See important safety information, including boxed warning, in the attached prescribing information.

Participants with coagulopathies or clotting disorders were not explicitly excluded from the placebo-controlled studies.1,2

However, participants were excluded if they had current serious or unstable illnesses including hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in the studies.1,2

The safety and efficacy of donanemab in this population have not been established. Clinicians are encouraged to use their independent clinical judgment to determine whether an individual patient with a comorbid coagulopathy is a candidate for treatment with donanemab.

Donanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody and is expected to be degraded by proteolytic enzymes in the same manner as endogenous IgG.3

As such, donanemab is not expected to

• inhibit metabolic or induce enzymatic pathways
• be metabolized by the cytochrome P450 families of drug-metabolizing enzymes, or
• produce any active metabolites.4

No formal drug interaction studies were performed with donanemab. No pharmacokinetic drug interactions are expected based on the characteristics of donanemab.4

Antithrombotic medications were allowed in the TRAILBLAZER-ALZ 2 study, including antiplatelet and anticoagulant medications.2 The majority of exposures to antithrombotic medications were to aspirin, with reported use in 81% of donanemab-treated participants.3,4 Other antithrombotic medications included thrombolytics, non-aspirin antiplatelets, and anticoagulants including heparins, warfarin, and direct oral anticoagulants.4

The number of events and the limited exposure to non-aspirin antithrombotic medications limit definitive conclusions about the risk of amyloid-related imaging abnormalities (ARIA) or intracerebral hemorrhage in participants taking antithrombotic medications.3

A fatal intracranial hemorrhage occurred in a participant treated with donanemab in the setting of focal neurological symptoms of ARIA and the use of a thrombolytic agent (eg, tissue plasminogen activator). Focal neurologic symptoms of ARIA-edema (ARIA-E) can mimic an ischemic stroke and treating clinicians should consider whether such symptoms could be due to ARIA-E before giving thrombolytic therapy in a patient being treated with donanemab.3

Caution should be exercised when considering the use of donanemab in patients with factors that indicate an increased risk for intracerebral hemorrhage and in particular for patients who need to be on anticoagulant therapy or patients with findings on MRI that are suggestive of cerebral amyloid angiopathy.3

KISUNLA™ (donanemab-azbt) injecton, for intravenous use, Lilly

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).