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LABELS · 62959a22-02f7-463c-80bb-3c5e621b1f58

TIVDAK

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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
2025-11-20
Captured
2026-09-09T23:37:51.659493+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ]. • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. ( 5.1 ) • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. ( 2.2 , 5.1 ) • Adhere to the required premedication and eye care before, during, and after infusion. ( 2.2 ) • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity. ( 2.3 , 5.1 )

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
Full extracted label fields
application numbers
  1. BLA761208
boxed warning exact
  1. WARNING: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . • Adhere to the required premedication and eye care before, during, and after infusion. [see Dosage and Administration (2.2) ]. • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity [see Dosage and Administration (2.3) , Warnings and Precautions (5.1) ]. WARNING: OCULAR TOXICITY See full prescribing information for complete boxed warning. • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss and corneal ulceration. ( 5.1 ) • Conduct an ophthalmic exam, including an assessment of ocular symptoms, visual acuity, and slit lamp exam of the anterior segment of the eye prior to initiation of TIVDAK, prior to every cycle for the first nine cycles, and as clinically indicated. ( 2.2 , 5.1 ) • Adhere to the required premedication and eye care before, during, and after infusion. ( 2.2 ) • Withhold TIVDAK until improvement and resume, reduce the dose, or permanently discontinue, based on severity. ( 2.3 , 5.1 )
brand names
  1. TIVDAK
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9fe3f32-4219-466e-acb9-3f609b4f4df1
generic names
  1. TISOTUMAB VEDOTIN
id
62959a22-02f7-463c-80bb-3c5e621b1f58
indications and usage exact
  1. 1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
indications and usage tables exact
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    manufacturer names
    1. SEAGEN INC.
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    1. cancer
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    1. 51144-003-01
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    1. 51144-003
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    1. HUMAN PRESCRIPTION DRUG
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        1. Active Ingredient
          TISOTUMAB VEDOTIN-TFTV
          Appl No
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          Drug Name
          TIVDAK
          Form
          INJECTABLE;INJECTION
          Product No
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          Reference Drug
          0
          Reference Standard
          0
          Strength
          40MG
          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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      1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on
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        1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
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          Read indication-specific status → · whole_fda_indication_text_present

          Passage 2 · positive indication candidate
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          1 INDICATIONS AND USAGE TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
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              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

              Read indication-specific status → · whole_fda_indication_text_present

              Passage 3 · unclassified context
              application numbers
              1. BLA761208
              brand names
              1. TIVDAK
              classification reasons
              1. no_unambiguous_positive_indication_predicate
              clinical review status
              pending
              content role
              unclassified_context
              context span
              end
              405
              end exclusive
              true
              exact text
              tor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )
              label id
              62959a22-02f7-463c-80bb-3c5e621b1f58
              offset unit
              unicode_code_points
              source array index
              0
              source field
              indications_and_usage_exact
              source text sha256
              5ccd8f1e7f0fefbd7bd40e462069f73aac2082b9988983fa65b1a5d26b2f89f6
              start
              200
              current approval status
              not_reconciled
              duplicate text group
              dup-148e9e56b575dba11e65
              extraction review status
              automated_candidate_pending_source_review
              generic names
              1. TISOTUMAB VEDOTIN
              id
              ind-span-87422b0c06a09c9e1194
              label id
              62959a22-02f7-463c-80bb-3c5e621b1f58
              positive predicate support span
              Source null
              qualifier mentions
                regulatory links
                  schema version
                  0.1.0
                  source batch sha256
                  a4bef6778baed183e5bcf581938b0b23d3576dfd9eb6150f2904934a750c5fef
                  source defined aliases
                    source span
                    end
                    405
                    end exclusive
                    true
                    exact text
                    ( 1 )
                    label id
                    62959a22-02f7-463c-80bb-3c5e621b1f58
                    offset unit
                    unicode_code_points
                    source array index
                    0
                    source field
                    indications_and_usage_exact
                    source text sha256
                    5ccd8f1e7f0fefbd7bd40e462069f73aac2082b9988983fa65b1a5d26b2f89f6
                    start
                    400
                    source url
                    https://api.fda.gov/drug/label.json?search=id%3A%2262959a22-02f7-463c-80bb-3c5e621b1f58%22
                    spl effective date
                    2025-11-20
                    spl set id
                    c9fe3f32-4219-466e-acb9-3f609b4f4df1
                    spl version
                    10
                    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