Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death.These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.
Other Serious Adverse Reactions: Patients treated with HUMIRA also may be at risk for other serious adverse reactions, including anaphylaxis, hepatitis B virus reactivation, demyelinating disease, cytopenias, pancytopenia, heart failure, and a lupus-like syndrome.
Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.
Unmatched pharmacy benefit preferred first-line Formulary status among targeted immunomodulators2*
See which plans in your area include HUMIRA on their preferred drug Formulary
Enter state for Formulary status
†Stelara, Cimzia, Actemra, and Orencia are also available as products on medical benefit plans.
The products and regimens listed here are not interchangeable and are not pharmaceutically equivalent or bioequivalent. They differ with respect to active and inactive ingredients, strength, dosage, indication, clinical efficacy, and clinical safety.
No conclusions regarding comparative safety or efficacy can be drawn from this information. Selection of a treatment regimen should be individualized for each patient based on factors including, but not limited to: product efficacy, adverse events, dosage and administration, potential for drug interactions, patients’ test results, and co-morbid conditions.
Formulary Definitions: Preferred/Step 1 means either (1) the product is placed on the plan's preferred Formulary or (2) non-preferred products require a higher out-of-pocket cost or step edit; or (3) are placed on a higher tier. “Disadvantaged” means the restriction is not applied consistently across the entire therapeutic class. Can be disadvantaged by: prior authorization, step edit, generic first policy, published clinical guidelines, or medical policies. First-line refers to a preferred or parity formulary status.
*A targeted immunomodulator is a pharmacologic agent that modifies the immune response by targeting certain mediators or select cell surface markers on immune cells.
Many national and regional health plans may not approve non-preferred products for patients who have shown clinical stability solely through the use of samples or other free goods.The HUMIRA Complete Savings Card can lower the monthly co-pay cost of HUMIRA alone or HUMIRA plus another medication‡ to as little as $5 per month§ »
‡Additional medication can be one of the following: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Arava and Plaquenil are registered trademarks and are the property of their respective owners.
§Terms and Conditions apply. This benefit covers HUMIRA® (adalimumab) alone or, for rheumatology patients, HUMIRA plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: In Massachusetts, co-pay assistance is not available for products with certain generic equivalents (for example, any product with an AB-rated generic equivalent). Available to patients with commercial prescription insurance coverage for HUMIRA. Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.
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.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely 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.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. 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 have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of 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.
For full Prescribing Information, visit rxabbvie.com/pdf/humira.pdf
References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file, AbbVie Inc. Source: Payer-reported lives and BusinessOne Technologies. October 2016.