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Hemlibra (emicizumab) 150 mg/mL Solution for Injection
Prescribing Information
Patient Leaflet
Product infomation

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency):

  • with factor VIII inhibitors
  • without factor VIII inhibitors who have: - severe disease (FVIII < 1%) - moderate disease (FVIII ≥ 1% and ≤ 5%) with severe bleeding phenotype18
     
 

 

For over ten years, Roche has worked with the leading minds in haematology to improve patient outcomes with HEMLIBRA®.1,2

 

In that time, we've been privileged to help you support your patients with haemophilia A to lead active, fulfilling everyday lives.3-9

Together, we’ve supported more than 30,000 haemophilia A patients and their families, including over 200 Irish patients treated with HEMLIBRA®,10,11 offering them a world where haemophilia A isn’t the thing they think about most each day.1,2

With over a decade of data* across the pivotal HAVEN trials, HEMLIBRA® demonstrated a significant reduction in bleeds (P < 0.001) regardless of age**, FVIII inhibitor status, or dosing regimen.1,2,12–17

 

Pooled data from long‑term follow-up of Phase 3 multicentre open-label studies demonstrated that over 80% of patients experienced zero treated bleeds.2† That means less time spent being held back by their condition and more spent doing what they love.
Supporting materials
Hemlibra (emicizumab) visual injection guide
Hemlibra (emicizumab) Patient Booklet

HEMLIBRA's 4 week half life1 continues to offer consistent and sustained bleed protection2 that empowers individuals with Hemophilia A to confidently participate in a wide range of physical activities and to live an active lifestyle 1,2, 4-9, 19,20 
Further Information

For full prescribing information please refer to the Hemlibra SmPC, available on www.medicines.ie

 

Medical Information/queries:

MedInfo, ireland.druginfo@roche.com

Product materials: catherine.dunne@roche.com

 

Please report adverse events to:

The Drug Surveillance Centre

Roche Products (Ireland) limited

3030, Lake Drive, Citywest, Naas Road, Dublin 24

Tel: +353 (0)1 469 0700

Email: ireland.drug_surveillance_centre@roche.com

Or

HPRA Pharmacovigilance

Website: hpra.ie

 


Marketing Authorisation Holder: Roche Registration GmbH, EmilBarell-Strasse 1, 79639 Grenzach-Wyhlen, Germany. Polivy® is a registered trademark

*Clinical trial experience started in 2013 with the Phase 1/2 study (date of study initiation).

FVIII, factor VIII

** There is no data available for patients over 77 years of age 

† Weeks 121 to 144 (24-week time interval) with pooled data from HAVEN 1–4 (n=170).

 

  1. Shima M, et al. Hemophilia 2021; 27 (1): 81–89.
  2. Callaghan M, et al. Blood 2021;137(16):2231–224.
  3. Shima M, et al. Blood 2023;142(Supp 1):3991.
  4. Astermark J, et al. EAHAD 2025. PO0081.
  5. Warren BB, et al. Res Pract Thromb Hemost 2021;5(5):e12571.
  6. Négrier C, et al. Lancet Hematol. 2023; 10(3).
  7. Di Minno MND, et al. ISTH 2025, PB1452.
  8. Hassan AS, et al. Egypt J Hematol 2023;49(2):192–196.
  9. Hassan AS, et al. J Pak Med Assoc 2023;73(Suppl. 4):S31–S3.
  10. Data on file, M-XX-00021449, June 2025.
  11. Data on file, Irish Hemlibra Numbers, April 2026 
  12. Data on file, M-XX-00022312, November 2025.
  13. Pipe SW, et al. Res Pract Thromb Hemost 2023.
  14. Oldenburg J, et al. NEJM 2017;377:809–19.
  15. Young G, et al. Blood. 2019;134:2127–2138.
  16. Mahlangu J, et al. NEJM 2018;379:811–22.
  17. Pipe SW, et al. Lancet Hematol 2019;6:e295–305
  18. Hemlibra 30/mg/ml and 150mg/ml solution for injection Summary of Product Characteristics. Available at www.medicines.ie
  19. Uchida N, Blood 2016;127(13):1633–1641. 
  20. Amano K, et al. Hemophilia. 2025;31(4):703-712
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