FVIII Treatment: Standard of Care for Hemophilia A

Trusted and Proven Safe and Effective Over Decades of Use

The way FVIII treatment works in the body is well understood by the doctors and nurses who prescribe it
The ability to accurately measure your FVIII levels with routine laboratory tests, like the chromogenic and one-stage assays, has helped make FVIII treatment the standard of care for Hemophilia
Lifelong treatment with FVIII replacement is recommended to maintain homeostasis, preserve joint function, and protect against bleeding events^1,2

Why is Hemophilia A Treated with FVIII Replacement?

Hemophilia A is an inherited bleeding disorder that results from a deficiency of a coagulation protein called Factor VIII (FVIII).
It’s only natural then, that the management of Hemophilia A is generally based on the replacement of the missing FVIII protein¹

Not all FVIII Treatments Are the Same

There are important differences in the way they are produced, purified, and formulated before they can be infused

rFVIII Protein from a Human Cell Line

The rFVIII protein produced in a human cell line, like NUWIQ, closely resembles the FVIII the body produces naturally
So, the body’s immune system may be less likely to see this protein as foreign and make antibodies (inhibitors) against it

rFVIII Protein from Hamster Cell Lines

rFVIII products made from hamster cell lines contain trace amounts of animal protein³ (also called glycan epitopes)³
The immune system may see glycan epitopes as foreign and produce antibodies (inhibitors) against it

References

Sandberg H, et al. Thromb Res 2012; 130:808-817.
Winge S, et al. Protein Expression and Purification 2015; 115: 165-175.
Casademunt E, et al. Eur J Haematol 2012; 89:165-176.

Indications and Important Safety Information for NUWIQ [Antihemophilic Factor (Recombinant)]

Please see NUWIQ full Prescribing Information. Instructions For Use

Indications and Important Safety Information for NUWIQ [Antihemophilic Factor (Recombinant)]

Please see NUWIQ full Prescribing Information. Instructions For Use

Indications and Use

NUWIQ^® is a recombinant antihemophilic factor [coagulation factor VIII (Factor VIII)] indicated 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. NUWIQ^® is not indicated for the treatment of von Willebrand Disease.

Contraindications

NUWIQ is contraindicated in patients who have manifested life-threatening hypersensitivity reactions, including anaphylaxis, to the product or its components.

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, are possible with NUWIQ. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, or pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

The formation of neutralizing antibodies (inhibitors) to Factor VIII can occur following the administration of NUWIQ. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests. If the plasma Factor VIII level fails to increase as expected, or if bleeding is not controlled after NUWIQ administration, suspect the presence of an inhibitor (neutralizing antibody).

Adverse Reactions

The most frequently occurring adverse reactions (>5%) in clinical trials were upper respiratory tract infection, headache, fever, cough, lower respiratory tract infection, rhinitis, chills, abdominal pain, arthralgia, anemia, and pharyngitis.

Please See NUWIQ full Prescribing Information. Instructions For Use