| SHL and EHL rFVIII options for your hemophilia A patients. |
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| Novoeight® 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. See full indication below. |
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| Esperoct® is indicated for on-demand treatment and control of bleeding episodes, perioperative bleed management, and routine prophylaxis in adults and children with hemophilia A. See limitations of use below. |
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| Kogenate® FS is being discontinued. |
| It’s time to make the switch with Novo Nordisk. |
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| If you are sticking with standard half-life (SHL) treatment for your hemophilia A patients, you should know: |
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Novoeight® provides the flexibility of the broadest range of temperature stability of any SHL rFVIII on the market—36°F to 104°F—to support a busy lifestyle.1-8,a,b |
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Novoeight® has a proven safety profile with 0 inhibitors confirmed in one of the largest clinical trial programs of an rFVIII.9-11,c-f |
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Data from guardian™2 showed Novoeight® to be effective in adults, adolescents, and children with a median ABR of 3.7 in all patients 0-65 (N=213).1,9-12,c-f |
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| Why choose extended half-life (EHL) Esperoct® for your hemophilia A patients? |
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Esperoct® offers the flexibility of the broadest range of temperature stability of any EHL rFVIII on the market—36°F to 104°F.13-16,g,h |
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Esperoct® provides effective prophylaxis with a low median annual bleed rate (ABR)—0.8 across all bleeds—in long-term trial results.13,17,18,i-l |
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Esperoct® achieves high factor levels for adults, adolescents, and children.13,m |
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Patients who take Esperoct® are likely to stay with Esperoct®. Among EHL products, fewer Esperoct® prescriptions were switched to another product.20,n |
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| Have more questions? Contact a rep. |
| aCompared with other SHL rFVIII products.1-8 |
| bPlease refer to the Novoeight® storage and handling instructions provided in the Prescribing Information. |
| cguardian™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).10 |
| dguardian™3: a multicenter, multinational, noncontrolled, open-label safety, efficacy, and pharmacokinetic trial in 63 previously treated pediatric patients (aged 0 to 11 years) with hemophilia A in which patients were exposed to turoctocog alfa for a mean of 60 exposure days (ranging from 20 to 104 exposure days).11 |
| eguardian™2: a prospective, open-label, uncontrolled extension trial investigating the safety and efficacy of turoctocog alfa in 55 pediatric, 23 adolescent, and 122 adult patients with severe hemophilia A for a mean of 361.6 exposure days. The data cutoff date was December 31, 2013.9,12 |
| fPatients with previous inhibitors were excluded from the trials. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight® for inhibitor formation.12 |
| gCompared with other EHL rFVIII products.13-16 |
| hPlease refer to the Esperoct® storage and handling instructions provided in the Prescribing Information. |
| iMedian annualized bleeding rate of 2 in the main phase of the clinical trial of 68 previously treated children (34 aged 0-5 and 34 aged 6-11) who received an average dose of approximately 65 IU/kg twice weekly for 26 weeks.19 |
| jMedian annualized bleeding rate of 0.8 (N=177) is from the main and extension phases of the pivotal clinical trial of previously treated people aged ≥12 years with severe hemophilia A who received Esperoct® 50 IU/kg every 4 days, for up to 6.6 years.17 |
| kMedian annualized bleeding rate of 0.8 (N = 68) is from the main and extension phases of previously treated children with severe hemophilia A who took Esperoct. 60 IU/kg (50-75 IU/kg) twice weekly for a median of 5 years.18 |
| l175 PTPs >=12 years old with severe hemophilia A received Esperoct® 50 IU/kg every 4 days for 76 weeks resulted in an median annualized bleed rates of 1.2 during the main phase of the clinical trial. |
| mFor children aged 6-11 years, trough level is 2%. |
| nBased on data for Q2 2020-Q2 2021; accounts for net gains and losses of patients switching to and from extended half-life rFVIII available for at least one year.20 |
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| Selected Important Safety Information for Novoeight® |
| Contraindications |
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Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins |
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| Warnings and Precautions |
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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 |
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| Why choose extended half-life (EHL) Esperoct® for your hemophilia A patients? |
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Esperoct® offers the flexibility of the broadest range of temperature stability of any EHL rFVIII on the market—36°F to 104°F.13-16,g,h |
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Esperoct® provides effective prophylaxis with a low median annual bleed rate (ABR)—0.8 across all bleeds—in long-term trial results.13,17,18,i-l |
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Esperoct® achieves high factor levels for adults, adolescents, and children.13,m |
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Patients who take Esperoct® are likely to stay with Esperoct®. Among EHL products, fewer Esperoct® prescriptions were switched to another product.20,n |
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| gCompared with other EHL rFVIII products.13-16 |
| hPlease refer to the Esperoct® storage and handling instructions provided in the Prescribing Information. |
| iMedian annualized bleeding rate of 2 in the main phase of the clinical trial of 68 previously treated children (34 aged 0-5 and 34 aged 6-11) who received an average dose of approximately 65 IU/kg twice weekly for 26 weeks.19 |
| jMedian annualized bleeding rate of 0.8 (N=177) is from the main and extension phases of the pivotal clinical trial of previously treated people aged ≥12 years with severe hemophilia A who received Esperoct® 50 IU/kg every 4 days, for up to 6.6 years.17 |
| kMedian annualized bleeding rate of 0.8 (N = 68) is from the main and extension phases of previously treated children with severe hemophilia A who took Esperoct. 60 IU/kg (50-75 IU/kg) twice weekly for a median of 5 years.18 |
| l175 PTPs >=12 years old with severe hemophilia A received Esperoct® 50 IU/kg every 4 days for 76 weeks resulted in an median annualized bleed rates of 1.2 during the main phase of the clinical trial. |
| mFor children aged 6-11 years, trough level is 2%. |
| nBased on data for Q2 2020-Q2 2021; accounts for net gains and losses of patients switching to and from extended half-life rFVIII available for at least one year.20 |
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| Selected Important Safety Information for Esperoct® |
| Contraindications |
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Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins |
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| Warnings and Precautions |
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Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment |
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| Indications and Usage for Novoeight® |
| 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. |
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Novoeight® is not indicated for the treatment of von Willebrand Disease |
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| Important Safety Information |
| Warnings and Precautions |
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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 |
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| Adverse Reactions |
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The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia. |
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| Please click here for Prescribing Information. |
| Indications and Usage for Esperoct® |
| 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 |
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Esperoct® is not indicated for the treatment of von Willebrand disease |
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| Important Safety Information |
| Warnings and Precautions |
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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 |
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| Adverse Reactions |
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The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions |
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| Please click here for Prescribing Information. |
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References:
| 1. | Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020. |
| 2. | Advate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018. |
| 3. | Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2021. |
| 4. | Kogenate® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2019. |
| 5. | Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2021. |
| 6. | Nuwiq® [package insert]. Hoboken, NJ : Octapharma USA, Inc.; 2020. |
| 7. | Recombinate® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2018. |
| 8. | Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2020. |
| 9. | Lentz SR, Cerqueira M, Janic D, et al. Interim results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016;22:e445-e449. |
| 10. | 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. |
| 11. | Kulkarni R, Karim FA, Glamocanin S, et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705. |
| 12. | Lejniece S, Martín-Salces M, Matytsina I, et al. Safety of turoctocog alfa for prevention and treatment of bleeds in patients with severe hemophilia A: final results from the guardian™2 trial. Poster presented at: 10th Annual Congress of the European Association of Hemophilia and Allied Disorders; February 1-3, 2017; Paris, France. |
| 13. | Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022. |
| 14. | Eloctate® [package insert]. Waltham, MA: Bioverativ Therapeutics Inc; 2020. |
| 15. | Adynovate® [package insert]. Lexington, MA: Baxalta US Inc; 2021. |
| 16. | Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018. |
| 17. | Giangrande P, Karim F, Nemes L, et al. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2. J Thromb Haemost. 2020;18(1):5-14. |
| 18. | Šaulytė Trakymiene S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: final results from pathfinder5. J Thromb Haemost. 2020;18(suppl 1):15-25. |
| 19. | Meunier S, Alamelu J, Ehrenforth S, et al. Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A. Thromb Haemost. 2017;117:1705-1713. |
| 20. | Data on file. Novo Nordisk Inc.; Plainsboro, NJ. |
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Esperoct® and Novoeight® are registered trademarks of Novo Nordisk Health Care AG.
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