Mitoxantrone Baxter Dosage/Direction for Use

Mitoxantrone should be administered only by physicians experienced with this drug.
Dosage must be individualized.
Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient's general state of health, organ function, and the results of laboratory monitoring.
Unless otherwise prescribed the following dosages are recommended: Intravenous application: Mammary carcinoma, non-Hodgkin's lymphoma, primary liver cell carcinoma, carcinoma of the ovaries: During monotherapy, a dose of 14 mg Mitoxantrone/m² body surface area is recommended as the initial dose for the first cycle. This dose can be repeated after 21 days.
In patients with diminished bone marrow reserves as a result of previous radiation and/or chemotherapy or those in a general poor state of health, the initial dose should be reduced to 12 mg/m² or corresponding to the haematological parameters.
For each repeated application of Mitoxantrone Baxter, the dose has always to be adjusted in accordance with individual patient progress, the extent and duration of myelosuppression.
The following general recommendations can be given: see Table.

Click on icon to see table/diagram/image

On combination of Mitoxantrone Baxter with other myelotoxic acting cytostatic agents, it is advisable to reduce the initial dose recommended in case of monotherapy by 2 to 4 mg Mitoxantrone/m² body surface area. In further treatment cycles, the Mitoxantrone dose should be likewise tailored to individual progress or to the duration and degree of myelosuppression.
Acute leukaemias: For the induction treatment of acute leukaemia in adults, it is recommended that a daily dose of 10 to 12 mg Mitoxantrone/m² body surface area is applied for five consecutive days (total dose 50 to 60 mg Mitoxantrone/m²). Higher remission rates can be achieved after daily dose of 12 mg/m² for five days. The higher dosage, however, should only be administered when the condition of the patient permits.
By combined use of Mitoxantrone Baxter with other cytostatic agents, dose modifications may be required depending on the condition of the patient. This must be taken into consideration either in the first induction course and/or in subsequent treatment courses.
If severe or life-threatening non-haematological side effects occur even during the first induction course, a second course of treatment should only be begun after these side effects have subsided.
Intrapleural instillation (eg to pleural metastases in cases of breast cancer and non-Hodgkin's lymphoma): A single dose of 20 to 30 mg Mitoxantrone is recommended for intrapleural instillation. Any pleural exudate should be drained off as far as possible before therapy. The retention time of this first Mitoxantrone dose in the pleural cavity is 48 hours.
The patients should be kept in a non-resting state during this period in order to achieve a good intrapleural distribution of the cytostatic agent.
After these 48 hours, further drainage of any exudate is carried out. The first treatment cycle is terminated if the volume of the drained exudate is less than 200 ml. if the volume is greater than 200 ml, a further instillation of 30 mg Mitoxantrone is given. Before this second application, the haematological parameters must be checked. The second intrapleural Mitoxantrone dose can be left in place. The maximum dose for one treatment cycle is 60 mg Mitoxantrone.
If the blood leucocyte and platelet counts show normal values after 4 weeks, the intrapleural instillation can be repeated.
Systemic therapy with cytostatic agents should be avoided for 4 weeks before and after intrapleural Mitoxantrone application.
Administration and duration of treatment: The application of Mitoxantrone Baxter should only be carried out by a physician specialising in oncology.
Intravenous application: Mitoxantrone Baxter should be administered slowly as an intravenous infusion over a period of 15-30 minutes (not less than 5 minutes).
Mitoxantrone Baxter is ideally injected slowly into a well-running intravenous infusion system. Isotonic saline or a 5% glucose solution are suitable carrier solutions.
The calculated dose should be diluted with 50 to 100 ml of one of the previously mentioned infusion solutions.
If a paravenous administration occurs, the infusion should be immediately stopped and restarted using a different venous access. Isolated cases of severe local reactions (necroses) have been reported due to inadvertent paravenous injection.
Intrapleural instillation: For intrapleural instillation, Mitoxantrone Baxter is diluted with isotonic sodium chloride solution. The Mitoxantrone containing solution must be warmed to body temperature and instilled very slowly (from 5 to 10 min), avoiding any noticeable injection pressure.
Duration of treatment: When a cumulative total dose of 200 mg Mitoxantrone/m² body surface area has been given, the administration of Mitoxantrone Baxter is to be stopped for all indications.