MELPHALAN HYDROCHLORIDE kit

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Fosun Pharma USA Inc

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Melphalan Hydrochloride for Injection is supplied as follows: NDC Melphalan Hydrochloride for Injection (Kit) Package Factor 72266-128-01 Single-Dose Vial of Melphalan Hydrochloride for Injection and 10 mL Vial of Sterile Diluent 1 vial per carton 1 vial per carton Each carton contains one single-dose clear glass vial of lyophilized melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
FOSUN PHARMA USA INC
----------
MELPHALAN HYDROCHLORIDE FOR INJECTION
(FOR INTRAVENOUS INFUSION)
RX ONLY
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.
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-structure
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,