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:

Mylan Institutional LLC

INN (International Name):

Melphalan Hydrochloride

Composition:

Melphalan 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 in a carton containing 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. NDC 67457-215-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
MYLAN INSTITUTIONAL LLC
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MELPHALAN HYDROCHLORIDE FOR INJECTION
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 Lsarcolysin, 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 Lisomer. 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 the inactive
ingredient povidone 20 mg. 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