22 Feb 2012 | Medication Safety
The European Medicines Agency is aware of three fatal cases of administration error that occurred with Velcade in the European Union, where the medicine was accidentally given intrathecally (into the space that surrounds the spinal cord) instead of intravenously (into a vein). The Agency’s Committee for Medicinal Products for Human Use (CHMP) is reminding healthcare professionals that Velcade should only be given by injection into a vein and is recommending precautionary measures to prevent further administration errors from occurring.
Velcade is an anticancer medicine that contains the active substance bortezomib. It is available as a powder that is made up into a solution for injection into a vein.
Velcade is used to treat patients with multiple myeloma, a cancer of the plasma cells in the bone marrow.
The active substance in Velcade, bortezomib, is a proteasome inhibitor. It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed. When the proteins in the cancer cells, such as the proteins that control the growth of the cells, are not broken down, the cells are affected and they eventually die.
Velcade has been authorised in the European Union since 26 April 2004 and is marketed in all Member States as well as Norway, Iceland and Liechtenstein.
Velcade is currently only authorised to be given by injection into a vein. The Agency was informed that since its authorisation in 2004, three patients had died because Velcade was accidentally injected Recommendations to prevent administration errors with Velcade (bortezomib) EMA/34910/2012 Page 2/2
intrathecally (into the space that surrounds the spinal cord) instead of intravenously. All three cases involved patients who were also receiving intrathecal chemotherapy at the same time as Velcade.
To prevent further administration errors from occurring, the CHMP has agreed for a letter to be sent out to healthcare professionals reminding them that Velcade should only be given intravenously. In addition, healthcare professionals are advised to consider specific precautionary measures.
As for all medicines, the Agency will continue to monitor the safety of Velcade closely.
Healthcare professionals are reminded that Velcade should only be given intravenously and are advised to consider the following precautionary measures:
The current European public assessment report for Velcade can be found on the Agency’s website.