TREXALL
Details
- Status
- Prescription
- First Approved
- 2001-03-21
- Routes
- ORAL
- Dosage Forms
- TABLET
TREXALL Approval History
What TREXALL Treats
6 indicationsTREXALL is approved for 6 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acute Lymphoblastic Leukemia
- Mycosis Fungoides
- Non-Hodgkin Lymphoma
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriasis
TREXALL Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific P...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . Methotrexate 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 adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate as appropriate [Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )] . 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, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception ( 4 , 5.1 , 8.1 , 8.3 ). Methotrexate 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 adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue methotrexate as appropriate ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ).
Drugs Similar to TREXALL
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
TREXALL FDA Label Details
ProIndications & Usage
TREXALL is a dihydrofolate reductase inhibitor 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 Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen Treatment of adults with rheumatoid arthritis Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) Treatment of adults with severe psoriasis 1.1 Neoplastic Diseases TREXALL is indicated for the: treatme...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, and SEVERE ADVERSE REACTIONS WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, methotrexate is contraind...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.