Rx Item-Alkeran 50mg Vial 1 By Apopharma USA

Clinical Information
Gen. Code and Des.
19196 melphalan HCl INTRAVEN VIAL 50 MG
GCN and Des.
38232 melphalan HCl INTRAVEN VIAL 50 MG
Strength
50MG
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
10000000 ANTINEOPLASTIC AGENTS
Active Ingredients
4144 melphalan HCl 3223072





ALKERAN- melphalan hydrochloride
Apo-Pharma USA, Inc

WARNING
Melphalan should be administered under the supervision of 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 phenylalanine derivative of nitrogen mustard. Melphalan is 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 C13 H18 Cl2 N2 O2 and the molecular weight is 305.20.
CLINICAL PHARMACOLOGY
Melphalan is an alkylating agent of the bischloroethylamine type. As result, its cytotoxicity appears to be related to the extent of its interstrand cross-linking with DNA, probably by binding at the N7 position of guanine. Like other bifunctional alkylating agents, it is active against both resting and rapidly dividing tumor cells.
INDICATIONS AND USAGE
ALKERAN for Injection is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.
CONTRAINDICATIONS
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
Pregnancy Category D.
DOSAGE AND ADMINISTRATION
The usual IV dose is 16 mg/m2. Dosage reduction of up to 50% should be considered in patients with renal insufficiency (BUN ?30 mg/dL) (see PRECAUTIONS: General). The drug is administered as single infusion over 15 to 20 minutes. Melphalan is administered at 2-week intervals for doses, then, after adequate recovery from toxicity, at 4-week intervals. Available evidence suggests about one third to one half of the patients with multiple myeloma show favorable response to the drug. Experience with oral melphalan suggests that repeated courses should be given since improvement may continue slowly over many months, and the maximum benefit may be missed if treatment is abandoned prematurely. Dose adjustment on the basis of blood cell counts at the nadir and day of treatment should be considered.

Rx Item-Alkeran 50mg Vial 1 By Apopharma
NDC No.52609-3001-00 UPC/GTIN No.3-52609-30010-5 MPN No. 300100 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA

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Apopharma USA Inc

MELPHALAN HCL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Drug info from Dailymed
Drug info from Dailymed