Giving patients the resources they need, when they need them.

Nurse Ambassadors*: Dedicated to helping patients make HUMIRA part of their routine.

With an average of 19 years of nursing experience, Nurse Ambassadors are the heart of HUMIRA Complete.² From the moment your patients enroll in HUMIRA Complete, a Nurse 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 and help patients stay on track with their prescribed treatment.

Ambassadors can help by

Reaching out to patients within 1 business day of enrollment in HUMIRA Complete
Identifying ways to help save on the cost of HUMIRA
Explaining how to navigate the insurance process
Providing ongoing supplemental injection training, at home or over the phone
Answering questions that come up and offer continuing guidance
Providing a Sharps Container to dispose of used Pens and syringes

Download Enrollment Forms

*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.

HUMIRA Complete provides ongoing injection training

Transcript

Citrate-free Injection Training (8:05 min)

Complete Pro and You Together

[Text on Screen and Spoken] This demonstration video offers you help and guidance for injecting with the HUMIRA® Pen. Watch it and read the entire Patient Instructions for Use found in your HUMIRA package. Don’t try to inject HUMIRA yourself until your doctor has decided you can, and you’ve been shown the right way to give injections.

Throughout this video, you will hear from actual patients. Individual experiences may vary.

[Text on Screen] Please see Uses and Important Safety Information within the website. Please see accompanying Full Prescribing Information, including Patient Instructions for Use and Medication Guide, and discuss with your doctor.

[Text on Screen] Injecting HUMIRA with HUMIRA Complete. Resources designed with you in mind.

JANET:

Hi, how are you? I’m Janet. And I know that there are a million things you’d rather be doing right now than learning about injecting your medication...I get it. Before we start, I want you to know that there are a lot more ways HUMIRA Complete can help you out than with this video. Because, well, let’s be real...there’s more to making HUMIRA a routine part of your life than just learning how to inject.

If you are concerned about being able to afford your medication, or have questions about insurance, or are wondering how you can do this on your own, HUMIRA Complete can help get you the answers you need when you need them. You even have a dedicated Nurse Ambassador available to you. Whether you are just starting or have been taking it awhile, HUMIRA Complete is there for you.

[Text on Screen] Call 1.800.4HUMIRA

Request a HUMIRA Complete Nurse Ambassador* at 1.800.4HUMIRA

*Ambassadors do not give medical advice and will direct you to your health care professional for any treatment-related questions, including further referrals.

Everyone has a different perspective about injecting and throughout this video you will hear from some actual patients.

[Text on Screen] Visit HUMIRAComplete.com to request an Injection Training Kit

LINDSEY:

I was very hesitant, my first thought was “you’ve been terrified of needles since you were a child.”

STEVEN:

Obviously it involves a little bit more than just taking a pill and what it would feel like.

DANAY:

It’s okay to be nervous, it’s okay to feel nervous. But, if this is something that’s gonna help me continue to move forward, why not give it a try?

LAURA:

Luckily, my Nurse Ambassador—she was awesome. So she came and she really was patient, took her time with me.

MICHAEL:

They have been very good about calling and keeping up with what’s going on.

JANET:

So, let’s clear some things up. Ready? Let’s do this.

First, wash your hands and get the things you need. And settle in a place where you feel relaxed.

[Text on Screen] Store HUMIRA in the refrigerator until time of use.

[Text on Screen] Do not use HUMIRA if frozen, even if it has been thawed. Do not use if the medicine has passed the expiration date.

If it’s more comfortable for you, take your HUMIRA out of the fridge and leave it at room temp fifteen to thirty minutes before you inject.

[Text on Screen] HUMIRA should not be frozen or exposed to direct sunlight.

LAURA:

Like I think having the routine in the beginning until I was comfortable made a lot of sense for me.

LINDSEY:

I lay everything out, I plan which side I’m going to inject, and I think the process actually calms me down.

DANAY:

I knew that one day I’m gonna have to do it on my own so, I just sucked it up and I did it.

JANET:

There’s an alcohol swab that’s included inside the package, a cotton ball (you can also use a gauze pad), a sharps container (that looks like this), and of course, the HUMIRA Pen. Your doctor may have prescribed you one of two Pens. The differences you can see here are the viewing window and the caps. Both Pens work the same way. Now check the Pen. There’s a large number one on the gray cap. And a large number two on the plum-colored cap. You can’t miss ‘em. Look at the Pen, with the gray cap pointing up to make sure that the liquid is clear and colorless. If the liquid is cloudy, has an unusual color, or has flakes or specks in it, you shouldn’t use it. Use another Pen in the fridge if you have one and call your pharmacy. If you see a few bubbles, no problem. And be sure to check the medicine’s expiration date. You can find what we’re about to cover inside the package.

I’ll break this down in 4 simple steps, let’s call them the “4 Ps”.

PICK the injection site
PULL the caps off
PLACE the white end of the Pen on the site
And PRESS the plum-colored button

[Text on Screen] 4Ps

PICK
PULL
PLACE
PRESS

[Text on Screen] PICK THE INJECTION SITE

To pick your site, rotate each time at least one inch from the previous injection site; you can inject in the right or left thigh or on your stomach.

[Text on Screen] Injectable Areas

[Text on Screen] A new injection should be at least 1 inch away from the site you chose the time before

If you choose the lower stomach area, make sure it’s at least 2 inches away from your belly button.

[Text on Screen] 2 inches

Clean the site with an alcohol swab. You shouldn’t inject through clothing. And don’t inject into any skin that doesn’t look normal.

[Text on Screen] Do not inject into skin that is sore, bruised, red, hard, scarred, raised, thick, has scaly patches, lesions, or stretch marks.

[Text on Screen]: PULL THE CAPS OFF

JANET:

So now, pick up the Pen with the gray cap pointing up, holding the middle of the Pen with one hand. With your other hand, pull that gray cap straight off. No need to recap the Pen, and be careful not to touch the needle. If a few drops of liquid come out of the needle, no worries. Now, from the bottom of the Pen, pull the plum-colored cap off, and you’ll see a plum button. Then flip the Pen so that the plum activator button is now pointing up and hold it so you can see the window. Don’t press the button just yet. Now, you’re just about ready to inject. If you’re still a little nervous...I totally get it.

DANAY:

Try to think about something else, like TV or something to distract you.

STEVEN:

Just listen to your favorite music.

MICHAEL:

I think the Pen, when you do not see the needle, would help anyone who is afraid of needles.

LAURA:

Honestly, and remembering to breathe. That’s huge!

DANAY:

Take a deep breath in...

STEVEN:

And then exhale.

DANAY:

And I just did it, one two three and it was over!

[Text on Screen] PLACE THE WHITE END OF THE PEN ON THE SITE

JANET:

With your free hand, gently pinch the area of skin that you’ve cleaned and hold it firmly to make sure you’re not injecting directly into any muscle.

[Text on Screen] PRESS THE PLUM-COLORED BUTTON

Place the white needle sleeve of the Pen straight at a ninety-degree angle and flat against your skin. And press the plum activator button with your thumb (you can also use your index finger) to start the injection. Hear that? That’s the click you’ll hear that signals the start of the injection. You may actually feel the medicine going in. Don’t let it startle you. And we’re off...

[Text on Screen] 90°

[Text on Screen counts down]: Injection is complete when the yellow indicator has stopped moving

[Text on Screen counts down]: Injection is complete when the yellow indicator has stopped moving. This could take 10 – 15 seconds depending on the dose.

Continue to press the button and hold the Pen against your skin for ten to fifteen seconds, to make sure that all of the medicine has been released. When the yellow marker in the window has stopped moving, you’re good to go. Pull the Pen away from your skin...

Drop the Pen into a sharps container—immediately. Instead of rubbing the site, gently press a cotton ball (or gauze) for ten seconds. There may be a small amount of fluid or a drop of blood...which is totally normal.

[Text on Screen] There may be pain, redness, rash, swelling, itching, or bruising. If it doesn’t go away within a few days or gets worse, call your doctor right away.

STEVEN:

It definitely hurt less than I had imagined it.

LAURA:

All those nerves I had in the beginning now it’s kind of almost nothing.

JANET:

In a nutshell, here’s what we just did:

PICK the site
PULL the caps off
PLACE the white end of the Pen on the site
And PRESS the plum-colored button

[Text on Screen] 4Ps

PICK
PULL
PLACE
PRESS

LINDSEY:

I made it through it.

MICHAEL:

You just have to get over that fear.

DANAY:

I have confidence, I know what I’m doing, I’m a pro, that’s what—I’m a pro!

JANET:

The HUMIRA Complete Sharps Disposal and Mail-back Service ensures your HUMIRA is disposed of safely and in a socially responsible way.

[Text on Screen] You can get a sharps container from HUMIRA Complete shipped to your home at no additional cost

[Text on Screen] For more information about sharps disposal, go to the FDA website: www.fda.gov/safesharpsdisposal

LINDSEY:

When I’m finished with my HUMIRA Pen, I put it in a sharps container.

LAURA:

I actually keep it on a shelf in my bedroom so it is out of reach. When it starts getting full, I call and they send me a new one and the box to send it back.

[Text on Screen] For sharps container, call 1.800.4HUMIRA or visit HUMIRA.com

DANAY:

It doesn’t cost me anything to send back the sharps container, which is good.

STEVEN:

The HUMIRA Complete app, it keeps on a two-week schedule.

[Text on Screen] Get it in the App Store or Google Play

Search HUMIRA Complete

LAURA:

It gave me every tool that I need to understand what I’m doing and how to do it.

MICHAEL:

They will text that I’ve got an injection coming up.

[Text on Screen] Schedule reminder calls, email, or texts on HUMIRA.com or call 1.800.4HUMIRA

DANAY:

It feels great to be able to be in control of my own medicine.

LINDSEY:

I completely own this disease, as well as my own health.

JANET:

OK, that’s it. If you have any questions, call your doctor. You can also call HUMIRA Complete at 1.800.4HUMIRA or your Nurse Ambassador. And you can always refer to this video to cover the basics. You’ve got this.

[Text on Screen] Call 1.800.4HUMIRA

[Text on Screen] Safety Considerations¹

[Text on Screen and Spoken] Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

[Text on Screen and Spoken] You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, visit www.pparx.org for assistance.

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

Injection training videos and kit

HUMIRA Complete provides ongoing injection training. While patients will get their initial injection from you, your staff, or their Nurse Ambassador, HUMIRA Complete can help reinforce it. Patients can choose from personalized training provided by a nurse, or online training videos.

Patients can request an Injection Training Kit by visiting HUMIRA.com, using the Complete App, or by calling 1.800.4HUMIRA (1.800.448.6472).^†

Download Enrollment Forms

^†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.

HUMIRA Complete Savings Card

HUMIRA savings card for eligible patients to receive monthly savings

Your patients could get HUMIRA for as little as $5 a month.^‡

HUMIRA Complete can help patients understand their insurance coverage and assist in identifying ways to save on HUMIRA, including the HUMIRA Complete Savings Card.

The HUMIRA Complete Savings Card can help your eligible commercially insured patients get HUMIRA for as little as $5 for each dose. Your patients can access the Savings Card by creating an account on HUMIRA.com, by downloading the Complete App, or using the downloadable forms linked below.

Download Enrollment Forms

^‡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: 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 Veteran's 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.

Do you have patients who are uninsured or unemployed?

Patients who are uninsured or unemployed may be eligible to receive HUMIRA at no cost from myAbbVie Assist or another foundation.

Find Financial Support

HUMIRA Complete App

The HUMIRA Complete App helps patients stay on track with their prescribed treatment through:

Setting up injection reminders
Tracking injections
Logging symptoms
Accessing HUMIRA Complete resources

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

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: 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 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: 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 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.

US-HUM-190292

References:

HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.
Data on file, HUMIRA Complete Metrics (February 2019).

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 concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient develops a serious infection or sepsis. 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.

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. Malignancy: Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

SERIOUS INFECTIONS

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.

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

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: 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 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: 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 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.

US-HUM-190292

Rheumatology

Dermatology

Gastroenterology

Ophthalmology

Giving patients the resources they need, when they need them.

Nurse Ambassadors*: Dedicated to helping patients make HUMIRA part of their routine.

HUMIRA Complete provides ongoing injection training

Complete Pro and You Together

HUMIRA Complete Savings Card

HUMIRA Complete App

Send your patients a link to download the Complete App

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹

Rheumatology

Dermatology

Gastroenterology

Ophthalmology

Giving patients the resources they need, when they need them.

Nurse Ambassadors*: Dedicated to helping patients make HUMIRA part of their routine.

HUMIRA Complete provides ongoing injection training

Complete Pro and You Together

HUMIRA Complete Savings Card

HUMIRA Complete App

Send your patients a link to download the Complete App

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

INDICATIONS1

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Select the product you would like to learn more about.

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IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION AND INDICATIONS1

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)1

INDICATIONS1

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION AND INDICATIONS¹

IMPORTANT SAFETY INFORMATION for HUMIRA (adalimumab)¹

INDICATIONS¹