Melphalan

Indications
 Oral
Multiple myeloma
Adult: 150 mcg/kg daily in divided doses for 4-7 days or 250 mcg/kg daily for 4 days or 6 mg daily for 2-3 wk. Usually combined with corticosteroids. Follow treatment course by a rest period of up to 6 wk to allow haematologic recovery. Then repeat the course or start maintenance treatment with 1-3 mg or up to 50 mcg/kg daily. For optimal effect, adjust therapy to produce moderate leucopenia (WBC counts of 3,000-3,500 cells/mm3).
Renal impairment: Dose reduction may be required.
Oral
Breast cancer
Adult: 150 mcg/kg daily or 6 mg/m2 daily for 5 days, repeated every 6 wk.
Renal impairment: Dose reduction may be required.
Oral
Ovarian carcinoma
Adult: 200 mcg/kg daily for 5 days every 4-8 wk.
Renal impairment: Dose reduction may be required.
Oral
Polycythemia vera
Adult: 6-10 mg daily for 5-7 days; 2-4 mg daily for remission induction. Maintenance dose: 2-6 mg wkly.
Renal impairment: Dose reduction may be required.
Intravenous
Ovarian adenocarcinoma
Adult: 1 mg/kg as a single dose repeated in 4 wk if platelet and neutrophil counts permit. May be infused in sodium chloride 0.9% or inj into the tubing of a fast-running drip.
Renal impairment: Reduce dose by 50%.
Intravenous
Multiple myeloma
Adult: 400 mcg/kg or 16 mg/m2 infused over 15-20 min. First 4 doses may be given every 2 wk and further doses given every 4 wk depending on toxicity. High-dose regimen: 100-200 mg/m2 followed by autologous stem cell rescue which is essential if doses exceed 140 mg/m2, to be given through a central venous catheter.
Renal impairment: Conventional dose: Reduce dose by 50%. High-dose regimen: Not recommended in moderate to severe impairment.
Intravenous
Neuroblastoma
Adult: High-dose regimen: 100-240 mg/m2 followed by autologous stem cell rescue which is essential if doses are >140 mg/m2. Give through a central venous catheter.
Renal impairment: High-dose regimen: Not recommended in moderate to severe impairment.
Intra-arterial
Melanoma
Adult: Upper extremity perfusions: 0.6-1 mg/kg. Lower extremity perfusions: 0.8-1.5 mg/kg (in melanoma) or 1-1.4 mg/kg (in sarcoma).
Renal impairment: Reduce dose by 50%.
Intra-arterial
Soft tissue sarcoma
Adult: Upper extremity perfusions: 0.6-1 mg/kg. Lower extremity perfusions: 0.8-1.5 mg/kg (in melanoma) or 1-1.4 mg/kg (in sarcoma).
Renal impairment: Reduce dose by 50%.

Special Populations: Reduce to 50% in patients with moderate to severe renal impairment.

Reconstitution: Inj must be prepared fresh. Keep to a minimum (<60 min) the time between reconstitution>Incompatibility: Dextrose 5% in water, Lactated Ringer's; variable stability in normal saline.
Contraindications
 Hypersensitivity. Severe bone marrow suppression. Pregnancy.
Warnings / Precautions
 Renal impairment. Lactation. Prior bone marrow suppression, prior chemotherapy or irradiation. May mask signs of infection e.g. fever and increased WBC. Elderly.
Adverse Reactions
 Diarrhoea, stomatitis, vomiting; haemolytic anaemia, vasculitis, pulmonary fibrosis, hepatic disorders, suppression of ovarian function in premenopausal women, temporary or permanent sterility in male patients. Allergic reactions.
Potentially Fatal: Bone marrow suppression. Secondary malignancy, cardiac arrest. Anaphylaxis.
Overdose Reactions
 Symptoms: Hypocalcaemia, hyponatraemia, pulmonary fibrosis, severe nausea and vomiting, diarrhoea, GI haemorrhage, mucositis, stomatitis, bone marrow suppression. Deaths have been reported (IV). Management: Symptomatic and supportive. Closely monitor haematologic function for 3-6 wk. Growth factor support, transfusions and antibiotics may be considered. Not removed by haemodialysis.
Drug Interactions
 Potentially Fatal: Fatal haemorrhagic enterocolitis with concurrent nalidixic acid in children. Potentiates risk of renal damage with ciclosporin.
See Below for More melphalan Drug Interactions
Lab Interactions
 False-positive Coombs' test.
Food Interactions
 Food significantly reduces oral absorption. Avoid excessive alcohol intake.
Mechanism of Actions
 Melphalan, a mechlorethamine derivative, is an alkylating antineoplastic agent. It forms carbonium ions, resulting in DNA and RNA synthesis inhibition. It cross-links DNA strands and acts on both resting and rapidly dividing tumour cells.
Absorption: Variable absorption from the GI tract; absorption reduced by food (oral).
Distribution: Rapid throughout body water. Protein-binding: 50-60%, mainly to albumin.
Metabolism: Inactivated by hydrolysis.
Excretion: Via urine (10%, as unchanged drug); 30-150 min (terminal half-life).
Administration
 Should be taken on an empty stomach. (Take on an empty stomach 1 hr before or 2 hr after meals.)
Storage Conditions
 Intravenous: Store at room temperature (15-30°C). Protect from light. Oral: Store in a refrigerator at 2-8°C (36-46°F). Protect from light.
ATC Classification
 L01AA03 - melphalan ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.
Storage
 Intravenous: Store at room temperature (15-30°C). Protect from light. Oral: Store in a refrigerator at 2-8°C (36-46°F). Protect from light.
Available As
  • Melphalan 2 mg
  • Melphalan 5 mg
  • Melphalan 50 mg

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