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 email@example.com or calling +44 (0)1707 367554.
HEMLIBRA has a half-life of weeks, not hours1
Therapeutic levels of HEMLIBRA are sustained between doses and are similar across dosing regimens1,2
- Therapeutic levels of HEMLIBRA were obtained with all three dosing regimens,2 and were consistent with pharmacokinetic model predictions3
- Trough plasma concentrations of approximately 52 µg/ml were achieved from week 5, following 4 weeks of HEMLIBRA initiation at 3 mg/kg every week1
- There is the potential for patients to develop neutralising, anti-drug antibodies to HEMLIBRA. In case of clinical signs of loss of efficacy, a change of treatment should be considered1
HEMLIBRA restores the haemostatic process4
HEMLIBRA is a therapeutic bispecific monoclonal antibody, with a novel mechanism of action (MOA).1,4 It:
- Does not induce FVIII inhibitor development1
- Is clinically effective in the presence of FVIII inhibitors1,5,6
- Has a 4–5 week half-life1
Scientific mechanism of action video
Simplified animated mechanism of action video
FIXa, activated Factor IX; FVIII, Factor VIII; FX, Factor X; MOA, mechanism of action; PK, pharmacokinetics; QW, every week; Q2W, every 2 weeks; Q4W, every 4 weeks.
- HEMLIBRA Summary of Product Characteristics.
- Pipe S et al. WFH 2018 [Oral Presentation].
- Yoneyama K et al. Clin Pharmacokinet 2018;57:1123–34.
- Kitazawa T et al. Nat Med 2012;18:1570–4.
- Oldenburg J et al. N Engl J Med 2017;377:809–18.
- Young G et al. ASH 2018;322 [Abstract].
Date of preparation: September 2021