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.
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.
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.
Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Adult Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have lost response to or are intolerant to infliximab.
Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.
Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.
Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa.
Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.
Encourage patients to enroll in HUMIRA Complete by using any of these 4 options:
After completing enrollment, patients will receive a call from his or her Ambassador within one business day.
HUMIRA Complete can help patients understand their insurance coverage and even assist in identifying ways to save on HUMIRA.
Help your patients request a savings card:
With the HUMIRA Complete Savings Card, 97.2% of eligible, commercially insured users received their HUMIRA for $5 per month, every month,* in 2016 alone.2
Have patients who are uninsured or unemployed?
Patients who are uninsured or unemployed may be able to get HUMIRA at no cost. They can work with an Ambassador or connect with independent foundations, such as the AbbVie Patient Assistance Foundation.
*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 (including Part D), Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense or Veteran’s Affairs programs) or where prohibited by law. If at any time a patient begins receiving prescription drug coverage under any such federal, state or government-funded healthcare program, patient will no longer be able to use the HUMIRA Savings Card and patient must call HUMIRA Complete at l.800.4HUMIRA to stop participation. Patients may not seek reimbursement for value received from the HUMIRA Complete program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.
Program Details: For all eligible patients, the HUMIRA Complete Savings program offers up to $12,000 in annual savings, with a monthly benefit maximum of $1,200 and an expanded benefit of $9,000 during any two-month period in the benefit year.
From the moment your patients enroll in HUMIRA Complete, an Ambassador is available to listen, to encourage them to make their own decisions, and to motivate them to reach their goals. Ambassadors reinforce your treatment plan, helping patients stay on track through every step of their treatment journey.
Ambassadors can help:
†Ambassadors do not provide medical advice and are trained to direct patients to speak with their health care professional about any treatment-related questions, including further referrals.
Send a link of the HUMIRA Complete App to your patient.Download app
While patients will get their initial injection training from you or your staff, HUMIRA Complete can help reinforce it. Patients can choose from personalized training provided by a nurse or online training videos.
Patients can access 24/7 on-call nurse injection training support at 1.800.4HUMIRA.‡ Training videos for the HUMIRA Pen and syringe are available on HUMIRA.com and the HUMIRA Complete app. They cover self-injection, as well as how to inject a child. Plus, a Talking Training Pen is available in English, Spanish, and Mandarin.Show videos
‡Nurses are available at 1.800.4HUMIRA (1.800.448.6472) for immediate assistance Monday through Friday, from 8 AM to 8 PM ET. At all other times, a nurse will return your call within 1 hour.
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. OPUS Health Analysis of OPUS Health Claims Data (Jan 2016-Dec 2016).