Same Dose of PRAXBIND is Recommended for all PRADAXA Patients1

Download Instruction For Use PDF

PRAXBIND is for intravenous use only.1

Recommended Dose1

  • Total 5 g dose: Provided as two separate vials each containing 2.5 g/50 mL idarucizumab
  • Additional 5 g dose: There are limited data to support administration of an additional 5 g of PRAXBIND
  • No reconstitution is needed

Preparation1

  • Ensure aseptic handling when preparing and administering 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
PRAXBIND Packaging

Flexible Administration Options for Immediate Reversal1

Important Considerations

  • Do not mix PRAXBIND with other medicinal products1
  • 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 access1

There are 2 OPTIONS for administering PRAXBIND

Infusion hook

Option 1: Infusion

Hang vials and administer as two consecutive infusions1

Syringe application

Option 2: Bolus Injection

Inject both vials consecutively via syringe1

Watch How to Prepare and Administer PRAXBIND

Video thumbnail - How to Prepare and Administer PRAXBIND

Restarting PRADAXA1

  • Patients being treated with Pradaxa® (dabigatran etexilate) therapy have underlying diseases that predispose them to thromboembolic events. Reversing PRADAXA 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.
  • PRAXBIND is a specific reversal agent for PRADAXA, with no impact on the effect of other anticoagulant or antithrombotic therapies.
    • PRADAXA can be re-initiated after 24 hours following PRAXBIND administration.

PRAXBIND can be used
in conjunction with standard supportive measures
as medically appropriate

See supportive measures here

Handling Your PRAXBIND Supply

  • Storage: PRAXBIND vials must be refrigerated between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake1
  • Prior to use: Unopened vials may be kept at room temperature 25°C (77°F) for up to 48 hours if kept in original packaging
    • PRAXBIND packaging protects it from light. When PRAXBIND is exposed to light it may be kept for 6 hours1
  • Supply information: NDC number 0597-0197-05: Carton containing two 2.5 g/50 mL vials1

PRAXBIND is stocked in over 3,300+ locations nationwide2*

Find PRAXBIND near you

*Accurate as of 12/28/2018, based on the current information provided to Boehringer Ingelheim Pharmaceuticals, Inc. The company cannot guarantee the availability of PRAXBIND at all facilities in every state.

References: 1. PRAXBIND [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. Revised 02/2019: PC-US-103643-R1

INDICATIONS AND USAGE FOR PRAXBIND

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Praxbind® (idarucizumab) is indicated 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

IMPORTANT SAFETY INFORMATION FOR PRAXBIND

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WARNINGS AND PRECAUTIONS

Thromboembolic Risk

  • Dabigatran-treated patients have underlying diseases predisposing them to thromboembolic events. Reversing dabigatran therapy exposes patients to thrombotic risk. Consider resumption of anticoagulant therapy as soon as medically appropriate.

Re-elevation of Coagulation Parameters

  • Elevated coagulation parameters (eg, activated partial thromboplastin time or ecarin clotting time) have been observed in a limited number of PRAXBIND-treated patients. If reappearance of clinically relevant bleeding together with elevated coagulation parameters is observed, or if patients requiring a second emergency surgery/urgent procedure have elevated coagulation parameters, an additional full dose may be considered.

Hypersensitivity Reactions

  • There is insufficient clinical experience evaluating risk of hypersensitivity to idarucizumab, but a possible relationship could not be excluded. Risk of hypersensitivity (eg, anaphylactoid reaction) to idarucizumab or excipients needs to be weighed cautiously against the potential benefit. If serious allergic reaction occurs, immediately discontinue PRAXBIND and institute appropriate treatment.

Risk in Patients With Hereditary Fructose Intolerance

  • PRAXBIND contains 4 g sorbitol as an excipient. When prescribing PRAXBIND in patients with hereditary fructose intolerance, consider the total daily amount of sorbitol/fructose consumption from all sources, as serious adverse reactions (eg, hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure, and death) may occur.

ADVERSE REACTIONS

  • The most frequently reported adverse reaction in ≥5% of idarucizumab-treated healthy volunteers was headache (5%). The most frequently reported adverse reactions in ≥5% of patients were constipation (7%) and nausea (5%).
  • Treatment-emergent antibodies with low titers were observed in 4% of healthy subjects and 2% of patients treated with idarucizumab.

USE IN SPECIFIC POPULATIONS

Pregnancy and Lactation

  • PRAXBIND should be given to a pregnant woman only if clearly needed. Caution should be exercised when PRAXBIND is administered to a nursing woman.

CL-PB-100001 April 2018

Please click here for full Prescribing Information for PRAXBIND.