![]() ![]() ![]() Unknown if distributed in human breast milkĬonsider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition Pregnancy CategoriesĪ: Generally acceptable. Has not been studied for use during labor and delivery Lactation There are no adequate and well-controlled studies of idarucizumab in pregnant women to inform on associated risksĪnimal 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 The safety and effectiveness of repeat treatment with idarucizumab have not been established.Similarly, patients who require a second emergency surgery/urgent procedure and have elevated coagulation parameters may receive an additional 5-g dose. ![]() If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed after administering idarucizumab 5 g, administration of an additional 5 g dose may be considered.In a limited number of patients in the clinical program, between 12-24 hr after administrating idarucizumab 5 g, elevated coagulation parameters (eg, aPTT, ECT) have been observed.There is insufficient clinical experience to evaluate risk of hypersensitivity to idarucizumab discontinue if a serious hypersensitivity reaction occursĬaution 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 Re-elevation of coagulation parameters 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 ![]()
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