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LABELS · db03295a-9939-43bb-92c5-768721d27a8b

Campath

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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
2025-11-05
Captured
2026-09-09T23:38:02.384588+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
Full extracted label fields
application numbers
  1. BLA103948
boxed warning exact
  1. WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS WARNING: CYTOPENIAS, INFUSION-RELATED REACTIONS, AND INFECTIONS See full prescribing information for complete boxed warning. Serious, including fatal, cytopenias, infusion-related reactions, and infections can occur (5.1–5.3). Limit doses to 30 mg (single) and 90 mg (cumulative weekly); higher doses increase risk of pancytopenia. ( 2.1 ) Escalate dose gradually and monitor patients during infusion. Withhold therapy for Grade 3 or 4 infusion-related reactions. ( 5.2 ) Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections. ( 2.2 , 5.3 ) Cytopenias : Serious, including fatal, pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia can occur in patients receiving CAMPATH. Single doses of CAMPATH greater than 30 mg or cumulative doses greater than 90 mg per week increase the incidence of pancytopenia [see Warnings and Precautions (5.1) ] . Infusion-Related Reactions : CAMPATH administration can result in serious, including fatal, infusion-related reactions. Carefully monitor patients during infusions and withhold CAMPATH for Grade 3 or 4 infusion-related reactions. Gradually escalate CAMPATH to the recommended dose at the initiation of therapy and after interruption of therapy for 7 or more days [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . Immunosuppression/Infections : Serious, including fatal, bacterial, viral, fungal, and protozoan infections can occur in patients receiving CAMPATH. Administer prophylaxis against Pneumocystis jirovecii pneumonia (PCP) and herpes virus infections [see Dosage and Administration (2.2) and Warnings and Precautions (5.3) ] .
brand names
  1. Campath
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f5f7255-7abc-4328-bd1a-ceaf139ef3e0
generic names
  1. ALEMTUZUMAB
id
db03295a-9939-43bb-92c5-768721d27a8b
indications and usage exact
  1. 1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. Genzyme Corporation
    matched search terms
    1. leukemia
    package ndcs
    1. 58468-0357-1
    2. 58468-0357-3
    product ndcs
    1. 58468-0357
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
      record type
      complete_spl_indications_section_candidate
      routes
      1. INTRAVENOUS
      rxcuis
      1. 828265
      2. 828267
      source batch
      file
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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.
      last updated
      2026-09-09
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      url
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      source url
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      spl effective date
      2025-11-05
      spl effective time
      20251105
      spl set id
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      spl version
      21
      substance names
      1. ALEMTUZUMAB
      uniis
      1. 3A189DH42V
      verification flags
      1. oncology_keyword_candidate_not_clinically_classified
      2. spl_text_not_verified_identical_to_latest_approved_label
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      Drugs@FDA application source records
      1. application number
        BLA103948
        payload
        all indexed label documents
        1. Appl No
          103948
          Application Docs Date
          2004-03-12 00:00:00
          Application Docs ID
          53947
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          1
          Submission Type
          ORIG
        2. Appl No
          103948
          Application Docs Date
          2017-12-14 00:00:00
          Application Docs ID
          53952
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5159
          Submission Type
          SUPPL
        3. Appl No
          103948
          Application Docs Date
          2018-07-18 00:00:00
          Application Docs ID
          54913
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5157
          Submission Type
          SUPPL
        4. Appl No
          103948
          Application Docs Date
          2018-11-30 00:00:00
          Application Docs ID
          56606
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5167
          Submission Type
          SUPPL
        5. Appl No
          103948
          Application Docs Date
          2018-12-03 00:00:00
          Application Docs ID
          56618
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5165
          Submission Type
          SUPPL
        6. Appl No
          103948
          Application Docs Date
          2018-12-03 00:00:00
          Application Docs ID
          56619
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5160
          Submission Type
          SUPPL
        7. Appl No
          103948
          Application Docs Date
          2019-01-17 00:00:00
          Application Docs ID
          57237
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5163
          Submission Type
          SUPPL
        8. Appl No
          103948
          Application Docs Date
          2019-01-17 00:00:00
          Application Docs ID
          57238
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5164
          Submission Type
          SUPPL
        9. Appl No
          103948
          Application Docs Date
          2019-08-02 00:00:00
          Application Docs ID
          59559
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5172
          Submission Type
          SUPPL
        10. Appl No
          103948
          Application Docs Date
          2019-10-30 00:00:00
          Application Docs ID
          60732
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5169
          Submission Type
          SUPPL
        11. Appl No
          103948
          Application Docs Date
          2019-10-30 00:00:00
          Application Docs ID
          60733
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5170
          Submission Type
          SUPPL
        12. Appl No
          103948
          Application Docs Date
          2019-11-29 00:00:00
          Application Docs ID
          61115
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5171
          Submission Type
          SUPPL
        all submission records
        1. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5193
          Submission Status
          AP
          Submission Status Date
          2024-05-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5192
          Submission Status
          AP
          Submission Status Date
          2024-02-08 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        3. Appl No
          103948
          Review Priority
          N/A
          Submission Class Code ID
          21
          Submission No
          5191
          Submission Status
          AP
          Submission Status Date
          2024-03-04 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        4. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5188
          Submission Status
          AP
          Submission Status Date
          2023-04-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        5. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5187
          Submission Status
          AP
          Submission Status Date
          2022-09-27 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5185
          Submission Status
          AP
          Submission Status Date
          2022-05-26 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
          Letter for LEMTRADA
        7. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5184
          Submission Status
          AP
          Submission Status Date
          2022-01-13 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
          Label and Medication Guide for LEMTRADA
        8. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5183
          Submission Status
          AP
          Submission Status Date
          2021-08-18 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
          Label for LEMTRADA
        9. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5182
          Submission Status
          AP
          Submission Status Date
          2021-04-28 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5181
          Submission Status
          AP
          Submission Status Date
          2020-10-22 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        11. Appl No
          103948
          Review Priority
          N/A
          Submission Class Code ID
          21
          Submission No
          5180
          Submission Status
          AP
          Submission Status Date
          2021-03-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        12. Appl No
          103948
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          5179
          Submission Status
          AP
          Submission Status Date
          2020-09-25 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        application number
        BLA103948
        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
        2024-05-20
        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
          103948
          Application Docs Date
          2024-05-22 00:00:00
          Application Docs ID
          78541
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          5193
          Submission Type
          SUPPL
        official application record
        Appl No
        103948
        Appl Public Notes
        Appl Type
        BLA
        Sponsor Name
        GENZYME
        openfda application present
        true
        products
        1. Active Ingredient
          ALEMTUZUMAB
          Appl No
          103948
          Drug Name
          CAMPATH
          Form
          VIAL; INTRAVENOUS
          Product No
          001
          Reference Drug
          0
          Reference Standard
          0
          Strength
          10MG/ML
          marketing status
          1. Prescription
        2. Active Ingredient
          ALEMTUZUMAB
          Appl No
          103948
          Drug Name
          CAMPATH
          Form
          VIAL; INTRAVENOUS
          Product No
          002
          Reference Drug
          0
          Reference Standard
          0
          Strength
          30MG/ML
          marketing status
          1. Prescription
        3. Active Ingredient
          ALEMTUZUMAB
          Appl No
          103948
          Drug Name
          LEMTRADA
          Form
          INJECTABLE;INJECTION
          Product No
          003
          Reference Drug
          0
          Reference Standard
          0
          Strength
          12MG/1.2ML (10MG/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 · positive indication candidate
      application numbers
      1. BLA103948
      brand names
      1. Campath
      classification reasons
      1. explicit_positive_indication_predicate
      2. tumor_or_malignant_hematology_words_in_positive_statement
      clinical review status
      pending
      content role
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      true
      exact text
      1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
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      qualifier mentions
      1. context exact
        1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
        kind
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          1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
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          Source null
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          1 INDICATIONS AND USAGE CAMPATH is indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
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            CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
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            as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL)
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              CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL).
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              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
              tumor_directed_candidate
              Passage 3 · unclassified context
              application numbers
              1. BLA103948
              brand names
              1. Campath
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              274
              end exclusive
              true
              exact text
              e treatment of B-cell chronic lymphocytic leukemia (B-CLL). CAMPATH is a CD52-directed cytolytic antibody indicated as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). ( 1 )
              label id
              db03295a-9939-43bb-92c5-768721d27a8b
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              f1c42113b13965db84e2dda853cdff6d674247d7a192a1e8e424426bbddf3be3
              start
              69
              current approval status
              not_reconciled
              duplicate text group
              dup-5f813fc8315089eb4121
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. ALEMTUZUMAB
              id
              ind-span-81e0350ee0ae641269db
              label id
              db03295a-9939-43bb-92c5-768721d27a8b
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
                  source defined aliases
                    source span
                    end
                    274
                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    db03295a-9939-43bb-92c5-768721d27a8b
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    f1c42113b13965db84e2dda853cdff6d674247d7a192a1e8e424426bbddf3be3
                    start
                    269
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%22db03295a-9939-43bb-92c5-768721d27a8b%22
                    spl effective date
                    2025-11-05
                    spl set id
                    4f5f7255-7abc-4328-bd1a-ceaf139ef3e0
                    spl version
                    21
                    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
                    unclear

                    Preserved source evidence · Not medical advice