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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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| Post-hoc data analysis shows a stabilization in mean FVIII trough levels over time for all ages with Esperoct®.1,a,b |
| In post hoc analyses, long-term prophylaxis (≥5 years) resulted in protective hemostatic effect, with stabilization in mean FVIII trough levels.1,a,b |
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| aPost hoc analyses were performed on data from the pathfinder 2 trial of patients aged >12 with severe hemophilia A. Exploratory descriptive analyses of the data were used to evaluate long-term annual bleed rates and mean factor VIII trough levels which were assessed over time in 61 patients who received ≥6 years of prophylaxis, every 4 days. Limitations of the analyses include the lack of baseline joint status data, which is clinically relevant for phenotypic assessment prior to treatment initiation. The absence limits the ability to draw conclusions regarding improvement in joint status over time. Several trough level data were excluded if it was believed that they were elevated due to dosing to treat a recent bleed.1 |
| bPost hoc analyses were performed on data from the pathfinder™ 5 trial of patients (aged <12) with severe hemophilia A. Exploratory descriptive analyses of the data were used to evaluate mean factor VIII trough levels which were assessed over time in 54 patients who received ≥5 years of twice-weekly prophylaxis. Limitations of the analyses include the exclusion of several trough-level data if believed that they were elevated due to dosing to treat a recent bleed.1 |
| cIn 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.2,3 |
| dSteady-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.2 |
| eIn a phase 3 study of children (aged <12 years) a single-dose PK comparison was performed in 27 children between previous SHL products and Esperoct® at the same administered dose prior to the start of routine prophylaxis. Half-life comparison is based on estimated terminal half-life ratio using a population-based method. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks.6 |
| fSteady-state FVIII activity profiles were estimated in 22 children using a one-compartment model with first-order elimination, including PK parameters of clearance and volume of distribution.2 |
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| Scroll to see why Esperoct® may interest your standard half-life (SHL) hemophilia A patients. |
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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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| Long-term Esperoct® trials show a lower overall median ABR was achieved in all patients, compared with the main phase.1,4,5,g,h |
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Adults &
Adolescents |
(overall bleeds per year)4,g
N=177 |
| The majority of adults/adolescents who completed the entire trial experienced no annual bleeds after year 1.4,i |
| Children |
(overall bleeds per year)2,5,h
N=68 |
| Based on a post-hoc analysis of patients who completed the entire trial, the proportion of patients <12 years old who experienced no bleeding episodes more than doubled from year 1 to year 5.5,j |
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| gMedian 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 years4 |
| hMedian annualized bleeding rate shown is from the main and extension phases of previously treated children <12 years with severe hemophilia A, who took Esperoct®. 60 IU/kg (50-75 IU/kg) twice weekly for a median of 5 years.5 |
| iBased on a post hoc analysis of patients who completed the entire pathfinder™ 2 trial who took Esperoct®. 50 IU/kg every 4 days for up to 6.6 years. Patients evaluated at year 2 (n=103), year 3 (n=66), year 4 (n=62), year 5 (n=62), year 6 (n=59).4 |
| jBased on a post-hoc analysis of patients who completed the entire pathfinder™ 5 trial who took Esperoct®. 60 IU/kg (50 IU/kg-75 IU/kg) twice weekly for up to 5 years (n=63). Approximately 32% of the patients that participated in both the main and extension phases experienced no bleeding episodes during year 1, ~50% during year 2, <50% during year 3, 56% during year 4, and ~70% during year 5 had no bleeding episodes.5 |
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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. |
Tiede A, Hampton K, Jiménez-Yuste V, Young G, Benchikh El Fegoun S, Chowdry P. Post-hoc analysis on the long-term response to fixed-dose prophylaxis with N8-GP in patients with haemophilia A. Haemophilia. 2021;10.1111/hae.14409. |
| 2. |
Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019. |
| 3. |
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. |
| 4. |
Giangrande P, Abdul 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(suppl 1):5-14. |
| 5. |
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. |
| 6. |
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(9):1705-1713. |
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