Appropriate route for the administration of bortezomib (Velcade®)

HSA would like to remind healthcare professionals that the correct procedure for administering bortezomib (Velcade®, Janssen) is via the intravenous route and to recommend additional measures to reduce the risk of incorrect administration.

Bortezomib is indicated in the treatment of multiple myeloma and mantle cell lymphoma. With the apparent increase in incidence of CNS myeloma, the addition of intrathecal chemotherapy to established bortezomib-based protocols may become a more common practice.¹

Cases of death associated with inadvertent intrathecal administration of Velcade®

The European Medicines Agency had recently released information regarding three fatalities resulting from bortezomib being accidentally administered intrathecally instead of by the intended intravenous route. In all these fatal cases, intrathecal chemotherapy was scheduled at the same time as bortezomib intravenous administration.² In response, a Dear Healthcare Professional Letter, containing specific precautionary measures, was sent out early this year by Janssen to remind healthcare professionals that Velcade® should be given intravenously.

Recommended precautionary measures

In order to reduce administration route errors, the following specific precautionary measures should be considered:

• When possible, use different connectors for medicinal products to be administered via the intrathecal as compared to those administered via the intravenous route.
• When possible, administer intrathecal and parenteral chemotherapy at different times
• All intrathecal drugs should be packaged separately and clearly labelled both on the syringe and outer container “For Intrathecal Use”. Bortezomib should be clearly labelled both on the syringe and outer container “For Intravenous or Subcutaneous Use Only; Fatal if Given by Other Routes.”
• Appropriate procedures should be put in place to enforce double checking of syringe labels before administration.
• Specifically designated containers should be used for intrathecal drugs, both for transportation from the pharmacy and for storage in the administration area.
• When possible, intrathecal drugs should be delivered to the administration area separately from drugs to be given by other routes.
• Intravenous and intrathecal injections should be prescribed, dispensed, prepared, administered and transported only by trained and authorised healthcare professionals.
• Train and inform healthcare professionals involved in administration and/or management of oncology chemotherapy on dangers of intrathecal administration of Velcade® and the above risk minimisation measures.

Healthcare professionals are advised to take into consideration the above safety precautions when administering Velcade® and are encouraged to report any serious adverse events suspected to be associated with the use of Velcade® to the Vigilance Branch of HSA.

References

1. J Clin Oncol 2012; 30(27):3427-3428
2. http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/01/WC500120701

Published: 28 Dec 2012

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