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Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo
Important Safety Information | Patient Site
Prescribing Information
    • Pharmacology
    • Mechanism of Action
    • Prophylaxis
    • On Demand
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    • Safety Profile
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Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo

Indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Esperoct® is not indicated for the treatment of von Willebrand disease.

Prescribing Information
Important Safety Information | Patient Site

Ready when they are

Esperoct® provides storage temperatures up to 104˚F for up to 3 months or 86˚F for up to 12 months and can be reconstituted in just 3 steps with MixPro®.1 

Esperoct® package, injection, vial

What’s included in the Esperoct® package:

Single-dose vial with color-coded cap

Differentiate dose strengths through color-coded vial caps.1

Esperoct® multiple vial sizes

Vial adapter

Connects the syringe and vial, with a 25-μm inline particle filter.1

Esperoct® vial adapter

MixPro® prefilled
diluent syringe

Latex-free syringe contains 4 mL of 0.9% saline solution—works with all dose strengths.1

MixPro® syringe

Basic reconstitution in 3 steps

1. Attach

Esperoct® reconstitute in 3 steps - attach

2. Twist

Esperoct® reconstitute in 3 steps - twist

3. Mix

Esperoct® reconstitute in 3 steps - mix

After mixing, the reconstituted solution can be stored for use within 4 hours at up to 86˚F.1

These are not the complete Esperoct® Instructions for Use. Please refer to the Instructions for Use provided with the Prescribing Information.

Prescribing Information | Important Safety Information
Esperoct® MixPro® Reconstitution Video
(7:31)
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Esperoct® MixPro® Reconstitution Video
Patients can learn how to prepare a dose of Esperoct® with the MixPro® syringe. It’s as easy as attach, twist, mix.
Watch video
Prescribing Information | Important Safety Information

Preparation

  • Always wash hands and ensure that the area is clean before performing the reconstitution procedures
  • Use aseptic technique during the reconstitution procedures
  • If the dose requires more than one vial of Esperoct® per infusion, reconstitute each vial according to the instructions

Administration: For intravenous infusion only

Esperoct® administration

Administer using the following procedure:

  1. Invert the Esperoct® vial and slowly draw the solution into the syringe. 
  2. Detach the syringe from the vial adapter by turning the syringe counterclockwise. 
  3. Attach the syringe to the luer end of an infusion needle set. 
  4. Infuse the reconstituted Esperoct® intravenously slowly over approximately 2 minutes. 
  5. After infusion, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused Esperoct®, and other waste materials. 
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The solution should be clear and have no particles. Do not use if particulate matter or discoloration is observed
  • Do not administer Esperoct® in the same tubing or container with other medicinal products 
  • Administer the Esperoct® solution immediately. If not used immediately after the reconstitution, store the solution in the vial with the vial adapter and the syringe attached, at room temperature ≤ 86˚F (30ºC) for ≤ 4 hours, or stored in a refrigerator at 36˚F to 46˚F (2˚C to 8˚C) for ≤ 24 hours

Caution:

  • The pre-filled diluent syringe is made of glass with an internal tip diameter of 0.037 inches, and is compatible with a standard Luer-lock connector. 
  • Some needleless connectors for intravenous catheters are incompatible with the glass diluent syringes (for example, certain connectors with an internal spike, such as Clave®/MicroClave®, InVision-Plus®, InVision-Plus CS®, Invision-Plus Junior®, Bionector®), and their use can damage the connector and affect administration. To administer Esperoct® through incompatible needleless connectors, withdraw the reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe.

Please note, these are not the complete Esperoct® Instructions for Use. Please refer to the Instructions for Use included in the Prescribing Information.

Esperoct® adult walking outside

For your patients: Starting Esperoct®

Novo Nordisk is here to help your hemophilia A patients who want to make the switch to Esperoct®. Learn about our trial prescriptiona and product support programs.

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.

aPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance or who are uninsured, may be eligible to receive a limited supply of free product. Patients who participate in any government, state, or federally funded medical or prescription benefit program, including Medicare, Medicaid, Medigap, VA, DOD, and TRICARE, including patients who participate in a managed Medicaid program or have Medicaid as secondary insurance, are not eligible to receive product support. Product is provided at no cost to the patient or the HCP and is not contingent on any product purchase, and the patient and HCP must not: (1) bill any third party for the free product, or (2) resell the free product.

Largest longest EHL clinical trial program

Count on the clinical trial experience of Esperoct®.

View safety data

Starting patients on Esperoct®

Esperoct® package

Novo Nordisk provides resources to help your patient get started on Esperoct®.

See how we can help

Selected Important Safety Information for Esperoct®

Contraindications

  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment

Indications and Usage

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes

  • Esperoct® is not indicated for the treatment of von Willebrand disease

Important Safety Information

Contraindications

  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment
  • Development of neutralizing antibodies (inhibitors) has occurred. Perform an assay that measures Factor VIII inhibitor concentration if bleeding is not controlled with the recommended dose of Esperoct® or if the expected plasma Factor VIII activity levels are not attained

Adverse Reactions

  • The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions

Please click here for Esperoct® Prescribing Information.

Reference:

  1. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
Rare Bleeding Disorders
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Esperoct®, NovoCare®, and MixPro® are registered trademarks and novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.
Non-US Health Care Professionals, please go to www.novonordiskpro.com.

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