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CHOOSE AN EXTENDED HALF-LIFE rFVIII WITH A FAST INFUSION

Esperoct® can be infused in ~2 minutes to fit in your patients’ lives.1

Esperoct® infusion
Esperoct® infusion

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

 MixPro® device
 MixPro® device

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 (30˚C) 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, this is not the complete Esperoct® instructions for use. Please refer to the Instructions for Use included in the Prescribing Information.

Count on the proven safety profile of Esperoct®.

Starting patients on Esperoct®.

Esperoct® package

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Selected 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

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 Prescribing Information

Reference:

  1. Esperoct® Summary of Product Characteristics, Novo Nordisk, 2019.