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LABELS · e81d34f1-0902-43ef-ab88-470bcc6c0544

ZYMFENTRA

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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
2026-08-18
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 See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2 ) SERIOUS INFECTIONS Patients treated with TNF blockers, inculding ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death [ see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patientsfor latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA 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 ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symtoms of infection during and after treatment with ZYMFENTRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products [ see Warnings and Precautions ( 5.2 ) ]. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in young adult males. [ see Use in Specific Population ( 8.4 ) ].

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.
Full extracted label fields
application numbers
  1. BLA761358
boxed warning exact
  1. WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as hitoplasmosis) and infections due to ohter opportunistic pathogens. (5.1) Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. (5.1) Perform test for latent TB; if positive, start treatment for TB prior to starting ZYMFENTRA. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. (5.1) Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products. (5.2) Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of cases were reported in patients with Crohn's disease or ulcerative colitis, most of whom were adolescent or young adult males. (5.2 ) SERIOUS INFECTIONS Patients treated with TNF blockers, inculding ZYMFENTRA, are at increased risk for developing serious infections that may lead to hospitalization or death [ see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patientsfor latent tuberculosis before ZYMFENTRA use and during therapy. Initiate treatment for latent infection prior to ZYMFENTRA 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 ZYMFENTRA prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symtoms of infection during and after treatment with ZYMFENTRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products [ see Warnings and Precautions ( 5.2 ) ]. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in young adult males. [ see Use in Specific Population ( 8.4 ) ].
brand names
  1. ZYMFENTRA
current indication status
not_reconciled
dailymed set url
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generic names
  1. INFLIXIMAB-DYYB
id
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indications and usage exact
  1. 1 INDICATIONS AND USAGE ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.
indications and usage tables exact
    is original packager
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    1. CELLTRION USA Inc.
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    1. 72606-025-01
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    4. 72606-025-04
    5. 72606-025-05
    6. 72606-025-06
    7. 72606-025-07
    8. 72606-025-08
    9. 72606-025-09
    10. 72606-025-10
    11. 72606-025-11
    12. 72606-025-12
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          Appl No
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          Drug Name
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          Product No
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          Reference Drug
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          Reference Standard
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          Strength
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          marketing status
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      1 INDICATIONS AND USAGE ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to
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