The manufacturer of Hemlibra, also called emicizumab, has let us know that a small number of treatment kits may include needles that are not as sharp as they should be.
A blunter needle may make the injection more painful than normal, but it should not be dangerous. Please report any concerns with the needles or any side effects you experience.
If you feel your needle is blunt, please do the following:
- Please ensure you notify your haemophilia centre in the first instance
- Do not dispose of it in a sharps bin
- Carefully package the needle with the rest of the Hemlibra kit
- Return the kit to your haemophilia centre or ask your centre to liaise with Roche to arrange for a courier to collect the package
- Obtain a new treatment kit. This can be done through your usual homecare provider if you report this issue to them or Roche can send a new kit to your haemophilia centre.
- Please report all incidents to Roche or B. Braun, the needle manufacturer. You could also report to the Medicines and Healthcare Products Registry (MHRA). Contact details are below. Every complaint will be logged and investigated by B. Braun.
A spokesperson from Roche told us: ‘Following feedback from the community, and as a result of our own rigorous quality assurance systems and alignment with the legal manufacturer of needles, B. Braun, we became aware of two specific needle batches (24N05G89A1 and 23N12G89A1) that may include a low percentage of complaints reported as ‘blunt’ needles. Needles from these two batches have been used in some B. Braun administration kits distributed by Roche along with Hemlibra®(emicizumab). B. Braun’s careful analysis of the overall complaint situation has shown that the complaint rate for the batches in scope is very low on a global level (below 0.01%). To date, B. Braun has not found any indications suggesting that the two needle batches are not conforming to specifications and regulations.’
The affected kits are difficult to identify due to three batch numbers being involved. The first is for the Hemlibra treatment, the second is for the administration kit and the third is for the injection needle which is inside the sealed kit.
Hemlibra is a treatment for severe and moderate haemophilia A which is injected subcutaneously (under the skin). Hemlibra is also available for people with all severities of haemophila A who have FVIII (eight) inhibitors.
Reporting of side effects
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 01707 367554. By reporting side effects (such as bruising) you can help provide more information on the safety of this medicine.
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. Please report suspected side effects to the Medicines and Healthcare Products Registry (MHRA) through its Yellow Card scheme, via the Yellow Card website www.mhra.gov.uk/yellowcard, or the free Yellow Card app available in the Apple App Store or Google Play Store.
Needle manufacturer B. Braun: productcomplaints.bbmuk@bbraun.com