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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 strength

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

Novoeight® Selected Important Safety Information

Who should not use Novoeight®?
  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins
What is the most important information I need to know about Novoeight®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What is Novoeight®?

Novoeight® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery

  • Novoeight® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Novoeight®?
  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins
What is the most important information I need to know about Novoeight®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands
What should I tell my healthcare provider before using Novoeight®?
  • Before taking Novoeight®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®
What are the possible side effects of Novoeight®?
  • Common side effects of Novoeight® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever
Please click here for Novoeight® Prescribing Information.
Novoeight® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

 

 

Esperoct® Selected Important Safety Information

Who should not use Esperoct®?
  • You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
What is the most important information I need to know about Esperoct®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
  • Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face

What is Esperoct®?

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct® when you have surgery

  • Esperoct® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Esperoct®?
  • You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
What is the most important information I need to know about Esperoct®?
  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
  • Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face
What should I tell my healthcare provider before using Esperoct®?
  • Before taking Esperoct®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Esperoct®, which may stop Esperoct® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Esperoct®
What are the possible side effects of Esperoct®?
  • Common side effects of Esperoct® include rash or itching, and swelling, pain, rash or redness at the location of infusion
Please click here for Esperoct® Prescribing Information.
Esperoct® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-10881-800-FDA-1088.

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  2. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.