METHOTREXATE sodium injection powder lyophilized for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Fresenius Kabi USA, LLC

INN (nemzetközi neve):

METHOTREXATE SODIUM

Összetétel:

METHOTREXATE 1 g

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHOTREXATE- METHOTREXATE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
----------
METHOTREXATE FOR INJECTION USP
Rx only
BOXED WARNINGS
METHOTREXATE SHOULD BE USED ONLY BY PHYSICIANS WHOSE KNOWLEDGE
AND EXPERIENCE INCLUDE THE USE OF ANTIMETABOLITE THERAPY.
BECAUSE OF THE POSSIBILITY OF SERIOUS TOXIC REACTIONS (WHICH CAN BE
FATAL):
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 FORMULATIONS AND DILUENTS CONTAINING PRESERVATIVES
MUST NOT BE USED FOR INTRATHECAL OR HIGH-DOSE METHOTREXATE
THERAPY.
1. 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).
2. Methotrexate elimination is reduced in patients with impaired renal
function, ascites, or pleural
effusions. Such patients require especially careful monitoring for
toxicity, and require dose
reduction or, in some cases, discontinuation of methotrexate
administration.
3. Unexpectedly severe (sometimes fatal) bone marrow suppression,