Idarucizumab

What is Idarucizumab?

Idarucizumab (PRAXBIND) is a humanized monoclonal antibody fragment (Fab) used in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

What are the uses of this medicine?

This medicine is used in patients treated with Pradaxa® when reversal of the anticoagulant effects of dabigatran is needed:

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

How does this medicine work?

• Idarucizumab is a specific reversal agent for dabigatran.
• It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with PRAXBIND.

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

Recommended Dosage:

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

Administration

• 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. The solution in vials may be stored at room temperature, 25°C (77°F), but must be used within 6 hours.
• 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 or
• Bolus injection by injecting both vials consecutively one after another via syringe.
• 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.
• Pradaxa treatment can be initiated 24 hours after administration of PRAXBIND.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 2.5 g/50 mL solution in a single-dose vial

This medicine is available in fallowing brand namesː

• PRAXBIND

What side effects can this medication cause?

The most common side effects of this medicine include:

• headache
• constipation
• nausea

What special precautions should I follow?

• Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate.
• In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered.
• 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.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• Safety and effectiveness have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient: IDARUCIZUMAB

Inactive ingredients:

Who manufactures and distributes this medicine?

• Packager: Boehringer Ingelheim Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store PRAXBIND vials in the refrigerator at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light.
• Do not freeze.
• Do not shake.
• PRAXBIND vials may be stored at room temperature, 25°C (77°F), for up to 48 hours in the original carton to protect from light.
• PRAXBIND vials may be stored at room temperature, 25°C (77°F), out of the carton and exposed to light but must be used within 6 hours

• Dailymed label info on Idarucizumab
• FDA Idarucizumab

Idarucizumab Resources
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