DISCLAIMER: This publication is intended for healthcare professionals. The information provided aims to update on medication safety issues and should not substitute clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss arising from the use of or reliance on this publication.
Overview
In Malaysia, Polivy® (polatuzumab vedotin) injection is approved for the treatment of adult patients with:
- Previously untreated diffuse large B-cell lymphoma (DLBCL), in combination with rituximab, cyclophosphamide, doxorubicin, and prednisolone (or prednisone) (R-CHP).
- Relapsed or refractory DLBCL, in combination with bendamustine and rituximab for patients who are not candidates for haematopoietic stem cell transplant.
Background of the Safety Issue
Infusion site extravasation, including severe events, has been identified as a new safety risk for polatuzumab vedotin. A comprehensive analysis of the data across the polatuzumab vedotin program identified cases providing sufficient evidence to support a causal association between infusion site extravasation events and polatuzumab vedotin.
Regulatory Action
On 17 April 2026, NPRA approved a Direct Healthcare Professional Communication (DHPC) letter issued by Roche (Malaysia) Sdn. Bhd. to inform healthcare professionals of this safety issue. For further information, please contact your local salesperson for a copy of the DHPC. The product label for Polivy® will be updated to reflect the new identified risk.
Advice for Health Care Professionals
- Ensure adequate venous access prior to initiating the Polivy® infusion.
- Monitor the infusion site closely throughout administration of Polivy® for signs and symptoms of extravasation, including:
- Initial signs & symptoms: Burning sensation, tingling, pain, swelling, and redness at the infusion site.
- Severe progressions: Blistering, necrosis, ulceration and cellulitis.
- Be aware that these events can occur early (within hours or days) or may have a delayed onset, appearing weeks after the incident of extravasation.
- If extravasation is suspected, stop the infusion immediately.
- Withdraw the needle following a brief aspiration.
- Elevate the affected limb and initiate appropriate symptomatic management as required.
- Resuming treatment:
- Mild symptoms: The remaining dose can be administered in the other limb after ensuring adequate venous access.
- Moderate to severe symptoms: The infusion may be reinitiated only after the events have resolved, at the discretion of the treating physician.
- Report all suspected adverse events related to the use of polatuzumab vedotin to the NPRA.
References
- Direct Healthcare Professional Communication (DHPC). Polivy® (Polatuzumab vedotin), Identified Risk: Severe Infusion Site Extravasation Events Associated with Polivy (Polatuzumab vedotin). Roche (Malaysia) Sdn. Bhd.; 2026 Apr 17.