IntravenousReversal of anticoagulant effectsAdult: For life-threatening or uncontrolled bleeding in patients treated with apixaban or rivaroxaban: Dosing regimen is based on the last dose and the timing of the last dose of apixaban or rivaroxaban before anticoagulation reversal. Low dose regimen: 400 mg IV bolus given at a rate of approx 30 mg/min over 15 minutes, followed by continuous IV infusion at a rate of 4 mg/min over 120 minutes. Administer the low dose regimen for reversal of ≤5 mg apixaban or ≤10 mg rivaroxaban given <8 hours or with unknown timing before reversal, or for any apixaban or rivaroxaban dose given ≥8 hours before reversal. High dose regimen: 800 mg IV bolus given at a rate of approx 30 mg/min over 30 minutes, followed by continuous IV infusion at a rate of 8 mg/min over 120 minutes. Administer the high dose regimen for reversal of >5 mg apixaban, >10 mg rivaroxaban, or an unknown apixaban or rivaroxaban dose given <8 hours or with unknown timing before reversal. Anticoagulant therapy may be restarted as soon as medically appropriate after treatment with andexanet alfa. Treatment recommendations may vary among countries (refer to country-specific product guidelines).
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Powder for solution for infusion: Reconstitute each vial required with 20 mL sterile water for inj (using ≥20 mL syringe and ≥20-gauge needle) to make a concentration of 10 mg/mL. Slowly inject the sterile water for inj into the vial, directing the stream towards the vial wall to minimise foaming; gently swirl until completely dissolved (approx 3-5 minutes). Do not shake. Discard if undissolved. Once all required vials are reconstituted, the solution may be withdrawn and transferred to sterile large volume syringes (for syringe pump administration), or suitable empty IV bags comprised of polyolefin or polyvinyl chloride (PVC) with a volume of ≤250 mL. Multiple 40-60 mL syringes or an equivalent 100 mL syringe may be used for the transfer of the reconstituted solution for continuous infusion. Refer to detailed product guidelines for specific instructions.
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Andexanet alfa may be used with standard haemostatic supportive measures when clinically appropriate. Avoid use before heparinisation. Pregnancy and lactation.
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Significant: Mild to moderate infusion-related reactions (e.g. flushing, rigors, chills, cough, dysgeusia, dyspnoea).
General disorders and administration site conditions: Pyrexia.
Nervous system disorders: Cerebral infarction.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Pneumonia.
Vascular disorders: Iliac artery occlusion.
Potentially Fatal: Arterial and venous thromboembolic events, ischaemic events (e.g. MI, ischaemic stroke), cardiac arrest.
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IV: Z (Not recommended. Consult product literature for specific recommendations.)
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Assess for signs and symptoms of haemostasis, arterial and venous thromboembolic events, cardiac arrest, or ischaemic events.
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May reduce the therapeutic effects of heparin.
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May interfere with the anti-factor Xa activity test, resulting in falsely elevated anti-factor Xa activity and thereby causing underestimation of reversal activity.
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Description:
Overview: Andexanet alfa is a recombinant modified form of the human factor Xa protein and a specific reversal agent for factor Xa inhibitors. It has been modified to lack factor Xa enzymatic activity by substituting the active site serine with alanine, which prevents prothrombin cleavage and activation, and removing the gamma-carboxyglutamic acid (Gla) domain to eliminate assembly into the prothrombinase complex, thereby removing potential anticoagulant effects.
Mechanism of Action: Andexanet alfa binds and sequesters the factor Xa inhibitors, rivaroxaban and apixaban. It also binds to and inhibits the tissue factor pathway inhibitor (TFPI).
Pharmacodynamics: Bolus administration of andexanet alfa results in a rapid reduction of anti-factor Xa activity, which is maintained throughout the continuous IV infusion. In addition, inhibition of TFPI activity enhances tissue factor (TF)-initiated thrombin generation, resulting in a pro-coagulant effect.
Onset: Rapid.
Pharmacokinetics:
Excretion: Elimination half-life: Low dose: 3.3 hours (range: 2.3-4 hours). High dose: 2.7 hours (range: 1.9-3.4 hours).
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Intact vial: Store between 2-8°C. Do not freeze. Reconstituted solution in vials: May store at room temperature for ≤8 hours or between 2-8°C for ≤24 hours. Reconstituted solution in IV bags: May store at room temperature for ≤8 hours. Storage recommendations may vary among countries and between individual products. Refer to specific product guidelines.
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V03AB38 - andexanet alfa ; Belongs to the class of antidotes. Used to reverse anticoagulant effects of factor Xa inhibitors.
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Andexanet Alfa (Coagulation Factor Xa [Recombinant], Inactivated). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/10/2025. Andexxa 200 mg Powder for Solution for Infusion (AstraZeneca Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/10/2025. Andexxa Injection, Powder, Lyophilized, for Solution (AstraZeneca Pharmaceuticals LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/10/2025. Brayfield A, Cadart C (eds). Andexanet Alfa. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/10/2025. Factor Xa, Andexanet Alfa. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 02/10/2025. Joint Formulary Committee. Andexanet Alfa. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/10/2025. Ondexxya 200 mg Powder for Solution for Infusion (AstraZeneca UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/10/2025.
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