HAEMATOLOGY

Nuwiq

HAEMATOLOGY

Nuwiq

Nuwiq® is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). It is a recombinant antihemophilic factor [blood coagulation factor VIII (Factor VIII)] used to treat Hemophilia A.

NUWIQ is not indicated for the treatment of von Willebrand Disease.

Fast and Accurate Control

Nuwiq® contains human coagulation factor VIII with no animal or human derived materials added during the manufacturing process or to the final medicinal product. It is a convenient twice-weekly dosing to effectively prevent bleeds in patients on personalised prophylaxis.

Nuwiq: Human Coagulation Factor VIII (rDNA) (simoctocog alfa)

Human coagulation factor VIII produced in a human cell line by recombinant DNA technology. No animal or human derived materials are added during the manufacturing process or to the final medicinal product.

Indication

Nuwiq® is indicated for treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) of all age groups.

Presentation

Supplied as powder and solvent for solution for injection, with all vial strengths in a 2.5 mL infusion volume and supplied with a pre-filled syringe. Available in vials of: 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU.

Key Features & Benefits

The First and Only Recombinant FVIII Produced in Human Cells Without Chemical Modification or Protein Fusion
Produced in human cells, not hamster cells
B-domain deleted, no chemical modification or protein fusion
High binding affinity to VWF (99% bound)
Minimizing unbound FVIII may reduce risk of inhibitor development
All Patients Experienced Fewer Bleeds with Nuwiq® Prophylaxis vs On-Demand Treatment with Another FVIII Product
References
  1. Nuwiq® full Prescribing Information
  2. Casademunt E, et al. The first recombinant human coagulation factor VIII of human origin: human cell line and manufacturing characteristics. Eur J Haematol. 2012;89:165-176.
  3. Winge S, et al. Development, upscaling and validation of the purification process for human-cl rhFVIII (Nuwiq®), a new generation recombinant factor VIII produced in a human cell-line. Protein Expr Purif. 2015;115:165-175.
  4. Sandberg H, et al. Functional characteristics of the novel, human-derived recombinant FVIII protein product, human-cl rhFVIII. Thromb Res. 2012;130:808-817.
  5. Kannicht C, et al. Characterisation of the post-translational modifications of a novel, human cell line-derived recombinant human factor VIII. Thromb Res. 2013;131:78-88.
  6. Valentino LA, et al. The first recombinant FVIII produced in human cells – an update on its clinical development programme. Haemophilia. 2014; 20 (Suppl. 1), 1-9.
  7. Kessler C, et al. Spotlight on the human factor: building a foundation for the future of haemophilia A management. Haemophilia. 2015;21(Suppl. 1): 1–12.
  8. Data on file. Hoboken, NJ: Octapharma USA, Inc; 2015.

Key Features & Benefits

Convenient twice-weekly dosing to effectively prevent bleeds in patients on personalised prophylaxis1:
  • 83% of patients free from spontaneous bleeds;
  • 57% of patients treated twice-weekly or less;
  • 0 inhibitors or severe treatment related adverse events.
Favourable rate of inhibitors in previously untreated patients (PUPs) demonstrated in NuProtect, the largest prospective study in true PUPs with a single FVIII product2:
  • 17.6% cumulative incidence of high-titre inhibitors;
  • 27.9% cumulative incidence of all inhibitors;
  • No inhibitors in patients with non-null F8 mutations.
Zero inhibitors in over 190 previously treated patients switching to Nuwiq® in clinical trials3
References
  1. Lissitchkov T et al. Haemophilia 2017; 23:697-704.
  2. Liesner R et al. Abstract accepted for presentation at ASH 2019, Orlando, US.
  3. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.

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