Other safety alerts
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| Singapore: Polivy (polatuzumab vedotin): New identified risk of severe infusion site extravasation events |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals on the new identified risk of infusion site extravasation with polatuzumab vedotin. Analysis of data from post marketing and clinical settings have provided sufficient evidence of a causal association of the events with polatuzumab vedotin.
Healthcare professionals are advised to ensure adequate venous access before initiating infusion and maintain close monitoring throughout administration for signs of extravasation. If extravasation is suspected, the infusion should be stopped immediately. The needle should be withdrawn following a brief aspiration and the affected limb elevated. Appropriate symptomatic management may be initiated as required. Roche will be updating the product label to reflect this risk.
Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Polivy in combination with bendamustine and MabThera is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for haematopoietic cell transplant.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/polivy-(polatuzumab-vedotin)--new-identified-risk-of-severe-infusion-site-extravasation-events
In Hong Kong, Polivy Powder For Concentrate For Solution For Infusion 140mg (HK-66664) and Polivy Powder For Concentrate For Solution For Infusion 30mg (HK-67107) are pharmaceutical products registered by Roche Hong Kong Limited. They are prescription-only medicines. So far, with regard to polatuzumab vedotin, the Department of Health (DH) has received 29 cases of adverse drug reaction, but these cases were not reported as infusion site extravasation. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Sep 5, 2025
Issued at HKT 17:00
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