Mitoxantron-LENS 2 mg/ml, 10 ml

• Adult acute non-lymphoblastic leukemia
• Multiple breast cancer
• Cancerous lymphomas
• Cancerous lymphoma

Primary hepatic cell cancer

• Hormone-resistant prostate cancer with pain syndrome
• Ovarian cancer

Active ingredient

Interaction

Directions for use

Intravenously slowly over 3-5 minutes or intravenously by IV drip over 15-30 minutes.

Intrathecal administration of the drug is prohibited!

Mitoxantrone is part of many chemotherapeutic treatment regimens; therefore, the data from the specialized literature should be used to guide the choice of regimen and doses in each individual case.

In monotherapy of breast cancer, non-Hodgkin’s lymphoma, and liver cancer, the recommended dose is 14 mg/m2 body surface once every 3 weeks. In patients who have previously received chemotherapy and in combination with other chemotherapeutic agents the dose is reduced to 10-12 mg/m2 .

In repeated courses the dose of mitoxantrone is adjusted taking into account the degree of severity and duration of inhibition of medullary hematopoiesis. If the neutrophil count < 1500/µl and/or platelets < 50000/µl have decreased in previous courses, the dose of mitoxantrone is reduced by 2 mg/m2 , if the neutrophil count < 1000/µl and/or platelets < 25000/µl, the subsequent doses are reduced by 4 mg/m2.

In the treatment of acute non-lymphoblastic leukemia in adults for induction of remission, mitoxantrone is administered at a dose of 10-12 mg/m2 daily for 2-3 days in combination with cytarabine. The detailed description of modes of combined chemotherapy is presented in special literature. It is possible to use high doses of mitoxantrone 14 mg/m2 or more daily for 3 days.

To treat hormone-resistant prostate cancer, mitoxantrone is prescribed at a dose of 12-14 mg/m2 once every 21 days in combination with daily administration of low doses of glucocorticosteroids (prednisolone 10 mg/day or hydrocortisone 40 mg/day).

The maximum total dose of Mitoxantrone-LENS® when administered intravenously is 200 mg/m2.

In metastatic pleural lesions, mitoxantrone may be administered intrapleural, with a recommended dose of 20-30 mg. Pleural exudate should be given before instillation if possible.

The time the drug remains in the pleural cavity is 48 hours, during which time the patient should move as much as possible to ensure optimal intrapleural distribution of the drug. After 48 hours the repeated drainage of the pleural cavity is carried out in order to remove the possible effusion.

If the amount of effusion is less than 200 ml, the first cycle of treatment is stopped. If the amount of effusion exceeds 200 ml, a repeat instillation of 30 mg of Mitoxantrone-LENS® is administered.

Hematologic parameters should be controlled before repeated instillation of the drug. There is no need to remove mitoxantrone from the pleural cavity after repeated instillation. The maximum dose for one cycle of treatment is 60 mg of Mitoxantrone-LENS® . If leukocyte and platelet counts are normal, intrapleural instillation of mitoxantrone (2nd cycle) can be repeated after 4 weeks.

For 4 weeks before and 4 weeks after intrapleural instillation of mitoxantrone-LENS®, systemic therapy with cytostatic agents should be avoided.

Special Instructions

Contraindications

Side effects

Blood system disorders: leukopenia, neutropenia, thrombocytopenia, rarely – anemia.

Digestive system disorders: nausea, vomiting, diarrhea, stomatitis, abdominal pain, constipation, anorexia; in some cases – transient liver failure.

Cardiovascular system: arrhythmia, sternary pain, myocardial ischemia, decreased left ventricular ejection fraction, congestive cardiovascular failure. Toxic myocardial damage, in particular congestive heart failure (CHF), can develop both during mitoxantrone treatment and months or years after therapy ends. The risk of cardiotoxic effects increases when the cumulative dose of 140 mg/m2 is reached.

Respiratory system disorders: cases of interstitial pneumonitis have been described.

Allergic reactions: there have been rare reports of arterial hypotension, urticaria, dyspnea and rash, anaphylactic reactions, including anaphylactic shock.

Local reactions: phlebitis; in extravasation – erythema, edema, pain, burning, necrosis of the surrounding tissues. Cases of intense blue staining of the veins into which the drug was injected and the surrounding tissues have been described.

Others: menstrual irregularities, amenorrhea, transient alopecia, fever, increased fatigue, general weakness, increased body temperature, nonspecific neurological symptoms; in some cases – renal dysfunction.

With mitoxantrone during the first 2 days transient blue-greenish staining of urine, sometimes sclerae, as well as nails and their separation from the nail bed is possible. Due to the immunosuppressive effect of the drug, secondary infections may develop.

Overdose