Andexanet alfa (Ondexxya®) is a specific reversal agent indicated for adults treated with a direct factor Xa (FXa) inhibitor (rivaroxaban or apixaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate. Evidence-based information on rivaroxaban from British National Formulary - BNF for health and social care. Andexanet alfa is currently being studied to see how well it works and whether it is safe to use. Darbepoetin alfa Both dalteparin and darbepoetin alfa can increase the risk of hyperkalaemia (hyperkalaemia is particularly notable when ACE inhibitors or angiotensin-II receptor antagonists are given with spironolactone or eplerenone). 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. An antidote for the factor Xa inhibitors apixaban and rivaroxaban (andexanet alfa) is undergoing NICE assessment. As a medication, it is mainly used to treat methemoglobinemia. N Engl J Med. Andexanet alfa 400 mg IV bolus (30 mg per minute) (part 1) or as a 400 mg IV bolus followed by a continuous infusion of 4 mg per minute for 120 minutes (480 mg in total) were trial doses Interactions. Siegal DM, Curnutte JT, Connolly SJ, et al. Back pain, chest pain, stroke,cough References. Specialist haematological advice should be sought regarding strategies for the reversal of the anticoagulant effects of DOACs. Andexanet alfa (Ondexxya)A new recombinant form of human factor X a, which binds specifically to apixaban or rivaroxaban, thereby reversing their anticoagulant effects.To be used under specialist supervision in hospitals only for life-threatening or uncontrolled bleeding. 2 Information about andexanet alfa Marketing authorisation indication 2.1 Andexanet alfa (Ondexxya, Portola Pharmaceuticals) has a conditional marketing authorisation for 'adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding'. February 2021 BNF/BNFC Newsletter Newsletter notes new drug monographs added include treprostini in BNF, caplacizumab in BNFC, and COVID-19 vaccine to both BNFs. Atezolizumab (Tecentriq®) with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer [NICE guidance]. Reversal of anticoagulation. Andexanet alfa (Ondexxya®): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa [MHRA/CHM advice]. The safety and efficacy of an additional dose have not been established. A specific reversal agent (andexanet alfa) antagonising the pharmacodynamic effect of rivaroxaban is available for adults, but not established in children (refer to the Summary of Product Characteristics of andexanet alfa). BNF Link. 2.8.4. 2015;373(25):2413-2424. Connolly SJ, Crowther M, Eikelbloom JW, et al. Dose. Andexanet alfa reverses the effects of anticoagulants, allowing the blood to clot normally again in an emergency. Protamine sulphate. Andexanet alfa for the reversal of factor Xa inhibitor activity. The use of activated charcoal to reduce absorption in case of rivaroxaban overdose may be considered. The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials. It also covers MHRA advice on andexanet alfa… Total Formulary PROTAMINE . N Engl J Med. Table 1: ANDEXXA Dosing Regimens; Dose* Initial IV Bolus Follow-On IV Infusion Total Number of 200 mg Vials * The safety and … Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. Andexanet alfa (andexanet) is a specific reversal agent that is designed to neutralize the anticoagulant effects of both direct and indirect factor Xa inhibitors. An antidote for dabigatran (idarucizumab – hospital only) is now available. See BNF Side effects. 26 Andexanet alfa also reversed betrixaban in a healthy control study. 2.8.3. 27, 28 Only 10 edoxaban‐treated patients were enrolled in ANNEXA‐4, though there is a plan to enroll more in an extension of the study in Germany and Japan. Andexanet alfa can be used in conjunction with standard haemostatic supportive measures, which should be considered as medically appropriate. Andexanet alfa has been shown to reverse edoxaban in a rabbit bleeding model and in healthy volunteers. The safety of andexanet alfa has not been evaluated in patients who received prothrombin complex concentrates, recombinant factor VIIa, or whole blood within seven days prior to the bleeding event, as they were excluded from clinical trials. Andexanet alfa is supported by two published, parallel, randomised, double-blind, placebo-controlled phase 3 studies (n=145) of IV andexanet used to reverse anticoagulation with apixaban (ANNEXA-A) or rivaroxaban ANNEXA-R) in healthy older volunteers. Also refer to the BNF. Andexanet alfa is injected directly into the bloodstream of patients who are taking anticoagulants and bleeding. Methylene blue, also known as methylthioninium chloride, is a medication and dye. Generic name: andexanet alfa 100mg in 10mL Dosage form: injection, powder, lyophilized, for solution For intravenous (IV) use only. It has previously been used for cyanide poisoning and urinary tract infections, but this use is no longer recommended. BNF Link. See Tayside ADTC Supplement 175 - August 2019 for further information. See BNF Cautions. Toggle navigation qehkl-bnf Formulary Report. It also covers MHRA advice on andexanet alfa, dimethyl fumarate, erythromycin, fingolimod, methylprednisolone and quinolones. Management of bleeding. Direct acting oral anticoagulants (DOACs) are not recommended treatment for patients with antiphospholipid syndrome (APS). BNF 79 now available! Risks of thrombosis Contraindications. In two phase 3 trials (ANNEXA-A and ANNEXA-R), andexanet alfa was shown to reverse the anti-coagulant activity of apixaban and rivaroxaban in older healthy participants within minutes after administration and for the duration of infusion, without evidence of clinical toxic effects. • Andexanet alfa (Ondexxya®): avoid use of andexanet prior to heparinisation [MHRA/CHM advice]. In the study, andexanet alfa was well tolerated, with no serious adverse events, thrombotic events, or antibodies to … The following summary provides a brief description of some of the key changes that have been made to BnF content since the last print edition (BnF 78) was published. public Back. In patients at extremes of weight (BMI <18.5kg/m 2 or >40kg/m 2) see BNF advice for appropriate measure of renal function for adjusting drug dosages. Newsletter notes new drug monographs added include treprostini in BNF, caplacizumab in BNFC, and COVID-19 vaccine to both BNFs. Andexanet alfa is a recombinant modified FXa protein. andexanet alfa (Ondexxya) SMC ID: SMC2273 Indication: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. • that andexanet alfa used for edoxaban reversal would be off-label use. Andexanet alfa Status filter ... andexanet alfa: Non-Formulary apixaban: Formulary NICE TA245 NICE TA275 NICE TA341 : argatroban monohydrate: Restricted aspirin: Formulary bivalirudin: Formulary clopidogrel: Formulary NICE TA210 : dabigatran etexilate: Formulary NICE TA157 NICE TA249 NICE TA327 : dalteparin sodium: Formulary … Purchase your copy. Specifically, it is used to treat methemoglobin levels that are greater than 30% or in which there are symptoms despite oxygen therapy. Use of andexanet alfa for the reversal of edoxaban is off-label. Step-by-step dosing & administration 1. bnf . Idarucizumab is licensed for the reversal of dabigatran in life-threatening or uncontrolled bleeding, or for preparation for emergency or urgent procedures. 3. Restrictions: Restricted to specialist use only. There is no data to support use, however due to the mechanism of action [of andexanet alfa] there is reason to believe it would work. Andexanet alfa is licensed for the reversal of apixaban and rivaroxaban in cases of life-threatening or uncontrolled bleeding. • Atezolizumab with bevacizumab for treating advanced or unresectable hepatocellular carcinoma [NICE guidance]. Compiled with the advice of clinical experts and continually updated to reflect the latest evidence from credible sources worldwide, the new edition of the British National Formulary 79 (BNF) provides up-to-date guidance on prescribing, dispensing, and administering medicines. BnF is published in print twice a year and interim updates are issued and published monthly in the digital versions. 2019;380(14):1326-1335. For dosing, choose either the low dose or high dose based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the … There are two dosing regimens (see Table 1).
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