Risk of Infections:

• Cases of tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections have been reported during therapy.
• Fatality Risk: Some of these reported infections have been fatal.
• Anti-TB therapy of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with adalimumab. However, active TB has developed in patients receiving adalimumab whose screening for latent TB infection was negative.
• Patients should be evaluated for latent TB risk factors and be tested for latent TB prior to initiating therapy with this agent and during therapy.
• Treat latent tuberculosis infection prior to therapy with adalimumab.
• Monitor patients receiving adalimumab for signs and symptoms of active TB, including those who tested negative for latent TB. (See Warnings and Adverse Reactions)

Malignancy in Children and Adolescents:

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which adalimumab is a member.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Evaluate patients for latent TB with tuberculin skin testing
• Treat latent tuberculosis infection prior to therapy with adalimumab.
• Monitor patients receiving adalimumab for signs and symptoms of active TB, including those who are TB skin test negative.
• Many of the serious infections have occurred in patients on concomitant immunosupressive therapy, that in addition, to their rheumatoid arthritis, could predisopse them to infections.
• Do not initiate adalimumab in patients with active infections (chronic or localized).
• Patients who develop new infections during therapy should be monitored closely.
• Discontinue adalimumab if patient develops a serious infection.
• Exercise caution when considering the use of this drug in patients with a history of recurrent infection or underlying conditions which may predispose to infections or patients who have resided in regions where TB and histoplasmosis are endemic (See PRECAUTIONS).
• The benefits and risk of adalimumab treatment should be carefully considered before intiation of therapy.

FDA and Industry Communications

Revised Boxed Warnings Planned per FDA Safety Review: Increased Risk of Lymphomas and Other Malignancies in Children/Adolescents Treated with TNF Blockers (August 2009)

Revised Boxed Warning: TNF Blockers (November 2009)

Patient Counseling Information

• Humira

Medication Guides

Patient Medication Guide

Package Inserts

Adalimumab