Idarucizumab

DEA Class; Rx

Common Brand Names; Praxbind

None

Patients treated with dabigatran have underlying disease states that predispose them to thromboembolic events; reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease; to reduce this risk, resume anticoagulant therapy as soon as medically appropriate

There is insufficient clinical experience to evaluate risk of hypersensitivity to idarucizumab; discontinue if a serious hypersensitivity reaction occurs

Caution with hereditary fructose intolerance; the recommended dose of idarucizumab contains 4 g sorbitol as an excipient; when prescribing to patients with hereditary fructose intolerance, consider the combined daily metabolic load of sorbitol/fructose from all sources; administration of sorbitol in these patients is known to cause serious adverse reactions, including fatal reactions including hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, and acute liver failure with breakdown of excretory and synthetic function

There are no adequate and well-controlled studies of idarucizumab in pregnant women to inform on associated risks

Animal reproductive and development studies have not been conducted; it is also not known whether idarucizumab can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

Has not been studied for use during labor and delivery

Unknown if distributed in human breast milk