Mitoxantrone Baxter

Mitoxantrone Baxter Dosage/Direction for Use



Baxter Oncology


Full Prescribing Info
Dosage/Direction for Use
The dose should be adjusted to each patient carefully.
Unless otherwise prescribed, the following dosages are recommended:
IV 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 1st 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, 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 with other myelotoxic-acting cytostatic agents, it is advisable to reduce the initial dose recommended in case of monotherapy by 2-4 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 10-12 mg mitoxantrone/m2 body surface area is applied for 5 consecutive days (total dose 50-60 mg mitoxantrone/m2). Higher remission rates can be achieved after a daily dose of 12 mg/m2 for 5 days. The higher dosage, however, should only be administered when the condition of the patient permits.
By combined use of mitoxantrone 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 1st induction course and/or in subsequent treatment courses.
If severe or life-threatening nonhaematological side effects occur even during the 1st induction course, a 2nd 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 20-30 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 1st mitoxantrone dose in the pleural cavity is 48 hrs.
The patients should be kept in a nonresting state during this period in order to achieve a good intrapleural distribution of the cytostatic agent.
After these 48 hrs, further drainage of any exudate is carried out. The 1st treatment cycle is terminated if the volume of the drained exudate is <200 mL. If the volume is >200 mL, a further instillation of mitoxantrone 30 mg is given. Before this 2nd application, the haematological parameters must be checked. The 2nd intrapleural mitoxantrone dose can be left in place. The maximum dose for 1 treatment cycle is mitoxantrone 60 mg.
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: The application of mitoxantrone should only be carried out by a physician specialising in oncology.
IV Application: Mitoxantrone can be administered as a slow IV injection (not less than 5 min).
Mitoxantrone is ideally injected slowly into a well-running IV infusion system. Isotonic saline or a 5% glucose solution are suitable carrier solutions.
Mitoxantrone can also be infused for short periods (15-30 min). The calculated dose should be diluted with 50-100 mL of one of the previously mentioned infusion solutions.
If a paravenous infiltration occurs, the application should be immediately stopped and restarted using a different point of entry to the vein.
So far, only isolated cases of severe local reactions (necroses) have been described due to inadvertent paravenous injection.
Intrapleural Instillation: For intrapleural instillation, mitoxantrone is diluted with isotonic sodium chloride solution.
The mitoxantrone-containing solution must be warmed to body temperature and instilled very slowly (from 5-10 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 is to be stopped for all indications.
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