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LABELS · 1208dfda-344d-4919-b876-559e52119c8f

AMJEVITA

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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
2026-07-13
Captured
2026-09-09T23:37:39.774134+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SERIOUS INFECTIONS AND MALIGNANCY 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 AMJEVITA 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 AMJEVITA. 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 with TNF 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. SERIOUS INFECTIONS Patients treated with adalimumab products, including AMJEVITA, 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 AMJEVITA 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 AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA 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 AMJEVITA 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 AMJEVITA, 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) ].

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis AMJEVITA 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. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease AMJEVITA 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 AMJEVITA 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 AMJEVITA 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. AMJEVITA 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 AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis AMJEVITA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
Full extracted label fields
application numbers
  1. BLA761024
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS AND MALIGNANCY 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 AMJEVITA 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 AMJEVITA. 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 with TNF 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. SERIOUS INFECTIONS Patients treated with adalimumab products, including AMJEVITA, 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 AMJEVITA 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 AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA 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 AMJEVITA 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 AMJEVITA, 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) ].
brand names
  1. AMJEVITA
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b7178e36-6787-45ab-8fee-be59bc6a4aa4
generic names
  1. ADALIMUMAB-ATTO
id
1208dfda-344d-4919-b876-559e52119c8f
indications and usage exact
  1. 1 INDICATIONS AND USAGE AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. ( 1.7 ) Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. ( 1.8 ) Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. ( 1.9 ) 1.1 Rheumatoid Arthritis AMJEVITA 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. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease AMJEVITA 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 AMJEVITA 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 AMJEVITA 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. AMJEVITA 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 AMJEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis AMJEVITA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Amgen USA Inc.
    matched search terms
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    package ndcs
    1. 72511-400-01
    2. 72511-400-02
    3. 72511-482-01
    4. 72511-482-02
    5. 72511-399-01
    6. 72511-479-02
    7. 72511-481-02
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    2. 72511-400
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    4. 72511-479
    5. 72511-481
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage ( 1.8 , 1.9 ) 10/2025 Dosage and Administration ( 2.1 , 2.3 , 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025
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    Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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    spl effective date
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    spl effective time
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    spl set id
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    substance names
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    Drugs@FDA application source records
    1. application number
      BLA761024
      payload
      all indexed label documents
      1. Appl No
        761024
        Application Docs Date
        2017-09-12 00:00:00
        Application Docs ID
        49717
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
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        761024
        Application Docs Date
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        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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        Submission Type
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      3. Appl No
        761024
        Application Docs Date
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        Application Docs ID
        59067
        Application Docs Title
        0
        Application Docs Type ID
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        Submission No
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        Submission Type
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      4. Appl No
        761024
        Application Docs Date
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        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        SUPPL
      5. Appl No
        761024
        Application Docs Date
        2023-03-23 00:00:00
        Application Docs ID
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        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      6. Appl No
        761024
        Application Docs Date
        2023-04-07 00:00:00
        Application Docs ID
        73962
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        Submission Type
        SUPPL
      7. Appl No
        761024
        Application Docs Date
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        Application Docs ID
        74762
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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        SUPPL
      8. Appl No
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        Application Docs Date
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        Application Docs ID
        75088
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        15
        Submission Type
        SUPPL
      9. Appl No
        761024
        Application Docs Date
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        Application Docs ID
        79457
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      10. Appl No
        761024
        Application Docs Date
        2025-04-08 00:00:00
        Application Docs ID
        81841
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        23
        Submission Type
        SUPPL
      11. Appl No
        761024
        Application Docs Date
        2025-05-20 00:00:00
        Application Docs ID
        82229
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      12. Appl No
        761024
        Application Docs Date
        2025-09-18 00:00:00
        Application Docs ID
        83387
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761024
        Review Priority
        Submission Class Code ID
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        Submission No
        26
        Submission Status
        AP
        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      2. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
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        Submission Status
        AP
        Submission Status Date
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        Submission Type
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        Submissions Public Notes
      3. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2025-09-17 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2025-05-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2024-08-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761024
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        Submission Class Code ID
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        Submission No
        17
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        AP
        Submission Status Date
        2023-07-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        15
        Submission Status
        AP
        Submission Status Date
        2023-08-14 00:00:00
        Submission Type
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        Submissions Public Notes
      8. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2023-03-22 00:00:00
        Submission Type
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        Submissions Public Notes
      9. Appl No
        761024
        Review Priority
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        Submission No
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        Submissions Public Notes
      10. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        10
        Submission Status
        AP
        Submission Status Date
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        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        4
        Submission Status
        AP
        Submission Status Date
        2019-06-13 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        761024
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        3
        Submission Status
        AP
        Submission Status Date
        2018-03-15 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
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      current indication status
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      true
      latest approved submission date
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      latest label selection rule
      max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
      latest posted label documents
      1. Appl No
        761024
        Application Docs Date
        2025-10-17 00:00:00
        Application Docs ID
        83800
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        26
        Submission Type
        SUPPL
      official application record
      Appl No
      761024
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      AMGEN INC
      openfda application present
      true
      products
      1. Active Ingredient
        ADALIMUMAB-ATTO
        Appl No
        761024
        Drug Name
        AMJEVITA
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        Strength
        20MG/0.4ML
        marketing status
        1. Prescription
      2. Active Ingredient
        ADALIMUMAB-ATTO
        Appl No
        761024
        Drug Name
        AMJEVITA
        Form
        INJECTABLE;INJECTION
        Product No
        002
        Reference Drug
        0
        Reference Standard
        Strength
        40MG/0.8ML
        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
    application numbers
    1. BLA761024
    brand names
    1. AMJEVITA
    classification reasons
    1. explicit_positive_indication_predicate
    2. tumor_or_malignant_hematology_words_in_positive_statement
    clinical review status
    pending
    content role
    positive_indication_candidate
    context span
    end
    508
    end exclusive
    true
    exact text
    1 INDICATIONS AND USAGE AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis . ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting
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                                                            patients with moderately to severely active rheumatoid arthritis. AMJEVITA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and imp
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                                                                1.2 Juvenile Idiopathic Arthritis AMJEVITA 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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                                                                Juvenile Idiopathic Arthritis AMJEVITA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis AMJEVITA 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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                                                                    g signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. AMJEVITA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis AMJEVITA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondy
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                                                                        1.3 Psoriatic Arthritis AMJEVITA 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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                                                                            AMJEVITA can be used alone or in combination with non-biologic DMARDs.
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                                                                            ibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. AMJEVITA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease AMJEVITA 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 AMJEVITA
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                                                                                1.4 Ankylosing Spondylitis AMJEVITA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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                                                                                  moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
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                                                                                    1.5 Crohn's Disease AMJEVITA 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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                                                                                    active ankylosing spondylitis. 1.5 Crohn's Disease AMJEVITA 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 AMJEVITA 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 Plaq
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                                                                                        1.6 Ulcerative Colitis AMJEVITA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                        isease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis AMJEVITA 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 AMJEVITA 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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                                                                                                                Preserved source evidence · Not medical advice