• Humira is a brand (trade) name for adalimumab.
• Humira (adalimumab) works by binding specifically to TNF-alfa, which is a signaling protein (also called a cytokine) that is released by white blood cells during inflammation that can trigger cell damage or cell death. By binding to TNF-alfa, adalimumab blocks the action of TNF-alfa, reducing inflammation and tissue destruction. Increased levels of TNF-alfa have been found in conditions such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis.
• Humira belongs to the class of medicines called TNF-alfa (alpha) inhibitors. Humira may also be called a biologic.

• May be used to treat many different diseases where inflammation can lead to pain and swelling.
• Approved to treat rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis in adults.
• May be used to treat juvenile idiopathic arthritis (JIA) in patients aged 2 years and older.
• Approved to treat Crohn's disease in adults and children aged 6 years and older and ulcerative colitis in adults and children aged 5 years and older.
• Other conditions Humira may treat include Hidradenitis Suppurativa in patients aged 12 years and older and uveitis in patients aged 2 years and older.
• Most people will start to feel relief from their symptoms within 2 to 12 weeks. Results vary depending on the condition being treated, how well you tolerate treatment, and interacting medications.
• People can be taught how to self-administer Humira injection under the skin and most people find it easy to do this.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• A headache, cold symptoms, rash, or redness, bruising, or itching at the injection site are the most commonly reported side effects.
• Humira is only available as an injection; however, people can be taught how to self-administer it.
• Children under the age of six years with Crohn's disease, under five years with ulcerative colitis, under 12 years with Hidradenitis Suppurative, or aged under two with either JIA or uveitis should not receive Humira. For conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis, Humira is only approved for use in adults.
• Humira does not cure inflammatory conditions; however, it does help relieve symptoms and may prevent disease worsening.
• Humira is an immunosuppressant and can lower the ability of your immune system to fight bacterial, viral, or fungal infections or make an infection worse. It may cause some infections, such as tuberculosis, to become active again. Some people have died from these infections.
• All patients must be screened for TB before starting treatment with Humira.
• Humira should not be initiated in any person who currently has an infection or symptoms of an infection. Humira may also lead to the reactivation of the hepatitis B virus.
• Humira may increase the risk of developing certain kinds of fungal infections (such as histoplasmosis, coccidioidomycosis, or blastomycosis), which are common in certain parts of the country (such as the Ohio and Mississippi River valleys).
• Humira interacts with several different medicines (see interactions below), some of which may increase your risk of infection. Live vaccines such as the nasal flu vaccine (FluMist); measles, mumps, rubella (MMR); chickenpox; and yellow fever vaccine should not be administered to a person taking Humira. Other vaccinations are usually compatible.
• Use of Humira may increase your risk of developing certain cancers, such as lymphoma, or a rare type of cancer called hepatosplenic T-cell lymphoma. Teenagers and young men with Crohn's disease or ulcerative colitis appear to be more susceptible.
• Humira must be stored in a refrigerator.
• Humira has not been studied during pregnancy or breastfeeding and is possibly not safe.
• Humira is expensive.
• Currently no generic exists for Humira.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• Before starting treatment with Humira, tell your doctor if you have tuberculosis (TB), or have been in close contact with someone with TB (for example, someone in your household). Tell your doctor if you were born in, lived in, or traveled to countries where there is more risk of getting TB. Ask your doctor if you are not sure. Symptoms of TB may include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Also tell your doctor if you are scheduled to receive a vaccination, as some vaccinations are not compatible with Humira. Children should be brought up to date with all vaccines in current immunization guidelines before starting Humira. Because the flu shot is not a live virus, people taking Humira should receive this yearly.
• Humira may also not be suitable for people currently with or who have had cancer, hepatitis B, diabetes, congestive heart failure, any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome, an allergy to latex rubber; or in those scheduled to have major surgery. Make sure your doctor knows if any of these apply to you.
• Take Humira out of the refrigerator and allow it to warm up naturally to room temperature for 30 minutes before administering it. Once out of the refrigerator, it may be kept at room temperature up to a maximum of 77 degrees F (25 degrees C) for a period of up to 14 days. If it is not used within this time, throw it away. If you are traveling, follow the package instructions for storage during travel.
• Only administer the dosage prescribed by your doctor. Do not exceed the recommended dosage and do not stop Humira without your doctor's advice. Always dispose of your used Humira injection in an FDA-approved sharps bin.
• if you develop an allergic reaction to Humira (such as a skin rash, facial swelling, or difficulty breathing, contact your doctor immediately). Call your doctor if you are using Humira to treat psoriasis and it gets worse if you develop liver problems (nausea, abdominal pain, skin yellowing), joint pain, or nerve pain.
• Talk to your doctor or pharmacist before taking any other medications with Humira, including those brought over the counter. Some antibiotics may not work as intended when taken with Humira.
• Call your doctor if you develop any symptoms of an infection such as fever, sweats or chills, muscle aches, coughing, warm, painful or red skin or sores on your body, diarrhea, stomach pain, shortness of breath, blood in phlegm, or burning when you urinate. Try to avoid being near people who currently have infections.
• People without insurance or who are unemployed may be eligible to receive Humira at no cost from the AbbVie Patient Assistance Program (my AbbVie Assist) or another foundation if they meet certain income criteria.
• Tell your doctor if you are pregnant or you become pregnant while taking Humira. Although the effects of Humira during pregnancy have not been studied it is recommended that you don't become pregnant while taking it.

• Most people will start to feel relief from their symptoms within 2 to 12 weeks.
• Response rates vary depending on the condition being treated, but for Rheumatoid Arthritis, patients reported the following response rates after receiving Humira 40mg every second week: a 20% improvement from their baseline scores was reported by 65% of people; a 50% improvement from their baseline scores was reported by 52% of people; a 70% improvement from their baseline scores was reported by 24% of people.
• For people with psoriatic arthritis, a 75% improvement in baseline psoriasis severity scores was reported by 59% of people, and a 90% improvement in baseline scores was reported by 42% of people.
• For ankylosing spondylitis, an improvement of 20% in their baseline scores was reported by 58% of people, a 50% improvement was reported by 38% of people, and an improvement of 70% was reported by 23% of people.
• For Crohn's disease, 21% to 36% achieved clinical remission by week 4 and 52% to 58% achieved a clinical response.
• For ulcerative colitis, 16.5% to 18.5% experienced symptom improvement after 8 weeks.

Medicines that interact with Humira may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Humira. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Humira include:

• anticonvulsants, such as fosphenytoin
• antivirals, such as ganciclovir
• benzodiazepines, such as alprazolam, clobazam
• chemotherapy medications, such as fluorouracil
• chloroquine
• corticosteroids, such as budesonide, cortisone, or dexamethasone
• cyclosporine
• heart medications, such as amiodarone, felodipine, flecainide
• hormones, such as ethinyl estradiol or levonorgestrel
• hydroxyurea
• immunosuppressants, such as azathioprine or mercaptopurine
• interferons
• live vaccinations, such as chickenpox, MMR, yellow fever, or the nasal flu vaccine
• medications that lower cholesterol, such as atorvastatin or simvastatin
• methotrexate, although a dosage adjustment is not necessary
• other biologics, such as anakinra, abatacept, etanercept, or rituximab (no added benefit with an increased risk of serious infections)
• probiotics, such as lactobacillus
• theophylline
• warfarin.

Note that this list is not all-inclusive and includes only common medications that may interact with Humira. You should refer to the prescribing information for Humira for a complete list of interactions.