Important Safety Information1
Patients treated with HUMIRA are at increased
risk for developing serious infections that may
lead to hospitalization or death. Most patients who
developed these infections were taking concomitant
immunosuppressants such as methotrexate
HUMIRA should be discontinued if a patient develops
a serious infection or sepsis.
Reported infections include:
• Active tuberculosis (TB), including reactivation
of latent TB. Patients with TB have frequently
presented with disseminated or extrapulmonary
disease. Patients should be tested for latent
TB before HUMIRA use and during therapy.
Treatment for latent TB should be initiated prior
to HUMIRA use.
• Invasive fungal infections, including
candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or
other invasive fungal infections may present with
disseminated, rather than localized, disease.
Antigen and antibody testing for histoplasmosis
may be negative in some patients with active
infection. Empiric anti-fungal therapy should be
considered in patients at risk for invasive fungal
infections who develop severe systemic illness.
• Bacterial, viral, and other infections due to
opportunistic pathogens, including Legionella
The risks and benefits of treatment with HUMIRA
should be carefully considered prior to initiating
therapy in patients with chronic or recurrent
infection. Patients should be closely monitored
for the development of signs and symptoms of
infection during and after treatment with HUMIRA,
including the possible development of TB in patients
who tested negative for latent TB infection prior to
HEPATITIS B VIRUS REACTIVATION • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. • Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF blocker therapy. • Exercise caution in patients who are carriers of HBV and monitor them during and after treatment with HUMIRA. • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. • Exercise caution when considering resumption of HUMIRA therapy after appropriate treatment for HBV. NEUROLOGIC REACTIONS • TNF blockers, including HUMIRA, have been associated in rare cases with new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain- Barré syndrome. • Exercise caution when considering HUMIRA for patients with these disorders. HEMATOLOGIC REACTIONS • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia (e.g. thrombocytopenia, leukopenia) has been infrequently reported with HUMIRA. • Consider stopping HUMIRA in patients with significant hematologic abnormalities. CONGESTIVE HEART FAILURE • Worsening or new onset congestive heart failure (CHF) may occur. • Exercise caution in patients with CHF and monitor them carefully. AUTOIMMUNITY • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. • Discontinue treatment if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS • Patients on HUMIRA should not receive live vaccines. • It is recommended that juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating HUMIRA therapy. ADVERSE REACTIONS • The most common adverse reactions in HUMIRA clinical trials (incidence >10%) were: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache, and rash.
HUMIRA is the #1 prescribed self-injectable biologic for moderate to
severe Crohn’s disease in the U.S.
Please see Brief Summary of full Prescribing Information on the following pages.
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: Abbott Laboratories.
2. Data on file, Abbott Laboratories.
* Based on IMS NPA data, August 2009 - September 2011.