Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Idarucizumab binds specifically to dabigatran and reverses its anticoagulant effect. It will not reverse the effects of other anticoagulants (see section 5.1).

Praxbind                                                                     Updated prescribing information Solution for I.V. injection/infusion 50mg/ml                                                    August 2020 Praxbind treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.


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 section 4.2).

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 section 5.2). The transient proteinuria is not indicative of renal damage, which should be taken into account for urine testing.

Sodium content

This medicinal product contains 50 mg sodium per dose, equivalent to 2.5 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Effects on Driving

4.7 Effects on ability to drive and use machines
Not relevant.