ABRILADA™ (adalimumab-afzb) 6 ADVERSE REACTIONS

(adalimumab-afzb)

Prescribing Information

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•: Serious Infections [see Warnings and Precautions (5.1)]
•: Malignancies [see Warnings and Precautions (5.2)]
•: Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
•: Hepatitis B Virus Reactivation [see Warnings and Precautions (5.4)]
•: Neurologic Reactions [see Warnings and Precautions (5.5)]
•: Hematological Reactions [see Warnings and Precautions (5.6)]
•: Heart Failure [see Warnings and Precautions (5.8)]
•: Autoimmunity [see Warnings and Precautions (5.9)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reaction with adalimumab was injection site reactions. In placebo-controlled trials, 20% of subjects treated with adalimumab developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of subjects receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.

The proportion of subjects who discontinued treatment due to adverse reactions during the double-blind, placebo-controlled portion of studies in subjects with RA (i.e., Studies RA-I, RA-II, RA-III and RA-IV) was 7% for subjects taking adalimumab and 4% for placebo-treated subjects. The most common adverse reactions leading to discontinuation of adalimumab in these RA studies were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).

Infections

In the controlled portions of the 39 global adalimumab clinical trials in adult subjects with RA, PsA, AS, CD, UC, Ps, HS and UV, the rate of serious infections was 4.3 per 100 patient-years in 7973 adalimumab-treated subjects versus a rate of 2.9 per 100 patient-years in 4848 control-treated subjects. Serious infections observed included pneumonia, septic arthritis, prosthetic and post-surgical infections, erysipelas, cellulitis, diverticulitis, and pyelonephritis [see Warnings and Precautions (5.1)].

Tuberculosis and Opportunistic Infections

In 52 global controlled and uncontrolled clinical trials in RA, PsA, AS, CD, UC, Ps, HS and UV that included 24,605 adalimumab-treated subjects, the rate of reported active tuberculosis was 0.20 per 100 patient-years and the rate of positive PPD conversion was 0.09 per 100 patient-years. In a subgroup of 10,113 U.S. and Canadian adalimumab-treated subjects, the rate of reported active TB was 0.05 per 100 patient-years and the rate of positive PPD conversion was 0.07 per 100 patient-years. These trials included reports of miliary, lymphatic, peritoneal, and pulmonary TB. Most of the TB cases occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease. In these global clinical trials, cases of serious opportunistic infections have been reported at an overall rate of 0.05 per 100 patient-years. Some cases of serious opportunistic infections and TB have been fatal [see Warnings and Precautions (5.1)].

Autoantibodies

In the rheumatoid arthritis controlled trials, 12% of subjects treated with adalimumab and 7% of placebo-treated subjects that had negative baseline ANA titers developed positive titers at Week 24. Two subjects out of 3046 treated with adalimumab developed clinical signs suggestive of new-onset lupus-like syndrome. The subjects improved following discontinuation of therapy. No subjects developed lupus nephritis or central nervous system symptoms. The impact of long-term treatment with adalimumab products on the development of autoimmune diseases is unknown.

Liver Enzyme Elevations

There have been reports of severe hepatic reactions including acute liver failure in subjects receiving TNF-blockers. In controlled Phase 3 trials of adalimumab (40 mg SC every other week) in subjects with RA, PsA, and AS with control period duration ranging from 4 to 104 weeks, ALT elevations ≥3 × ULN occurred in 3.5% of adalimumab-treated subjects and 1.5% of control-treated subjects. Since many of these subjects in these trials were also taking medications that cause liver enzyme elevations (e.g., NSAIDs, MTX), the relationship between adalimumab and the liver enzyme elevations is not clear. In a controlled Phase 3 trial of adalimumab in subjects with polyarticular JIA who were 4 to 17 years, ALT elevations ≥3 × ULN occurred in 4.4% of adalimumab-treated subjects and 1.5% of control-treated subjects (ALT more common than AST); liver enzyme test elevations were more frequent among those treated with the combination of adalimumab and MTX than those treated with adalimumab alone. In general, these elevations did not lead to discontinuation of adalimumab treatment. No ALT elevations ≥3 × ULN occurred in the open-label study of adalimumab in subjects with polyarticular JIA who were 2 to <4 years.

In controlled Phase 3 trials of adalimumab (initial doses of 160 mg and 80 mg, or 80 mg and 40 mg on Days 1 and 15, respectively, followed by 40 mg every other week) in adult subjects with Crohn's Disease with a control period duration ranging from 4 to 52 weeks, ALT elevations ≥3 × ULN occurred in 0.9% of adalimumab-treated subjects and 0.9% of control-treated subjects. In the Phase 3 trial of adalimumab in pediatric subjects with Crohn's disease which evaluated efficacy and safety of two body weight based maintenance dose regimens following body weight based induction therapy up to 52 weeks of treatment, ALT elevations ≥3 × ULN occurred in 2.6% (5/192) of subjects, of whom 4 were receiving concomitant immunosuppressants at baseline; none of these subjects discontinued due to abnormalities in ALT tests. In controlled Phase 3 trials of adalimumab (initial doses of 160 mg and 80 mg on Days 1 and 15 respectively, followed by 40 mg every other week) in adult subjects with UC with control period duration ranging from 1 to 52 weeks, ALT elevations ≥3 × ULN occurred in 1.5% of adalimumab-treated subjects and 1.0% of control-treated subjects. In controlled Phase 3 trials of adalimumab (initial dose of 80 mg then 40 mg every other week) in subjects with Ps with control period duration ranging from 12 to 24 weeks, ALT elevations ≥3 × ULN occurred in 1.8% of adalimumab-treated subjects and 1.8% of control-treated subjects. In controlled trials of adalimumab (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in subjects with HS with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥3 x ULN occurred in 0.3% of adalimumab-treated subjects and 0.6% of control-treated subjects. In controlled trials of adalimumab (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult subjects with uveitis with an exposure of 165.4 PYs and 119.8 PYs in adalimumab-treated and control-treated subjects, respectively, ALT elevations ≥3 x ULN occurred in 2.4% of adalimumab-treated subjects and 2.4% of control-treated subjects.

Other Adverse Reactions

Rheumatoid Arthritis Clinical Studies

The data described below reflect exposure to adalimumab in 2468 subjects, including 2073 exposed for 6 months, 1497 exposed for greater than one year and 1380 in adequate and well-controlled studies (Studies RA-I, RA-II, RA-III, and RA-IV). Adalimumab was studied primarily in placebo-controlled trials and in long-term follow up studies for up to 36 months duration. The population had a mean age of 54 years, 77% were female, 91% were Caucasian and had moderately to severely active rheumatoid arthritis. Most subjects received 40 mg adalimumab every other week [see Clinical Studies (14.1)].

Table 1 summarizes reactions reported at a rate of at least 5% in subjects treated with adalimumab 40 mg every other week compared to placebo and with an incidence higher than placebo. In Study RA-III, the types and frequencies of adverse reactions in the second year open-label extension were similar to those observed in the one-year double-blind portion.

Table 1. Adverse Reactions Reported by ≥5% of Subjects Treated with Adalimumab During Placebo-Controlled Period of Pooled RA Studies (Studies RA-I, RA-II, RA-III, and RA-IV)
* Laboratory test abnormalities were reported as adverse reactions in European trials. † Does not include injection site erythema, itching, hemorrhage, pain, or swelling.
Adverse Reaction (Preferred Term)	Adalimumab 40 mg Subcutaneous Every Other Week (N=705)	Placebo (N=690)
Respiratory
Upper respiratory infection	17%	13%
Sinusitis	11%	9%
Flu syndrome	7%	6%
Gastrointestinal
Nausea	9%	8%
Abdominal pain	7%	4%
Laboratory Tests*
Laboratory test abnormal	8%	7%
Hypercholesterolemia	6%	4%
Hyperlipidemia	7%	5%
Hematuria	5%	4%
Alkaline phosphatase increased	5%	3%
Other
Headache	12%	8%
Rash	12%	6%
Accidental injury	10%	8%
Injection site reaction†	8%	1%
Back pain	6%	4%
Urinary tract infection	8%	5%
Hypertension	5%	3%

Less Common Adverse Reactions in Rheumatoid Arthritis Clinical Studies

Other infrequent serious adverse reactions that do not appear in the Warnings and Precautions or Adverse Reaction sections that occurred at an incidence of less than 5% in adalimumab-treated subjects in RA studies (RA-I, RA-II, RA-III, and RA-IV) were:

•: Body as a Whole: Pain in extremity, pelvic pain, surgery, thorax pain
•: Cardiovascular System: Arrhythmia, atrial fibrillation, chest pain, coronary artery disorder, heart arrest, hypertensive encephalopathy, myocardial infarct, palpitation, pericardial effusion, pericarditis, syncope, tachycardia
•: Digestive System: Cholecystitis, cholelithiasis, esophagitis, gastroenteritis, gastrointestinal hemorrhage, hepatic necrosis, vomiting
•: Endocrine System: Parathyroid disorder
•: Hemic and Lymphatic System: Agranulocytosis, polycythemia
•: Metabolic and Nutritional Disorders: Dehydration, healing abnormal, ketosis, paraproteinemia, peripheral edema
•: Musculo-Skeletal System: Arthritis, bone disorder, bone fracture (not spontaneous), bone necrosis, joint disorder, muscle cramps, myasthenia, pyogenic arthritis, synovitis, tendon disorder
•: Neoplasia: Adenoma
•: Nervous System: Confusion, paresthesia, subdural hematoma, tremor
•: Respiratory System: Asthma, bronchospasm, dyspnea, lung function decreased, pleural effusion
•: Special Senses: Cataract
•: Thrombosis: Thrombosis leg
•: Urogenital System: Cystitis, kidney calculus, menstrual disorder

Juvenile Idiopathic Arthritis Clinical Studies

In general, the adverse reactions in the adalimumab-treated subjects in the polyarticular juvenile idiopathic arthritis (JIA) trials (Studies JIA-I and JIA-II) [see Clinical Studies (14.2)] were similar in frequency and type to those seen in adult subjects [see Warnings and Precautions (5), Adverse Reactions (6)]. Important findings and differences from adults are discussed in the following paragraphs.

In Study JIA-I, adalimumab was studied in 171 subjects who were 4 to 17 years of age, with polyarticular JIA. Severe adverse reactions reported in the study included neutropenia, streptococcal pharyngitis, increased aminotransferases, herpes zoster, myositis, metrorrhagia, and appendicitis. Serious infections were observed in 4% of subjects within approximately 2 years of initiation of treatment with adalimumab and included cases of herpes simplex, pneumonia, urinary tract infection, pharyngitis, and herpes zoster.

In Study JIA-I, 45% of subjects experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. The types of infections reported in adalimumab-treated subjects were generally similar to those commonly seen in polyarticular JIA subjects who are not treated with TNF blockers. Upon initiation of treatment, the most common adverse reactions occurring in this population treated with adalimumab were injection site pain and injection site reaction (19% and 16%, respectively). A less commonly reported adverse event in subjects receiving adalimumab was granuloma annulare which did not lead to discontinuation of adalimumab treatment.

In the first 48 weeks of treatment in Study JIA-I, non-serious hypersensitivity reactions were seen in approximately 6% of subjects and included primarily localized allergic hypersensitivity reactions and allergic rash.

In Study JIA-I, 10% of subjects treated with adalimumab who had negative baseline anti-dsDNA antibodies developed positive titers after 48 weeks of treatment. No subject developed clinical signs of autoimmunity during the clinical trial.

Approximately 15% of subjects treated with adalimumab developed mild-to-moderate elevations of creatine phosphokinase (CPK) in Study JIA-I. Elevations exceeding 5 times the upper limit of normal were observed in several subjects. CPK concentrations decreased or returned to normal in all subjects. Most subjects were able to continue adalimumab without interruption.

In Study JIA-II, adalimumab was studied in 32 subjects who were 2 to <4 years of age or 4 years of age and older weighing <15 kg with polyarticular JIA. The safety profile for this population was similar to the safety profile seen in subjects 4 to 17 years of age with polyarticular JIA.

In Study JIA-II, 78% of subjects experienced an infection while receiving adalimumab. These included nasopharyngitis, bronchitis, upper respiratory tract infection, otitis media, and were mostly mild to moderate in severity. Serious infections were observed in 9% of subjects receiving adalimumab in the study and included dental caries, rotavirus gastroenteritis, and varicella.

In Study JIA-II, non-serious allergic reactions were observed in 6% of subjects and included intermittent urticaria and rash, which were all mild in severity.

Psoriatic Arthritis and Ankylosing Spondylitis Clinical Studies

Adalimumab has been studied in 395 subjects with psoriatic arthritis (PsA) in two placebo-controlled trials and in an open-label study and in 393 subjects with ankylosing spondylitis (AS) in two placebo-controlled studies [see Clinical Studies (14.3, 14.4)]. The safety profile for subjects with PsA and AS treated with adalimumab 40 mg every other week was similar to the safety profile seen in subjects with RA, adalimumab Studies RA-I through IV.

Crohn's Disease Clinical Studies

Adults: The safety profile of adalimumab in 1478 adult subjects with Crohn's disease from four placebo-controlled and two open-label extension studies [see Clinical Studies (14.5)] was similar to the safety profile seen in subjects with RA.

Pediatric Patients 6 Years to 17 Years: The safety profile of adalimumab in 192 pediatric subjects from one double-blind study (Study PCD-I) and one open-label extension study [see Clinical Studies (14.6)] was similar to the safety profile seen in adult subjects with Crohn's disease.

During the 4-week open-label induction phase of Study PCD-I, the most common adverse reactions occurring in the pediatric population treated with adalimumab were injection site pain and injection site reaction (6% and 5%, respectively).

A total of 67% of children experienced an infection while receiving adalimumab in Study PCD-I.
These included upper respiratory tract infection and nasopharyngitis.

A total of 5% of children experienced a serious infection while receiving adalimumab in Study PCD-I. These included viral infection, device related sepsis (catheter), gastroenteritis, H1N1 influenza, and disseminated histoplasmosis.

In Study PCD-I, allergic reactions were observed in 5% of children which were all non-serious and were primarily localized reactions.

Ulcerative Colitis Clinical Studies

Adults: The safety profile of adalimumab in 1010 adult subjects with ulcerative colitis (UC) from two placebo-controlled studies and one open-label extension study [see Clinical Studies (14.7)] was similar to the safety profile seen in subjects with RA.

Plaque Psoriasis Clinical Studies

Adalimumab has been studied in 1696 subjects with plaque psoriasis (Ps) in placebo-controlled and open-label extension studies [see Clinical Studies (14.8)]. The safety profile for subjects with Ps treated with adalimumab was similar to the safety profile seen in subjects with RA with the following exceptions. In the placebo-controlled portions of the clinical trials in Ps subjects, adalimumab-treated subjects had a higher incidence of arthralgia when compared to controls (3% vs. 1%).

Hidradenitis Suppurativa Clinical Studies

Adalimumab has been studied in 727 subjects with hidradenitis suppurativa (HS) in three placebo-controlled studies and one open-label extension study [see Clinical Studies (14.9)]. The safety profile for subjects with HS treated with adalimumab weekly was consistent with the known safety profile of adalimumab.

Flare of HS, defined as ≥25% increase from baseline in abscesses and inflammatory nodule counts and with a minimum of 2 additional lesions, was documented in 22 (22%) of the 100 subjects who were withdrawn from adalimumab treatment following the primary efficacy timepoint in two studies.

Uveitis Clinical Studies

Adalimumab has been studied in 464 adult subjects with uveitis (UV) in placebo-controlled and open-label extension studies [see Clinical Studies (14.10)]. The safety profile for subjects with UV treated with adalimumab was similar to the safety profile seen in subjects with RA.

6.2 Immunogenicity

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of adalimumab or of other adalimumab products.

There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were <2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples. The incidence of anti-adalimumab antibody (AAA) development in patients treated with adalimumab are presented in Table 2.

Table 2. Anti-Adalimumab Antibody Development Determined by ELISA and ECL Assay in Patients Treated with Adalimumab
n: number of patients with anti-adalimumab antibody; NR: not reported; NA: Not applicable (not performed).
* In patients receiving concomitant methotrexate (MTX), the incidence of anti-adalimumab antibody was 1% compared to 12% with adalimumab monotherapy. † In patients receiving concomitant MTX, the incidence of anti-adalimumab antibody was 6% compared to 26% with adalimumab monotherapy. ‡ This patient received concomitant MTX. § In patients receiving concomitant MTX, the incidence of antibody development was 7% compared to 1% in RA. ¶ Subjects enrolled after completing 2 previous studies of 24 weeks or 12 weeks of treatments. # In plaque psoriasis patients who were on adalimumab monotherapy and subsequently withdrawn from the treatment, the rate of antibodies to adalimumab after retreatment was similar to the rate observed prior to withdrawal. Þ One 12-week Phase 2 study and one 52-week Phase 3 study. ß Among subjects in the 2 Phase 3 studies who stopped adalimumab treatment for up to 24 weeks and in whom adalimumab serum levels subsequently declined to <2 mcg/mL (approximately 22% of total subjects studied). à No apparent association between antibody development and safety was observed. è No correlation of antibody development to safety or efficacy outcomes was observed.
Indications		Study Duration	Anti-Adalimumab Antibody Incidence by ELISA (n/N)		Anti-Adalimumab Antibody Incidence by ECL Assay (n/N)
Indications		Study Duration	In all patients who received adalimumab	In patients with serum adalimumab concentrations <2 mcg/mL
Rheumatoid Arthritis*		6 to 12 months	5% (58/1062)	NR	NA
Juvenile Idiopathic Arthritis (JIA)	4 to 17 years of age†	48 weeks	16% (27/171)	NR	NA
Juvenile Idiopathic Arthritis (JIA)	2 to 4 years of age or ≥4 years of age and weighing <15 kg	24 weeks	7% (1/15)‡	NR	NA
Psoriatic Arthritis§		48 weeks¶	13% (24/178)	NR	NA
Ankylosing Spondylitis		24 weeks	9% (16/185)	NR	NA
Adult Crohn's Disease		56 weeks	3% (7/269)	8% (7/86)	NA
Pediatric Crohn's Disease		52 weeks	3% (6/182)	10% (6/58)	NA
Adult Ulcerative Colitis		52 weeks	5% (19/360)	21% (19/92)	NA
Plaque Psoriasis#		Up to 52 weeksÞ	8% (77/920)	21% (77/372)	NA
Hidradenitis Suppurativa		36 weeks	7% (30/461)	28% (58/207)ß	61% (272/445)à
Non-infectious Uveitis		52 weeks	5% (12/249)	21% (12/57)	40% (99/249)è

Rheumatoid Arthritis and Psoriatic Arthritis: Subjects in Studies RA-I, RA-II, and RA-III were tested at multiple time points for antibodies to adalimumab using the ELISA during the 6- to 12-month period. No apparent correlation of antibody development to adverse reactions was observed. With monotherapy, subjects receiving every other week dosing may develop antibodies more frequently than those receiving weekly dosing. In subjects receiving the recommended dosage of 40 mg every other week as monotherapy, the ACR 20 response was lower among antibody-positive subjects than among antibody-negative subjects. The long-term immunogenicity of adalimumab products is unknown.

6.3 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of adalimumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to adalimumab products exposure.

•: Gastrointestinal disorders: Diverticulitis, large bowel perforations including perforations associated with diverticulitis and appendiceal perforations associated with appendicitis, pancreatitis
•: General disorders and administration site conditions: Pyrexia
•: Hepato-biliary disorders: Liver failure, hepatitis, autoimmune hepatitis
•: Immune system disorders: Sarcoidosis
•: Neoplasms benign, malignant and unspecified (including cysts and polyps): Merkel Cell Carcinoma (neuroendocrine carcinoma of the skin)
•: Nervous system disorders: Demyelinating disorders (e.g., optic neuritis, Guillain-Barré syndrome), cerebrovascular accident
•: Respiratory disorders: Interstitial lung disease, including pulmonary fibrosis, pulmonary embolism
•: Skin reactions: Stevens Johnson Syndrome, cutaneous vasculitis, erythema multiforme, new or worsening psoriasis (all sub-types including pustular and palmoplantar), alopecia, lichenoid skin reaction
•: Vascular disorders: Systemic vasculitis, deep vein thrombosis

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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