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IMPORTANT SAFETY INFORMATION¹

SERIOUS INFECTIONS

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 or corticosteroids.

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 histoplasmosis, coccidioidomycosis, 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 and Listeria.

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 initiating therapy.

• Do not start HUMIRA in patients with an active infection, including localized infections.
• Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
• Exercise caution in patients with chronic or recurrent infection or with underlying conditions which may predispose them to infection, patients who have been exposed to TB, patients with a history of opportunistic infection, or patients who have resided or traveled in regions where TB or mycoses are endemic.
• Patients who develop a new infection should undergo a prompt and complete diagnostic workup, and appropriate antimicrobial therapy should be initiated.
• Drug interactions with biologic products: Concurrent use of anakinra or abatacept with HUMIRA is not recommended, as the combination of anakinra or abatacept with TNF blockers has been associated with an increased risk of serious infections. This risk has also been observed with rheumatoid arthritis patients treated with rituximab who received subsequent treatment with a TNF blocker.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases has occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

• The risks and benefits of HUMIRA treatment should be considered prior to initiating or continuing therapy in a patient with known malignancy.
• More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials.
• Non-melanoma skin cancer (NMSC) has been reported during clinical trials for HUMIRA-treated patients. All patients, particularly those with history of prolonged immunosuppressant or PUVA therapy, should be examined for the presence of NMSC prior to and during treatment with HUMIRA.
• In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
• Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use.
• Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

• Anaphylaxis and angioneurotic edema have been reported rarely following HUMIRA administration.
• If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

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.

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