MELPHALAN HYDROCHLORIDE kit

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Melphalan Hydrochloride (UNII: 1VXP4V453T) (melphalan - UNII:Q41OR9510P)

可用日期:

Sagent Pharmaceuticals

INN（国际名称）:

Melphalan Hydrochloride

组成:

melphalan 50 mg in 10 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Melphalan Hydrochloride for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. Melphalan should not be used in patients whose disease has demonstrated prior resistance to this agent. Patients who have demonstrated hypersensitivity to melphalan should not be given the drug.

授权状态:

Abbreviated New Drug Application

产品特点

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
SAGENT PHARMACEUTICALS
----------
MELPHALAN HYDROCHLORIDE FOR INJECTION
(FOR INTRAVENOUS INFUSION)
SAGENT
Rx only
WARNING
Melphalan Hydrochloride for Injection should be administered under the
supervision of a
qualified physician experienced in the use of cancer chemotherapeutic
agents. Severe bone
marrow suppression with resulting infection or bleeding may occur.
Controlled trials comparing
intravenous (IV) to oral melphalan have shown more myelosuppression
with the IV formulation.
Hypersensitivity reactions, including anaphylaxis, have occurred in
approximately 2% of patients
who received the IV formulation. Melphalan is leukemogenic in humans.
Melphalan produces
chromosomal aberrations _in vitro_ and _in vivo_ and, therefore,
should be considered potentially
mutagenic in humans.
DESCRIPTION
Melphalan, also known as L-phenylalanine mustard, phenylalanine
mustard, L-PAM, or L-sarcolysin, is a
phenylalanine derivative of nitrogen mustard. Melphalan is a
bifunctional alkylating agent that is active
against selected human neoplastic diseases. It is known chemically as
4-[bis(2-
chloroethyl)amino]-_L-_phenylalanine. The molecular formula is C
H Cl
N O and the molecular
weight is 305.20. The structural formula is:
Melphalan is the active L-isomer of the compound and was first
synthesized in 1953 by Bergel and
Stock; the D-isomer, known as medphalan, is less active against
certain animal tumors, and the dose
needed to produce effects on chromosomes is larger than that required
with the L-isomer. The racemic
(DL-) form is known as merphalan or sarcolysin.
Melphalan is practically insoluble in water and has a pKa of ~2.5.
CLINICAL PHARMACOLOGY
Melphalan is an alkylating agent of the bischloroethylamine type. As a
result, its cytotoxicity appears to
be related to the extent of its interstrand cross-linking with DNA,
probably by binding at the N position
®
13
18
2
2
2
1
Melphalan Hydrochloride for Injection is supplied as a sterile,
nonpyrogenic, freeze-dried
powder. Each