HUMIRA® for HCPs
SkyRizi™ for HCPs
RINVOQ™ for HCPs
Insurance coverage can change for your patients but broad access to HUMIRA remains consistent Insurance coverage can change for your patients but broad access to HUMIRA remains consistent Insurance coverage can change for your patients but broad access to HUMIRA remains consistent

Quick start with
preferred access
from Day 1*

99% of national commercial,
Medicare Part D, and Medicaid
patients have access to
HUMIRA
as a preferred,
first‑line TIM on formulary2,§

Your patients can
save on costs

with the
HUMIRA Complete
Savings Card3

HUMIRA Complete offers
one-on-one attention,
helping patients start and
stay on track with their
prescribed treatment plan

*Day 1 starts after required prior authorization.
Formulary Definitions: Preferred/Step 1 means the product is placed on the plan’s preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit,
or are placed on a higher tier. First-line refers to a preferred or parity formulary status.
A TIM (targeted immunomodulator) is a pharmacologic agent that modifies the immune response by targeting certain mediators or select cell surface markers on immune cells.
§Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.

Not actual patients.

Formulary Coverage & Savings

Give your patients a quick start with preferred access from Day 1*

Ninety-nine percent preferred

2020 National Commercial, Medicare Part D, and Medicaid Access

In 2020, 99% of national commercial, Medicare Part D, and
Medicaid patients have access to HUMIRA as a preferred, first-line TIM on formulary.2,§

In 2019, 94% of eligible, commercially
insured HUMIRA Complete Savings
Card users received their HUMIRA for $5 per month, every month.3,|| 

HUMIRA savings card

*Day 1 starts after required prior authorization.
Formulary Definitions: Preferred/Step 1 means the product is placed on the plan’s preferred formulary. Non-preferred products require a higher out-of-pocket cost or step edit, or are placed on a higher tier. First-line refers to a preferred or parity formulary status.
A TIM (targeted immunomodulator) is a pharmacologic agent that modifies the immune response by targeting certain mediators or select cell surface markers on immune cells.
§Coverage requirements and benefit designs vary by payer and may change over time. Please consult with payers directly for the most current reimbursement policies.
IITerms 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: Available to patients with commercial prescription insurance coverage for HUMIRA who
meet eligibility criteria. 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 Veterans Affairs programs) or where prohibited by law or by the patient’s health insurance provider. 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 Complete Savings Card and patient must call HUMIRA Complete at 1.800.4HUMIRA to stop participation. Patients residing in or receiving treatment in certain
states may not be eligible. 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. Please see full Terms and Conditions.

HUMIRA Complete

HUMIRA Complete: committed
to supporting an exceptional patient experience

Enroll your patients in HUMIRA Complete

Help them start and stay on track with their treatment plan. HUMIRA Complete provides your patients with the resources they need, when they need them, throughout their whole treatment journey – and at no additional cost to them.

Resources designed with patients in mind

One-step enrollment: simple for patients

Here’s how to enroll…

Enrollment Fax Form

1.800.4HUMIRA (1.800.448.6472)

HUMIRA Complete Pro

Enrollment Fax Form

1.800.4HUMIRA (1.800.448.6472)

HUMIRA Complete Pro

HUMIRA Complete Enrollment Form

HUMIRA Citrate‑free
Referral and
Prescription Form

Our Nurse Ambassadors* are the heart
of HUMIRA Complete. From the moment
of enrollment in HUMIRA Complete, a Nurse Ambassador is available to listen and motivate patients to reach their goals.

*Ambassadors do not provide medical advice and are trained to direct patients to speak with their healthcare professional about any treatment-related questions, including further referrals.

Tomorrow

A Nurse Ambassador is personally
assigned to your patient and
calls within 1 business day

As Soon As Possible

Explains to your patients how to navigate
the insurance process
and identify ways
to help save on the cost of HUMIRA

Provides ongoing supplemental injection
training
, in-person or over-the-phone

Empowers patients with disease state
education
to equip them with the knowledge
needed to understand their disease journey

Moving Forward

Answers questions that come up
and
offers continuing guidance

>1.6 MILLION

personalized, one-to-one discussions with patients.
That’s over 281,500 in 2019 alone.4

HUMIRA Complete Nurses are
available 24/7

Your patients can reach out to their
nurse by calling 1.800.4HUMIRA (1.800.448.6472)

Your patients can reach out to their
nurse by calling 1.800.4HUMIRA (1.800.448.6472)

Sharps disposal containers and a
mail-back service are provided by
HUMIRA Complete for
your patients’
used Pens or syringes

Watch how Nurse Ambassadors make a difference to your patients’ treatment journey

HUMIRA Nurse Ambassadors: Empowering Patients

Navigating the Challenge of Insurance

Too many forms? Enroll patients even faster with Complete Pro

Complete Pro is an online resource designed to help your patients obtain their prescription in a timely manner.

You can choose the capabilities that are most relevant to you and your patients’ needs, such as:

Instant benefits verification

  • Patient out-of-pocket costs
  • Prior authorization requirements
  • Pharmacy options available to the patient
  • Patient eligibility for any drug discount from
    the pharmaceutical company

Online prescribing efficiencies

  • Complete prior authorization forms and send
    it directly to the
    insurer and to the patient’s chosen pharmacy
  • Send HUMIRA Complete Savings Card information
    electronically to the pharmacy
  • Be notified via text, e-mail, or website in advance of the
    patient's prior authorization expiration
  • Easily access each patient's Rx fill status

Visit Complete Pro to register your patients

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 calls
within 1 hour.

NURTURE Adherence Study

In a retrospective claims analysis,
HUMIRA Complete helped patients get started on therapy faster, helped to increase refill adherence, and helped them to continue therapy longer5,6,*

FASTER ON THERAPY

GREATER REFILL ADHERENCE

LONGER TIME ON THERAPY

Patients filled their first prescription
TWICE AS FAST when prescription
was initiated through HUMIRA Complete Pro
(HCPro)5,*

HCPro Patients

7
DAYSa

(n=299)

Non-HCPro Patients

14
DAYS

(n=13,611)

aP<0.0001, HCPro Patients vs Non-HCPro Patients.
*Based on retrospective studies using patient-level data from HUMIRA Complete.

Study Objective:5

To evaluate the impact of HCPro on HUMIRA treatment initiation:

  • Time from HUMIRA prescription written to first fill

Study Design Summary:5

Patient-level HCPro data for an FDA-approved indication were combined with Symphony Health Solutions claims for patients initiating HUMIRA between 01/2012 and 04/2015. The retrospective sample included commercially‑insured patients aged ≥ 18 years with a diagnosis of RA, PsA, AS, CD, UC, and Ps. Time to first fill was compared between patients who initiated prescription process through HCPro (n=299) and those who did not (n=13,611).

Limitations:5

  • Results are for commercially‑insured adult patients in the US and may not be applicable to other patient populations
  • Prescriptions that were never submitted to a pharmacy are not observed in these data
  • Factors unobservable in the data could be related to both HCPro use and patient outcomes, and thus be a source of bias

Enrolled patients had 29.3% HIGHER (relative difference) refill adherence over one year vs patients not enrolled6,*

Enrolled Patients

64.8%a

(n=1,134)

Non-enrolled Patients

50.1%

(n=1,134)

Mean refill adherence measured by Proportion of Days Covered (PDC) was higher for the HUMIRA Complete cohort vs the non-HUMIRA Complete cohort at 12 months (P<0.0001).6,†

aP<0.0001, Enrolled Patients vs non-enrolled patients.
*Based on retrospective studies using patient-level data from HUMIRA Complete.
P-value based on two-sample t-test of means. Relative difference calculated as Patient Support Program (PSP) – Non-PSP/Non-PSP.

Study Objective:6

To compare prescription refill adherence based on enrollment in HUMIRA Complete among commercially‑insured patients.

Study Design Summary:6,7

A longitudinal retrospective study (N=2,268) was conducted for an FDA-approved indication using patient‑level data from HUMIRA Complete linked with Symphony Health Solutions claims.
Commercially‑insured biologic-naïve patients aged ≥18 years initiating HUMIRA between 01/2015 to 02/2016 (index date) were included. Patients who participated with HUMIRA Complete were matched to those who did not. Refill adherence as measured by proportion of days covered (PDC) was assessed over the following 12 months.

Limitations:6,7

  • Enrollment files were not available to determine continuous periods of health care coverage. Data coverage was instead based on the observed frequency of pharmacy and medical claims
  • The data from these retrospective claims analysis do not provide information about whether or not the patient took his or her dispensed medication as prescribed
  • Factors unobservable in the data could be related to both HUMIRA Complete enrollment and patient outcomes, and thus be a source of bias
  • Results are for commercially‑insured adult patients in the US and may not be applicable to other patient populations

Patients continued refilling 22.6% LONGER WHEN ENROLLED IN HUMIRA COMPLETE vs non‑enrolled patients over one year6,*

Mean 266 days vs 217 days, P<0.0001.

*Refill discontinuation was defined as a gap in the filling of pharmacy claims for HUMIRA treatment greater than the days of supply on the patient’s last claim without any further HUMIRA prescription or switching to another biologic medication.

Study Objective:6

To compare refill discontinuation based on enrollment in HUMIRA Complete among commercially‑insured patients.

Study Design Summary:6,7

A longitudinal retrospective study (N=2,268) was conducted for an FDA-approved indication using patient‑level data from HUMIRA Complete linked with Symphony Health Solutions claims.
Commercially‑insured biologic-naïve patients aged ≥18 years initiating HUMIRA between 01/2015 to 02/2016 (index date) were included. Patients who participated with HUMIRA Complete were matched to those who did not. Refill discontinuation was assessed over the following 12 months.

Limitations:6,7

  • Enrollment files were not available to determine continuous periods of health care coverage. Data coverage was instead based on the observed frequency of pharmacy and medical claims
  • The data from these retrospective claims analysis do not provide information about whether or not the patient took his or her dispensed medication as prescribed
  • Factors unobservable in the data could be related to both HUMIRA Complete enrollment and patient outcomes, and thus be a source of bias
  • Results are for commercially‑insured adult patients in the US and may not be applicable to other patient populations

AS=ankylosing spondylitis; CD=Crohn’s disease; Ps=plaque psoriasis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; UC=ulcerative colitis

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INDICATIONS1

Adult Crohn's Disease (CD): 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. HUMIRA is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Ulcerative Colitis (UC): 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.

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.

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.

Discontinue HUMIRA 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. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB 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. Consider empiric anti‑fungal therapy 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.

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.

  • Do not start HUMIRA during 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.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

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.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non‑melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA‑treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, 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 those 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 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.
  • Evaluate patients at risk for HBV infection 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 HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of 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; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor 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.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live‑attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live‑attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS1

Rheumatoid Arthritis (RA): 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 (JIA): 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 (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): 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 also 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 (UC): 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 (Ps): 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 (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: HUMIRA is indicated for the treatment of non‑infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Please see full Prescribing Information.

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on File, AbbVie Inc. Payer-reported lives. December 2019. 3. Data on File, AbbVie Inc. ZS Associates Analysis of OPUS Health Claims Data. June 2019. 4. Data on File, AbbVie Inc. HUMIRA Complete Metrics, August 2019. 5. Data on File, AbbVie Inc. H16.DOF.028. 6. Brixner D, Rubin OT, Mease P, et al. Benefits of a patient support program on adherence, discontinuation, and costs in the U.S. commercial population of adalimumab‑treated patients. Abstract presented at the Academy of Managed Care Pharmacy (AMCP). April 23–26, 2018; Boston, MA. 7. Data on File, AbbVie Inc. H17.DOF.058.

Indications1

Ulcerative Colitis (UC): 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.

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.

Important Safety Information
and Indications1

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

Indications1

Ulcerative Colitis (UC): 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.

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.

Important Safety Information
and Indications1

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

INDICATION1

Ulcerative Colitis (UC): 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.

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.

Discontinue HUMIRA 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. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB 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. Consider empiric anti‑fungal therapy 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.

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.

  • Do not start HUMIRA during 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.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

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.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non‑melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA‑treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, 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 those 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 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.
  • Evaluate patients at risk for HBV infection 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 HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of 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; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor 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.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live‑attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live‑attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS1

Rheumatoid Arthritis (RA): 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 (JIA): 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 (PsA): 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 (AS): HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Adult Crohn's Disease (CD): 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 also 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 (UC): 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 (Ps): 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 (HS): HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

Uveitis: HUMIRA is indicated for the treatment of non‑infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Please see full Prescribing Information.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.