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LABELS · 53bd9776-70ec-46f9-e063-6294a90a7011

JYLAMVO

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
2026-06-08
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS and SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with Jylamvo [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3) ] . Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [ Contraindications (4), Warnings and Precautions (5.2) ] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate [ Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7, 5.8 , 5.9, 5.11) ] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS See full prescribing information for complete boxed warning. Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during and after treatment with Jylamvo ( 4, 5.1, 8.1, 8.3 ). Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis ( 4, 5.2 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate ( 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9 , 5.11 ).

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE JYLAMVO is a folate analog metabolic inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis (1.4 ) 1.1 Neoplastic Disease JYLAMVO is indicated for the: treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen. 1.2 Rheumatoid Arthritis JYLAMVO is indicated for the treatment of adults with rheumatoid arthritis. 1.3 Polyarticular Juvenile Idiopathic Arthritis JYLAMVO is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.4 Psoriasis JYLAMVO is indicated for the treatment of adults with severe psoriasis.
Full extracted label fields
application numbers
  1. NDA212479
boxed warning exact
  1. WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS and SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception during and after treatment with Jylamvo [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3) ] . Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [ Contraindications (4), Warnings and Precautions (5.2) ] . Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate [ Warnings and Precautions (5.3, 5.4, 5.5, 5.6, 5.7, 5.8 , 5.9, 5.11) ] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS See full prescribing information for complete boxed warning. Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Jylamvo is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during and after treatment with Jylamvo ( 4, 5.1, 8.1, 8.3 ). Jylamvo is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis ( 4, 5.2 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for infections and adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Jylamvo as appropriate ( 5.3, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9 , 5.11 ).
brand names
  1. JYLAMVO
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=96e931f5-51ae-4bdf-a441-bb0dd26d4c0e
generic names
  1. METHOTREXATE
id
53bd9776-70ec-46f9-e063-6294a90a7011
indications and usage exact
  1. 1 INDICATIONS AND USAGE JYLAMVO is a folate analog metabolic inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis (1.4 ) 1.1 Neoplastic Disease JYLAMVO is indicated for the: treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen. 1.2 Rheumatoid Arthritis JYLAMVO is indicated for the treatment of adults with rheumatoid arthritis. 1.3 Polyarticular Juvenile Idiopathic Arthritis JYLAMVO is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.4 Psoriasis JYLAMVO is indicated for the treatment of adults with severe psoriasis.
indications and usage tables exact
    is original packager
    1. true
    manufacturer names
    1. SHORLA ONCOLOGY INC.
    matched search terms
    1. lymphoma
    2. lymphomas
    3. leukemia
    package ndcs
    1. 81927-204-01
    product ndcs
    1. 81927-204
    product types
    1. HUMAN PRESCRIPTION DRUG
    recent major changes exact
    1. Boxed Warning 04/2026 Warnings and Precautions ( 5.9 ) 04/2026
    record type
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    routes
    1. ORAL
    rxcuis
    1. 2671456
    2. 2671462
    source batch
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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
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    spl effective time
    20260608
    spl set id
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    spl version
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    substance names
    1. METHOTREXATE
    uniis
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    verification flags
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    Drugs@FDA application source records
    1. application number
      NDA212479
      payload
      all indexed label documents
      1. Appl No
        212479
        Application Docs Date
        2022-12-02 00:00:00
        Application Docs ID
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        Application Docs Title
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        Application Docs Type 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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        Application Docs Title
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        Application Docs Type ID
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        Submission No
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        Submission Type
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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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        Application Docs Title
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        Application Docs Type ID
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        Submission No
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      5. Appl No
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        Application Docs Date
        2024-10-25 00:00:00
        Application Docs ID
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      6. Appl No
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        Application Docs Date
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        Application Docs ID
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        0
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        Submission No
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      7. Appl No
        212479
        Application Docs Date
        2026-06-01 00:00:00
        Application Docs ID
        86082
        Application Docs Title
        0
        Application Docs Type ID
        2
        Submission No
        9
        Submission Type
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      all submission records
      1. Appl No
        212479
        Review Priority
        STANDARD
        Submission Class Code ID
        15
        Submission No
        1
        Submission Status
        AP
        Submission Status Date
        2022-11-29 00:00:00
        Submission Type
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        Submissions Public Notes
      2. Appl No
        212479
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2022-11-29 00:00:00
        Submission Type
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        Submissions Public Notes
      3. Appl No
        212479
        Review Priority
        STANDARD
        Submission Class Code ID
        2
        Submission No
        2
        Submission Status
        AP
        Submission Status Date
        2024-10-23 00:00:00
        Submission Type
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        Submissions Public Notes
      4. Appl No
        212479
        Review Priority
        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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        Submission Type
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        Submissions Public Notes
      5. Appl No
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        Review Priority
        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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        Submission Type
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        Submissions Public Notes
      6. Appl No
        212479
        Review Priority
        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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        Submission Type
        ORIG
        Submissions Public Notes
      7. Appl No
        212479
        Review Priority
        STANDARD
        Submission Class Code ID
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        Submission No
        9
        Submission Status
        AP
        Submission Status Date
        2026-05-27 00:00:00
        Submission Type
        SUPPL
        Submissions Public Notes
      application number
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      approval interpretation
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      current indication status
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      has approved submission record
      true
      latest approved submission date
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      latest label selection rule
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      latest posted label documents
      1. Appl No
        212479
        Application Docs Date
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        Application Docs ID
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        Application Docs Title
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        Submission No
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      official application record
      Appl No
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      Appl Public Notes
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      Sponsor Name
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      openfda application present
      true
      products
      1. Active Ingredient
        METHOTREXATE
        Appl No
        212479
        Drug Name
        JYLAMVO
        Form
        SOLUTION;ORAL
        Product No
        001
        Reference Drug
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        Reference Standard
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        Drug Name
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        marketing status
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      3. Active Ingredient
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        Appl No
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        Drug Name
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        Form
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        Product No
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        Reference Drug
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        Reference Standard
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        Strength
        2MG/ML
        marketing status
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      4. Active Ingredient
        METHOTREXATE
        Appl No
        212479
        Drug Name
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        Form
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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
        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
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    brand names
    1. JYLAMVO
    classification reasons
    1. explicit_positive_indication_predicate
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    exact text
    1 INDICATIONS AND USAGE JYLAMVO is a folate analog metabolic inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis (1.4 ) 1.1 Neoplastic Disease JYLAMVO is indicated for the: treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. trea
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      1 INDICATIONS AND USAGE JYLAMVO is a folate analog metabolic inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblas
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                        Preserved source evidence · Not medical advice