Safety Communication

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Interaction Between Rosuvastatin and Ticagrelor Resulting In Rhabdomyolysis

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As a form of Risk Management Plan (RMP) implemented by Pharmaceutical Industries, Roche Indonesia Ltd. as the party appointed by Boehringer Ingelheim Ltd. to implement pharmacovigilance on ZELBORAF (Vemurafenib) product, published Dear Healthcare Professional Communication (DHPC) on the risk of Dupuytren Involvement and Fascial Plantar Fibromatosis on Zelboraf® use. Although the incidence of Dupuytrent Contracture and Fascial Plantar is uncommon, as well as improving and restoring conditions after Zelboraf® therapy is suspended or terminated completely, healthcare professional need to provide information about these risks to patients and should be vigilant when handling patients with Dupuytren contracture and Fibial Fibromatosis Plantar that had already existed before. More detailed security information can be found on DHPC Zelboraf® approved by NADFC.

 

Jakarta,   June 2017

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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.

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