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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.

In a clinical trial of PUPs, 42.9% developed inhibitorsb

  • 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 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.

Step 1
Step 1

Detergent Inactivation
Helps eliminate enveloped viruses.

Step 2

Immunoaffinity Chromatography
Uniquely selects intact molecules.

Step 3

Anion-exchange Chromatography
Separates molecules from impurities, based on their charge.

Step 4

Double Nanofiltration
State-of-the-art double 20-nm filters remove small pathogens, reducing nonenveloped viruses.

Step 5

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

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

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Considering a switch?

Novoeight® box with all the contents displayed

It’s important to know how a treatment will fit into your life.

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Product support.

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Selected Important Safety Information

Who should not use Novoeight®?

  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins

What is the most important information I need to know about Novoeight®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What is Novoeight®?

Novoeight® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery

  • Novoeight® is not used to treat von Willebrand Disease

Important Safety Information

Who should not use Novoeight®?

  • You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins

What is the most important information I need to know about Novoeight®?

  • Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
  • Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction:rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands

What should I tell my healthcare provider before using Novoeight®?

  • Before taking Novoeight®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
  • Your body can make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®

What are the possible side effects of Novoeight®?

  • Common side effects of Novoeight® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever

Please click here for Prescribing Information.

Novoeight® is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800- FDA-1088.