andexanet alfa manufacturer

Andexanet alfa is a modified recombinant factor Xa molecule that reverses oral direct (e.g., apixaban, edoxaban, rivaroxaban) and injectable indirect (e.g., enoxaparin, fondaparinux) factor Xa inhibitors. It has not been found to be useful for other factor Xa inhibitors. As part of the regulatory approval process, the manufacturer has requested a label that includes the reversal of apixaban, rivaroxaban, edoxaban, and enoxaparin. The active ingredient in ANDEXXA is a genetically modified variant of human FXa. Table 1 Assignment of patients to either high dose or low dose regimen . If you are allergic to andexanet alfa; any part of andexanet alfa; or any other drugs, foods, or substances. This is the first approved antidote for apixaban- or rivaroxaban-treated patients with uncontrolled bleeds. J Blood Med. ANDEXXA contains no preservatives. Anti-Xa activity can rebound after completing the infusion of andexanet. Indication: For patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. [1], Andexanet alfa is a biologic agent, a recombinant modified version of human activated factor X (FXa). ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is also referred to by the US adopted name (USAN) of andexanet alfa. Data source: US Food and Drug Administration Novel Drugs 2018; European Medicines Agency Human Medicines Highlights 2018; Health Canada databases. Andexanet alfa (coagulation factor Xa [recombinant], inactivated-zhzo) is a modified recombinant inactive form of human factor Xa designed specifically to bind and sequester factor Xa … [7], Common side effects include pneumonia and urinary tract infections. 2017;8:141-149. Available at: "Andexxa- andexanet alfa injection, powder, lyophilized, for solution", "Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity", "Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors", https://clinicaltrials.gov/ct2/show/NCT03661528, "Trial of Andexanet in ICH Patients Receiving an Oral FXa Inhibitor", "Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors", "Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization", https://en.wikipedia.org/w/index.php?title=Andexanet_alfa&oldid=988263296, Chemicals that do not have a ChemSpider ID assigned, Infobox drug articles without a structure image, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License, Coagulation factor Xa (recombinant), inactivated-zhzo, PRT06445, r-Antidote, PRT4445, This page was last edited on 12 November 2020, at 03:05. Andexanet alfa. [5] This study reports results on 352 people and demonstrates a reduction of anti-fXa-activity while also showing an excellent or good hemostatic efficacy in 82%. Portola proposed two dosing regimens for ANDEXXA. There are three intravenous antidotes currently under development for the reversal of direct oral anticoagulants. Andexanet alfa produced rapid reversal of the anticoagulant effect of apixaban, as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion. Medicare New Technology Add-on Payment (NTAP) In addition to the MS-DRG payment, NTAP may facilitate an additional payment, … Idarucizumab is a humanized, monoclonal, antibody fragment that reverses the direct thrombin inhibitor dabigatran. Manufacturer; Andexanet alfa (Andexxa) Indicated for patients treated with rivaroxaban and … 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. You will not receive a reply. As a consequence in the presence of andexanet alfa natural FXa is partially freed, which can lead to effective hemostasis. [30][31] [32] [33] While andexanet alfa is … 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 in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product: Marketing Information : Marketing Category Application Number or Monograph … Medscape - Factor Xa inhibitor antidote dosing for AndexXa, andexanet alfa (coagulation factor Xa recombinant, inactivated-zhzo), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. The drug is not effective against factor IIa inhibitor dabigatran. [2] It is given by injection into a vein. 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? (INN) andexanet alfa. 10. Indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, Indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC), Indicated to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure, Indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours, Indicated for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults, Indicated to treat unresectable or metastatic melanoma, Indicated to treat X-linked hypophosphataemia (XLH) in adult and pediatric patients 1 year of age and older, Indicated to treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years, Indicated to treat acquired thrombotic thrombocytopenic purpura (aTTP), Indicated to treat adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation, Indicated for the first-line treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations. [3][9] In other words, it acts as a decoy receptor. Andexanet alfa (andexanet; r-Antidote, PRT064445; Portola Pharmaceuticals, South San Francisco, CA) is a modified, recombinant human factor Xa that binds to direct factor Xa inhibitors such as apixaban, edoxaban, and rivaroxaban and indirect factor Xa inhibitors, such as LMWHs. It was developed by Portola Pharmaceuticals and was approved in in May 2018. Off-label use of andexanet alfa to reverse FXa anticoagulation prior to surgery with intended heparin anticoagulation has been reported to cause unresponsiveness to heparin and healthcare professionals are advised to avoid such use. Subsequently, this may result in increased tissue factor-initiated thrombin generation. Justin Morgenstern, "Andexanet Alfa: More garbage science in the New England Journal of Medicine", First10EM blog, February 11, 2019. [8] FXa inhibitors bind to andexanet alfa with the same affinity as to natural FXa. Andexanet alfa for the reversal of factor Xa inhibitor activity. Based largely on that publication, the Food and Drug Administration already approved andexanet alfa in 2018. Andexanet Alfa. Indications from: 1 Health Canada (HC); 2 US Food and Drug Administration (FDA); 3 European Medicines Agency (EMA). There was no relationship between hemostatic efficacy and reduced anti-Xa-activity. Truven Health Analytics, DOAC Market Data Report. What do I need to tell my doctor BEFORE I take Andexanet Alfa? Uses of Andexanet Alfa: It is used to undo the effects of a certain blood thinner. Targets (1) Andexanet alfa. Manufacturer: Portola Pharmaceuticals, Inc. Data month ending September 2019. [1] It has not been found to be useful for other factor Xa inhibitors. Andexanet alfa reverses effect of all anticoagulants that act directly through FXa or by binding antithrombin III. •Andexanet alfa prolongs aPTT in a concentration-dependent manner in-vitro, with negligible effects on PT or TCT •Andexanet alfa (250μg/mL) neutralises rivaroxaban and apixaban by ~85-90%, based on anti-Xa assays •Rivaroxaban induces a false-positive LA test via dRVVT in a concentration-dependent manner. It is given by injection into a vein. It is … Indicated to treat adult and pediatric patients with solid tumours that: Indicated to treat adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib, Indicated to treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure, Indicated to treat two rare types of non-Hodgkin lymphoma, Indicated to treat hairy cell leukemia, Indicated to treat onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older, Indicated to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, Indicated to treat polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), Indicated to treat adults with a rare and serious genetic disease known as phenylketonuria (PKU), Indicated to treat adults with complicated urinary tract infections, Indicated to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH), Indicated to treat patients with chronic obstructive pulmonary disease (COPD), Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older, New vaginal ring used to prevent pregnancy for an entire year, Indicated to the radical cure (prevention of relapse) of Plasmodium vivax malaria, Indicated to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), Indicated to treat adult patients with a deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated human epidermal growth factor receptor 2 (HER2)-negative locally advanced (not amenable to curative radiation or surgery) or metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, unless patients were inappropriate for these treatments, Indicated to treat cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T, Indicated to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Indicated to treat mild to moderate alpha-mannosidosis, Indicated to treat hyperkalemia in adult patients, Routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes, Control and prevention of episodic bleeding, Peri-operative management of bleeding (surgical prophylaxis). Portola has entered into Phase 3 clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors while retaining all commercial rights to andexanet alfa. Andexanet alfa is predicted to affect the anticoagulant effect of dalteparin. Based on the last dose of apixaban/rivaroxaban and the time since the last drug intake, the manufacturer’s instructions propose either a high dose regimen or a low dose regimen (table 1). Portola has entered into Phase 3 clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors while retaining all commercial rights to andexanet alfa. * B: biologic; C: cancer; O: orphan medicines. [5][11], Initial pricing (AWP) is $58,000 per reversal (800 mg bolus + 960 mg infusion, $3,300 per 100 mg vial) which is higher than reversal agents for other DOAC agents (idarucizumab for use in dabigatran reversal is $4,200 per reversal).[12]. Clinical trials suggest peak anti-Xa activity at 4 hours after infusion, then decrease at a rate similar to clearance of the factor Xa inhibitor. [10], It was approved in the United States in 2018 based on data from two phase III studies on reversing the anticoagulant activity of FXa inhibitors rivaroxaban and apixaban in healthy volunteers. Introduction of Andexanet Alfa, Factor Xa Inhibitor Reversal Agent into Central Vein, Percutaneous Approach, New Technology Group 2. State Experimental Properties. [2] Severe side effects may include blood clots, heart attacks, strokes, or cardiac arrest. The US Food and Drug Administration (FDA) has cleared andexanet alfa (Andexxa) as a reversal agent for the anticoagulant effects of the two most commonly used factor Xa inhibitors in patients with life-threatening or uncontrolled bleeding, manufacturer Portola Pharmaceuticals announced late yesterday.. For enquiries, contact us. [2], Andexanet alfa has a boxed warning that it is associated with arterial and venous blood clots, ischemic events, cardiac arrest, and sudden deaths. Truven Bleeding Events Report: Commercial, Medicare, & Medicaid Populations. N Engl J Med 2015; 373: 2413-24. That is why we need science. Since it is a genetically modified variant of human factor Xa, andexanet alfa is not able to cleave and activate [2], It was approved for medical use in the United States in May 2018. Portola applied for FDA approval of its Xarelto antidote AndexXa back in 2015. In the study, andexanet alfa was well tolerated, with no serious adverse events, thrombotic events, or antibodies to Factor X or Xa reported [10]. Manufacturer advises avoid. Andexanet alfa will likely correct anti-Xa values, but the correlation of lab results with improved clinical outcomes has not been established. 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. Tell … Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). How shall we apply andexanet alfa? 7. have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and. Manufacturers Packagers Dosage Forms Prices Patents. Consequently in August 2016, the FDA requested additional efficacy and safety data for … As a rule, all of our actions can be harmful. Frontera JA, Lewin JJ 3rd, Rabinstein AA, et al. [4] The only published clinical trial is a prospective, open label, single group study. The following table provides supplementary information on the manufacturer and approved indication(s) for each medicine that received first-time market authorization by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and/or Health Canada in 2018. [1], There are no randomised clinical trials as of 2019. The active site serine was substituted with alanine, rendering the molecule unable to cleave and activate … [2], Common side effects include pneumonia and urinary tract infections. Human physiology is complex, which makes it very difficult to predict the outcomes of our interventions. Expert Rev Hematol 2016; 9: 115-22. [3], Andexanet alfa is used to stop life threatening or uncontrollable bleeding in people who are taking rivaroxaban or apixaban. 2. 8. Siegal DM, Curnutte JT, Connolly SJ, et al. Targets (1) Identification Name Andexanet alfa Accession Number DB14562 Description. The Company is currently evaluating andexanet alfa in the Phase 3 and Phase 4 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) registration studies. Data month ending November 2018. 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 spotlight on AndexXa (andexanet alfa) is even brighter now that an new decision date is on the calendar. Doctors were hopeful that the drug might quickly be approved to help prevent potentially extreme Xarelto bleeding episodes. The Company is currently evaluating andexanet alfa in the Phase 3 and Phase 4 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) registration studies. [2] Severe side effects may include blood clots or cardiac arrest. 1. 9. Ondexxya (andexanet alfa) is a medication used for the treatment of patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Reversing factor Xa inhibitors–clinical utility of andexanet alfa. Studies in healthy volunteers show that the molecule binds fXa-inhibitors and counters their anti-fXa-activity. In-vitro data suggest binding of andexanet alfa to the heparin-antithrombin III (ATIII) complex and neutralisation of the anticoagulant effect of heparin. [2] It works by binding to rivaroxaban and apixaban. Although ANNEXA-A and ANNEXA-R study the reversal of apixaban and rivaroxaban by andexanet, they exclude edoxaban and enoxaparin. Truven Health Analytics, DOAC Market Data Report. Andexanet alfa is clearly not a parachute, as 14% of a healthy population still died. Indicated for use in previously treated adults and adolescents (≥12 years of age) with hemophilia A (congenital Factor VIII deficiency) for: Indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine, Indicated to treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma, Indicated for the treatment of moderate to severe pain associated with endometriosis, Indicated to treat Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID), Indicated to treat primary hemophagocytic lymphohistiocytosis (HLH), Indicated to treat complicated intra-abdominal infections in patients 18 years of age and older, Indicated to treat migraine in adults who have at least 4 migraine days per month, Indicated to treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP), Indicated for the preventive treatment of migraine in adults, Indicated to treat patients who have relapsed or refractory acute myeloid leukemia (AML), Indicated to treat newly-diagnosed acute myeloid leukemia (AML) in adult patients, Indicated to treat HIV patients who have limited treatment options, Indicated to treat stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR), Indicated to treat patients with relapsed or refractory acute myeloid leukemia, Indicated for routine prevention of attacks of hereditary angioedema (HAE) in adolescents and adults. Andexanet alfa is a recombinant human coagulation Factor Xa that promotes blood coagulation. Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein designed to reverse the anticoagulant activity in patients treated with an oral or injectable Factor Xa inhibitor. After reconstitution of the lyophilized powder with SWFI for IV administration, the product is a clear, colorless to slightly yellow solution. Drug maker Portola Pharmaceuticals manufacturers a drug called andexanet alfa (AndexXa) that supposedly reverses Xarelto’s effects. TFPI by andexanet alfa resulted in a transient increase in the level of prothrombin fragments 1 and 2, thrombin-antithrombin complex and D-dimer. [4] As a condition of its accelerated approval there is a study being conducted comparing it to other currently used reversal agents ("usual care"). [1] It was developed by Portola Pharmaceuticals. [6] The FDA has demanded a randomised clinical trial: the first results are not expected before 2023. This publication expands on the interim report from 2015 (N Engl J Med 2015;373:2413-24) on the safety and efficacy of andexanet alfa treatment for patients with major bleeding following recent factor Xa inhibitor use. While people who were expected to die in 30 days were excluded from the study, 14% of participants died. Andexanet alfa (AA) is an antidote for factor Xa inhibitors and its usage has been associated with thrombotic complications. August 16, 2016. Andexanet alfa (andexanet) is a specific reversal agent that is designed to neutralize the anticoagulant effects of both direct and indirect factor Xa inhibitors. The trick is to ensure that benefit is likely to outweigh that harm. Among the watchful eyes will surely be a handful of big pharma players — Pfizer Inc., Bristol-Myers Squibb Co., Daiichi Sankyo Inc., Bayer Pharma AG and Janssen Pharmaceuticals Inc. — that have partnered with Portola to develop the highly anticipated drug. Properties. Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to … Andexanet alfa for the reversal of Factor Xa inhibitor related anticoagulation.

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