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:

Actavis Pharma, Inc.

INN (International Name):

MELPHALAN HYDROCHLORIDE

Composition:

MELPHALAN 50 mg in 10 mL

Administration route:

INTRAVENOUS

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 Hydrochloride for Injection 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 45963-686-02). Store at controlled room temperature 15° to 30°C (59° to 86°F) and protect from light. Retain in carton. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MELPHALAN HYDROCHLORIDE- MELPHALAN HYDROCHLORIDE
ACTAVIS PHARMA, INC.
----------
MELPHALAN HYDROCHLORIDE FOR INJECTION
RX ONLY
WARNING
MELPHALAN HYDROCHLORIDE FOR INJECTION 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 TO ORAL MELPHALAN HAVE SHOWN MORE MYELOSUPPRESSION WITH
THE INTRAVENOUS FORMULATION. HYPERSENSITIVITY REACTIONS, INCLUDING
ANAPHYLAXIS, HAVE OCCURRED IN APPROXIMATELY 2% OF PATIENTS WHO
RECEIVED THE INTRAVENOUS 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-dose vial contains melphalan hydrochloride
equivalent to 50 mg
melphalan and 20 mg povidone K12. Melphalan Hydrochloride for
Injection is
reconstituted using the sterile diluent provided. Each vial of sterile
diluent contains
13
18
2
2
2
1
sodium citrate 0.2 g, propylene