![]() Since IV administration of sorbitol in patients with hereditary fructose intolerance has been reported to result in serious reactions (eg, acute hepatic failure, hypoglycemia, hypophosphatemia, metabolic acidosis, uric acid elevations) including fatalities, consider the combined daily metabolic load of sorbitol/fructose from all sources including idarucizumab and other drugs containing sorbitol minimum amount of sorbitol known to cause serious adverse reactions is unknown. Hereditary fructose intolerance: Formulation contains 4 grams of sorbitol as an excipient.In the phase 3 clinical trial, not all thromboembolic events that occurred reflected the underlying disease state being treated with dabigatran adverse thromboembolic events included DVT, PE, atrial thrombus, NSTEMI, and ischemic stroke (Giannandrea 2018 Pollack 2015). Dabigatran can be re-initiated 24 hours after idarucizumab administration if appropriate. Thromboembolic risk: Since patients being treated with dabigatran, have underlying disease states predisposing them to thromboembolic events and reversing the effects of dabigatran will expose the patient to an elevated thrombotic risk resume anticoagulant therapy as soon as it is appropriate.Discontinue use if serious allergic reaction occurs (eg, anaphylaxis) and institute appropriate management. The risk of using idarucizumab in patients with known hypersensitivity (eg, anaphylactoid reaction) to idarucizumab or any of the components of the formulation should be evaluated cautiously against the potential benefit of emergency dabigatran reversal. Hypersensitivity reactions: Although there is insufficient clinical experience with idarucizumab to fully evaluate the risk of hypersensitivity reactions, some reported adverse events possibly indicative of hypersensitivity reactions could not exclude a potential relationship.
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