MELPHALAN HYDROCHLORIDE kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

MELPHALAN HYDROCHLORIDE (UNII: 1VXP4V453T) (MELPHALAN - UNII:Q41OR9510P)

Dostępny od:

Gland Pharma Limited

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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 68083-259-01). Store at 200 to 250 C (680 to 770 F) [see USP Controlled Room Temperature] and protect from light.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
GLAND PHARMA LIMITED
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MELPHALAN HYDROCHLORIDE FOR INJECTION
BOXED WARNING
Melphalan 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 melphalan 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, white to off white
lyophilized cake or 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
diluent provided. Each vial of sterile diluent contains sodium citrate
0.2 g, propylene glycol 6 mL,
ethanol (96%) 0.52 mL,