Idarucizumab

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Indications

PRAXBIND is indicated in patients treated with dabigatran when reversal of the anticoagulant effects of this drug is needed:

• For emergency surgery/urgent procedures
• In life-threatening or uncontrolled bleeding

This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study.

Dosage

• For intravenous use only.

• The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1).

• There is limited data to support administration of an additional 5 g of PRAXBIND.

• Restarting Antithrombotic Therapy

• Patients being treated with dabigatran therapy 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.

• Idarucizumab is a specific reversal agent for dabigatran, with no impact on the effect of other anticoagulant or antithrombotic therapies.

• Dabigatran treatment can be initiated 24 hours after administration of PRAXBIND.

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Thromboembolic Risk

Patients being treated with dabigatran therapy 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.

Hypersensitivity Reactions

There is insufficient clinical experience with PRAXBIND in patients to evaluate risk of hypersensitivity to idarucizumab. In clinical studies adverse events possibly indicative of hypersensitivity reactions where a possible relationship could not be excluded were reported. 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, immediately discontinue administration of PRAXBIND and institute appropriate treatment.

Risks of Serious Adverse Reactions in Patients with Hereditary Fructose Intolerance due to Sorbitol Excipient

In patients with the condition of hereditary fructose intolerance who have received parenteral administration of sorbitol, serious adverse reactions, including fatal reactions, have been reported. Reactions have included hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure with breakdown of excretory and synthetic function.

The recommended dose of PRAXBIND contains 4 g sorbitol as an excipient. When prescribing PRAXBIND to patients with hereditary fructose intolerance consider the combined daily metabolic load of sorbitol/fructose from all sources, including PRAXBIND and other drugs containing sorbitol. The minimum amount of sorbitol at which serious adverse reactions may occur in these patients is not known.

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• Preparation

• Ensure aseptic handling when preparing the infusion.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Once solution has been removed from the vial, administration should begin promptly or within 1 hour.

• Administration
• Do not mix with other medicinal products. Use aseptic technique when administering PRAXBIND.
• Intravenously administer the dose of 5 g (2 vials, each contains 2.5 g) as

• Two consecutive infusions (see Figure 2) or
• Bolus injection by injecting both vials consecutively one after another via syringe (see Figure 3).

• A pre-existing intravenous line may be used for administration of PRAXBIND. The line must be flushed with sterile 0.9% Sodium Chloride Injection, USP solution prior to infusion. No other infusion should be administered in parallel via the same intravenous access.
• PRAXBIND treatment can be used in conjunction with standard supportive measures, which should be considered as medically appropriate.

This image is provided by the National Library of Medicine.

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Idarucizumab
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