Praxbind Special Precautions

Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants (see Pharmacology: Pharmacodynamics under Actions).
Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.
Hypersensitivity: The risk of using Praxbind in patients with known hypersensitivity (e.g. anaphylactoid reaction) to idarucizumab or to any of the excipients needs to be weighed cautiously against the potential benefit of such an emergency treatment. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Praxbind should be discontinued immediately and appropriate therapy initiated.
Hereditary fructose intolerance: The recommended dose of Praxbind contains 4 g sorbitol as an excipient. In patients with hereditary fructose intolerance, parenteral administration of sorbitol has been associated with reports of hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function, and death. Therefore, in patients with hereditary fructose intolerance the risk of treatment with Praxbind must be weighed against the potential benefit of such an emergency treatment. If Praxbind is administered in these patients, intensified medical care during Praxbind exposure and within 24 hours of exposure is required.
Thromboembolic Events: Patients being 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, resumption of anticoagulant therapy should be considered as soon as medically appropriate (see Dosage & Administration).
Urinary protein testing: Praxbind causes transient proteinuria as a physiologic reaction to renal protein overflow after bolus/short term application of 5g idarucizumab intravenously (see Pharmacology: Pharmacokinetics under Actions). The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.
Sodium content: This medicinal product contains 2,2 mmol (or 50 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
Effects on Ability to Drive and Use Machines: Not relevant.
Impairment of Fertility: There are no data on the effect of Praxbind on fertility (see Pharmacology: Toxicology under Actions).