ONDEXXYA® is the FIRST AND
ONLY ANTIDOTE for apixaban
and rivaroxaban1,2*†
in adult patients treated with FXa inhibitors (rivaroxaban or apixaban) when rapid reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding1
ONDEXXYA®, indicated for adult patients treated with FXa inhibitors (rivaroxaban or apixaban)
when rapid reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for ONDEXXYA® please refer to Health Canada’s Notice of Compliance with conditions – drug products website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/ notice-compliance/conditions.html.1
ONDEXXYA® 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
Click here for additional safety information and for a link to the product monograph discussing:
The most serious warnings and precautions regarding the risk of serious and life-threatening adverse events, including arterial and venous thromboembolic events, ischemic events, including myocardial infarction and ischemic stroke, cardiac arrest, and the thrombotic risk of the patient’s underlying disease1
Other relevant warnings and precautions regarding the time course of reversal of anti-FXa activity, treatment monitoring, use in conjunction with supportive measures other than standard hemostatic supportive measures, interaction with heparin, infusion-related reactions, the potential for immunogenicity, and use in pregnant or breastfeeding women1
Conditions of clinical use, adverse reactions, drug interactions, and dosing instructions
* Clinical significance unknown.
† Comparative clinical significance has not been established.
References: 1. ONDEXXYA® Product Monograph. AstraZeneca Canada Inc. June 16, 2023. 2. Data on file. AstraZeneca Canada Inc. May 11, 2023.