METHOTREXATE SODIUM PRESERVATIVE FREE (methotrexate sodium) · Hikma
Methotrexate is a folate antimetabolite indicated for the treatment of specific neoplastic and inflammatory conditions. In oncology, it is used for acute lymphoblastic leukemia (adult and pediatric), as well as mycosis fungoides and relapsed or refractory non-Hodgkin lymphoma in adults. Additionally, it is indicated for the management of severe psoriasis and rheumatoid arthritis in adults, and polyarticular juvenile idiopathic arthritis in pediatric patients.
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.
METHOTREXATE SODIUM PRESERVATIVE FREE Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. Methotrexate Injection can cau...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )]. Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )]. Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.2 )]. Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low-birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.3 )]. Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low-birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing for
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
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 Injection is a folate analog metabolic inhibitor indicated for The following neoplastic diseases for the: Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia Treatment of adult and pediatric patients with non-Hodgkin lymphoma Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen Treatment of adults with breast cancer as part of a combination chemotherapy regimen Treatment of adult...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.