Doxorubicin is an anthracycline antibiotic with antitumor activity.
Release form and composition
Doxorubicin has two dosage forms, a lyophilisate and a concentrate, intended for preparing a solution for intravesical and intravascular administration.
The active ingredient Doxorubicin is the same substance in the form of hydrochloride. In 1 mg of lyophilisate it contains 1 mg, in 1 ml of concentrate - 2 mg.
Indications for use
As indicated in the instructions for doxorubicin, the drug is used to treat a variety of tumor diseases, including breast, stomach, lung (small cell), esophagus, head and neck cancer, bladder, endometrium, and several other organs; sarcoma of the soft tissues, uterus, Ewing's and Kaposi's sarcoma, osteosarcoma; primary hepatocellular carcinoma, mesothelioma, carcinoid, insulin, malignant thymoma, germ cell tumors of the testicle, rhabdomyosarcoma, neuroblastoma, Wilms tumor, acute myeloblastic and lymphoblastic leukemia, Hodgkin's disease, multiple myeloma, lymphocytosis, lymphoma, lymphoma and lymphocytic leukemia
The absolute contraindications to the use of Doxorubicin are hypersensitivity to the components of the drug, as well as to anthracenedione derivatives or to any of the drugs of the anthracycline group, pregnancy, and breastfeeding.
Intravesical injection of the solution, in addition, is contraindicated in patients who have infectious or inflammatory diseases of the bladder and urinary tract.
Relative contraindications are:
- Functional inferiority of hematopoiesis (including bone marrow infiltration with tumor cells, prior radiotherapy or chemotherapy);
- Active or recently transferred (including contact with a sick person in the recent past) infectious and parasitic diseases of fungal, viral or bacterial origin (for example, strongyloidosis, diseases caused by herpes viruses, amoebiasis, chickenpox, etc.);
- Presence of prerequisites for the development of a serious generalized disease;
- Organic heart disease;
- Gout (in active form or in history);
- Uric nephrolourithiasis (in active form or in history);
- Liver failure.
Dosing and Administration
Methods for the administration of doxorubicin:
- Intravenously (the solution is injected into the vein in a streamed manner for 3-5 minutes, optimally - through the tube of the system during the drip injection of 0.9% sodium chloride solution or 5% dextrose solution);
- In the bladder.
Adult patients in / in the introduction shown once every 3-4 weeks at a dose of 60-75 mg / m². Doxirubicin may also be administered:
- 25-30 mg / m² per day for 2 or 3 days in a row every 3-4 weeks;
- At 20 mg / m² once a week for 3-4 weeks.
The cycle dose can be divided into several injections (for example, to administer the drug on days 1 and 8 of the cycle or for the first 3 consecutive days).
To reduce the toxic effect of the agent (especially cardiotoxicity), you can enter 10-20 mg / m² of doxyrubicin weekly.
If the drug is used in combination with other anticancer agents, the patient is administered 40-60 mg / m² every 3-4 weeks.
According to the Doxorubicin instructions, the total dose of the administered drug should not exceed 550 mg / m².
For children, the solution is injected into a vein at a dose of 30 mg / m² / day for 3 consecutive days every 4 weeks.
In the bladder doxirubicin should be administered in a dose of 30-50 mg. Between installations withstand intervals ranging from 7 days to 1 month. The total cumulative dose should not exceed 500-550 mg / m².
A solution of sodium chloride or water for injection is used to dilute the lyophilisate / concentrate. The optimal concentration of doxorubicin is 1 mg / ml. To ensure a uniform effect of the drug on the mucous membrane of the bladder after the completion of the injection every 15 minutes, the patient should roll over from one side to the other.
The solution should remain in the cavity of the bladder for 1-2 hours, after this time the patient must empty it.
To prevent excessive dilution of Doxorubicin with urine, the patient should refrain from drinking liquid for 12 hours before the procedure.
Systemic absorption of the substance when injected into the bladder is estimated to be very low.
Doxorubicin can cause thrombocytopenia, leukopenia, stomatitis, nausea, vomiting, reversible alopecia (partial or complete baldness), allergic reactions, inflammation of the veins, and necrosis of subcutaneous fatty tissue (in cases where the solution falls under the skin).
A characteristic toxicological feature of the product is its cardiotoxicity. In the course of treatment with Doxorubicin, cardiomyopathy, cardiac arrhythmias, decrease in blood pressure, pain in the region of the heart, and heart failure are possible. In case of pronounced disorders of the pumping function of the heart and its rhythm, treatment is immediately stopped.
In the first two days after drug administration, urine may stain red.
Treatment with doxorubicin should be carried out under the supervision of medical personnel who have experience in administering anticancer drugs. Therapy should be carried out under strict control of the cellular composition of the blood.
If the installation of Doxorubicin in the bladder is accompanied by local toxic effects (nocturia, dysuria, polyuria, hematuria, and other manifestations of chemical cystitis), the dose to be administered is further diluted with a solution of sodium chloride (50-100 ml).
Doxorubicin-Ebeve, Rastocin, Adriblastin instant, Kelix, Doksolek.
Terms and conditions of storage
Doxorubicin is sold by prescription. It is necessary to store the drug in a dark place at temperatures up to 5 ºС. Shelf life - 2 years.