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For your patients with hemophilia A who are looking for a product that’s ready to go, proven effective, and has an established safety profile, Novoeight® offers all three.

Michael, 30 years old, lives with hemophilia A.


Michael,
30 years old, lives with hemophilia A. 

For your patients with hemophilia A who are looking for a product that’s ready to go, proven effective, and has an established safety profile, Novoeight® offers all three.


Novoeight® is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.1 Novoeight® is not indicated for the treatment of von Willebrand disease.


Novoeight® at a glance:

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Reliable

Effective bleed control, with a median of 1.4 bleeds in the long-term safety trial.1
Read the data

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Portable

To support a patient's busy lifestyle, Novoeight® offers a higher degree of stability—it's the only SHL rFVIII with stability up to 104°F for up to 3 months.1,a    
Learn about portability

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Safety

Proven safety profile, with 0 inhibitors confirmed for PTPs and over 9 years of clinical experience.2,b
See the study results

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Access

Is your patient covered? Novo Nordisk is working to improve insurance access for all.
Find out about access

rFVIII=recombinant factor VIII.
PTP=previously treated patient.
aCompared with other selected rFVIII SHL and EHL products.3-12
b
guardian™1: a multicenter, multinational, open-label, single-arm efficacy and safety trial in 150 patients (aged 12 to 65 years) with severe hemophilia A on a prophylactic treatment regimen who were exposed to turoctocog alfa for a mean of 85 exposure days (ranging from 11 to 172 exposure days).2

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Do your patients want a portable treatment?

Novoeight® offers stability up to 104˚F for up to 3 months before reconstitution, plus the longest room temperature storage time after reconstitution for any standard half-life treatment.1,c It's the storage flexibility they need to help them stay on the go.


cCompared with other standard half-life recombinant FVIII products.3-8


Peter
lives with hemophilia A.
 

Do you have patients who could benefit from a rFVIII with an extended half-life? 

If so, consider Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]. With one simple 50 IU/kg dose every 4 days,d Esperoct® can deliver high trough levelse,f and a low median ABRe for adolescent and adult prophylaxis patients.13 Next time you see a hemophilia A patient, consider Esperoct®. It might be right for them.

Please click here for Esperoct® Prescribing Information and see Important Safety Information at the bottom of the page.

ABR=annualized bleed rate.
dRegimen can be individually tailored to less or more frequent dosing based on bleeding episodes.13
e
In a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in PTPs aged ≥12 years with severe hemophilia A. Single-dose PK studies were performed in 42 adults after receiving Esperoct® 50 IU/kg; 175 PTPs received routine prophylaxis (50 IU/kg Q4D) for 76 weeks and 12 adults elected to be treated on demand during the main phase. Treatment-requiring bleeds were reported by patients through diaries. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL.13, 14
f
Steady-state FVIII activity profiles were estimated in 143 patients using a one-compartment model with first-order elimination with PK parameters of clearance and volume of distribution.13

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. Lentz SR, Misgav M, Ozelo M, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013; 19:691-697.
  3. Kogenate® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2019.
  4. Advate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
  5. Eloctate™ [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
  6. Adynovate® [package insert]. Westlake Village, CA: Baxalta US Inc., 2021.
  7. Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
  8. Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2020.
  9. Nuwiq® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2017.
  10. Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016.
  11. Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2020.
  12. ReFacto® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2007.
  13. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  14. Giangrande P, Andreeva T, Chowdary P, et al. Clinical evaluation of glycoPEGylated recombinant FVIII: efficacy and safety in severe haemophilia A. Thromb Haemost. 2017;117(2):252-261.