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LABELS · 48b7e44a-945f-487d-b2fd-3da13d6d6fdb

HYRIMOZ

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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
2025-10-17
Captured
2026-09-09T23:37:44.904352+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 HYRIMOZ, 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 HYRIMOZ 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 HYRIMOZ use and during therapy. Initiate treatment for latent TB prior to HYRIMOZ 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 HYRIMOZ 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 HYRIMOZ, 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 HYRIMOZ 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 HYRIMOZ. • 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.

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE HYRIMOZ 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 HYRIMOZ 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. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HYRIMOZ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HYRIMOZ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ 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 HYRIMOZ 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 HYRIMOZ 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. HYRIMOZ 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 HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
  2. 1.6 Ulcerative Colitis HYRIMOZ 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) ] .
  3. 1.7 Plaque Psoriasis HYRIMOZ 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. HYRIMOZ 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) ] .
Full extracted label fields
application numbers
  1. BLA761071
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including HYRIMOZ, 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 HYRIMOZ 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 HYRIMOZ use and during therapy. Initiate treatment for latent TB prior to HYRIMOZ 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 HYRIMOZ 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 HYRIMOZ, 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 HYRIMOZ 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 HYRIMOZ. • 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.
brand names
  1. HYRIMOZ
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ac7d061-3380-468c-b077-c05f8dfbc829
generic names
  1. ADALIMUMAB-ADAZ
id
48b7e44a-945f-487d-b2fd-3da13d6d6fdb
indications and usage exact
  1. 1 INDICATIONS AND USAGE HYRIMOZ 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 HYRIMOZ 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. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HYRIMOZ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HYRIMOZ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ 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 HYRIMOZ 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 HYRIMOZ 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. HYRIMOZ 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 HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
  2. 1.6 Ulcerative Colitis HYRIMOZ 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) ] .
  3. 1.7 Plaque Psoriasis HYRIMOZ 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. HYRIMOZ 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) ] .
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Sandoz Inc
    matched search terms
    1. tumor
    package ndcs
    1. 61314-454-20
    2. 61314-454-36
    3. 61314-454-68
    4. 61314-473-64
    5. 61314-473-20
    6. 61314-473-92
    7. 61314-476-64
    8. 61314-509-64
    9. 61314-517-36
    10. 61314-454-96
    11. 61314-473-96
    12. 61314-531-64
    product ndcs
    1. 61314-454
    2. 61314-473
    3. 61314-476
    4. 61314-509
    5. 61314-517
    6. 61314-531
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 10/2025 Indications and Usage, Uveitis ( 1.9 ) 10/2025 Dosage and Administration, Uveitis ( 2.3 ) 10/2025 Dosage and Administration, Hidradenitis Suppurativa ( 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025
    record type
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    12. 2641665
    source batch
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    meta
    disclaimer
    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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    2026-09-09
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    sha256
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    url
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    source url
    https://api.fda.gov/drug/label.json?search=id%3A%2248b7e44a-945f-487d-b2fd-3da13d6d6fdb%22
    spl effective date
    2025-10-17
    spl effective time
    20251017
    spl set id
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    spl version
    14
    substance names
    1. ADALIMUMAB
    uniis
    1. FYS6T7F842
    verification flags
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    2. spl_text_not_verified_identical_to_latest_approved_label
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    4. fda_label_posted_after_spl_effective_date_requires_version_review
    Drugs@FDA application source records
    1. application number
      BLA761071
      payload
      all indexed label documents
      1. Appl No
        761071
        Application Docs Date
        2018-10-31 00:00:00
        Application Docs ID
        56201
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        ORIG
      2. Appl No
        761071
        Application Docs Date
        2021-02-26 00:00:00
        Application Docs ID
        66408
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        1
        Submission Type
        SUPPL
      3. Appl No
        761071
        Application Docs Date
        2022-03-29 00:00:00
        Application Docs ID
        70646
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        11
        Submission Type
        SUPPL
      4. Appl No
        761071
        Application Docs Date
        2022-07-20 00:00:00
        Application Docs ID
        71611
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        12
        Submission Type
        SUPPL
      5. Appl No
        761071
        Application Docs Date
        2022-07-20 00:00:00
        Application Docs ID
        71612
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        10
        Submission Type
        SUPPL
      6. Appl No
        761071
        Application Docs Date
        2023-03-27 00:00:00
        Application Docs ID
        73866
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        14
        Submission Type
        SUPPL
      7. Appl No
        761071
        Application Docs Date
        2023-04-17 00:00:00
        Application Docs ID
        74005
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        15
        Submission Type
        SUPPL
      8. Appl No
        761071
        Application Docs Date
        2023-09-13 00:00:00
        Application Docs ID
        75442
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        16
        Submission Type
        SUPPL
      9. Appl No
        761071
        Application Docs Date
        2024-04-09 00:00:00
        Application Docs ID
        78097
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        19
        Submission Type
        SUPPL
      10. Appl No
        761071
        Application Docs Date
        2024-06-13 00:00:00
        Application Docs ID
        78795
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        21
        Submission Type
        SUPPL
      11. Appl No
        761071
        Application Docs Date
        2025-05-20 00:00:00
        Application Docs ID
        82231
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        22
        Submission Type
        SUPPL
      12. Appl No
        761071
        Application Docs Date
        2025-07-30 00:00:00
        Application Docs ID
        82990
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        24
        Submission Type
        SUPPL
      all submission records
      1. Appl No
        761071
        Review Priority
        Submission Class Code ID
        28
        Submission No
        31
        Submission Status
        AP
        Submission Status Date
        2025-10-16 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      2. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        24
        Submission Status
        AP
        Submission Status Date
        2025-07-29 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      3. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        6
        Submission No
        22
        Submission Status
        AP
        Submission Status Date
        2025-05-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      4. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        21
        Submission Status
        AP
        Submission Status Date
        2024-06-12 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      5. Appl No
        761071
        Review Priority
        UNKNOWN
        Submission Class Code ID
        1
        Submission No
        19
        Submission Status
        AP
        Submission Status Date
        2024-04-05 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      6. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        1
        Submission No
        16
        Submission Status
        AP
        Submission Status Date
        2023-09-08 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      7. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        19
        Submission No
        15
        Submission Status
        AP
        Submission Status Date
        2023-04-14 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      8. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        14
        Submission Status
        AP
        Submission Status Date
        2023-03-20 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      9. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        12
        Submission Status
        AP
        Submission Status Date
        2022-07-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      10. Appl No
        761071
        Review Priority
        N/A
        Submission Class Code ID
        4
        Submission No
        11
        Submission Status
        AP
        Submission Status Date
        2022-03-28 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      11. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        10
        Submission Status
        AP
        Submission Status Date
        2022-07-18 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      12. Appl No
        761071
        Review Priority
        STANDARD
        Submission Class Code ID
        3
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2021-02-24 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
      BLA761071
      approval interpretation
      Application linkage and approved submission are not indication-level current approval verification
      current indication status
      not_reconciled
      has approved submission record
      true
      latest approved submission date
      2025-10-16
      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
        761071
        Application Docs Date
        2025-10-21 00:00:00
        Application Docs ID
        83834
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        31
        Submission Type
        SUPPL
      official application record
      Appl No
      761071
      Appl Public Notes
      Appl Type
      BLA
      Sponsor Name
      SANDOZ INC
      openfda application present
      true
      products
      1. Active Ingredient
        ADALIMUMAB-ADAZ
        Appl No
        761071
        Drug Name
        HYRIMOZ
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        Strength
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    Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

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          1 INDICATIONS AND USAGE HYRIMOZ 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, inhibit
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                                                                                              • Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
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                                                                                                    brand names
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                                                                                                        1.1 Rheumatoid Arthritis HYRIMOZ 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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                                                                                                        brand names
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                                                                                                        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. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HYRIMOZ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and olde
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                                                                                                            application numbers
                                                                                                            1. BLA761071
                                                                                                            brand names
                                                                                                            1. HYRIMOZ
                                                                                                            classification reasons
                                                                                                            1. explicit_positive_indication_predicate
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                                                                                                            patients with moderately to severely active rheumatoid arthritis. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis HYRIMOZ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HYRIMOZ 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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                                                                                                              polarity
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                                                                                                                1.2 Juvenile Idiopathic Arthritis HYRIMOZ 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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                                                                                                                Passage 23 · unclassified context
                                                                                                                application numbers
                                                                                                                1. BLA761071
                                                                                                                brand names
                                                                                                                1. HYRIMOZ
                                                                                                                classification reasons
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                                                                                                                2 Juvenile Idiopathic Arthritis HYRIMOZ is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HYRIMOZ 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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                                                                                                                    application numbers
                                                                                                                    1. BLA761071
                                                                                                                    brand names
                                                                                                                    1. HYRIMOZ
                                                                                                                    classification reasons
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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. HYRIMOZ can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis HYRIMOZ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondyli
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                                                                                                                        1.3 Psoriatic Arthritis HYRIMOZ 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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                                                                                                                        application numbers
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                                                                                                                        brand names
                                                                                                                        1. HYRIMOZ
                                                                                                                        classification reasons
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                                                                                                                        tic Arthritis HYRIMOZ is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ is indicated for the treatment of mod
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                                                                                                                            application numbers
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                                                                                                                            brand names
                                                                                                                            1. HYRIMOZ
                                                                                                                            classification reasons
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                                                                                                                            hibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ 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 HYRIMOZ i
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                                                                                                                                1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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                                                                                                                                brand names
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                                                                                                                                MOZ can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis HYRIMOZ is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ 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 HYRIMOZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of adalimumab products has n
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                                                                                                                                    brand names
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                                                                                                                                    h active ankylosing spondylitis. 1.5 Crohn’s Disease HYRIMOZ 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 HYRIMOZ 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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                                                                                                                                        1.6 Ulcerative Colitis HYRIMOZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                                        brand names
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                                                                                                                                        disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis HYRIMOZ 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 HYRIMOZ 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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                                                                                                                                              brand names
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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 HYRIMOZ 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. HYRIMOZ 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 HYR
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                                                                                                                                                  1.7 Plaque Psoriasis HYRIMOZ 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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                                                                                                                                                  use intent
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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. HYRIMOZ 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 HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HYRIMOZ is indicated for the trea
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                                                                                                                                                        HYRIMOZ 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) ] .
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                                                                                                                                                        application numbers
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                                                                                                                                                        brand names
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                                                                                                                                                        are medically less appropriate. HYRIMOZ 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 HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
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                                                                                                                                                            1.8 Hidradenitis Suppurativa HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
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                                                                                                                                                            brand names
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                                                                                                                                                            ysician [see Warnings and Precautions (5) ] . 1.8 Hidradenitis Suppurativa HYRIMOZ is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
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                                                                                                                                                                1.9 Uveitis HYRIMOZ is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
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                                                                                                                                                                Source null
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                                                                                                                                                                application numbers
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                                                                                                                                                                brand names
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                                                                                                                                                                1.6 Ulcerative Colitis HYRIMOZ 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) ] .
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                                                                                                                                                                  ment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                                                                    1.6 Ulcerative Colitis HYRIMOZ is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                                                                    brand names
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                                                                                                                                                                    1.6 Ulcerative Colitis HYRIMOZ 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) ] .
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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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                                                                                                                                                                          application numbers
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                                                                                                                                                                          brand names
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                                                                                                                                                                          1.7 Plaque Psoriasis HYRIMOZ 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. HYRIMOZ 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) ] .
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                                                                                                                                                                            Plaque Psoriasis HYRIMOZ is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are ca
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                                                                                                                                                                              1.7 Plaque Psoriasis HYRIMOZ 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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                                                                                                                                                                              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. HYRIMOZ 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) ] .
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                                                                                                                                                                                    HYRIMOZ 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) ] .
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                                                                                                                                                                                    Preserved source evidence · Not medical advice