During a routine examination of drug product batches, as part of our quality assurance systems and processes, hardly visible, translucent particles were identified in Hemlibra (emicizumab), outside our particle specification.
These particles are inherent to the drug product and based on toxicology and safety assessments and review of available data, the benefit/risk profile of Hemlibra remains unchanged as a result. They consist of protein (Hemlibra drug substance) and silicone oil (PDMS, polydimethylsiloxane). Silicone oil is a non-toxic, organic polymer that is included in all parenteral medicines. Translucent particles are commonly observed and present in other approved biologics.
We have informed health authorities in March 2019. The European Medicines Agency (EMA), US Food and Drug Administration (FDA), Swissmedic, Health Canada, and the Ministry for Health, Labour and Welfare (MHLW) in Japan all agreed with our assessment that the benefit/risk profile of Hemlibra remains unchanged, and have supported the continued distribution of Hemlibra to patients to avoid therapy interruption. We have submitted the results of our final analysis to the health authorities and continue to engage with these health authorities.
We are committed to producing high quality products for our patients, which is why we have rigorous manufacturing monitoring, controls and testing in place for all our medicines, including Hemlibra.
Please contact your haemophilia care team or email Roche UK Medical Information firstname.lastname@example.org for additional inquiries.
▼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 email@example.com or calling +44(0)1707 367554.
As Hemlibra is a biological medicine, healthcare professionals should report adverse reactions by brand name and batch number.
More information can be found here: www.ehc.eu/european-haemophilia-consortium-ehc-communication-on-particulate-matter-in-emicizumab-hemlibra-and-other-biologic-agents/