Active Ingredient: Carmustine
Carmustine is effective in brain tumours (glioblastoma, Brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery).
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
150 - 200 mg per m² of body surface area (BSA)
From 150 To 200 mg per m² of body surface area (BSA) once every 42 day(s)
The recommended dose of carmustine as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks. This may be given as a single dose or divided into daily infusions such as 75 to 100 mg/m2 on two successive days.
When carmustine is used in combination with other myelosuppressive medicinal products or in patients in whom bone marrow reserve is depleted, the doses should be adjusted according to the haematologic profile of the patient as shown below.
A repeat course of carmustine should not be given until circulating blood elements have returned to acceptable levels (platelets above 100,000/mm3, leukocytes above 4,000/mm3), and this is usually in six weeks. Blood counts should be monitored frequently and repeat courses should not be given before six weeks because of delayed haematologic toxicity.
Doses subsequent to the initial dose should be adjusted according to the haematologic response of the patient to the preceding dose, in both monotherapy as well as in combination therapy with other myelosuppressive medicinal products. The following schedule is suggested as a guide to dosage adjustment:
Table 1:
| Nadir after prior dose | Percentage of prior dose to be given | |
|---|---|---|
| Leucocytes/mm3 | Platelets/mm3 | |
| >4,000 | >100,000 | 100% |
| 3,000-3,999 | 75,000-99,999 | 100% |
| 2,000-2,999 | 25,000-74,999 | 70% |
| <2,000 | <25,000 | 50% |
In cases where the nadir after initial dose does not fall in the same row for leucocytes and platelets (e.g. leucocytes >4,000 and platelets <25,000) the value given the lowest percentage of prior dose should be used (e.g. platelets <25,000 then a maximum of 50% of prior dose should be given).
There are no limits for the period of application of carmustine therapy. In case the tumor remains incurable or some serious or intolerable adverse reactions appear, the carmustine therapy must be terminated.
It should then be administered immediately by intravenous drip over a one- to two-hour period protected from light.
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