rs for tuberculosis infection. Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.
Strongly consider tuberculosis in the differential diagnosis in patients who develop a new infection during Humira treatment, especially in patients who have previously or recently traveled to countries with a high preva lence of tuberculosis, or who have had close contact with a person with active tuberculosis.
Monitoring
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Humira, 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 Humira.
Discontinue Humira if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with Humira, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy.
Invasive Fungal Infections
If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider appropriate empiric antifungal therapy, taking into account both the risk for severe fungal infection and the risks of antifungal therapy, while a diagnostic workup is being performed. To aid in the management of such patients, consider consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections.
Malignancies
Consider the risks and benefits of TNF-blocker treatment including Humira prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF blocker in patients who develop a malignancy.
Malignancies in Adults
In the controlled portions of clinical trials of some TNF-blockers, including Humira, more cases of malignancies have been observed among TNF-blocker-treated adult patients compared to control-treated adult patients. During the controlled portions of 34 global Humira clinical trials in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC) and plaque psoriasis (Ps), malignancies, other than non-melanoma (basal cell and squamous cell) skin cancer, were observed at a rate (95% confidence interval) of 0.6 (0.38, 0.91) per 100 patient-years among 7304 Humira-treated patients versus a rate of 0.6 (0.30, 1.03) per 100 patient-years among 4232 control-treated patients (median duration of treatment of 4 months for Humira-treated patients and 4 months for control-treated patients). In 47 global controlled and uncontrolled clinical trials of Humira in adult patients with RA, PsA, AS, CD, UC, and Ps, the most frequently observed malignancies, other than lymphoma and NMSC, were breast, colon, prostate, lung, and melano |
