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LABELS · e7565b3d-b98e-46bb-906f-e821077068dc

Cyltezo

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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
2026-05-22
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 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 CYLTEZO 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 CYLTEZO. 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 CYLTEZO, 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 CYLTEZO 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 CYLTEZO use and during therapy. Initiate treatment for latent TB prior to CYLTEZO 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 CYLTEZO 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 CYLTEZO, 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 CYLTEZO 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 CYLTEZO 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. CYLTEZO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. CYLTEZO can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease CYLTEZO 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 CYLTEZO 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 CYLTEZO 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. CYLTEZO 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 CYLTEZO is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis CYLTEZO 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. BLA761058
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 CYLTEZO 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 CYLTEZO. 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 CYLTEZO, 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 CYLTEZO 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 CYLTEZO use and during therapy. Initiate treatment for latent TB prior to CYLTEZO 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 CYLTEZO 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 CYLTEZO, 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. Cyltezo
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=115ea79b-7209-7f19-b35d-36ec0828fbf5
generic names
  1. ADALIMUMAB-ADBM
id
e7565b3d-b98e-46bb-906f-e821077068dc
indications and usage exact
  1. 1 INDICATIONS AND USAGE CYLTEZO 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 CYLTEZO 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. CYLTEZO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. CYLTEZO can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease CYLTEZO 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 CYLTEZO 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 CYLTEZO 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. CYLTEZO 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 CYLTEZO is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. 1.9 Uveitis CYLTEZO 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
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    manufacturer names
    1. Boehringer Ingelheim Pharmaceuticals, Inc.
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    1. 0597-0370-82
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    3. 0597-0370-45
    4. 0597-0405-80
    5. 0597-0405-10
    6. 0597-0400-89
    7. 0597-0375-48
    8. 0597-0375-97
    9. 0597-0375-23
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    4. 0597-0375
    5. 0597-0485
    6. 0597-0495
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    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Hidradenitis Suppurativa ( 1.8 ) 10/2025 Uveitis ( 1.9 ) 10/2025 Dosage and Administration, Juvenile Idiopathic Arthritis or Pediatric Uveitis ( 2.3 ) 10/2025 Hidradenitis Suppurativa ( 2.7 ) 10/2025 Warnings and Precautions, Autoimmunity ( 5.9 ) 10/2025
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          Drugs@FDA application source records
          1. application number
            BLA761058
            payload
            all indexed label documents
            1. Appl No
              761058
              Application Docs Date
              2017-08-25 00:00:00
              Application Docs ID
              49544
              Application Docs Title
              0
              Application Docs Type ID
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              Submission No
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              761058
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              Application Docs ID
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              0
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            5. Appl No
              761058
              Application Docs Date
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              73393
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              0
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            6. Appl No
              761058
              Application Docs Date
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              Application Docs Title
              0
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              761058
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              Application Docs Title
              0
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              2
              Submission No
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            9. Appl No
              761058
              Application Docs Date
              2023-07-21 00:00:00
              Application Docs ID
              74865
              Application Docs Title
              0
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            10. Appl No
              761058
              Application Docs Date
              2024-05-03 00:00:00
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              0
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            11. Appl No
              761058
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              2025-05-20 00:00:00
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              Submission No
              31
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              761058
              Application Docs Date
              2025-10-22 00:00:00
              Application Docs ID
              83871
              Application Docs Title
              0
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              2
              Submission No
              35
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              761058
              Review Priority
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              Submission Class Code ID
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            3. Appl No
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              Review Priority
              STANDARD
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            4. Appl No
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            5. Appl No
              761058
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              761058
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              STANDARD
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              AP
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              2023-05-18 00:00:00
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              Submissions Public Notes
            7. Appl No
              761058
              Review Priority
              STANDARD
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              AP
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              Submissions Public Notes
            8. Appl No
              761058
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              STANDARD
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              Submissions Public Notes
            10. Appl No
              761058
              Review Priority
              STANDARD
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              Submission Status Date
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            11. Appl No
              761058
              Review Priority
              STANDARD
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              Submission Status Date
              2019-09-13 00:00:00
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              Submissions Public Notes
            12. Appl No
              761058
              Review Priority
              STANDARD
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              2017-08-25 00:00:00
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              Submissions Public Notes
            application number
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            approval interpretation
            Application linkage and approved submission are not indication-level current approval verification
            current indication status
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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
              761058
              Application Docs Date
              2025-10-22 00:00:00
              Application Docs ID
              83871
              Application Docs Title
              0
              Application Docs Type ID
              2
              Submission No
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              Submission Type
              SUPPL
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            Appl No
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            Appl Public Notes
            Appl Type
            BLA
            Sponsor Name
            BOEHRINGER INGELHEIM
            openfda application present
            true
            products
            1. Active Ingredient
              ADALIMUMAB-ADBM
              Appl No
              761058
              Drug Name
              CYLTEZO
              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
          application numbers
          1. BLA761058
          brand names
          1. Cyltezo
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          exact text
          1 INDICATIONS AND USAGE CYLTEZO 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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                                                              1.1 Rheumatoid Arthritis CYLTEZO is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
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                                                                  patients with moderately to severely active rheumatoid arthritis. CYLTEZO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and impro
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                                                                      1.2 Juvenile Idiopathic Arthritis CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
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                                                                      2 Juvenile Idiopathic Arthritis CYLTEZO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic
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                                                                          ng signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. CYLTEZO can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis CYLTEZO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. CYLTEZO can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis CYLTEZO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondyli
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                                                                              1.3 Psoriatic Arthritis CYLTEZO 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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                                                                                              1.6 Ulcerative Colitis CYLTEZO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.
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                                                                                                                      1.9 Uveitis CYLTEZO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
                                                                                                                      label id
                                                                                                                      e7565b3d-b98e-46bb-906f-e821077068dc
                                                                                                                      offset unit
                                                                                                                      unicode_code_points
                                                                                                                      source array index
                                                                                                                      0
                                                                                                                      source field
                                                                                                                      indications_and_usage_exact
                                                                                                                      source text sha256
                                                                                                                      a90082f2042d4dd3fc83e9273c014217357cb55f05785aa094a34f6c154f80d9
                                                                                                                      start
                                                                                                                      3663
                                                                                                                      source url
                                                                                                                      https://api.fda.gov/drug/label.json?search=id%3A%22e7565b3d-b98e-46bb-906f-e821077068dc%22
                                                                                                                      spl effective date
                                                                                                                      2026-05-22
                                                                                                                      spl set id
                                                                                                                      115ea79b-7209-7f19-b35d-36ec0828fbf5
                                                                                                                      spl version
                                                                                                                      18
                                                                                                                      structured fields status
                                                                                                                      not_extracted_no_values_inferred_from_mentions
                                                                                                                      structured indication
                                                                                                                      age
                                                                                                                      Source null
                                                                                                                      approval pathway
                                                                                                                      Source null
                                                                                                                      biomarker and test
                                                                                                                      Source null
                                                                                                                      disease stage
                                                                                                                      Source null
                                                                                                                      limitations
                                                                                                                      Source null
                                                                                                                      line
                                                                                                                      Source null
                                                                                                                      prior therapy
                                                                                                                      Source null
                                                                                                                      regimen
                                                                                                                      Source null
                                                                                                                      tumor histology
                                                                                                                      Source null
                                                                                                                      use intent
                                                                                                                      non_oncology_or_unclear_candidate

                                                                                                                      Preserved source evidence · Not medical advice