METHOTREXATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Parenteral Medicines, Inc.

INN (International Name):

METHOTREXATE SODIUM

Composition:

METHOTREXATE 25 mg in 1 mL

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent. Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for

Product summary:

How Supplied Parenteral: Methotrexate Injection, USP, Isotonic Liquid, Preservative Free, Single Dose Vials. Each 25 mg/mL, 2 mL, 10 mL, and 40 mL vials contain methotrexate sodium equivalent to 50 mg, 250 mg, and 1 g methotrexate, USP respectively. Contents NDC Package 50 mg, 2 mL Vial 0703-3671 -01 Individually packaged 250 mg, 10 mL Vial 0703-3675 -01 Individually packaged 1 g, 40 mL Vial 0703-3678 -01 Individually packaged Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Methotrexate Injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHOTREXATE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METHOTREXATE
INJECTION.
METHOTREXATE INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS,
OR INTRATHECAL USE
INITIAL U.S. APPROVAL: 1953
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL
ALCOHOL TOXICITY, AND OTHER SERIOUS ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
METHOTREXATE INJECTION CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING
FETAL DEATH. USE IN
NON-NEOPLASTIC DISEASES IS CONTRAINDICATED DURING PREGNANCY. ADVISE
FEMALES AND
MALES OF REPRODUCTIVE POTENTIAL TO USE EFFECTIVE CONTRACEPTION DURING
AND AFTER
TREATMENT WITH METHOTREXATE INJECTION. (4, 5.1, 8.1, 8.3)
METHOTREXATE INJECTION IS CONTRAINDICATED IN PATIENTS WITH A HISTORY
OF SEVERE
HYPERSENSITIVITY REACTIONS TO METHOTREXATE, INCLUDING ANAPHYLAXIS. (4,
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.
(2.1, 5.3)
OTHER SERIOUS ADVERSE REACTIONS, INCLUDING DEATH, HAVE BEEN REPORTED
WITH
METHOTREXATE. CLOSELY MONITOR FOR INFECTIONS AND ADVERSE REACTIONS OF
THE BONE
MARROW, KIDNEYS, LIVER, NERVOUS SYSTEM, GASTROINTESTINAL TRACT, LUNGS,
AND SKIN.
WITHHOLD OR DISCONTINUE METHOTREXATE INJECTION AS APPROPRIATE. (5.4,
5.5, 5.6, 5.7,
5.8, 5.9, 5.10, 5.11)
RECENT MAJOR CHANGES
Boxed Warning 3/2021
Indications and Usage (1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.10)
3/2021
Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7,
2.8, 2.9, 2.10, 2.11, 2.12) 3/2021
Warnings and Precautions