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LABELS · b96b0022-c4f5-458e-aa7e-21c62ac5cd8c

RYTELO

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
2026-04-22
Captured
2026-09-09T23:37:58.719708+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). ( 1 )
Full extracted label fields
application numbers
  1. NDA217779
boxed warning exact
    brand names
    1. RYTELO
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b0fab7ca-e578-43c5-9df6-bdaff4182257
    generic names
    1. IMETELSTAT SODIUM
    id
    b96b0022-c4f5-458e-aa7e-21c62ac5cd8c
    indications and usage exact
    1. 1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). ( 1 )
    indications and usage tables exact
      is original packager
      1. true
      manufacturer names
      1. Geron Corporation
      matched search terms
      1. myelodysplastic
      package ndcs
      1. 82959-112-01
      2. 82959-111-01
      product ndcs
      1. 82959-111
      2. 82959-112
      product types
      1. HUMAN PRESCRIPTION DRUG
      recent major changes exact
        record type
        complete_spl_indications_section_candidate
        routes
        1. INTRAVENOUS
        rxcuis
        1. 2685241
        2. 2685246
        3. 2685248
        4. 2685250
        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
        results
        limit
        100
        skip
        600
        total
        830
        sha256
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        url
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        source url
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        spl effective date
        2026-04-22
        spl effective time
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        spl set id
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        spl version
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        substance names
        1. IMETELSTAT SODIUM
        uniis
        1. 2AW48LAZ4I
        verification flags
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        2. spl_text_not_verified_identical_to_latest_approved_label
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        Drugs@FDA application source records
        1. application number
          NDA217779
          payload
          all indexed label documents
          1. Appl No
            217779
            Application Docs Date
            2024-06-07 00:00:00
            Application Docs ID
            78741
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
            ORIG
          all submission records
          1. Appl No
            217779
            Review Priority
            STANDARD
            Submission Class Code ID
            7
            Submission No
            1
            Submission Status
            AP
            Submission Status Date
            2024-06-06 00:00:00
            Submission Type
            ORIG
            Submissions Public Notes
          2. Appl No
            217779
            Review Priority
            STANDARD
            Submission Class Code ID
            3
            Submission No
            6
            Submission Status
            AP
            Submission Status Date
            2026-04-14 00:00:00
            Submission Type
            SUPPL
            Submissions Public Notes
          application number
          NDA217779
          approval interpretation
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          current indication status
          not_reconciled
          has approved submission record
          true
          latest approved submission date
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          latest posted label documents
          1. Appl No
            217779
            Application Docs Date
            2024-06-07 00:00:00
            Application Docs ID
            78741
            Application Docs Title
            0
            Application Docs Type ID
            2
            Submission No
            1
            Submission Type
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          official application record
          Appl No
          217779
          Appl Public Notes
          Appl Type
          NDA
          Sponsor Name
          GERON
          openfda application present
          true
          products
          1. Active Ingredient
            IMETELSTAT SODIUM
            Appl No
            217779
            Drug Name
            RYTELO
            Form
            POWDER;INTRAVENOUS
            Product No
            001
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 47MG BASE/VIAL
            marketing status
            1. Prescription
          2. Active Ingredient
            IMETELSTAT SODIUM
            Appl No
            217779
            Drug Name
            RYTELO
            Form
            POWDER;INTRAVENOUS
            Product No
            002
            Reference Drug
            1
            Reference Standard
            1
            Strength
            EQ 188MG BASE/VIAL
            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 · unclassified context
        application numbers
        1. NDA217779
        brand names
        1. RYTELO
        classification reasons
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        clinical review status
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        202
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        true
        exact text
        1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more re
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              biomarker and test
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              limitations
              Source null
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              prior therapy
              Source null
              regimen
              Source null
              tumor histology
              Source null
              use intent
              unclear
              Passage 2 · positive indication candidate
              application numbers
              1. NDA217779
              brand names
              1. RYTELO
              classification reasons
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              clinical review status
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              547
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              exact text
              1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requ
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              is indicated
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              qualifier mentions
              1. context exact
                ICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes
                kind
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                  INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
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                  biomarker and test
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                  limitations
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                  line
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                  prior therapy
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                  regimen
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                  tumor histology
                  Source null
                  use intent
                  supportive_care_candidate
                  Passage 3 · positive indication candidate
                  application numbers
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                  brand names
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                  clinical review status
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                  716
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                  true
                  exact text
                  th transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). ( 1 )
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                  is an oligonucleotide telomerase inhibitor indicated
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                      RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
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                      th transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). ( 1 )
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                            Preserved source evidence · Not medical advice