Adalimumab-aacf Kit — NDC 65219-612-69 (Billing 65219-0612-69)

1 INDICATIONS AND USAGE Adalimumab-aacf is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA. Juvenile Idiopathic Arthritis (JIA) ( 1.2 ): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. Psoriatic Arthritis (PsA) ( 1.3 ): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

Ankylosing Spondylitis (AS) ( 1.4 ): reducing signs and symptoms in adult patients with active AS. Crohn's Disease (CD) ( 1.5 ): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC) ( 1.6 ): treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis (Ps) ( 1.7 ): 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. Hidradenitis Suppurativa (HS) ( 1.8 ): treatment of moderate to severe hidradenitis suppurativa in adult patients.

Uveitis (UV) ( 1.9 ): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

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

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

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

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

1.5Crohn's Disease Adalimumab-aacf 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 Adalimumab-aacf is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies ( 14.7 )] .

1.7Plaque Psoriasis Adalimumab-aacf 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. Adalimumab-aacf 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 Adalimumab-aacf is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

1.9Uveitis Adalimumab-aacf is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

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 ( 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).

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

2.1Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) 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 Adalimumab-aacf. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of Adalimumab-aacf to 40 mg every week or 80 mg every other week.

2.2Juvenile Idiopathic Arthritis The recommended subcutaneous dosage of Adalimumab-aacf for patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with Adalimumab-aacf. 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 The only dosage form for Adalimumab-aacf that allows weight-based dosing for pediatric patients below 30 kg is the single-dose glass vial kit for institutional use only.

Adalimumab products have not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

2.3Crohn's Disease Adults The recommended subcutaneous dosage of Adalimumab-aacf for adult patients with Crohn's disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week. Aminosalicylates and/or corticosteroids may be continued during treatment with Adalimumab-aacf.

Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions ( 5.2 )] or MTX may be continued during treatment with Adalimumab-aacf if necessary. Pediatrics The recommended subcutaneous dosage of Adalimumab-aacf for pediatric patients 6 years of age and older with Crohn's disease (CD) is based on body weight as shown below: Pediatric Weight Reco… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Adalimumab-aacf is a clear and colorless to pale yellow solution available as: Pen (Adalimumab-aacf Pen) Injection: 40 mg/0.8 mL in a single-dose pen. Prefilled Syringe Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe. Single-Dose Institutional Use Vial Kit Injection: 40 mg/0.8 mL in a single-dose, glass vial kit for institutional use only.

Injection: Single-dose prefilled pen (Adalimumab-aacf Pen): 40 mg/0.8 mL ( 3 ) Single-dose prefilled glass syringe: 40 mg/0.8 mL ( 3 ) Single dose glass vial kit for institutional use only: 40mg/0.8 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 Adalimumab-aacf 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 Adalimumab-aacf [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions Advise patients to seek immediate medical attention if they experience any symptoms of severe hypersensitivity reactions. 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 Adalimumab-aacf, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of Adalimumab-aacf [see Instructions for Use ]. For patients who will use the Adalimumab-aacf Pen, tell them to: Remove the needle cap of the Pen and push and hold the Pen firmly against the skin on the chosen injection site.

Activate Pen by pressing the injection button. The click means the start of the injection. Keep holding the Adalimumab-aacf Pen against their skin until the injection has finished.

Will know that the injection has finished when the syringe plunger moves all the way down to the bottom of the transparent syringe housing to enable the safety guard to cover the needle 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 Pens 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. Manufactured by: Fresenius Kabi USA, LLC Lake Zurich, IL 60047, U.S.A US License Number 2146

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 06/2024 MEDICATION GUIDE Adalimumab-aacf (ada-LIM-u-mab aacf) injection, for subcutaneous use This product is IDACIO® (adalimumab-aacf). Read the Medication Guide that comes with Adalimumab-aacf 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 healthcare provider about your medical condition or treatment. What is the most important information I should know about Adalimumab-aacf?

Adalimumab-aacf is a medicine that affects your immune system. Adalimumab-aacf can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products.

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 healthcare provider should test you for TB before starting Adalimumab-aacf.

Your healthcare provider should check you closely for signs and symptoms of TB during treatment with Adalimumab-aacf. You should not start taking Adalimumab-aacf if you have any kind of infection unless your healthcare provider says it is okay. Before starting Adalimumab-aacf, tell your healthcare provider 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 healthcare provider 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 Adalimumab-aacf. Ask your healthcare provider 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 Adalimumab-aacf, call your healthcare provider right away if you have an infection, or any sign of an infection. Adalimumab-aacf 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 Adalimumab-aacf, 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 Adalimumab-aacf 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 healthcare provider if you have a bump or open sore that does not heal. Some people receiving TNF blockers including Adalimumab-aacf 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 Adalimumab-a… [Excerpted — this section continues on DailyMed.]

Read this Instructions for Use before using your Adalimumab-aacf prefilled pen. Do not try to inject Adalimumab-aacf yourself until you have been shown the right way to give the injections and have read and understand this Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of Adalimumab-aacf at home, you should receive training on the right way to prepare and inject Adalimumab-aacf.

It is important that you read, understand, and follow these instructions so that you inject Adalimumab-aacf the right way. It is also important to talk to your healthcare provider to be sure you understand your Adalimumab-aacf dosing instructions. To help you remember when to inject Adalimumab-aacf, you can mark your calendar ahead of time.

Call your healthcare provider if you or your caregiver have any questions about the right way to inject Adalimumab-aacf. Important information Read the Medication Guide that comes with your Adalimumab-aacf prefilled pen for important information you need to know before using it. Call your healthcare provider if you have any questions about Adalimumab-aacf or how to give your injection.

Adalimumab-aacf prefilled pen is for single-dose (one-time) use only. Do not share your Adalimumab-aacf prefilled pen with another person. You may give another person an infection or get an infection from them.

Storing Adalimumab-aacf prefilled pens Store Adalimumab-aacf prefilled pen in the original carton to protect it from light. Store Adalimumab-aacf prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze Adalimumab-aacf.

Do not use Adalimumab-aacf if frozen, even if it has been thawed. Refrigerated Adalimumab-aacf may be used until the expiration date printed on the Adalimumab-aacf carton, dose tray or pen. Do not use Adalimumab-aacf after the expiration date.

If needed, for example when traveling, Adalimumab-aacf prefilled pen can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 28 days. Throw away Adalimumab-aacf if it has been kept at room temperature and not been used within 28 days. Record the date you first remove Adalimumab-aacf from the refrigerator in the spaces provided on the carton.

Throw away (dispose of) the Adalimumab-aacf prefilled pen in a sharps disposal container if it has been stored above 77°F (25°C). (See Step 7 “Dispose of your prefilled pens” ). Do not store Adalimumab-aacf in extreme heat or cold.

Do not use Adalimumab-aacf if the liquid is cloudy, discolored, or has flakes or particles in it. Do not drop or crush Adalimumab-aacf. Keep the Adalimumab-aacf prefilled pen, injection supplies, and all other medicines out of the reach and sight of children.

Using the Adalimumab-aacf prefilled pen Only use Adalimumab-aacf prefilled pen if your healthcare provider has instructed you on how to use it. Do not try to reuse the Adalimumab-aacf prefilled pen. Before injecting, let Adalimumab-aacf sit at room temperature for 15-30 minutes after removing it from the refrigerator.

Always inject Adalimumab-aacf using the technique your healthcare provider taught you. Do not use an Adalimumab-aacf prefilled pen to give Adalimumab-aacf to a child who weighs less than 66 pounds (30 kg). Do not insert your fingers into the opening of the safety guard.

Do not use the prefilled pen if the new carton is open or damaged. Do not use an Adalimumab-aacf prefilled pen that has been frozen or left in direct sunlight. Do not use and do call your healthcare provider or pharmacist if: you drop or crush your Adalimumab-aacf prefilled pen.

Your Adalimumab-aacf prefilled pen

1.1Gather the supplies for your injection. You will need the following supplies for each injection of Adalimumab-aacf (figure C). Find a clean flat surface, such as a table or countertop, in a well-lit area. 1 Alcohol swab 1 cotton ball or gauze (not included in your Adalimumab-aacf carton) 1 Adalimumab-aacf prefilled pen (see figure A) Puncture… [Excerpted — this section continues on DailyMed.]