NUWIQ Proven Safe in Clinical Studies of PTPs and PUPs
NUWIQ Safety in Previously Treated Patients (PTPs)
As a person living with Hemophilia A, or a caregiver for a child or loved one, you probably know that the development of inhibitors can be a serious complication of factor VIII treatment. Once inhibitors develop, they can significantly impair the effectiveness of treatment, making it more difficult to stop or prevent bleeding episodes1.
In clinical studies with PTPs (N=135) who switched to NUWIQ, there were zero FVIII inhibitors after > 50 exposure days and > 6 months of treatment2,3
Zero Inhibitors with PTPs Who Switched to NUWIQ2,3
- Zero patients experienced serious or severe adverse drug reactions
- Zero patients experienced anaphlylaxis, a very serious allergic reaction
- Zero patients dropped out of the study because of adverse reactions
- Zero deaths were reported
Final NuProtect results demonstrated a 16.2% absolute incidence of high-titer inhibitors with NUWIQ in PUPs—and a cumulative incidence of high-titer inhibitors of 17.6%.1,3
in PUPs treated with rFVIII from hamster cells
in PUPs treated with plasma-derived FVIII
- Centers for Disease Control and Prevention. https://www.cdc.gov/features/inhibitors/index.html
- NUWIQ full Prescribing Information. Paramus, NJ: Octapharma; rev 2020.
- Data on file. Paramus, NJ: Octapharma USA, Inc; 2015.
- van den Berg, HM. Thrombosis Journal 2016, 14(Suppl 1):31 DOI 10.1186/s12959-016-0102-4./li>
- Peyvandi F, et al. N Engl J Med. 2016;374:2054-2064.