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:

GeneraMedix Inc.

INN (International Name):

MELPHALAN HYDROCHLORIDE

Composition:

MELPHALAN HYDROCHLORIDE 50 mg in 10 mL

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 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.

Product summary:

Melphalan Hydrochloride for Injection is supplied as a single use kit (NDC 10139-321-01) containing one single-use clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan (NDC 10139-319-10) and one 10 mL clear glass vial of sterile diluent (NDC 10139-320-01). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured for: GeneraMedix Inc. 150 Allen Road Liberty Corner, NJ 07938 Manufactured by: Coldstream Laboratories, Inc 1775 McGrathiana Parkway Lexington, KY 40511 August 2008 PI32101.01

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MELPHALAN HYDROCHLORIDE - MELPHALAN HYDROCHLORIDE
GENERAMEDIX INC.
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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 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 diluent provided.
Each vial of sterile diluent contains sodium citrate 0.2 g, propylene
glycol 6.0 mL, ethanol (96%) 0.52
mL, and Water for Injection to a total of 10 mL. Melphalan
Hydrochlorid