Biotech-kenner schreef op 5 oktober 2017 16:50:
From HAEA President Tony Castaldo
Cinryze Shipments Resume
The HAEA has confirmed that Shire will be shipping CINRYZE to specialty pharmacies over the next few days.
Today, patients and physicians will receive letters from Shire with information on the Cinryze “lots” being shipped. The company reports that the water system associated with the manufacturing of these lots was not working properly and created a “possible risk” that small metal particles may be present in the product.
Before deciding to release this medicine, Shire worked closely with the FDA and conducted an extensive investigation that included visual inspection and opening a sample of vials for specific testing.
While the inspection and testing did not reveal the presence of metal fragments, out of an abundance of caution, Shire advises that patients using these “lots” of medicine use an additional filter prior to each administration to. “…mitigate the possible risk of small metal particles being administered.” The filter, along with instructions, will be included in materials that are shipped with the medication. The HAEA advises that Cinryze patients discuss this information with their prescribing physician.
The manufacturing problem has been fixed and production of Cinryze has resumed.
We are in touch with Shire and will provide additional information to the patient community as it becomes available.