Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
126 patients on HEMLIBRA underwent surgery in the HAVEN studies2
215 minor and 18 major surgeries were performed in patients receiving HEMLIBRA2
Unplanned surgeries and elective minor procedures were allowed in the HAVEN study programme and were managed at the investigator’s discretion. No major or minor surgical procedure resulted in death, thrombosis, FVIII inhibitor development, or an unexpected bleed.2
The safety and efficacy of HEMLIBRA have not been formally evaluated in the surgical setting.1
126 patients receiving HEMLIBRA had at least one surgical procedure. HAVEN 1, n=38 of 113* adults and adolescents with inhibitors; HAVEN 2, n=27 of 88 paediatrics with inhibitors; HAVEN 3, n=45 of 152 adults and adolescents without inhibitors; HAVEN 4, n=16 of 48 adults and adolescents with and without inhibitors.2
*One participant in HAVEN 1 discontinued prior to treatment.
The surgery analysis includes more patients than the primary efficacy analyses, due to later data cut-offs of 2–11th October 2018.2,3 All data available at time of presentation are included here.
Watch Professor Guy Young’s overview of surgical experience in the HAVEN study programme
Related links:
Surgeries were managed with HEMLIBRA alone or with HEMLIBRA and additional prophylaxis2
FVIII, Factor VIII.
References:
- HEMLIBRA Summary of Product Characteristics.
- Santagostino E et al. ECTH 2019 [Oral Presentation].
- Oldenburg J et al. N Engl J Med 2017;377:809-18.
M-GB-00004693
Date of preparation: September 2021
