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LABELS · 801f0478-b00c-4e98-90c0-0a32201be6a2

BESREMi

Open original source → · Download preserved record

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
2026-08-25
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy [see Warnings and Precautions ( 5.1 , 5,2 , 5.3 , 5.4 ) and Adverse Reactions ( 6.1 )] . WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. ( 5.1 , 5.2 , 5.3 , 5.4 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
Full extracted label fields
application numbers
  1. BLA761166
boxed warning exact
  1. WARNING: RISK OF SERIOUS DISORDERS Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy [see Warnings and Precautions ( 5.1 , 5,2 , 5.3 , 5.4 ) and Adverse Reactions ( 6.1 )] . WARNING: RISK OF SERIOUS DISORDERS See full prescribing information for complete boxed warning. Risk of Serious Disorders: Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Monitor closely and withdraw therapy with persistently severe or worsening signs or symptoms of the above disorders. ( 5.1 , 5.2 , 5.3 , 5.4 )
brand names
  1. BESREMi
  2. BESREMi Pen
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9583405d-53a0-49dc-88eb-5e6384ebabcb
generic names
  1. ROPEGINTERFERON ALFA-2B
id
801f0478-b00c-4e98-90c0-0a32201be6a2
indications and usage exact
  1. 1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. PharmaEssentia USA
    matched search terms
    1. polycythemia
    2. thrombocythemia
    package ndcs
    1. 73536-500-01
    2. 73536-511-01
    product ndcs
    1. 73536-500
    2. 73536-511
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Indications and Usage, Essential Thrombocythemia ( 1.1 ) 08/2026 Dosage and Administration ( 2.2 , 2.3 ) 08/2026 Dosage and Administration ( 2.4 ) 06/2026 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.9 , 5.10 , 5.11 ) 08/2026
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      1. application number
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        payload
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        1. Appl No
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          Application Docs Date
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          Application Docs ID
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          Application Docs Date
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          Application Docs ID
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          Submission No
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        3. Appl No
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          Application Docs Date
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          Application Docs ID
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          0
          Application Docs Type ID
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        4. Appl No
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          Application Docs Date
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          Application Docs ID
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          Submission No
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          Submission Type
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          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submissions Public Notes
        2. Appl No
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          Review Priority
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          Submission Class Code ID
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          Submission No
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        3. Appl No
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          Review Priority
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        5. Appl No
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          Review Priority
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          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
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          Submission Type
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        application number
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        approval interpretation
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        1. Appl No
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          Application Docs Date
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          Application Docs ID
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        Appl No
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        Sponsor Name
        PHARMAESSENTIA CORP
        openfda application present
        true
        products
        1. Active Ingredient
          ROPEGINTERFERON ALFA-2B-NJFT
          Appl No
          761166
          Drug Name
          BESREMI
          Form
          INJECTABLE;SUBCUTANEOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          500 MCG/ML
          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 · indication intro context
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      1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adu
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            1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for:
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            1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera
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                1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi
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                      1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with poly
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                          1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia
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                                1 INDICATIONS AND USAGE BESREMi is an interferon alfa-2b indicated for: • The treatment of adults with essential thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
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                                    1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia.
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                                    ntial thrombocythemia. ( 1.1 ) • The treatment of adults with polycythemia vera. ( 1.2 ) 1.1 Essential Thrombocythemia BESREMi is indicated for the treatment of adults with essential thrombocythemia. 1.2 Polycythemia Vera BESREMi is indicated for the treatment of adults with polycythemia vera.
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                                        Preserved source evidence · Not medical advice