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.1,2 Sustained mean trough plasma concentrations of HEMLIBRA were achieved across all doses (open-label studies).1–3

Efficacy

Proven efficacy in congenital haemophilia A, classified as severe or with FVIII inhibitors

Significantly fewer treated bleeds with HEMLIBRA prophylaxis vs. episodic FVIII1

  •  In the HAVEN 3 study, treated ABR (primary efficacy endpoint) was 38.2 with episodic FVIII (n=18) compared with:2
    • 1.5 with HEMLIBRA prophylaxis QW, a 96% reduction (n=36; p<0.001)
    • 1.3 with HEMLIBRA prophylaxis Q2W, a 97% reduction (n=35; p<0.001)
  • 56% and 60% of patients had zero treated bleeds with HEMLIBRA prophylaxis QW and Q2W vs. 0% with episodic FVIII (n=20/36; n=21/35 and n=0/18)1,2

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Safety

Safety

HEMLIBRA was generally well tolerated.¹

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Safety

Dosing

Dosing

HEMLIBRA is a subcutaneous injection given every week, 2 weeks or 4 weeks.1

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Dosing Pharmacokinetics and MOA

▼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; QW, every week; Q2W, every 2 weeks; RCT, randomised clinical trials.

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.

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Date of preparation: November 2019