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LABELS · e4f35584-c5c1-4878-a715-8e09c488d05e

Adalimumab-bwwd

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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
2026-09-09T23:38:02.384588+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 Adalimumab-bwwd, 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 Adalimumab-bwwd 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 Adalimumab-bwwd use and during therapy. Initiate treatment for latent TB prior to Adalimumab-bwwd 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 Adalimumab-bwwd 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 Adalimumab-bwwd, 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 Adalimumab-bwwd 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 Adalimumab-bwwd. • 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 Adalimumab-bwwd 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 adult patients ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients ( 1.9 ) . 1.1 Rheumatoid Arthritis Adalimumab-bwwd 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. Adalimumab-bwwd can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-bwwd can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-bwwd can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-bwwd is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-bwwd 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 Adalimumab-bwwd 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 Adalimumab-bwwd 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. Adalimumab-bwwd 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 Adalimumab-bwwd is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis Adalimumab-bwwd is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Full extracted label fields
application numbers
  1. BLA761059
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including Adalimumab-bwwd, 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 Adalimumab-bwwd 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 Adalimumab-bwwd use and during therapy. Initiate treatment for latent TB prior to Adalimumab-bwwd 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 Adalimumab-bwwd 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 Adalimumab-bwwd, 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 Adalimumab-bwwd 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 Adalimumab-bwwd. • 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. Adalimumab-bwwd
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c24655e5-796e-4127-b716-92f08d649c83
generic names
  1. ADALIMUMAB-BWWD
id
e4f35584-c5c1-4878-a715-8e09c488d05e
indications and usage exact
  1. 1 INDICATIONS AND USAGE Adalimumab-bwwd 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 adult patients ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients ( 1.9 ) . 1.1 Rheumatoid Arthritis Adalimumab-bwwd 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. Adalimumab-bwwd can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-bwwd can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-bwwd can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-bwwd is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-bwwd 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 Adalimumab-bwwd 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 Adalimumab-bwwd 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. Adalimumab-bwwd 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 Adalimumab-bwwd is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis Adalimumab-bwwd is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
indications and usage tables exact
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    Drugs@FDA application source records
    1. application number
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      payload
      all indexed label documents
      1. Appl No
        761059
        Application Docs Date
        2019-07-23 00:00:00
        Application Docs ID
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        Application Docs Date
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        Submission No
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        Application Docs Date
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      7. Appl No
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        Application Docs Date
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        Application Docs Title
        0
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      8. Appl No
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        Application Docs Date
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        Application Docs Title
        0
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        Submission No
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      9. Appl No
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        Application Docs Date
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        Application Docs ID
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        2
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      10. Appl No
        761059
        Application Docs Date
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        Application Docs ID
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        0
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        Submission No
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        SUPPL
      11. Appl No
        761059
        Application Docs Date
        2025-06-24 00:00:00
        Application Docs ID
        82647
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        30
        Submission Type
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      12. Appl No
        761059
        Application Docs Date
        2025-10-20 00:00:00
        Application Docs ID
        83823
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
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      1. Appl No
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        Review Priority
        STANDARD
        Submission Class Code ID
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        1
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        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 Status Date
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        Submissions Public Notes
      3. Appl No
        761059
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        5
        Submission Status
        AP
        Submission Status Date
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        Submissions Public Notes
      4. Appl No
        761059
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        6
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        AP
        Submission Status Date
        2023-06-26 00:00:00
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      5. Appl No
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        STANDARD
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      6. Appl No
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      7. Appl No
        761059
        Review Priority
        STANDARD
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        Submission No
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      8. Appl No
        761059
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        STANDARD
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      9. Appl No
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      10. Appl No
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      11. Appl No
        761059
        Review Priority
        STANDARD
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        2025-06-23 00:00:00
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        Submissions Public Notes
      12. Appl No
        761059
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        Submission Status Date
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      application number
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      1. Appl No
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      products
      1. Active Ingredient
        ADALIMUMAB-BWWD
        Appl No
        761059
        Drug Name
        HADLIMA
        Form
        INJECTABLE;INJECTION
        Product No
        001
        Reference Drug
        0
        Reference Standard
        0
        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
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    exact text
    1 INDICATIONS AND USAGE Adalimumab-bwwd 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
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                                                                1.2 Juvenile Idiopathic Arthritis Adalimumab-bwwd 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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                                                                le Idiopathic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-bwwd can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis Adalimumab-bwwd is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active ps
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                                                                            the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-bwwd can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis Adalimumab-bwwd is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-bwwd 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 A
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                                                                                1.4 Ankylosing Spondylitis Adalimumab-bwwd is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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                                                                                    ankylosing spondylitis. 1.5 Crohn’s Disease Adalimumab-bwwd 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 Adalimumab-bwwd 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 Adalimumab-bwwd is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                Preserved source evidence · Not medical advice