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LABELS · 4e3b0925-2cdc-4743-91cf-860d98dd4661

Xatmep

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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
2026-05-28
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY, AND RISK OF MEDICATION ERRORS Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. o Bone marrow suppression [see Warnings and Precautions ( 5.1 )] o Serious infections [see Warnings and Precautions ( 5.2 )] o Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] o Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] o Hepatic toxicity [see Warnings and Precautions ( 5.5 )] o Pulmonary toxicity [see Warnings and Precautions ( 5.6 )] o Hypersensitivity and dermatologic reactions [see Warnings and Precautions ( 5.7 )] Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications ( 4 ), Warnings and Precautions (5.9), Use in Specific Populations ( 8.1 , 8.3 )]. Oral methotrexate when inadvertently administered once daily has resulted in death [see Warnings and Precautions ( 5.15 )]. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY, AND RISK OF MEDICATION ERRORS See full prescribing information for complete boxed warning. Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression ( 5.1 ), infection ( 5.2 ), renal ( 5.3 ), gastrointestinal ( 5.4 ), hepatic ( 5.5 ), pulmonary ( 5.6 ), hypersensitivity and dermatologic ( 5.7 ). Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy ( 4 ). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP ( 5.9 , 8.1 , 8.3 ). Oral methotrexate when inadvertently administered once daily has resulted in death [see Warnings and Precautions ( 5.15 )] .

Indications and usage: exact source text

  1. 1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
Full extracted label fields
application numbers
  1. NDA208400
boxed warning exact
  1. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY, AND RISK OF MEDICATION ERRORS Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. o Bone marrow suppression [see Warnings and Precautions ( 5.1 )] o Serious infections [see Warnings and Precautions ( 5.2 )] o Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] o Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] o Hepatic toxicity [see Warnings and Precautions ( 5.5 )] o Pulmonary toxicity [see Warnings and Precautions ( 5.6 )] o Hypersensitivity and dermatologic reactions [see Warnings and Precautions ( 5.7 )] Methotrexate can cause embryo-fetal toxicity, including fetal death. Use in pJIA is contraindicated in pregnancy. Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise females and males of reproductive potential to use effective contraception during and after treatment with XATMEP [see Contraindications ( 4 ), Warnings and Precautions (5.9), Use in Specific Populations ( 8.1 , 8.3 )]. Oral methotrexate when inadvertently administered once daily has resulted in death [see Warnings and Precautions ( 5.15 )]. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY, AND RISK OF MEDICATION ERRORS See full prescribing information for complete boxed warning. Methotrexate can cause severe or fatal toxicities. Monitor closely and modify dose or discontinue for the following toxicities: bone marrow suppression ( 5.1 ), infection ( 5.2 ), renal ( 5.3 ), gastrointestinal ( 5.4 ), hepatic ( 5.5 ), pulmonary ( 5.6 ), hypersensitivity and dermatologic ( 5.7 ). Methotrexate can cause embryo-fetal toxicity and fetal death. Use in polyarticular juvenile idiopathic arthritis is contraindicated in pregnancy ( 4 ). Consider the benefits and risks of XATMEP and risks to the fetus when prescribing XATMEP to a pregnant patient with a neoplastic disease. Advise patients to use effective contraception during and after treatment with XATMEP ( 5.9 , 8.1 , 8.3 ). Oral methotrexate when inadvertently administered once daily has resulted in death [see Warnings and Precautions ( 5.15 )] .
brand names
  1. Xatmep
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aec9984e-34c5-481b-b6bf-9bb5caf1daf8
generic names
  1. METHOTREXATE
id
4e3b0925-2cdc-4743-91cf-860d98dd4661
indications and usage exact
  1. 1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
indications and usage tables exact
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    manufacturer names
    1. Azurity Pharmaceuticals, Inc.
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    1. leukemia
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    1. 52652-2001-1
    2. 52652-2001-6
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    1. HUMAN PRESCRIPTION DRUG
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    1. Boxed Warning 05/2026 Warnings and Precautions ( 5.15 ) 05/2026
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        Submission No
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        Application Docs ID
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      Appl No
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      products
      1. Active Ingredient
        METHOTREXATE SODIUM
        Appl No
        208400
        Drug Name
        XATMEP
        Form
        SOLUTION;ORAL
        Product No
        001
        Reference Drug
        1
        Reference Standard
        1
        Strength
        EQ 2.5MG BASE/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
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    1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblas
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        1 INDICATIONS AND USAGE XATMEP is a folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ).
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        folate analog metabolic inhibitor indicated for the: Treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as a component of a combination chemotherapy maintenance regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance reg
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            nce regimen ( 1.1 ). Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy ( 1.2 ). 1.1 Acute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient
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                cute Lymphoblastic Leukemia XATMEP is indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) as part of a multi-phase, combination chemotherapy maintenance regimen. 1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
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                    1.2 Polyarticular Juvenile Idiopathic Arthritis XATMEP is indicated in the management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).
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                    Preserved source evidence · Not medical advice