ing the use of Humira in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
Hematological Reactions
Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia (e.g., thrombocytopenia, leukopenia) have been infrequently reported with Humira. The causal relationship of these reports to Humira remains unclear. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Humira. Consider discontinuation of Humira therapy in patients with confirmed significant hematologic abnormalities.
Use with Anakinra
Concurrent use of anakinra (an interleukin-1 antagonist) and another TNF-blocker, was associated with a greater proportion of serious infections and neutropenia and no added benefit compared with the TNF-blocker alone in patients with RA. Therefore, the combination of Humira and anakinra is not recommended [see Drug Interactions (7.2)].
Heart Failure
Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with Humira. Humira has not been formally studied in patients with CHF; however, in clinical trials of another TNF blocker, a higher rate of serious CHF-related adverse reactions was observed. Exercise caution when using Humira in patients who have heart failure and monitor them carefully.
Autoimmunity
Treatment with Humira may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira, discontinue treatment [see Adverse Reactions (6.1)].
Immunizations
In a placebo-controlled clinical trial of patients with RA, no difference was detected in anti-pneumococcal antibody response between Humira and placebo treatment groups when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with Humira. Similar proportions of patients developed protective levels of anti-influenza antibodies between Humira and placebo treatment groups; however, titers in aggregate to influenza antigens were moderately lower in patients receiving Humira. The clinical significance of this is unknown. Patients on Humira may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission of infection by live vaccines in patients receiving Humira.
It is recommended that JIA patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating Humira therapy. Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Use with Abatacept
In controlled trials, the concurrent administration of TNF-blockers and abatacept was associated with a greater proportion of serious infections than the use of a TNF-blocker alone; the combination therapy, compared to the use of a TNF-blocker alone, has not demonstrated improved clinical benefit in the treatment of RA. Therefore, the combination of abatacept with TNF-blockers including Humira is not recommended [see Drug Interactions (7.2)].
Adverse Reactions
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