Novo Nordisk

Important Safety Information | Prescribing Information

Esperoct^®: Indicated for on-demand treatment and control of bleeding episodes, perioperative bleed management, and routine prophylaxis in adults and children with hemophilia A.

Esperoct^®: A prescriber’s perspective

Dr. Tami Singleton,

Chief of Pediatric Hematology and Director of the Hemophilia Treatment Center at the Mississippi Center for Advanced Medicine

Dear [Dr/Mr/Ms]. [Last Name],

I wanted to share a video featuring Dr. Singleton. One of the key reasons she decided to prescribe Esperoct^® was its ability to help her patients with hemophilia A achieve high trough levels.

“In clinical trials…for adults and adolescents, factor levels were ≥3% for the entire dosing interval and, based on PK modeling, ≥5% for 90% of the time.” ^1,a

With the longest half-life of any rFVIII product on the market,^1,3,a,b watch and learn why Dr. Tami Singleton prescribes Esperoct^®.

I’m interested to hear what you take away from the video. Which aspects of Esperoct^® would be most valuable to your patients?

If there is a convenient time to talk, let me know, and I can schedule an appointment.

I look forward to connecting with you soon!

Best,

[Representative Name]

[Phone]

[mail]

^a In a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct^® were evaluated in previously treated patients (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. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL.^1,2
^b Esperoct^® has an unprecedented 22-hour mean half-life in adults compared with other EHL FVIII products. The mean half-life in adults is 19.7 hours for Eloctate^®, 14.7 for Adynovate^®, and 17.9-18.6 for Jivi^®.^1,4-6

Selected Important Safety Information

Contraindications

Do not use in patients who have known hypersensitivity to Esperoct^® or its components, including hamster proteins

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct^® and administer appropriate treatment

Please click here or scroll below for additional Important Safety Information.

Indications and Usage

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

Esperoct^® is not indicated for the treatment of von Willebrand disease

Important Safety Information (cont’d)

Warnings and Precautions

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

Adverse Reactions

The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions

Please click here for Prescribing Information.

References:

Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
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.
Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013;11(4):670-678.
Eloctate^® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2019.
Adynovate^® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
Jivi^® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.

Please click on the link to see WAC pricing for the product mentioned above: Product Pricing.

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