MELPHALAN HYDROCHLORIDE kit

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

melphalan hydrochloride (UNII: 1VXP4V453T) (melphalan - UNII:Q41OR9510P)

Dostupné s:

Athenex Pharmaceutical Division, LLC.

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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.

Přehled produktů:

Melphalan Hydrochloride for Injection is supplied as follows: Each carton contains one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
ATHENEX PHARMACEUTICAL DIVISION, LLC.
----------
MELPHALAN HYDROCHLORIDE FOR INJECTION
(FOR INTRAVENOUS INFUSION)
ATHENEX
RX ONLY
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 viv_o 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
C1 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-dose 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 gl