Use for edoxaban- or enoxaparin-reversal is not recommended due to lack of data. Andexanet alfa is not suitable for pre-treatment of urgent surgery.
4.3 ContraindicationsĬlinical efficacy is based upon reversal of anti-FXa-activity in healthy volunteers and bleeding patients dosed with apixaban or rivaroxaban. Ondexxya is administered as an IV 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 (low dose) or 8 mg (high dose) per minute for 120 minutes (see table 1).įor instructions on reconstitution of the medicinal product before administration, see section 6.6. Prior to administration by IV infusion a 0.2 or 0.22 micron in-line polyethersulfone (PES) or equivalent low protein- binding filter should be used. No data are available.Īfter an appropriate number of vials of Ondexxya has been reconstituted, the reconstituted solution (10 mg/mL) without further dilution is transferred to sterile large volume syringes in case a syringe pump is used for administration or to suitable empty intravenous bags comprised of polyolefin (PO) or polyvinyl chloride (PVC) material (see section 6.6). Paediatric population: The safety and efficacy of andexanet alfa in children and adolescents have not been established. The safety and efficacy have not been studied in patients with hepatic impairment (see section 5.2).
Hepatic impairment: Based on the existing data on clearance of andexanet alfa, no dose adjustment is recommended. Based on the existing data on clearance, no dose adjustment is recommended. Renal impairment: The effect of renal impairment on andexanet alfa exposure levels has not been evaluated. Medical judgement should balance the benefits of anticoagulation with the risks of re-bleeding (see section 4.4).Įlderly patients (aged 65 years and over): No dose adjustment is required in elderly patients (see section 5.2). Timing of last dose before Ondexxya initiationįollowing administration of Ondexxya and cessation of a major bleed, re-anticoagulation should be considered to prevent thrombotic events due to the patient's underlying medical condition.Īntithrombotic therapy can be re-initiated as soon as medically indicated following treatment if the patient is clinically stable and adequate haemostasis has been achieved.
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