TREXALL- methotrexate tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Commercializzato da:

Teva Women's Health, Inc.

INN (Nome Internazionale):

METHOTREXATE SODIUM

Composizione:

METHOTREXATE 5 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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. TREXALL is indicated for the treatment of adults with rheumatoid arthritis. TREXALL is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). TREXALL is indicated for the treatment of adults with severe psoriasis. 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 P

Dettagli prodotto:

TREXALL® (methotrexate tablets, USP) are supplied as follows: 5 mg:  Green, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 927/5 on the other side. They are available in bottles of 30 tablets (NDC 51285-366-01). 7.5 mg:  Blue, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 928/7½ on the other side. They are available in bottles of 30 tablets (NDC 51285-367-01). 10 mg:  Pink, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 929/10 on the other side. They are available in bottles of 30 tablets (NDC 51285-368-01). 15 mg:  Purple, oval-shaped, film-coated, scored, biconvex tablet. Debossed with stylized b on one side and 945/15 on the other side. They are available in bottles of 30 tablets (NDC 51285-369-01). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Methotrexate is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TREXALL- METHOTREXATE TABLET, FILM COATED
TEVA WOMEN'S HEALTH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TREXALL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TREXALL.
TREXALL (METHOTREXATE TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
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).
RECENT MAJOR CHANGES
Boxed Warning
5/2020
Indications and Usage (1)
5/2020
Dosage and Administration (2)
5/2020
Contraindications (4)
5/2020
Warnings and Precautions (5)
5/2020
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)
DOSAGE AND ADMINISTRATION
Instruct patients and caregivers to