PRAXBIND®

Side effects and safety

Contraindications

None.

Special warnings and precautions

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

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.

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.

Re-elevation of Coagulation Parameters

In a limited number of patients in the clinical program, between 12 and 24 hours after administration of 5 g idarucizumab, elevated coagulation parameters (e.g., activated partial thromboplastin time [aPTT] or ecarin clotting time [ECT]) have been observed.

If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed after administration of 5 g PRAXBIND®, administration of an additional 5 g dose of PRAXBIND® may be considered. Similarly, patients who require a second emergency surgery/urgent procedure and have elevated coagulation parameters may receive an additional 5 g dose of PRAXBIND®.

The safety and effectiveness of repeat treatment with PRAXBIND® have not been established.

Traceability

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

Side effects

In a phase III trial the safety of PRAXBIND® has been evaluated in 503 patients, who had uncontrolled bleeding or required emergency surgery or procedures and were under treatment with PRADAXA®, as well as in 224 volunteers in phase I trials.

No adverse reactions have been identified.