial pack of 200 mg of powder for solution for infusion (excluding VAT, BNF online accessed March 2020). It acts as a decoy, binding to factor Xa inhibitors and neutralizing their anticoagulant effect. 3 DOSAGE FORMS AND STRENGTHS . Andexanet alfa (Hersteller: Portola Pharmaceuticals) ist ein strukturell mit dem menschlichen Blutgerinnungsfaktor Faktor Xa verwandtes Protein, das biotechnologisch erzeugt wird. Andexanet alfa reverses edoxaban-induced anticoagulation in a rabbit liver laceration model of acute bleeding. Dosage in the marketing authorisation 2.2 There are 2 possible doses for andexanet alfa, depending on the timing of the last dose of apixaban or rivaroxaban: Low dose: 400 mg initial intravenous bolus at a target rate of 30 mg per minute, then 4 mg per minute by intravenous infusion for 120 minutes (480 mg) Pine P, Hollenbach S, Tan S, et al. Eleven patients had a thromboembolic event within 5 days of receiving andexanet alfa and 8 patients had an event after restarting anticoagulation. Struktur. BackgroundAndexanet alfa (andexanet) is a recombinant modified human factor Xa decoy protein that has been shown to reverse the inhibition of factor Xa in … Andexanet alfa wird durch rekombinante DNA-Technologie in Ovarialzellen des chinesischen Hamsters hergestellt. 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. Because of the more limited number of participating sites using andexanet alfa as the preferred agent at this time, data collection for this study is ongoing. The safety and efficacy of repeated doses of andexanet alfa have not been established. Der Wirkstoff hat ein Molekulargewicht von rund 41 kDa. The patients received a bolus of andexanet, followed by a 2-hour infusion. Andexanet alfa will not reverse the effects of non-FXa inhibitors. Andexxa with NDC 69853-0102 is a a human prescription drug product labeled by Alexion Pharmaceuticals, Inc.. Andexanet alfa is not suitable for pre-treatment of urgent surgery. Dosage and Administration (2) 03/2020 Warnings and Precautions (5) 09/2020----- INDICATIONS AND USAGE -----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. rhage.9,12 Institution-specific dosing recommendations mirror those recommended by the manufacturer and can be found in Supplementary Appendix A.12 Requests for andexanet alfa use were approved by pharmacy or hematology to ensure use met aforementioned bleeding criteria. Special warnings and precautions for use . The approval for andexanet alfa is supported by data from two phase 3 studies (ANNEXA-A, ANNEXA-R) and preliminary data from the phase 3b/4 ANNEXA-4 trial. 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa. 3 Wirkmechanismus. The approval for andexanet alfa is supported by data from two phase 3 studies (ANNEXA-A, ANNEXA-R) and preliminary data from the phase 3b/4 ANNEXA-4 trial. ANDEXXA- Andexanet alfa injection DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS PRESCRIBING HIGHLIGHTS: Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. Expert Rev Hematol 2016; 9: 115-22. Dosing of andexanet alfa, as a bolus followed by a 2-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. Continuous intravenous infusion. Limitations of use […] Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available. Andexanet alfa reduced the amount of free, unbound apixaban (up to a 90% decrease) in a dose-dependent manner within 2 min of the initial bolus across all dosing cohorts. N Engl J Med 2015; 373: 2413-24. The generic name usually includes the active ingredient(s) of the product. It was developed by Portola Pharmaceuticals and was approved in in May 2018. Approved dosing is cumbersome ... Andexanet alfa for the reversal of Factor Xa inhibitor related anticoagulation. Nine patients had andexanet alfa infusing during the procedure, of which two patients' procedures were longer than the andexanet infusion. The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form. Treatment-emergent, non-neutralizing antibodies to andexanet alfa were detected in approximately 10% (35/345). Es hebt die Wirkung von bestimmten blutgerinnungshemmenden Wirkstoffen auf und wirkt somit als Antidot.In den USA und der EU ist Andexanet alfa für die Behandlung nicht kontrollierbarer Blutungen unter Therapie … Other Name: Andexxa® Outcome Measures. dosing.fachinfo.header.title ... Andexanet alfa ist ein Antidot zur Behandlung von Blutungen unter Xabanen (Antikoagulantien). Apixaban was reversed with andexanet alfa. Intravenous andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo; Andexxa®] is a first-in-class recombinant modified factor Xa protein that has been developed by Portola Pharmaceuticals as a universal antidote to reverse anticoagulant effects of direct or indirect factor Xa inhibitors. The average cost of a course of treatment at list price is £15,000 per patient. Drug: andexanet alfa Andexanet is a recombinant version of human FXa. Table 1: Dosing regimens Initial intravenous bolus. 11-Digit NDC Billing Format: 69853010201 NDC Format for Billing For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. Apixaban levels were lowered most after the bolus in cohorts 3–6. These antibodies were generally low titre, and no clinical consequences were observed. Although determination of anti-FXa-activity in emergency situations is increasingly recommended, no recommendation for adapted andexanet alfa dosage is available.
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