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:

Hospira, Inc.

INN (International Name):

METHOTREXATE SODIUM

Composition:

METHOTREXATE 25 mg in 1 mL

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas. Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection

Product summary:

Parenteral: Methotrexate Injection, USP, Isotonic Liquid, Preservative Free, for Single Use Only . Each 25 mg/mL, 40 mL vial contains methotrexate sodium equivalent to 1 g methotrexate.       1 g, 40 mL Vial               NDC 61703-408-41 Store at controlled room temperature, 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]; excursions permitted to 15° to 30°C (59° to 86°F). PROTECT FROM LIGHT. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                    Clinical Situation Laboratory Findings Leucovorin Dosage and Duration Normal Methotrexate Elimination Serum methotrexate level approximately 10 micromolar at 24 hours after administration, 1 micromolar at 48 hours, and less than 0.2 micromolar at 72 hours. 15 mg PO, IM, or IV q 6 hours for 60 hours (10 doses starting at 24 hours after start of methotrexate infusion). Delayed Late Methotrexate Elimination Serum methotrexate level remaining above 0.2 micromolar at 72 hours, and more than 0.05 micromolar at 96 hours after administration. Continue 15 mg PO, IM, or IV q six hours, until methotrexate level is less than 0.05 micromolar. Delayed Early Methotrexate Elimination and/or Evidence of Acute Renal Injury Serum methotrexate level of 50 micromolar or more at 24 hours, or 5 micromolar or more at 48 hours after administration, OR; a 100% or greater increase in serum creatinine level at 24 hours after methotrexate administration, (e.g., an increase from 0.5 mg/dL to a level of 1 mg/dL or more). 150 mg IV q three hours, until methotrexate level is less than 1 micromolar; then 15 mg IV q three hours until methotrexate level is less than 0.05 micromolar.

Authorization status:

New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE INJECTION, SOLUTION
HOSPIRA, INC.
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METHOTREXATE INJECTION, USP
Rx only
WARNINGS
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FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-
FREE FORMULATION OF METHOTREXATE. DO NOT USE THE PRESERVED
FORMULATION FOR INTRATHECAL OR HIGH-DOSE THERAPY BECAUSE IT
CONTAINS BENZYL ALCOHOL.
METHOTREXATE SHOULD BE USED ONLY IN LIFE THREATENING
NEOPLASTIC DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID
ARTHRITIS WITH SEVERE, RECALCITRANT, DISABLING DISEASE WHICH IS
NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY.
DEATHS HAVE BEEN REPORTED WITH THE USE OF METHOTREXATE IN THE
TREATMENT OF MALIGNANCY, PSORIASIS, AND RHEUMATOID ARTHRITIS.
PATIENTS SHOULD BE CLOSELY MONITORED FOR BONE MARROW, LIVER,
LUNG AND KIDNEY TOXICITIES. (See PRECAUTIONS).
PATIENTS SHOULD BE INFORMED BY THEIR PHYSICIAN OF THE RISKS
INVOLVED AND BE UNDER A PHYSICIAN'S CARE THROUGHOUT THERAPY.
THE USE OF METHOTREXATE HIGH-DOSE REGIMENS RECOMMENDED FOR
OSTEOSARCOMA REQUIRES METICULOUS CARE. (See DOSAGE AND
ADMINISTRATION.) HIGH-DOSE REGIMENS FOR OTHER NEOPLASTIC
DISEASES ARE INVESTIGATIONAL AND A THERAPEUTIC ADVANTAGE HAS
NOT BEEN ESTABLISHED.
Methotrexate has been reported to cause fetal death and/or congenital
anomalies. Therefore,
it is not recommended for women of childbearing potential unless there
is clear medical
evidence that the benefits can be expected to outweigh the considered
risks. Pregnant
women with psoriasis or rheumatoid arthritis should not receive
methotrexate. (See
CONTRAINDICATIONS).
Methotrexate elimination is reduced in patients with impaired renal
functions, ascites, or
pleural effusions. Such patients require especially careful monitoring
for toxicity, and
require dose reduction or, in some cases, discontinuation of
methotrexate administration.
Unexpectedly severe (sometimes fatal) bone marrow suppression,
aplastic anemia, and
gastrointestinal toxicity have been reported with concomitant
administration of methotrexate
(usually in high