Class: Biologic Therapy

Generic Name: idarucizumab

Trade Name: Praxbind

For which conditions is this drug approved? Praxbind® is indicated for patients specifically treated with Pradaxa® (dabigatran etexilate mesylate), an anti-clotting agent, when reversal of the anti-clotting effects of the agent is needed for emergency procedures, life-threatening instances, or uncontrolled bleeding.

What is the mechanism of action?  Praxbind is a monoclonal antibody made to reverse Pradaxa, a compound that directly blocks thrombin. Thrombin is a key element in the coagulation process. Praxbind binds with Pradaxa with higher affinity than the Pradaxa does to the thrombin. This allows thrombin to resume its role in the coagulation process in blood cells.

How is Praxbind typically given (administered)? Praxbind is given as an infusion into a vein.

What are the most common side effects of treatment with Praxbind?

• Hypokalemia (decreased potassium)
• Deleriuim
• Constipation
• Fever
• Pneumonia
• Headache

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What should patients be aware of after treatment with Praxbind?

• Get immediate medical attention if any signs or symptoms of bleeding occur.
• Patients need to be informed of signs and symptoms of allergic hypersensitivity reactions that may be experienced during or after injection of Praxbind.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should discuss resuming anticoagulant therapy (Pradaxa) after taking Praxbind with their doctors in order to keep their underlying disease under control.
• Patients with elevated coagulation parameters after an initial emergency surgery/urgent procedure may require an additional 5 g dose of Praxbind before a second surgery/urgent procedure.
• Patients with hypersensitivity reactions must discontinue Praxbind to be evaluated.
• Because Praxbind contains sorbitol, patients with hereditary fructose intolerance (HFI) may be at risk of adverse reactions including: hypoglycemia, hypophosphatemia, metabolic acidosis, an increase in uric acid, acute liver failure, or death.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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