Adalimumab (a da LIM yoo mab)
US: Humira, Humira Pediatric Crohns Start, Humira Pen, Humira Pen-Crohns Starter, Humira Pen-Psoriasis Starter
Humira (AE, AR, AT, AU, BE, BG, BH, BR, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EE, EG, FI, FR, GB, GR, HK, HN, HR, HU, IE, IL, IQ, IR, IS, IT, JO, JP, KR, KW, LB, LT, LY, MT, MX, MY, NL, NO, NZ, OM, PE, PL, PT, PY, QA, RO, RU, SA, SE, SG, SI, SK, SY, TR, TW, UY, VE, VN, YE, ZA), Trudexa (AT, BE, BG, CH, CZ, DE, DK, EE, FI, FR, GB, GR, HN, IE, IT, NL, NO, PL, PT, RU, SE, SK, TR)
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.