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Adalimumab (a da LIM yoo mab)
Contents
Brand names
US: Humira, Humira Pediatric Crohns Start, Humira Pen, Humira Pen-Crohns Starter, Humira Pen-Psoriasis Starter
CAN: Humira
INT: Show/Hide
Black box warning
See product data sheet for complete boxed warning.
WARNING: Malignancy - Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA (Adalimumab) is a member. Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ? 18 years of age), of which HUMIRA is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months of therapy (range 1 to 84 months). Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources including registries and spontaneous postmarketing reports.
