In a clinical trial of PUPs, 42.9% developed inhibitorsb
Designed for the safety and purity you want in your treatment.
0 inhibitors were confirmed in one of the largest clinical trials programs involving previously treated patients of a rFVIII to date.a
aPeople with previous inhibitors and those new to treatment were not included in the trial. People with hemophilia A may develop inhibitors to factor VIII.
Designed for the safety and purity you want in your treatment.
0 inhibitors were confirmed in one of the largest clinical trials programs involving previously treated patients of a rFVIII to date.a
aPeople with previous inhibitors and those new to treatment were not included in the trial. People with hemophilia A may develop inhibitors to factor VIII.
Sion lives with hemophilia A.
An established safety profile.
![Safety results Safety results](/content/dam/novonordisk/novoeight/why-novoeight/0-inhibitors-large.png)
- Safety results were consistent among adults, adolescents, and children
- No blood clots occurred during the trials
- The most frequently reported adverse reactions included swelling or itching at the location of the injection, and fever
- Safety results reported after FDA approval have been similar to those observed during clinical trials
![Safety results Safety results](/content/dam/novonordisk/novoeight/why-novoeight/0-inhibitors-large.png)
- Safety results were consistent among adults, adolescents, and children
- No blood clots occurred during the trials
- The most frequently reported adverse reactions in previously treated patients included swelling or itching at the location of the injection, and fever
- Safety results reported after FDA approval have been similar to those observed during clinical trials
- In a clinical trial of PUPs, 42.9% developed inhibitorsb
Text: double click to edit.
PUP=previously untreated patient
b59 PUPs with severe hemophilia A (factor VIII level ≤1%) received at least one dose of Novoeight® as part of either routine prophylaxis, on-demand treatment of bleeding episodes. Patients developed inhibitors with a mean of 14.1 exposure days at the time of the first positive inhibitor test. High risk genetic mutations were identified in 91.7% of the overall inhibitors and 93.3% of the high titer inhibitors.
Novoeight®
offers purity
through a 5-step
purification
process.
![Step 1 Step 1](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process1.png)
![Step 1 Step 1](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process1.png/_jcr_content/renditions/mobile)
Detergent Inactivation
Helps eliminate enveloped viruses.
![Step 2 Step 2](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process2.png)
Immunoaffinity Chromatography
Uniquely selects intact molecules.
![Step 3 Step 3](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process3.png)
Anion-exchange Chromatography
Separates molecules from impurities, based on their charge.
![Step 4 Step 4](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process4.png)
Double Nanofiltration
State-of-the-art double 20-nm filters remove small pathogens, reducing nonenveloped viruses.
![Step 5 Step 5](/content/dam/novonordisk/novoeight/why-novoeight/safety-purification-process5.png)
Gel Filtration
Reduces FVIII multimers.
Recombinant manufacturing minimizes risk.
Novoeight® is produced by recombinant technology, with no animal- or human-derived components. Recombinant manufacturing minimizes the possibility of viral contamination.
What are the latest recommendations?
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) recommends recombinant products as a first-line therapy.
![MASAC guidelines chart MASAC guidelines chart](/content/dam/novonordisk/novoeight/why-novoeight/recommendation-table.png)
Patient: Rare Bleeding Disorder
MASAC Recommendation: Recombinant
Product if Available
Patient: Previously Treated Patient with Hemophilia A or B
MASAC Recommendation: Recombinant Product
Patient: Previously Untreated Patient with Hemophilia A
MASAC Recommendation: Recombinant FVlll Product or Plasma-Derived VIII Product Containing von Willebrand Factor
What if I’m new to Novoeight®?
![Step 1 Step 1](/content/dam/novonordisk/novoeight/global-images/three-col-cta-icon-step1.png)
It’s easy to get started; we’ll show you step-by-step.
Considering a switch?
![Novoeight® box with all the contents displayed Novoeight® box with all the contents displayed](/content/dam/novonordisk/novoeight/global-images/three-col-cta-package.png)
It’s important to know how a treatment will fit into your life.
Product support.
![](/content/dam/novonordisk/novoeight/global-images/three-col-cta-icon-support.png)
Access the product support NovoSecure™ offers for qualified patients.