Life on Hemlibra
It is very important you talk to your doctor or nurse about when and how to use bypassing agents if you have a bleed while taking Hemlibra. This may be different from how you used them in the past.
If you are using HealthID or have a MedicAlert bracelet or necklace, you could consider updating your information.
The package leaflet contained in the box with your medicine, the guide for patients/carers and patient alert card also have guidance for using bypassing agents while you are taking Hemlibra
What side effects might I get with Hemlibra?
Very common: may affect more than 1 in 10 people
- A reaction in the area where the injection is given (redness, itching, pain)
- Headache
- Joint pain
Common: may affect up to 1 in 10 people
- Fever
- Muscle aches
- Diarrhoea
- Itchy rash or hives (urticaria)
- Skin rash
Uncommon: may affect up to 1 in 100 people
- Destruction of red blood cells (thrombotic microangiopathy)
- Blood clot in a vein behind your eye (cavernous sinus thrombosis)
- Severe damage of the skin tissue (skin necrosis)
- Blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
- Swollen face, tongue and/or throat and/or difficulty in swallowing, or hives, together with difficulty in breathing which are suggestive of an angioedema
- Lack of effect or decreased response to treatment
- Allergic reaction
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
You should also report side effects to Roche Products Ltd by emailing the Roche Drug Safety Centre at welwyn.uk_dsc@roche.com or calling +44 (0) 1707 367554.
By reporting side effects you can help provide more information on the safety of this medicine.
Antibody formation (immunogenicity)
You may notice that bleeding is not being controlled with your prescribed dose of Hemlibra. This could be due to the development of antibodies to this medicine.
Talk to your doctor immediately if you or your caregiver notices an increase in bleeds. Your doctor may decide to change your treatment if this medicine stops working for you.
Using bypassing agents with Hemlibra
In clinical trials, serious side effects were seen in patients using aPCC (Feiba) while receiving Hemlibra. Use of aPCC should be avoided unless no other treatment options/alternatives are available.
If aPCC is needed while you are using Hemlibra, an initial dose of no more than 50 units/kg should be used. If bleeding is not controlled, additional aPCC should only be administered under medical guidance/supervision. The total dose of aPCC should not exceed 100 units/kg in the first 24-hours of treatment.
Stop using Hemlibra and aPCC and talk to a doctor immediately if you or your caregiver notices any of the following side effects:
Destruction of red blood cells (thrombotic microangiopathy, TMA):
- Confusion, weakness, swelling of arms and legs, yellowing of skin and eyes, vague belly (abdominal) or back pain, feeling sick (nausea), being sick (vomiting) or urinating less – these symptoms may be signs of TMA
Blood clots (thromboembolism):
- Swelling, warmth, pain or redness – these symptoms 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 problems with your vision – these symptoms may be signs of a blood clot in a vein behind your eye
- Blackening of the skin – this symptom may be a sign of severe damage to the skin tissue
If you need to go to hospital for a bleed, make sure you tell the healthcare team that you are taking Hemlibra. Remember to take your patient alert card with you.
Hemlibra clinical trials1
Hemlibra has been tested in clinical trials in people with people with haemophilia A, with inhibitors to factor VIII.
Hemlibra treatment was tested in people who previously used either: on-demand treatment with bypassing agents or prophylaxis with bypassing agents
Findings from these clinical trials suggest that taking Hemlibra can help prevent bleeding or reduce the number of bleeding episodes.
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