Safety Communication

As one form of Risk Management Plan (RMP) which is an obligation of pharmaceutical industries, Roche Indonesia Ltd. would like to emphasize the importance of the information contained in the Herceptin Product Information (Trastuzumab) regarding the monitoring of heart function.

Although there are no signs of a new risk to cardiovascular safety in Trastuzumab therapy, survey results in European countries show that adherence to cardiovascular monitoring recommendations may decrease the incidence and severity of left ventricular dysfunction and congestive heart failure (CHF) in patients receiving Trastuzumab therapy. In some patients, the risk of heart occurring during therapy with Trastuzumab is reversible after treatment with Trastuzumab is discontinued, thus this matter emphasizes the importance of monitoring LVEF function in patients during and after Trastuzumab therapy.

More detailed security information can be seen on DHPC Herceptin approved by NADFC.

 

Jakarta,       June 2017

 

NATIONAL PHARMACOVIGILANCE CENTER


Download : Safety Communication DHPC Herceptin (Trastuzumab).pdf
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