gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.
•Prefilled Syringe
Injection: A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg (0.8 mL) of Humira.
Injection: A single-use, 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 20 mg (0.4 mL) of Humira.
•Institutional Use Vial
Injection: A single-use, glass vial, providing 40 mg (0.8 mL) of Humira for institutional use only.
Contraindications
None.
Warnings and Precautions
Serious Infections
Patients treated with Humira are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death [see Boxed Warning]. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been reported with TNF blockers. Patients have frequently presented with disseminated rather than localized disease.
The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections in patients with rheumatoid arthritis (RA); therefore, the concomitant use of Humira and these biologic products is not recommended in the treatment of patients with RA [see Warnings and Precautions (5.7, 5.11) and Drug Interactions (7.2)].
Treatment with Humira should not be initiated in patients with an active infection, including localized infections. Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Consider the risks and benefits of treatment prior to initiating therapy in patients:
•with chronic or recurrent infection;
•who have been exposed to tuberculosis;
•with a history of an opportunistic infection;
•who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or
•with underlying conditions that may predispose them to infection.
Tuberculosis
Cases of reactivation of tuberculosis and new onset tuberculosis infections have been reported in patients receiving Humira, including patients who have previously received treatment for latent or active tuberculosis. Reports included cases of pulmonary and extrapulmonary (i.e., disseminated) tuberculosis. eva luate patients for tuberculosis risk factors and test for latent infection prior to initiating Humira and periodically during therapy.
Treatment of latent tuberculosis infection prior to therapy with TNF blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. Prior to initiating Humira, assess if treatment for latent tuberculosis is needed; and consider an induration of ≥ 5 mm a positive tuberculin skin test result, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).
Consider anti-tuberculosis therapy prior to initiation of Humira in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk facto |
