Esperoct® is the result of a multi-year clinical trial shown to provide a safe and effective routine prophylaxis when administered every 4 days in adults, or twice weekly in children.
A thorough assessment.
- 0 blood clots in 270 previously treated patients
- 0 PEG-related safety concerns
- 1 previously treated patient with a high-risk gene mutation developed an inhibitor to Esperoct®a
- Similar to the reported rate in patients with severe hemophilia A
aAn 18-year-old African-American male developed an inhibitor after 93 infusion days of Esperoct®. The inhibitor rose to 13.5 Bethesda units and the patient stopped participation in the study. There was no change in efficacy, and the inhibitor eventually went away on its own (without use of immune tolerance induction therapy).
A look at side effects.
During the Esperoct® clinical trial, the most commonly reported adverse reactions were:
A product that can take the heat.
The Esperoct® difference means you can store your factor at or below 104˚ for up to 3 months, opening the door to more of life’s adventures. Read about storage
Manufactured in the U.S. with exacting standards.
The Novo Nordisk manufacturing principles make product safety the centerpiece of our efforts—from development to delivery.
With your safety as our guide, we commit to purity in every step of the Esperoct® process.
You count on us to make sure your factor is available when you need it. And we do.
Our well-established manufacturing process means you can rely on the same safe product with every infusion.
Esperoct® is made under tight control measures with quality our number one priority.
Your questions, answered.
Question: When you say the “largest and longest clinical trial in hemophilia A,” what does that mean?
Answer: Let’s look at the numbers of the Pathfinder clinical program, research that evaluated Esperoct®:
- In 270 previously treated people with severe hemophilia A
- During five, multi-center clinical trials
- Over 80,425 exposure days (corresponding to 889 patient years of treatment)
Beyond the numbers, the sheer breadth of the Pathfinder trial reflects the Novo Nordisk commitment to purity, reliability, consistency and quality. We understand how important these values are to the bleeding disorder community. The Pathfinder clinical trial represents our dedication to your safety, as well as the effectiveness of Esperoct®.
Question: What is an “exposure day” and why is it an important safety consideration for factor VIII products?
Answer: An “exposure day” (ED) is typically considered a unit of time (1 day) during which a patient receives replacement treatment. Considering EDs during a clinical trial is helpful since inhibitors typically develop in those with severe hemophilia A after a median treatment time of 10-15 days. After 50-75 EDs, the cumulative incidence of inhibitors plateaus. However, EDs don’t tell the whole story. Other considerations that affect safety considerations include the amount of factor, frequency of infusions, the type of factor concentrate, and more.