Management of bleeding and availability of reversal agents *In patients with serum creatinine ≥1.5mg/dL (133micromole/L) associated with age ≥80 years or body weight ≤60kg. Should only be used in some indications after a careful evaluation of the individual thromboembolic and bleeding risk Table 1 - Recommendations for use of DOACs in patients with renal impairment Severity of renal impairment (creatinine clearance) Refer to table 1 and product information for specific dosing recommendations. In patients with severe renal impairment (creatinine clearance of lower than 30mL/min) use of dabigatran is contraindicated, while other DOACs should be used with caution or at a reduced dose. The product information for dabigatran and edoxaban advises to assess renal function if a decline in function is suspected during treatment (for example, due to hypovolaemia, dehydration, and in case of concomitant use of certain medicinal products).ĭOACs can be used in patients with moderate renal impairment (creatinine clearance of 30mL/min or higher) but a reduced dose may be required depending on the indication. Estimated glomerular filtration rate (eGFR) can overestimate renal function and increase the risk of bleeding events (see Drug Safety Update).ĭose adjustment may be necessary if renal function significantly changes during treatment. Calculate creatinine clearance (CrCl) in order to determine renal function for dosing of DOACs. Dose of DOACs depends on renal functionĮxposure to DOACs is increased in patients with renal impairment and it is therefore important that patients receive an appropriate dose depending on renal function. Strong inhibitors of P- glycoprotein or CYP3A4 (or both) increase circulating levels of DOACs therefore may be not recommended or may require DOAC dose reduction. Of note, DOACs should not be taken with other anticoagulants. Refer to product information (Summaries of Product Characteristics linked to above) for advice on use of DOACs with other medicines. Treatment with DOACs should be discontinued if severe bleeding occurs.ĭOACs interact with a number of medicines, some of which increase bleeding risk. Bleeding can occur at any site during treatment with DOACs. Although routine anticoagulant monitoring is not required for DOACs as it is for vitamin K antagonists, patients (particularly those with an increased bleeding risk) should be made aware of the risk of bleeding and be routinely examined clinically for signs of bleeding or anaemia. In many reported cases, patients have underlying factors that suggest they are at increased risk of bleeding events.įor this reason, DOACs should be used with caution in patients at increased risk of bleeding such as older people and patients with low body weight or renal impairment. We continue to receive reports of bleeds, often life-threatening or fatal, in association with DOACs in patients in the UK. Use of DOACs increases the risk of bleeding and can cause serious, potentially fatal, bleeds. Available DOACs include the direct factor Xa inhibitors apixaban ( Eliquis), edoxaban ( Lixiana▼), and rivaroxaban ( Xarelto▼) and the direct thrombin inhibitor dabigatran etexilate ( Pradaxa).
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Report suspected adverse drug reactions associated with DOACs on a Yellow Card, including thromboembolic or haemorrhagic eventsĭirect-acting oral anticoagulants (DOACs) are approved for a variety of uses related to anticoagulation (see full indications in further information section). Monitor the reversal effects of andexanet alfa using clinical parameters anti-FXa assays should not be used to measure the effectiveness of andexanet alfa as the results may not be reliable Specific DOAC reversal agents are available for dabigatran, apixaban, and rivaroxaban Remind patients of the signs and symptoms of bleeding and encourage them to always read the patient information leaflet that accompanies their medicinesĮnsure patients with renal impairment receive an appropriate dose (see advice below) and monitor renal function during treatment to ensure dose remains appropriate Remain vigilant for signs and symptoms of bleeding complications during treatment, especially patients with increased bleeding risk Use caution if prescribing direct-acting oral anticoagulants (DOACs) to patients at increased risk of bleeding (for example, older people or people with renal impairment)
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