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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
  • The most frequently reported adverse reactions included swelling or itching at the location of the injection, fever, and inhibitors in previously untreated patients
  • Safety results reported after FDA approval have been similar to those observed during clinical trials
Safety results

In a clinical trial of PUPs, 42.9% developed inhibitorsb

  • Safety results were consistent among adults, adolescents, and children
  • The most frequently reported adverse reactions in previously treated patients included swelling or itching at the location of the injection, fever, and inhibitors in previously untreated patients 
  • Safety results reported after FDA approval have been similar to those observed during clinical trials

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 or 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

It’s easy to get started; we’ll show you step-by-step.

See the Steps

Considering a switch?

Novoeight® box with all the contents displayed

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

See Your Options

Product support.

Access the product support NovoCare® offers for qualified patients.

Get Product Support

Novoeight® 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 (cont'd)

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 for Novoeight®.

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.