Active Ingredient: Melphalan
High-dose of melphalan used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of mammary adenocarcinoma.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A
Oral, 0.15 milligrams melphalan per kilogram of body weight, once daily, over the duration of 5 days.
Regimen B
Oral, 6 milligrams melphalan per square meter of body surface, once daily, over the duration of 5 days.
Melphalan has been given orally at a dose of 0.15 mg/kg bodyweight or 6 mg/m² body surface area/day for 5 days and repeated every 6 weeks. The dose was decreased if bone marrow toxicity was observed.
For:
Intravenous, between 100 milligrams melphalan per square meter of body surface and 200 milligrams melphalan per square meter of body surface, one dose.
The dose regimen is as follows: one dose between 100 and 200 mg/m² body surface area (approximatively 2.5 to 5.0 mg/kg body weight). The dose can be divided equally over 2 or 3 consecutive days. Autologous hematopoietic stem cell transplantation is required following doses above 140 mg/m² body surface area.
It is recommended to ensure patients' adequate hydration and forced diuresis and the prophylactic administration of anti-infective agents (bacterial fungal, viral).
Cyclophosphamide pre-treatment appears to reduce the severity of gastrointestinal damage induced by high-dose.
Adoption of prohylactic measures such as the administration of anti-infective agents can be useful.
The occurrence of GvHD can be prevented by using immunosuppressive therapy after haematopoietic stem cell transplantation as prophylaxis.
Melphalan is for intravenous use only.
Risk of extravasation could be observed when melphalan is administered via peripheral intravenous route.
In case of extravasation, the administration should be interrupted immediately and a central venous line route should be used.
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