Trexall 5 mg/1
Methotrexate · TABLET, FILM COATED · Teva Women's Health, Inc.
Trexall (methotrexate) is an oral tablet used to treat certain cancers, autoimmune diseases like rheumatoid arthritis, and other conditions where the body's cell growth or immune system needs to be controlled. Your doctor will determine the right dose and schedule for your specific condition.
Key Facts
- Brand Name
- Trexall
- Generic Name
- Methotrexate
- NDC Code (Product)
51285-366- Manufacturer
- Teva Women's Health, Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040385
- Marketing Start
- 05/03/2001
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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 ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases TREXALL is 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 (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen. 1.2 Rheumatoid Arthritis TREXALL is indicated for the treatment of adults with rheumatoid arthritis. 1.3 Polyarticular Juvenile …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths. ( 2.1 , 5.9 ) Verify pregnancy status in females of reproductive potential before starting TREXALL ( 4 , 5.1 ). ALL : The recommended dosage is 20 mg/m 2 orally once weekly as a part of a combination chemotherapy maintenance regimen. ( 2.2 ) Mycosis fungoides : The recommended dosage is 25 mg to 75 mg orally once weekly as monotherapy; 10 mg/m 2 orally twice weekly as part of combination chemotherapy. ( 2.2 ) Relapsed or refractory non-Hodgkin lymphoma : The recommended dosage is 2.5 mg orally two to four times per week as part of metronomic combination chemotherapy. ( 2.2 ) Rheumatoid Arthritis : The recommended starting dosage is 7.5 mg orally once weekly; adjust dose to achieve an optimal response ( 2.3 ) pJIA : The recommended starting dosage is 10 mg/m 2 orally once weekly; adjust dose to achieve an optimal response ( 2.4 ) Psoriasis : The recommended dosage is 10 to 25 mg orally once weekly until adequate response is achieved. ( 2.5 ) 2.1 Important Dosage and Safety Information Verify pregnancy status in females of reproductive…
Contraindications
4 CONTRAINDICATIONS TREXALL is contraindicated in: Pregnant women receiving TREXALL for treatment of non-neoplastic diseases [see Warnings and Precautions ( 5.1 ), and Use in Specific Populations ( 8.1 , 8.3 )] . Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to TREXALL [see Warnings and Precautions ( 5.2 )]. In pregnancy for non-neoplastic diseases ( 4 ) History of severe hypersensitivity to TREXALL ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Refer to the full prescribing information for drug interactions with methotrexate. ( 7 ) 7.1 Effects of Other Drugs on Methotrexate Drugs that Increase Methotrexate Exposure Coadministration of methotrexate with the following products may increase methotrexate plasma concentrations, which may increase the risk of methotrexate severe adverse reactions. In some cases, the coadministration of methotrexate with these products may also subsequently reduce active metabolite formation, which may decrease the clinical effectiveness of methotrexate. Increased organ specific adverse reactions may also occur when methotrexate is coadministered with hepatotoxic or nephrotoxic products. If coadministration cannot be avoided, monitor closely for methotrexate adverse reactions when coadministered with: Oral antibiotics (including neomycin) Oral or intravenous penicillin or sulfonamide antibiotics Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, and tetracyclines) Probenecid Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Aspirin and other nonsteroidal anti-inflammatory drugs Hepatotoxic pro…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Myelosuppression [see Warnings and Precautions ( 5.3 )] Gastrointestinal Toxicity [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.6 )] Dermatologic Reactions [see Warnings and Precautions ( 5.7 )] Renal Toxicity [see Warnings and Precautions ( 5.8 )] Serious Infections [see Warnings and Precautions ( 5.11 )] Neurotoxicity [see Warnings and Precautions ( 5.12 )] Secondary Malignancies [see Warnings and Precautions ( 5.13 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.14 )] Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions ( 5.17 )] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials and other studies are …
Frequently Asked Questions
What is Trexall used for?
Trexall (methotrexate) is an oral tablet used to treat certain cancers, autoimmune diseases like rheumatoid arthritis, and other conditions where the body's cell growth or immune system needs to be controlled. Your doctor will determine the right dose and schedule for your specific condition.
Is Trexall a controlled substance?
Trexall is not classified as a controlled substance by the DEA.
What is the generic name for Trexall?
The generic name for Trexall is Methotrexate. There are 11 other brand versions of Methotrexate.
What is the NDC code for Trexall 5 mg/1?
The NDC (National Drug Code) for Trexall 5 mg/1 is 51285-366, listed by Teva Women's Health, Inc..