HEMLIBRA is a treatment for people of all ages with haemophilia A with or without factor VIII inhibitors2

 

HEMLIBRA can be administered subcutaneously once weekly, once every two weeks or once every four weeks providing2

 

UNPRECEDENTED BLEED PROTECTION

 

Superior bleed protection vs. bypassing agents (BPA)<sup>1-3</sup>

Superior bleed protection vs. bypassing agents (BPA)1-3

First and only subcutaneous prophylaxis injection for people with haemophilia A<sup>2-6</sup>

First and only subcutaneous prophylaxis injection for people with haemophilia A2-6

Zero Treated Bleeds** People with inhibitors to FVIII 1-3
Clinically meaningful improvements in quality of life compared to on-demand treatment with BPAs<sup>1</sup>

Clinically meaningful improvements in quality of life compared to on-demand treatment with BPAs1

Safety and tolerability profile evaluated in largest clinical trial programme in people with inhibitors<sup>2-6</sup>

Safety and tolerability profile evaluated in largest clinical trial programme in people with inhibitors2-6

Treated bleeds defined as a bleed that was directly followed by a haemophilia medication reported to be a “treatment for bleed”, regardless of the time between the treatment and the preceding bleed.3

About Hemlibra

Safety Information

HEMLIBRA has risks and benefits. As with all medications, there are several side effects that are associated with taking HEMLIBRA. Before you start treatment with HEMLIBRA, it is important that you are aware of all potential side effects of the medication. Always contact your healthcare provider immediately if you have any concerns regarding side effects.

HEMLIBRA Consumer Panel

HEMLIBRA® (emicizumab), 30 mg in 1 mL, 60 mg in 0.4 mL, 105 mg in 0.7 mL and 150 mg in 1 mL ready-to-use solution for subcutaneous (SC) injection, is a Prescription Medicine used to prevent bleeding or reduce the frequency of bleeding in people with haemophilia A with or without factor VIII inhibitors.

Do not use HEMLIBRA if: you have had an allergic reaction to HEMLIBRA or any of the ingredients, or to any medicines that are made using Chinese hamster ovary cells.

Tell your doctor if: you have allergies to any other medicines, foods, preservatives or dyes; you are taking bypassing agents or any other blood product; you are pregnant or plan to become pregnant or are breastfeeding; you are using any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following: confusion, weakness, swelling of arms and legs, yellowing of skin and eyes, abdominal or back pain, feeling sick (nausea), being sick (vomiting) or urinating less – may be signs of thrombotic microangiopathy (TMA); swelling, warmth, pain or redness – may be signs of a blood clot in a vein near the surface of the skin; headache, numbness in your face, eye pain or swelling or vision impairment – may be signs of a blood clot in a vein behind your eye; blackening of the skin – may be a sign of severe damage to the skin tissue. Possible unwanted effects include: injection site reactions, headache, joint pains, high temperature or fever, diarrhoea, muscle aches, TMA. HEMLIBRA has risks and benefits. Ask your haematologist if HEMLIBRA is right for you. Use strictly as directed. If symptoms continue or you have side effects, see your healthcare professional. For further information on HEMLIBRA, please talk to your health professional or visit www.medsafe.govt.nz for HEMLIBRA Consumer Medicine Information.

HEMLIBRA is not funded by PHARMAC. You will need to pay the full cost of this medicine. A prescription charge and normal doctor’s fees may apply.

Consumer panel dated 9 May 2019 based on CMI dated 29 August 2018. Roche Products (New Zealand) Limited, Auckland. Phone: 0800 656 464. www.roche.co.nz. All trademarks mentioned herein are protected by law.

References:

  1. Oldenburg J, et al. Haemophilia. 2019 Jan;25(1):33-44
  2. New Zealand data sheet February 2019
  3. Oldenburg J, Mahlangu J, Kim B, et al. Emicizumab prophylaxis in haemophilia A with inhibitors. N Engl J Med. 2017;377:809-818.
  4. Young G, Sidonio RF, Liesner R, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia a A with inhibitors: results from the HAVEN 2 study Blood 2018;132:632
  5. Mahlangu J, Oldenburg J, Paz‑Priel I, et al. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors N Engl J Med. 2018; 379:811-22.
  6. Pipe S, Shima M, Lehle M et al. Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label,non-randomised phase 3 study Lancet Haemotol April 2019 published online S2352-3026(19)30054-7

Click Here to view the full HEMLIBRA Consumer Medicine Information

PM-NZ-0531/TAPSNA11139/JULY2019

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This website was last updated on 29/7/2019. © 2019 Roche Products (New Zealand) Ltd.