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LABELS · 92fff88b-7e54-47b3-92ed-e57bbb9b6a84

YUSIMRY

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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date
2025-05-16
Captured
2026-09-09T23:37:54.830918+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions ( 5.2 ) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 ) ]. WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning . SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUSIMRY if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting YUSIMRY. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated withTNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE YUSIMRY 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 andsymptoms 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 ): The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. 1.1 Rheumatoid Arthritis YUSIMRY 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. YUSIMRY can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY 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 ) ]. 1.7 Plaque Psoriasis YUSIMRY 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. YUSIMRY 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 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Full extracted label fields
application numbers
  1. BLA761216
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including YUSIMRY are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue YUSIMRY if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before YUSIMRY use and during therapy. Initiate treatment for latent TB prior to YUSIMRY use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with YUSIMRY prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with YUSIMRY, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 ) ]. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products [see Warnings and Precautions ( 5.2 ) ]. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6–MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions ( 5.2 ) ]. WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning . SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens. Discontinue YUSIMRY if a patient develops a serious infection or sepsis during treatment. Perform test for latent TB; if positive, start treatment for TB prior to starting YUSIMRY. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. MALIGNANCY ( 5.2 ): Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated withTNF blockers including adalimumab products. Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.
brand names
  1. YUSIMRY
current indication status
not_reconciled
dailymed set url
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generic names
  1. ADALIMUMAB-AQVH
id
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indications and usage exact
  1. 1 INDICATIONS AND USAGE YUSIMRY 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 andsymptoms 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 ): The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. 1.1 Rheumatoid Arthritis YUSIMRY 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. YUSIMRY can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY 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 ) ]. 1.7 Plaque Psoriasis YUSIMRY 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. YUSIMRY 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 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
indications and usage tables exact
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    recent major changes exact
    1. Indication and Usage, Uveitis ( 1.9 ) 09/2023 Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 04/2023 Dosage Forms and Strengths, 40mg/0.8mL Pen ( 3 ) 02/2023
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      1. Active Ingredient
        ADALIMUMAB-AQVH
        Appl No
        761216
        Drug Name
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        Form
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        Product No
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        marketing status
        1. Prescription

    Source passages and status connections

    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

    Passage 1 · positive indication candidate
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    1 INDICATIONS AND USAGE YUSIMRY 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 ): re
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        1 INDICATIONS AND USAGE YUSIMRY 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.
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                                                  1.1 Rheumatoid Arthritis YUSIMRY 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.
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                                                      patients with moderately to severely active rheumatoid arthritis. YUSIMRY can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and impro
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                                                        ive polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
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                                                          1.2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
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                                                          2 Juvenile Idiopathic Arthritis YUSIMRY is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic
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                                                              ng signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. YUSIMRY can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondyli
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                                                                  1.3 Psoriatic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.
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                                                                  tic Arthritis YUSIMRY is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of mod
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                                                                      hibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. YUSIMRY can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY i
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                                                                          1.4 Ankylosing Spondylitis YUSIMRY is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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                                                                          application numbers
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                                                                          brand names
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                                                                          1. ADALIMUMAB-AQVH
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                                                                          qualifier mentions
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                                                                            eatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
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                                                                            age
                                                                            polarity
                                                                            not_inferred
                                                                            span
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                                                                          2. context exact
                                                                            moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
                                                                            kind
                                                                            age
                                                                            polarity
                                                                            not_inferred
                                                                            span
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                                                                            2839
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                                                                            2821
                                                                          3. context exact
                                                                            ely active Crohn's disease in adults and pediatric patients 6 years of age and older.
                                                                            kind
                                                                            age
                                                                            polarity
                                                                            not_inferred
                                                                            span
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                                                                            2854
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                                                                            6 years of age
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                                                                              1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
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                                                                              Source null
                                                                              biomarker and test
                                                                              Source null
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                                                                              Source null
                                                                              prior therapy
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                                                                              regimen
                                                                              Source null
                                                                              tumor histology
                                                                              Source null
                                                                              use intent
                                                                              non_oncology_or_unclear_candidate
                                                                              Passage 19 · positive indication candidate
                                                                              application numbers
                                                                              1. BLA761216
                                                                              brand names
                                                                              1. YUSIMRY
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                                                                              h active ankylosing spondylitis. 1.5 Crohn's Disease YUSIMRY is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY 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 ) ]. 1.7 Pla
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                                                                              2897
                                                                              qualifier mentions
                                                                              1. context exact
                                                                                ment of moderately to severely active ulcerative colitis in adult patients.
                                                                                kind
                                                                                age
                                                                                polarity
                                                                                not_inferred
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                                                                                adult patients
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                                                                                  1.6 Ulcerative Colitis YUSIMRY is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                  source url
                                                                                  https://api.fda.gov/drug/label.json?search=id%3A%2292fff88b-7e54-47b3-92ed-e57bbb9b6a84%22
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                                                                                  application numbers
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                                                                                  1. YUSIMRY
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                                                                                  disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis YUSIMRY 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 ) ]. 1.7 Plaque Psoriasis YUSIMRY 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
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                                                                                        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 ) ].
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                                                                                        Source null
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                                                                                        not_applicable
                                                                                        Passage 21 · positive indication candidate
                                                                                        application numbers
                                                                                        1. BLA761216
                                                                                        brand names
                                                                                        1. YUSIMRY
                                                                                        classification reasons
                                                                                        1. explicit_positive_indication_predicate
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                                                                                        tients. 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 ) ]. 1.7 Plaque Psoriasis YUSIMRY 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. YUSIMRY 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 ) ]. 1.8 Hidradenitis Suppurativa YU
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                                                                                        qualifier mentions
                                                                                        1. context exact
                                                                                          Plaque Psoriasis YUSIMRY is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
                                                                                          kind
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                                                                                            1.7 Plaque Psoriasis YUSIMRY 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.
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                                                                                            source url
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                                                                                            application numbers
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                                                                                            brand names
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                                                                                            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. YUSIMRY 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 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infecti
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                                                                                                  disease stage
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                                                                                                  line
                                                                                                  Source null
                                                                                                  prior therapy
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                                                                                                  regimen
                                                                                                  Source null
                                                                                                  tumor histology
                                                                                                  Source null
                                                                                                  use intent
                                                                                                  not_applicable
                                                                                                  Passage 23 · positive indication candidate
                                                                                                  application numbers
                                                                                                  1. BLA761216
                                                                                                  brand names
                                                                                                  1. YUSIMRY
                                                                                                  classification reasons
                                                                                                  1. explicit_positive_indication_predicate
                                                                                                  2. no_tumor_directed_keyword_in_positive_statement
                                                                                                  clinical review status
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                                                                                                  are medically less appropriate. YUSIMRY 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 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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                                                                                                      1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
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                                                                                                      line
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                                                                                                      regimen
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                                                                                                      tumor histology
                                                                                                      Source null
                                                                                                      use intent
                                                                                                      non_oncology_or_unclear_candidate
                                                                                                      Passage 24 · positive indication candidate
                                                                                                      application numbers
                                                                                                      1. BLA761216
                                                                                                      brand names
                                                                                                      1. YUSIMRY
                                                                                                      classification reasons
                                                                                                      1. explicit_positive_indication_predicate
                                                                                                      2. no_tumor_directed_keyword_in_positive_statement
                                                                                                      clinical review status
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                                                                                                      exact text
                                                                                                      up visits with a physician [see Warnings and Precautions ( 5 ) ]. 1.8 Hidradenitis Suppurativa YUSIMRY is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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                                                                                                          exact text
                                                                                                          1.9 Uveitis YUSIMRY is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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                                                                                                          disease stage
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                                                                                                          Preserved source evidence · Not medical advice