ABRILADA™ (adalimumab-afzb) 2 DOSAGE AND ADMINISTRATION

(adalimumab-afzb)

Prescribing Information

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Tuberculosis Evaluation

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

2.2 Recommended Dosage in Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The recommended subcutaneous dosage of ABRILADA for adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) [see Indications 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 ABRILADA. In the treatment of RA, some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of ABRILADA to 40 mg every week or 80 mg every other week.

2.3 Recommended Dosage in Juvenile Idiopathic Arthritis

The recommended subcutaneous dosage of ABRILADA for pediatric patients 2 years of age and older with polyarticular juvenile idiopathic arthritis (JIA) [see Indications and Usage (1.2)], based on weight, is shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with ABRILADA.

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

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.

2.4 Recommended Dosage in Crohn's Disease

Subcutaneous Adult Dosage Regimen

The recommended subcutaneous dosage of ABRILADA for adult patients with moderately to severely active 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 ABRILADA. Azathioprine, 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] or MTX may be continued during treatment with ABRILADA if necessary.

Subcutaneous Pediatric Dosage Regimen

The recommended subcutaneous dosage of ABRILADA for pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease (CD), based on body weight, is shown below:

Pediatric Weight	Recommended Dosage
Pediatric Weight	Days 1 through 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

2.5 Recommended Dosage in Ulcerative Colitis

Subcutaneous Adult Dosage Regimen

The recommended subcutaneous dosage of ABRILADA for adult patients with moderately to severely active ulcerative colitis 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) continue with a dosage of 40 mg every other week.

Discontinue ABRILADA in adult patients without evidence of clinical remission by eight weeks (Day 57) of therapy. Aminosalicylates and/or corticosteroids may be continued during treatment with ABRILADA. Azathioprine and 6-mercaptopurine (6-MP) [see Warnings and Precautions (5.2)] may be continued during treatment with ABRILADA if necessary.

2.6 Recommended Dosage in Plaque Psoriasis or Adults with Uveitis

The recommended subcutaneous dosage of ABRILADA for adult patients with plaque psoriasis (Ps) or uveitis (UV) [see Indications and Usage (1.7, 1.9)] is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. The use of adalimumab products in moderate to severe chronic Ps beyond one year has not been evaluated in controlled clinical studies.

2.7 Recommended Dosage in Hidradenitis Suppurativa

Subcutaneous Adult Dosage Regimen

The recommended subcutaneous dosage of ABRILADA for adult patients with moderate to severe hidradenitis suppurativa (HS) is an initial dose of 160 mg (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Begin 40 mg weekly or 80 mg every other week dosing two weeks later (Day 29).

2.8 General Considerations for Administration

ABRILADA is intended for use under the guidance and supervision of a physician. A patient may self-inject ABRILADA or a caregiver may inject ABRILADA using either the ABRILADA pen or prefilled syringe if a physician determines that it is appropriate, and with medical follow-up, as necessary, after proper training in subcutaneous injection technique.

ABRILADA can be taken out of the refrigerator for 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Carefully inspect the solution in the ABRILADA pen, prefilled syringe, or single-dose institutional use vial for particulate matter and discoloration prior to subcutaneous administration. If particulates or discolorations are noted, do not use the product. ABRILADA does not contain preservatives; therefore, discard unused portions of drug remaining from the syringe [see How Supplied/Storage and Handling (16)].

Instruct patients using the ABRILADA pen or prefilled syringe to inject the full amount in the syringe, according to the directions provided in the Instructions for Use [see Instructions for Use].

Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

The ABRILADA single-dose institutional use vial is for administration within an institutional setting only, such as a hospital, physician's office or clinic. Withdraw the dose using a sterile needle and syringe and administer promptly by a healthcare provider within an institutional setting. Only administer one dose per vial. The vial does not contain preservatives; therefore, discard unused portions.

Medication Guide

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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 4/2024
MEDICATION GUIDE ABRILADA™ (AH brill-ah-dah) (adalimumab-afzb) injection, for subcutaneous use
Read the Medication Guide that comes with ABRILADA 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 ABRILADA? ABRILADA is a medicine that affects your immune system. ABRILADA 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 ABRILADA. • Your healthcare provider should check you closely for signs and symptoms of TB during treatment with ABRILADA. You should not start taking ABRILADA if you have any kind of infection unless your healthcare provider says it is okay. Before starting ABRILADA, tell your healthcare provider if you: • think you have an infection or have symptoms of infection such as:
	o fever, sweats, or chills o muscle aches o cough o shortness of breath o blood in phlegm	o warm, red, or painful skin or sores on your body o diarrhea or stomach pain o burning when you urinate or urinate more often than normal o feel very tired o 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 ABRILADA. 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 ABRILADA, call your healthcare provider right away if you have an infection, or any sign of an infection. ABRILADA 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 ABRILADA, 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 ABRILADA 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 ABRILADA 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 ABRILADA? ABRILADA is a medicine called a tumor necrosis factor (TNF) blocker. ABRILADA is used: • To reduce the signs and symptoms of: o moderate to severe RA in adults. ABRILADA can be used alone, with methotrexate, or with certain other medicines. o moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. ABRILADA can be used alone or with methotrexate. o psoriatic arthritis (PsA) in adults. ABRILADA can be used alone or with certain other medicines. o ankylosing spondylitis (AS) in adults. o moderate to severe hidradenitis suppurativa (HS) in adults. • To treat moderate to severe Crohn's disease (CD) in adults and children 6 years of age and older. • To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines. • To treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). • To treat non-infectious intermediate, posterior, and panuveitis in adults.
What should I tell my healthcare provider before taking ABRILADA? ABRILADA may not be right for you. Before starting ABRILADA, tell your healthcare provider about all of your medical conditions, including if you: • have an infection. See "What is the most important information I should know about ABRILADA?" • have or have had cancer. • have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome. • have or had heart failure. • have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using ABRILADA. Children should be brought up to date with all vaccines before starting ABRILADA. • are allergic to ABRILADA or to any of its ingredients. The ABRILADA prefilled syringe and prefilled pen are not made with natural rubber latex. See the end of this Medication Guide for a list of ingredients in ABRILADA. • are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take ABRILADA while you are pregnant or breastfeeding. • have a baby and you were using ABRILADA during your pregnancy. Tell your baby's healthcare provider before your baby receives any vaccines. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use: • ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use ABRILADA while you are also using one of these medicines. • RITUXAN (rituximab). Your healthcare provider may not want to give you ABRILADA if you have received RITUXAN (rituximab) recently. • IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP). Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take ABRILADA? • ABRILADA is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of ABRILADA. This is based on your condition to be treated. Do not inject ABRILADA more often than you were prescribed. • See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject ABRILADA. • Make sure you have been shown how to inject ABRILADA before you do it yourself. You can call your healthcare provider or 1-800-438-1985 if you have any questions about giving yourself an injection. Someone you know can also help you with your injection after they have been shown how to prepare and inject ABRILADA. • Do not try to inject ABRILADA yourself until you are shown the right way to give the injections and read and understand the Instructions for Use. If your healthcare provider decides that you or a caregiver may be able to give your injections of ABRILADA at home, you should receive training on the right way to prepare and inject ABRILADA. • Do not miss any doses of ABRILADA unless your healthcare provider says it is okay. If you forget to take ABRILADA, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject ABRILADA, call your healthcare provider or pharmacist. • If you take more ABRILADA than you were told to take, call your healthcare provider.
What are the possible side effects of ABRILADA? ABRILADA can cause serious side effects, including: See "What is the most important information I should know about ABRILADA?" • Serious Infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with ABRILADA and during treatment with ABRILADA. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking ABRILADA. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking ABRILADA:
	o cough that does not go away o low grade fever	o weight loss o loss of body fat and muscle (wasting)
• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ABRILADA. Your healthcare provider should do blood tests before you start treatment, while you are using ABRILADA, and for several months after you stop treatment with ABRILADA. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
	o muscle aches o feel very tired o dark urine o skin or eyes look yellow o little or no appetite o vomiting	o clay-colored bowel movements o fever o chills o stomach discomfort o skin rash
• Allergic reactions. Allergic reactions can happen in people who use ABRILADA. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:
	o hives o trouble breathing	o swelling of your face, eyes, lips or mouth
• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. • Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. • New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking ABRILADA, including:
	o shortness of breath o sudden weight gain	o swelling of your ankles or feet
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop ABRILADA. • Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms:
	o feel very tired o poor appetite or vomiting	o skin or eyes look yellow o pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with ABRILADA. Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with ABRILADA may be stopped. The most common side effects of ABRILADA include: • injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. Call your healthcare provider right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse. • upper respiratory infections (including sinus infections). • headaches. • rash. These are not all of the possible side effects with ABRILADA. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ABRILADA? • Store ABRILADA in the refrigerator at 36°F to 46°F (2°C to 8°C). Store ABRILADA in the original carton until use to protect it from light. • Do not freeze ABRILADA. Do not use ABRILADA if frozen, even if it has been thawed. • Refrigerated ABRILADA may be used until the expiration date printed on the ABRILADA carton, pen or prefilled syringe. Do not use ABRILADA after the expiration date. • If needed, for example when you are traveling, you may also store ABRILADA at room temperature up to 86°F (30°C) for up to 30 days. Store ABRILADA in the original carton until use to protect it from light. • Throw away ABRILADA if it has been kept at room temperature and not been used within 30 days. • Record the date you first remove ABRILADA from the refrigerator in the spaces provided on the ABRILADA pen carton or the prefilled syringe carton. • Do not store ABRILADA in extreme heat or cold. • The medicine in ABRILADA should be clear and colorless to very light brown. Do not use a pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. • Do not drop or crush ABRILADA. The prefilled syringe is glass. Keep ABRILADA, injection supplies, and all other medicines out of the reach of children.
General information about the safe and effective use of ABRILADA Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ABRILADA for a condition for which it was not prescribed. Do not give ABRILADA to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about ABRILADA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABRILADA that is written for health professionals.
What are the ingredients in ABRILADA? Active ingredient: adalimumab-afzb ABRILADA pen 40 mg/0.8 mL, ABRILADA 40 mg/0.8 mL prefilled syringe, ABRILADA 20 mg/0.4 mL prefilled syringe, ABRILADA 10 mg/0.2 mL prefilled syringe, and ABRILADA 40 mg/0.8 mL institutional use vial: Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 80, sucrose, and Water for Injection. Manufactured by Pfizer Inc. New York, NY 10001 Distributed by Pfizer Labs Division of Pfizer Inc. New York, NY 10001 US License No. 2001 LAB-1351-6.0 For more information go to www.Pfizer.com.

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