Reactions 1510, p3 - 19 Jul 2014 Telavancin: important safety concerns Information on safety concerns (nephrotoxicity, QT interval prolongation, and a potential for teratogenic effects) associated with the use of telavacin (Vibativ), and recommendations for reducing the risks, have been provided by Clinigen as a condition of marketing authorisation set by the EMA, and reported by the UK MHRA. Telavancin has been approved in the EU for the treatment of MRSA * -associated nosocomial pneumonia when other drugs are not appropriate or have failed, and should not be used for non-approved indications. Telavancin has been reported to increase the risk of death in patients with acute renal failure, and is therefore contraindicated in patients with CrCl <30 mL/min. It should be used with caution in patients at high risk of QTc prolongation or receiving other drugs which prolong the QTc interval. It is contraindicated during pregnancy because of potential fetal toxicity. Suspected adverse reactions should be reported to Clinigen † or to the MHRA. †† * methicillin-resistant Staphylococcus aureus † [email protected] †† www.mhra.gov.uk/yellowcard MHRA. Direct Healthcare Professional Communication on the launch of Vibativ (telavancin): recommendations for use and important risks (nephrotoxicity, QTc prolongation, reproductive toxicity and off-label use). Internet Document : 16 Jun 2014. Available from: URL: http://www.mhra.gov.uk/home/groups/comms-ic/ documents/drugsafetymessage/con428392.pdf 803105896 1 Reactions 19 Jul 2014 No. 1510 0114-9954/14/1510-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved

Telavancin: important safety concerns

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Reactions 1510, p3 - 19 Jul 2014

Telavancin: important safetyconcerns

Information on safety concerns (nephrotoxicity, QTinterval prolongation, and a potential for teratogeniceffects) associated with the use of telavacin (Vibativ),and recommendations for reducing the risks, have beenprovided by Clinigen as a condition of marketingauthorisation set by the EMA, and reported by the UKMHRA.

Telavancin has been approved in the EU for thetreatment of MRSA*-associated nosocomial pneumoniawhen other drugs are not appropriate or have failed, andshould not be used for non-approved indications.Telavancin has been reported to increase the risk ofdeath in patients with acute renal failure, and istherefore contraindicated in patients with CrCl<30 mL/min. It should be used with caution in patientsat high risk of QTc prolongation or receiving other drugswhich prolong the QTc interval. It is contraindicatedduring pregnancy because of potential fetal toxicity.Suspected adverse reactions should be reported toClinigen† or to the MHRA.††

* methicillin-resistant Staphylococcus aureus† [email protected]†† www.mhra.gov.uk/yellowcard

MHRA. Direct Healthcare Professional Communication on the launch of Vibativ(telavancin): recommendations for use and important risks (nephrotoxicity, QTcprolongation, reproductive toxicity and off-label use). Internet Document : 16 Jun2014. Available from: URL: http://www.mhra.gov.uk/home/groups/comms-ic/documents/drugsafetymessage/con428392.pdf 803105896