HEMLIBRA

With the sustained protection of HEMLIBRA,1–3 life can be beautifully spontaneous

Treated annualised bleed rate (ABR) was 1.5 for HEMLIBRA every week (1.5 mg/kg/QW) and 1.3 for HEMLIBRA every 2 weeks (3.0 mg/kg/Q2W) vs. 38.2 for episodic FVIII. Sustained mean trough plasma concentrations of HEMLIBRA were achieved across all doses (open-label studies).1–3

Sustained protection1-3



HEMLIBRA delivers sustained protection with the majority of patients achieving zero treated bleeds.1–3

Efficacy was maintained over time in patients receiving HEMLIBRA, across the HAVEN studies4
Efficacy

HEMLIBRA has a half-life of weeks, not hours1
Pharmacokinetics and MOA

HEMLIBRA was evaluated in HAVEN – an extensive clinical trial programme1-3,5,6
Study designs

Consistent safety profile1



HEMLIBRA delivers sustained protection with a consistent safety profile.

  • HEMLIBRA was generally well tolerated
  • Serious TE/TMA events were uncommon in the HAVEN studies
  • Access safety considerations for patients receiving HEMLIBRA

Safety

No routine laboratory monitoring required with HEMLIBRA
Laboratory assays

Additional benefits1

 


HEMLIBRA delivers sustained protection with additional benefits.

Convenient dosing
Dosing

Patient support

Information for people who have been prescribed HEMLIBRA by their healthcare professional HEMLIBRA resource centre

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 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. As HEMLIBRA® is a biological medicine, healthcare professionals should report adverse reactions by brand and batch number.

For full details please refer to the HEMLIBRA® Summary of Product Characteristics.

ABR, annualised bleed rate; FVIII, Factor VIII; MOA, mechanism of action; QW, every week; Q2W, every 2 weeks; TE, thrombotic event; TMA, thrombotic microangiopathy.

References:

  1. HEMLIBRA Summary of Product Characteristics.
  2. Mahlangu J et al. N Engl J Med 2018;379:811-22.
  3. Oldenburg J et al. N Engl J Med 2017;377:809-18.
  4. Callaghan MU et al. ASH 2020:1800 [Poster Presentation].
  5. Young G et al. Blood 2019;134:2127-38.
  6. Pipe S et al. Lancet Haematol 2019;6:e295-38.


M-GB-00002368
Date of preparation: December 2020