Serious Infections and Malignancy
- Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
- Discontinue adalimumab if a patient develops a serious infection or sepsis during treatment.
- Perform test for latent TB; if positive, start treatment for TB prior to starting adalimumab.
- Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers including adalimumab products.
- Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF-blockers including adalimumab products.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Closely monitor patients for the development of signs and symptoms of infection during and after treatment with adalimumab, including the development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. Tests for latent tuberculosis infection may also be falsely negative while on therapy with adalimumab.
- Discontinue adalimumab if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.
PATIENT CARE PLAN
FDA and Industry Communications
Patient Counseling Information
Updated March 2023