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 Studies a U.S.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) request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.find information in order to request access to clinical study data, for listed studies.Requestors can use the following link to: studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials 3.

studies in products where Boehringer Ingelheim is not the license holder 2.

Individual Participant Data (IPD) Sharing Statement:Ĭlinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. Related Info Layout table for additonal information

Why Should I Register and Submit Results?.

Praxbind cost