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Reconstitution and administration.

MixPro® makes reconstitution quick and easy, to accommodate patients' busy lifestyles. Each vial comes with a prefilled syringe—no extra steps required to fill a syringe with diluent.1

Preparation

  • Always wash hands and ensure that the area is clean before performing the procedures
  • Use aseptic technique during the reconstitution procedures
  • If the patient uses more than one vial of Novoeight® per injection, reconstitute each vial according to the following instructions

Please note, this is not the complete Novoeight® Instructions for Use. Please refer to the Instructions for Use provided with the Prescribing Information.

Overview of the Novoeight® package:

Prefilled Diluent Syringe

Contains 4 mL of diluent—works with any dose strength1 

Novoeight® prefilled syringe

Adapter

Connects the syringe and vial, with a 25-μm inline particle filter1 

Adapter

Vial with colored cap

Easy recognition of different dose strengths by color-coded vial caps1 

A 1000 IU teal topped vial of Novoeight®
Colored Novoeight® labels: 250 IU (Purple), 500 IU (Orange), 1000 IU (Teal), 1500 IU (Light Grey), 3000 IU (Black)

Reconstituting a dose of Novoeight® is as easy as attach, twist, and mix.1

Administration.

For intravenous injection only.

  • Accidental needle stick with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single-use
  • Inspect the reconstituted Novoeight® solution visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is observed
  • Do not administer Novoeight® in the same tubing or container with other medicinal products

Administer Novoeight® using the following procedures:

  1. Invert the Novoeight® 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. Inject the reconstituted Novoeight® intravenously slowly over 2 to 5 minutes
  5. After injection, safely dispose of the syringe with the infusion set, the vial with the vial adapter, any unused Novoeight® and other waste materials

Please see the Prescribing Information for further details.

Caution:

  • The prefilled 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 product through incompatible needleless connectors, withdraw reconstituted product into a standard 10 mL sterile Luer-lock plastic syringe
  • If you have encountered any problems with attaching the prefilled histidine diluent syringe to any Luer-lock compatible device, please contact Novo Nordisk at (844) 303-4448

Available from Novo Nordisk:

NovoSeven® RT Logo

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Tretten® Logo

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Selected Important Safety Information

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment

Indications and Usage

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

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

Important Safety Information

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment
  • Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors

Adverse Reactions

  • The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.

Please click here for Prescribing Information

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  2. Santagostino E. A new recombinant factor VIII: from genetics to clinical use. Drug Des Devel Ther. 2014;8:2507-2515.
  3. Tiede A, Klamroth R, Oldenburg J. Turoctocog alfa (recombinant factor VIII). Hamostaseologie. 2015;35(4):364-371.