MELPHALAN HYDROCHLORIDE- melphalan hydrochloride injection, powder, lyophilized, for solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

MELPHALAN (UNII: Q41OR9510P) (MELPHALAN - UNII:Q41OR9510P)

Disponível em:

Par Pharmaceutical, Inc.

DCI (Denominação Comum Internacional):

MELPHALAN

Composição:

MELPHALAN 50 mg in 10 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Melphalan hydrochloride for injection is supplied in a carton containing one single-use clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10-mL clear glass vial of sterile diluent (NDC 42023-149-01). Store between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature). Protect from light. Retain in carton.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
PAR PHARMACEUTICAL, INC.
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MELPHALAN HYDROCHLORIDE FOR INJECTION
PRESCRIBING INFORMATION
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 hydrochloride for injection
is leukemogenic in
humans. Melphalan hydrochloride for injection 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 C 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.
Melphalan hydrochloride for injection is supplied as a sterile,
nonpyrogenic, freeze-dried powder.
Each single-use vial contains melphalan hydrochloride equivalent to 50
mg melphalan and 20 mg
povidone. Melphalan hydrochloride for injection is reconstituted using
the sterile