Humira Adalimumab Kit

1 INDICATIONS AND USAGE HUMIRA is a tumor necrosis factor (TNF) blocker indicated 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 r heumatoid a rthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis .

( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. 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. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 )

1.1Rheumatoid Arthritis HUMIRA is indicated 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. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

1.2Juvenile Idiopathic Arthritis HUMIRA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.

1.3Psoriatic Arthritis HUMIRA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.

1.4Ankylosing Spondylitis HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

1.5Crohn’s Disease HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

1.6Ulcerative Colitis HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older. Limitations of Use The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 , 14.8 ) ] .

1.7Plaque 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 [see Warnings and Precautions ( 5 ) ] .

1.8Hidradenitis Suppurativa HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

1.9Uveitis HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection ( 2 ) Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis ( 2.1 ): Adults: 40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week. Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 2.2 ): Pediatric Weight 2 Years of Age and Older Recommended Dosage 10 kg (22 lbs) to less than 15 kg (33 lbs) 10 mg every other week 15 kg (33 lbs) to less than 30 kg (66 lbs) 20 mg every other week 30 kg (66 lbs) and greater 40 mg every other week Crohn's Disease ( 2.3 ): Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.

Pediatric Patients 6 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 and 15 Starting on Day 29 17 kg (37 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 15: 40 mg 20 mg every other week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 15: 80 mg 40 mg every other week Ulcerative Colitis ( 2.4 ) : Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

Pediatric Patients 5 Years of Age and Older : Pediatric Weight Recommended Dosage Days 1 through 15 Starting on Day 29* 20 kg (44 lbs) to less than 40 kg (88 lbs) Day 1: 80 mg Day 8: 40 mg Day 15: 40 mg 40 mg every other week or 20 mg every week 40 kg (88 lbs) and greater Day 1: 160 mg (single dose or split over two consecutive days) Day 8: 80 mg Day 15: 80 mg 80 mg every other week or 40 mg every week * Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen.

Plaque Psoriasis or Adult Uveitis ( 2.5 ): Adults : 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose. Hidradenitis Suppurativa ( 2.6 ): Adults : ◦ Day 1: 160 mg (given in one day or split over two consecutive days) ◦ Day 15: 80 mg ◦ Day 29 and subsequent doses: 40 mg every week or 80 mg every other week Adolescents 12 years of age and older: Adolescent Weight Recommended Dosage 30 kg (66 lbs) to less than 60 kg (132 lbs) Day 1: 80 mg Day 8 and subsequent doses: 40 mg every other week 60 kg (132 lbs) and greater Day 1: 160 mg (given in one day or split over two consecutive days) Day 15: 80 mg Day 29 and subsequent doses: 40 mg every week or 80 mg every other week

2.1Recommended Tuberculosis Evaluation Prior to initiating HUMIRA and periodically during therapy, evaluate patients for active tuberculosis and test for latent infection [see Warnings and Precautions ( 5.1 ) ] .

2.2Recommended Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of HUMIRA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) [see Indication and Usage ( 1.1 , 1.3 , 1.4 )] is 40 mg administered every other week. Methotrexate (MTX), other non-biologic DMARDS, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics may be continued during treatment with HUMIRA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of HUMIRA to 40 mg every week or 80 mg every other week.

2. 3 Recommended Dosage in Juvenile Idiopathic Arthritis or Pediatric Patients with Uveitis The recommended subcutaneous dosage of HUMIRA for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) or pediatric uveitis [see Indications and Usage ( 1.2 , 1.9 )] , based on weight, is shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.

Pediatric Weight (2 Years o…

3 DOSAGE FORMS AND STRENGTHS HUMIRA is a clear and colorless solution available as: Pen (HUMIRA Pen) Injection: 80 mg/0.8 mL in a single-dose pen. Injection: 40 mg/0.8 mL in a single-dose pen. Injection: 40 mg/0.4 mL in a single-dose pen.

Prefilled Syringe Injection: 80 mg/0.8 mL in a single-dose prefilled glass syringe. Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe. Injection: 40 mg/0.4 mL in a single-dose prefilled glass syringe.

Injection: 20 mg/0.2 mL in a single-dose prefilled glass syringe. Injection: 10 mg/0.1 mL in a single-dose prefilled glass syringe. Injection: Single-dose prefilled pen (HUMIRA Pen): 80 mg/0.8 mL, 40 mg/0.8 mL, and 40 mg/0.4 mL ( 3 ) Single-dose prefilled glass syringe: 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.1 mL ( 3 )

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Infections Inform patients that HUMIRA may lower the ability of their immune system to fight infections. Instruct patients of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and reactivation of hepatitis B virus infections [see Warnings and Precautions ( 5.1 , 5.2 , 5.4 )] .

Malignancies Counsel patients about the risk of malignancies while receiving HUMIRA [see Warnings and Precautions ( 5.2 ) ] Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. Advise latex-sensitive patients that the needle cap of the HUMIRA 40 mg/0.8 mL Pen and 40 mg/0.8 mL prefilled syringe may contain natural rubber latex [see Warnings and Precautions ( 5.3 ) , How Supplied/Storage and Handling ( 16 ) ] . Other Medical Conditions Advise patients to report any signs of new or worsening medical conditions such as congestive heart failure, neurological disease, autoimmune disorders, or cytopenias.

Advise patients to report any symptoms suggestive of a cytopenia such as bruising, bleeding, or persistent fever [see Warnings and Precautions ( 5.5 , 5.6 , 5.8 , 5.9 )] . Instructions on Injection Technique Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer HUMIRA, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of HUMIRA [see Instructions for Use ].

For patients who will use the HUMIRA Pen, tell them that they: Will hear a loud ‘click’ when the plum-colored activator button is pressed. The loud click means the start of the injection. Must keep holding the HUMIRA Pen against their squeezed, raised skin until all of the medicine is injected.

This can take up to 15 seconds. Will know that the injection has finished when the yellow marker fully appears in the window view and stops moving. Instruct patients to dispose of their used needles and syringes or used Pen in a FDA-cleared sharps disposal container immediately after use.

Instruct patients not to dispose of loose needles and syringes or Pen in their household trash. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container. Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container.

Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDA’s website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in. Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this.

Instruct patients not to recycle their used sharps disposal container. AbbVie Inc. North Chicago, IL 60064, U.S.A.

US License Number 1889 20099010 12/2025 Manufactured for: Cordavis Trading Limited Dublin, Ireland

MEDICATION GUIDE HUMIRA ® (Hu-MARE-ah) (adalimumab) injection , for subcutaneous use Read the Medication Guide that comes with HUMIRA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about HUMIRA? HUMIRA is a medicine that affects your immune system. HUMIRA can lower the ability of your immune system to fight infections.

Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections.

Your doctor should test you for TB before starting HUMIRA. Your doctor should check you closely for signs and symptoms of TB during treatment with HUMIRA. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

Before starting HUMIRA, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes. have TB, or have been in close contact with someone with TB. were born in, lived in, or traveled to countries where there is more risk for getting TB.

Ask your doctor if you are not sure. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you do not know if you have lived in an area where these infections are common. have or have had hepatitis B. use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP). are scheduled to have major surgery.

After starting HUMIRA, call your doctor right away if you have an infection, or any sign of an infection. HUMIRA can make you more likely to get infections or make any infection that you may have worse. Cancer For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including HUMIRA, the chances of getting cancer may increase.

There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers. People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. If you use TNF blockers including HUMIRA your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin).

These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal. Some people receiving TNF blockers including HUMIRA developed a rare type of cancer called hepatosplenic T-cell lymphoma.

This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

What is HUMIRA? HUMIRA is a medicine called a Tumor Necrosis Factor (TNF) blocker. HUMIRA is used: To reduce the signs and symptoms of: moderate to severe RA in adults.

HUMIRA can be used alone, with methotrexate, or with certain other medicines. moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. HUMIRA can be used alone or with methotrexate. psoriatic arthritis (…