Mitoxantron concentrate for infusions 2 mg/ml. 10 ml. vial №1

Description

Mitoxantron composition
Main active ingredient: mitoxantrone.
Excipients: sodium chloride, sodium acetate trihydrate, glacial acetic acid, sodium sulfate anhydrous, diluted hydrochloric acid, water for injection.
1 milliliter of the drug contains 2 mg of mitoxantrone.

Release form
It is produced in the form of a concentrate for the preparation of infusions, in dosages of 5 ml in an ampoule.

Pharmacological properties
Mitoxantron belongs to the group of antineoplastic agents, anthracyclines and related compounds.
The main active ingredient of the drug is mitoxantrone, which is used in the form of mitoxantrone hydrochloride. It is an anthracenedion derivative. Possesses the property of binding to nuclear DNA.
As for the mechanism of action of mitoxantrone, it is still insufficiently understood.
At the same time, it is known that this substance exerts its effect regardless of the phases of the cell cycle, and is capable of producing a cytotoxic effect on non-proliferating, as well as on proliferating cells of the human body.
Due to its structural features, mitoxantrone can be used simultaneously with other antineoplastic drugs, as well as with glucocorticosteroids.
The changes in the mucous membrane and bone marrow that occur during this process are reversible. The strength of the side effects can be varied by the correct selection of the dosage used.

Indications
Mitoxantron is used to treat:

• metastatic breast cancer;
• non-Hodgkin’s lymphoma;
• acute non-lymphoblastic leukemia (as monotherapy or in combination with other antineoplastic agents);
• advanced hormone-refractory prostate cancer with pain syndrome, in case of insufficient effectiveness or inability to use analgesics (in combination with low doses of corticosteroids).

Contraindications
You should not use the specified drug if the patient has had a previous hypersensitivity (allergy) with respect to one of the components that are part of the drug – both main and auxiliary.
It is also contraindicated in severe bone marrow suppression.
Intrathecal or intra-arterial administration of mitoxantrone is not allowed.

Children
Treatment of children with mitoxantrone is not recommended. Safety and efficacy have not been established.

Application during pregnancy and lactation
Treatment of pregnant women with this drug is contraindicated due to the high toxicity of the drug.
During treatment with this drug, breastfeeding should be suspended.

Method of administration and dosage
Mitoxantron is administered exclusively intravenously. The solvent is 50 ml of 0.9% sodium chloride solution or 5% glucose solution.
After preparation of the resulting solution, it is administered as an infusion for at least 3 minutes through the side port of the infusion system, adding it to a stream of 0.9% sodium chloride solution or 5% glucose solution.
Mitoxantron is not intended for mixing in 1 bottle with other preparations!
The calculation of the dosage and the introduction of the drug is carried out in stationary conditions by experienced medical personnel. The introduction is made once a day, in courses for 5-7 days in a row. The courses of treatment can be repeated at intervals set by the doctor.
The dosage is calculated at the rate of 10 to 14 mg per 1 square meter of the patient’s skin surface area, with monotherapy. With combination therapy, the dose is reduced by 2-4 mg per square meter.
Correction of doses of mitoxantrone is carried out taking into account the severity of toxic effects, response to therapy, and individual characteristics of patients.
When treating patients with kidney and / or liver disease, the dosage may be reduced.

Overdose
An overdose of this drug can cause serious intoxication, and give complications in the form of damage to the hematopoietic system in the form of agranulocytosis, severe thrombocytopenia, gastrointestinal tract, liver and kidneys.
Dialysis and hemodialysis are ineffective.
Treatment is symptomatic. It is possible to prescribe antibiotics to avoid the development of infection.

Side effects
Side effects can occur in the form:

• inhibition of bone marrow function (myelosuppression);
• stomatitis, inflammation of the mucous membrane;
• leukopenia, neutropenia, anemia;
• drowsiness, neuritis, confusion, convulsions, anxiety, paresthesia, headache, dizziness, weakness;
• conjunctivitis, blue sclera staining;
• cardiomyopathy, bradycardia.
• rhinitis, shortness of breath, respiratory tract infections, pneumonia;
• diarrhea, nausea, pancreatitis;
• hyperuricemia, hyperkalemia, hyperphosphatemia and hypocalcemia.

Storage conditions and periods
Mitoxantron is able to maintain its medicinal properties for 3 years from the date of manufacture.
Does not require special storage conditions.