MELPHALAN HYDROCHLORIDE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr.Reddy's Laboratories Inc

INN (International Name):

Melphalan Hydrochloride

Composition:

Melphalan 50 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Melphalan hydrochloride for injection is supplied in a carton (NDC 43598-392-48). containing one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan (NDC 43598-391-50) and one 10 mL clear glass vial of sterile diluent (NDC 43598-393-35). Store at  20°-25°C (68°-77°F);  [see USP Controlled Room Temperature] and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
DR.REDDY'S LABORATORIES INC
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MELPHALAN HYDROCHLORIDE FOR INJECTION 50 MG
BOXED 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 monohydrochloride. The molecular formula is C
H C N O . HCl and the molecular
weight is 341.67. The structural formula is:
Melphalan is practically insoluble in water and has a pKa1 of 2.5.
Melphalan salt is practically insoluble
in acetone andchlorinated organic solvents. Slightly soluble in
methanol andethanol. Soluble in water,
0.1 N HCl and 0.1 N NaOH.
Melphalan hydrochloride for injection is supplied as a
sterile,nonpyrogenic, freeze-dried powder. Each
single-dose vialcontains melphalan hydrochloride equivalent to 50
mgmelphalan and 20 mg povidone.
Melphalan hydrochloride forinjection is reconstituted using the
sterile diluent provided. Eachvial of
sterile diluent contains sodium citrate 0.2 g, propyleneglycol 6 mL,
ethanol (96%) 0.52 mL, and Water
for Injection toa total of 10 mL. Melphalan hydrochloride for
injection isadministered intravenously.
CLINICAL PHARMACOLOGY
Melphalan is