NUWIQ – Safety & Efficacy
POWERFUL BLEEDING CONTROL Prophylaxis With NUWIQ Markedly Reduced Bleeding Frequency2
In Clinical Trials of Standard Prophylaxis With NUWIQ in Adult (N=32) and Pediatric (N=59) Patients Treated for ≥6 Months2*
All Patients Experienced Fewer Bleeds with NUWIQ Prophylaxis vs On-Demand Treatment With Another FVIII Product2,12†
Patients were switched from on-demand therapy (pre-study) with another FVIII product to prophylaxis with NUWIQ.
EFFECTIVE BLEEDING RESOLUTION
On-Demand Treatment Readily Controlled Bleeding2
NUWIQ Safety in PTPs1
- NUWIQ was shown to be safe in clinical studies that included 135 previously treated patients (PTPs)
- FVIII levels can be safely and accurately measured with both the chromogenic and one-stage assays
- No serious or severe reactions to NUWIQ in clinical studies, and no deaths reported
Inhibitor Risk in Previously Untreated Patients (PUPs)
The incidence of inhibitors with rFVIII products made in hamster cells
Results from the SIPPET Study (Survey of Inhibitors in Plasma-Product Exposed Toddlers)3
- The SIPPET study compared the rates of inhibitors in PUPs who were treated with either plasma-derived FVIII (pdFVIII) or recombinant FVIII (rFVIII) made from hamster cells
- Results from the SIPPET study showed:
PUPs treated with rFVIII from hamster cells had a 28.4% incidence of high-titer inhibitors
PUPs treated with pdFVIII had a 18.6% incidence of high-titer inhibitors
in PUPs treated with rFVIII from hamster cells.
in PUPs treated with plasma-derived FVIII.
in PUPs treated with NUWIQ®, made from human cells.
- NUWIQ Full Prescribing Information. Hoboken, NJ: Octapharma; 2015.
- Data on file. Hoboken, NJ: Octapharma USA Inc; 2015
- Peyvandi F, Mannucci PM, Garagiola I, et al. N Engl J Med. 2016;374:2054-2064.
- Liesner R. et al. Immunogencity, efficacy and safety of NUWIQ (human-cl rhFVIII) in previously untreated patients with severe haemophilia A-interim results from the NuProtect Study. Haemophilia [submitted for publication].