MITOMYCIN injection, powder, lyophilized, for solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

MITOMYCIN (UNII: 50SG953SK6) (MITOMYCIN - UNII:50SG953SK6)

Beszerezhető a:

Archis Pharma LLC

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy. Mitomycin is contraindicated in patients who have demonstrated a hypersensitive or idiosyncratic reaction to it in the past. Mitomycin is contraindicated in patients with thrombocytopenia, coagulation disorder, or an increase in bleeding tendency due to other causes.

Termék összefoglaló:

Mitomycin for injection, USP NDC 72819-152-05             5 mg; individually-boxed amber vial NDC 72819-153-02           20 mg; individually-boxed amber vial NDC 72819-154-04           40 mg; individually-boxed amber vial

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

MITOMYCIN- MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ARCHIS PHARMA LLC
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MITOMYCIN FOR INJECTION, USP
RX ONLY
WARNING
Mitomycin should be administered under the supervision of a qualified
physician
experienced in the use of cancer chemotherapeutic agents. Appropriate
management of therapy and complications is possible only when adequate
diagnostic and treatment facilities are readily available.
Bone marrow suppression, notably thrombocytopenia and leukopenia,
which may
contribute to overwhelming infections in an already compromised
patient, is the
most common and severe of the toxic effects of mitomycin. (see
WARNINGS and
ADVERSE REACTIONS sections).
Hemolytic Uremic Syndrome (HUS) a serious complication of
chemotherapy,
consisting primarily of microangiopathic hemolytic anemia,
thrombocytopenia, and
irreversible renal failure, has been reported in patients receiving
systemic
mitomycin. The syndrome may occur at any time during systemic therapy
with
mitomycin as a single agent or in combination with other cytotoxic
drugs, however,
most cases occur at doses ≥ 60 mg of mitomycin. Blood product
transfusion may
exacerbate the symptoms associated with this syndrome.
The incidence of the syndrome has not been defined.
DESCRIPTION
Mitomycin, USP (also known as mitomycin and/or mitomycin-C) is an
antibiotic isolated
from the broth of _Streptomyces caespitosus _which has been shown to
have antitumor
activity. The compound is heat stable, has a high melting point, and
is freely soluble in
organic solvents.
Mitomycin for Injection, USP is a sterile dry mixture of mitomycin,
USP and mannitol,
which when reconstituted with Sterile Water for Injection provides a
solution for
intravenous administration. Each vial contains either mitomycin, USP 5
mg and mannitol
10 mg, or mitomycin, USP 20 mg and mannitol 40 mg or mitomycin, USP 40
mg and
mannitol 80 mg. Each mL of reconstituted solution will contain 0.5 mg
mitomycin, USP
and have a pH between 6.0 and 8.0.
Mitomycin, USP is a blue-violet crystalline powde