METHOTREXATE SODIUM PRESERVATIVE FREE
Details
- Status
- Prescription
- First Approved
- 1959-08-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
METHOTREXATE SODIUM PRESERVATIVE FREE Approval History
What METHOTREXATE SODIUM PRESERVATIVE FREE Treats
6 indicationsMETHOTREXATE SODIUM PRESERVATIVE FREE is approved for 6 conditions since its original approval in 1959. 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
METHOTREXATE SODIUM PRESERVATIVE FREE Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are contraindicated...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are 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 Tablets 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 Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are 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 Tablets are 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 Tablets as appropriate. ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )
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Key Completed Trials
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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.
METHOTREXATE SODIUM PRESERVATIVE FREE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Methotrexate Tablets are a diydrofolate 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 Methotrexate...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.