METHOTREXATE SODIUM PRESERVATIVE FREE (methotrexate sodium)
METHOTREXATE SODIUM PRESERVATIVE FREE is indicated for the treatment of Acute Lymphoblastic Leukemia; Mycosis Fungoides; Non-Hodgkin Lymphoma; Rheumatoid Arthritis; Juvenile Idiopathic Arthritis; Psoriasis.
How METHOTREXATE SODIUM PRESERVATIVE FREE Works
Methotrexate inhibits dihydrofolic acid reductase, the enzyme responsible for reducing dihydrofolates to tetrahydrofolates. These tetrahydrofolates are essential cofactors for the synthesis of purine nucleotides and thymidylate. By depleting these building blocks, methotrexate interferes with DNA synthesis, repair, and cellular replication, especially in rapidly proliferating malignant cells. While its cytotoxic effects are well-characterized, the exact mechanism by which it exerts its therapeutic effects in rheumatoid arthritis and psoriasis is unknown.
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 )
METHOTREXATE SODIUM PRESERVATIVE FREE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in METHOTREXATE SODIUM PRESERVATIVE FREE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications METHOTREXATE SODIUM PRESERVATIVE FREE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to METHOTREXATE SODIUM PRESERVATIVE FREE
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02143414 results posted | NCI-2014-01047 NCI-2014-01047, SWOG-S1318 | Ph 2 | active not recruiting | Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia |
| NCT06354439 EcZOL | 77015224.6.1001.5327 | Ph 4 | recruiting | Use of Letrozole for Ectopic Pregnancy |
| NCT05575297 | MRFI | Ph 1 | completed | A Drug-drug Interaction Study to Evaluate the Effect of Rifampicin and Febuxostat on the Pharmacokinetics of Methotrexate in Healthy Subjects |
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.
METHOTREXATE SODIUM PRESERVATIVE FREE FDA Label Details
Indications & Usage
FDA Label (PDF)METHOTREXATE SODIUM PRESERVATIVE FREE is indicated for the treatment of Acute Lymphoblastic Leukemia; Mycosis Fungoides; Non-Hodgkin Lymphoma; Rheumatoid Arthritis; Juvenile Idiopathic Arthritis; Psoriasis.
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.