Why NUWIQ®️ is Made Without Hamster Glycan Epitopes

NUWIQ Closely Resembles Natural FVIII^1,4-6

NUWIQ is the first and only rFVIII produced in a human cell line without chemical modification or protein fusion. We call it ‘A Natural Choice‘
NUWIQ is produced in a human cell line with no added animal or human proteins^2,3

NUWIQ Does Not Contains Hamster Glycan Epitopes³

FVIII made from hamster cell lines may contain small amounts of animal proteins (also called glycan epitopes)⁴
The immune system may see glycan epitopes as foreign and produce antibodies (inhibitors) against it

Cell line comparisons

HEK = Human embryonic kidney; CHO = Chinese hamster ovary; BHK = Baby hamster kidney.

NUWIQ Has High Binding Affinity to von Willebrand Factor (VWF)²

VWF is another coagulation protein that’s important for helping the blood to clot²
In normal coagulation, FVIII and VWF bind and circulate together; VWF is like a chaperone for FVIII
This binding helps protect FVIII and keep it from being eliminated from the body too quickly^2,4
Minimizing the amount of unbound FVIII in circulation may also help reduce the risk of inhibitor development²

References

Sandberg H, et al. Thromb Res.2012;130:808-817.
Casademunt E, et al. Eur J Haematol. 2012;89:165-176.
Kannicht C, et al. Thromb Res. 2013;131:78-88.
Cafuir LA, Christine L. Kempton CL. Ther Adv Hematol. 2017;8(10):303–313.
NUWIQ full Prescribing Information. Paramus, NJ: Octapharma; rev 2021.
Lissitchkov T, Rusen L, Georgiev P, et al. Haemophilia. 2017;23:697-704.

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