The label for Cyltezo (adalimumab) was updated on 2026-03-03 to include a Boxed Warning. This significant revision highlights the risk of serious infections and malignancy associated with the use of Cyltezo, specifically noting an increased risk of serious infections leading to hospitalization.
Background
Adalimumab is a widely recognized therapeutic agent, available under various brand and biosimilar names. These include Humira, Hulio, Yusimry, Yuflyma, Idacio, Adalimumab-ryvk, Simlandi, Amjevita, Adalimumab-adbm, Cyltezo, Hadlima, Adalimumab-bwwd, Hyrimoz, Adalimumab-fkjp, Adalimumab-aqvh, Adalimumab-aaty, Adalimumab-aacf, and Adalimumab-atto. The current label revision specifically applies to Cyltezo (adalimumab-adaz).
What this means
The addition of a Boxed Warning to the Cyltezo label emphasizes critical safety information for healthcare providers and patients. The warning specifically details the potential for serious infections and malignancy. It alerts users to an increased risk of serious infections leading to hospitalization, as outlined in sections 5.1 and 6.1 of the prescribing information. Clinicians prescribing Cyltezo should review the updated prescribing information for the complete boxed warning and consider these risks in patient management and counseling. This update ensures that the most severe potential side effects are prominently communicated to all stakeholders.
Source
This information is based on an FDA label revision for Cyltezo (adalimumab) effective 2026-03-03. The updated prescribing information is available through DailyMed, a service of the National Library of Medicine, at dailymed.nlm.nih.gov.