ADR that result in revision of patient information
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| Singapore: Lunsumio (mosunetuzumab): New important identified risk of Hemophagocytic Lymphohistiocytosis |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to inform healthcare professionals that Hemophagocytic Lymphohistiocytosis (HLH) is a new important identified risk for LUNSUMIO.
HLH is a life-threatening syndrome, and early detection and management is essential. HLH, including immune effector cell-associated HLH-like syndrome (IEC-HS), may resemble severe cytokine release syndrome (CRS), but with clinical differences from CRS including a delayed onset, rapid increases in serum ferritin, and differences in cytokine profile.
For any case of suspected HLH, LUNSUMIO should be interrupted and treatment should be considered per current practice guidelines or ASTCT expert consensus guidelines. Consensus guidelines recommend frontline treatment with anakinra (an interleukin1 receptor antagonist), with or without corticosteroids. Expert consultation is recommended if HLH is suspected. The prescribing information of LUNSUMIO will be updated accordingly.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/lunsumio-(mosunetuzumab)--new-important-identified-risk-of-hemophagocytic-lymphohistiocytosis
In Hong Kong, there are 2 registered pharmaceutical products containing mosunetuzumab. All products are prescription-only medicines. So far, the Department of Health has not received any case of adverse drug reaction with regard to mosunetuzumab. In light of the above HSA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Sep 13, 2024
Issued at HKT 16:30
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