XATMEP
Details
- Status
- Prescription
- First Approved
- 2017-04-25
- Routes
- ORAL
- Dosage Forms
- SOLUTION
XATMEP Approval History
What XATMEP Treats
2 indicationsXATMEP is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Polyarticular Juvenile Idiopathic Arthritis
XATMEP Boxed Warning
SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see Warnings and Precautions ( 5.2 )] Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] Hepatic tox...
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see Warnings and Precautions ( 5.2 )] Renal toxicity and increased toxicity with renal impairment [see Warnings and Precautions ( 5.3 )] Gastrointestinal toxicity [see Warnings and Precautions ( 5.4 )] Hepatic toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary toxicity [see Warnings and Precautions ( 5.6 )] 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 )]. WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY 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 ).
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XATMEP FDA Label Details
ProIndications & Usage
FDA Label (PDF)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 . Management of pediatric patients with active polyarticular juvenile idiopathic arthritis (pJIA) who are intolerant of or had an inadequate response to first-line therapy . 1.1 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 J...
WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY Methotrexate can cause the following severe or fatal adverse reactions. Monitor closely and modify dose or discontinue methotrexate as appropriate. Bone marrow suppression [see Warnings and Precautions ( 5.1 )] Serious infections [see ...
XATMEP Patents & Exclusivity
Patents (9 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.