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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. |
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| The latest clinical trial data further demonstrates effective prophylaxis. |
| Long-term trial results for Esperoct®—part of the largest and longest EHL clinical trial program for hemophilia A1—confirm effective prophylaxis. A lower median ABR was achieved compared with the main phases in the studies for children, adolescents, and adults.2-5,a,b |
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| Esperoct® achieved a 0.8 median ABR (overall bleeds per year) in prophylaxis for pediatric patients ages 0 to <12 (n=68)c and for patients ages 12 to 70 years (n=177).d |
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| EHL=extended half-life; ABR = Annual Bleed Rate. |
| aIn a phase 3, open-label study, safety, PK, and efficacy of Esperoct® were evaluated in PTPs aged ≥12 years with severe hemophilia A; 175 received routine prophylaxis (50 IU/kg every 4 days) and 12 adults elected to be treated on-demand during the main phase where a median ABR of 1.2 was achieved. After the main phase, a subset of patients continued on in extension phase part 1. After 24 weeks, patients from extension phase part 1 continued into the non-randomized extension part 2 until the end of trial.2,3 |
| bIn a phase 3 multinational, open-label, single-arm, non-randomized, non-controlled trial of 68 previously treated male patients aged <12 years old with severe congenital hemophilia A, comprising of a main phase and an extension phase. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks and a median ABR of 2.0 was achieved.4,5 |
| cMedian annualized bleeding rate shown is from the main and extension phase 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.5 |
| dMedian annualized bleeding rate shown 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.2 |
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| Keep scrolling for more information about the extended half-life of Esperoct®. |
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| Selected Important Safety Information |
| 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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Please
click here
or scroll below for additional Important Safety Information.
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| Have your patients asked for fewer infusions? |
| With the extended half-life of Esperoct®, your adult and adolescent patients may need up to 50% fewer infusionse per year compared to standard half-life rFVIII treatments.6 |
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| e50% fewer if previously dosed every other day; 40% fewer if previously dosed 3x/week. |
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| Keep up with important information about bleeding disorders treatments. |
| Receive the latest bleeding disorders news from Novo Nordisk. |
| Download, order, and share educational materials for you and your patients. |
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| Indications and Usage |
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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 (cont’d)
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| 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. |
Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019. |
| 2. |
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. |
| 3. |
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. |
| 4. |
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. |
| 5. |
Trakymiene SŠ, Economou M, Kenet G, et al. 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(1):15-25. |
| 6. |
Cafuir L and Kempton C. Current and emerging factor VIII replacement products for hemophilia A. Ther Adv Hem. 2017;8(10):303–313. |
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