Expiration date: 01/2026
Composition and form of issue:
Powder lyophilized for the preparation of solution for injection of 1 vial:
doxorubicin hydrochloride 10 mg
excipients: lactose, methyl paraben water for injection
in bottles of 10 mg complete with solvent (water for injection in ampoules of 5 ml) in a pack of cardboard 1 set.
Powder lyophilized for the preparation of solution for injection of 1 vial:
doxorubicin hydrochloride 50 mg
excipients: lactose, methyl paraben water for injection
in bottles of 50 mg in a pack of cardboard 1 bottle.
Description of dosage form:
Loose porous mass (powder) or tablet red.
Pharmacological action:
It interacts with DNA, disrupts the synthesis of nucleic acids, inhibits the mitotic activity of cells, promotes the formation of chromosomal aberrations.
Description of pharmacological action:
Along with antitumor, it has an immunosuppressive effect.
Clinical pharmacology:
In violation of liver function slows the excretion of adriblastine, which leads to its accumulation in the blood plasma and tissues.
Indications:
Breast, thyroid, lung, bladder cancer (including superficial tumors), ovarian cancer, osteosarcoma, soft tissue sarcoma, lymphogranulomatosis, non-Hodgkin's lymphoma, neuroblastoma, Wilms tumor, acute lymphoblastic leukemia, acute myeloblastic leukemia.
Contraindications:
Acute myelosuppression (including as a result of chemotherapy or radiation therapy) prior to treatment cumulative doses farmorubicin, dunabrattin or even adriblastina bladder tumors complicated by narrowing of the urethra, urinary tract infection (intravesical instillation) cardiomyopathy (including history).
Use during pregnancy and breast-feeding:
Contraindicated (there are experimental data on reducing the viability of the fetus).
Side effect:
At/in the introduction, myelosuppression, disruption of the heart, sometimes manifested a few weeks after discontinuation of therapy (heart failure), alopecia (85% of patients), cessation of hair growth (including beard) stomatitis (5-10 days after the first injection) with painful erosions, especially on the lateral surfaces of the tongue, hyoid region, nausea, vomiting, diarrhea and others gastrointestinal disorders severe tissue injury, including necrosis (in contact with the solution in the tissue, especially with repeated use of the same vein), sclerosis of the veins.
When administered into the bladder-burning in the bladder and urethra, urination disorders (pain, difficulty, frequency, etc.), hematuria.
Drug interaction:
It can be used in combination with other chemotherapeutic antitumor agents.
Dosage and administration:
In / in, intravesical, in / a.
Adriblastin can be used as monotherapy, and in combination with other cytostatics in different doses, depending on the therapy regimen.
In/in the introduction.
As monotherapy, the recommended standard dose per cycle is 60-75 mg / m2 of body surface. Typically, the drug is administered once during the cycle but the cyclic dose can be divided into several introductions (eg administered during the first 3 days in a row or in 1 and 8 day cycle). Cycles are repeated every 3-4 weeks. Also, a weekly regimen of 10-20 mg/m2 in combination with other anticancer drugs is used — in a cyclic dose of 30-60 mg/m2 every 3-4 weeks.
Repeated administration of the drug is possible only with the disappearance of all signs of toxicity (especially gastrointestinal and hematological).
In patients with abnormal liver function with elevated levels of bilirubin in the serum of doxorubicin dose reduced depending on the indicators of the level of total bilirubin: when the level of bilirubin in the serum of 1, 2 or 3 mg/DL — 50%, above 3 mg/DL by 75%.
It is recommended to prescribe lower doses or increase the intervals between cycles in patients who previously received massive antitumor therapy, in children, in elderly patients, in obesity (if the body weight is more than 130% ideal, there is a decrease in the systemic clearance of Adriblastin), as well as in patients with tumor infiltration of the bone marrow.
In / in the introduction of Adriblastine should be carried out with caution. To reduce the risk of thrombosis and extravasation, it is recommended to introduce Adriblastin through the tube of the system for I / V administration, during infusion of 0, 9% sodium chloride solution or 5% glucose solution, for 3-5 min.
The total dose of doxorubicin should not exceed 550 mg / m2.
In patients who previously received radiation therapy on the mediastinal region/pericardial region or treated with other cardiotoxic drugs, if necessary, exceeding the total dose of doxorubicin more than 450 mg / m2, the drug should be administered under strict monitoring of heart function.
Introduction to the bladder.
Introduction into the bladder is used in the treatment of superficial tumors of the bladder, as well as as prevention, to reduce the likelihood of recurrence after transurethral resection.
Intravesical-the recommended dose of 30-50 mg for instillation, with intervals between injections from 1 week to 1 month, depending on the purpose of therapy (treatment or prevention).
The recommended solution concentration is 1 mg / ml of water for injection or 0, 9% sodium chloride solution. After instillation to ensure uniform effect of the drug on the mucosa of the bladder patients should roll from side to side every 15 min. As a rule, the drug should be in the bladder for 1-2 h. At the end of the instillation, the patient should empty the bladder.
To prevent excessive dilution of the drug with urine, patients should be warned that they should refrain from taking the liquid for 12 hours before instillation. Systemic absorption of Adriblastin during instillation into the bladder is very low.
While local manifestations of toxic action (chemical cystitis, which can be manifested by dysuria, polyuria, nocturia, painful urination, hematuria, discomfort in the bladder, necrosis of the bladder wall) dose intended for instillation should be diluted in 50-100 ml of saline.
Particular attention should be paid to problems associated with catheterization (for example, obstruction of the urethra due to massive intravesical tumors).
B / a introduction.
Patients with hepatocellular cancer to provide intensive local exposure while reducing the overall toxic effect of Adriblastin can be introduced in/a in the main hepatic artery at a dose of 30-150 mg / m2 with an interval of 3 weeks to 3 months. Higher doses should be used only in cases where the drug is simultaneously carried out extracorporeal excretion.
Since this method is potentially dangerous, and its use can occur common tissue necrosis,/and the introduction can only be carried out by doctors who are fluent in this technique.
Precautionary measures:
During treatment, it is necessary to determine the number of red blood cells, white blood cells and platelets in the blood. Before and during therapy, it is recommended to monitor liver function (using conventional tests), heart (ECG). For patients who have undergone a course of irradiation of the mediastinal zone, the maximum dose is 400 mg / m2. When calculating the maximum permissible cumulative dose should take into account the previous and concomitant treatment of other potentially cardiotoxic drugs (cyclophosphamide, daunorubicin, etc.). Since Adriblastin has a strong irritant effect, after intravesical administration, the periurethral region (skin, mucous) is thoroughly washed. Avoid mixing in one syringe with other anticancer drugs.
Special instruction:
Urine turns red.
