Small cell lung carcinoma. Diseminada carcinoma of the testis. Acute myelomonocytic and myelocytic leukemia (aML, M4 or M5 subtypes according to the FAB classification), as part of combination therapy when induction therapy is ineffective. Palliative therapy for non-small cell lung cancer, induction therapy for Hodgkin’s disease, induction therapy for non-Hodgkin’s lymphoma and acute myelocytic leukemia, as well as induction and reinduction therapy with choriocarcin.
active substance: 1 ml of concentrate contains etoposide in terms of 100% substance – 20 mg
excipients: citric acid alcohol benzyl polysorbate 80 polyethylene glycol (macrogol) 300 ethanol.
Etopozid-TEVA Dosage form
Concentrate for preparation of solution for infusion.
Basic physical and chemical properties:
transparent, from almost colorless to light yellow solution without visible mechanical particles.
Etopozid-TEVA Pharmacological group
ATX code L01C B01.
Pharmacodynamics. Etoposide is a semi-synthetic derivative of podophilotoxin. The drug disrupts DNA synthesis, suppresses mitosis, blocks cells mainly in the G2 phase and late S-phase of the cell cycle. The cytotoxic effect on healthy cells is observed only with the use of high doses of the drug.
Pharmacokinetics. After administration, the pharmacokinetics of the drug is biphasic with a half-life in the first phase of about 1.5 hours, in the second – 4-11 hours. The total clearance varies between 33-48 ml / min. Etoposide in a small amount penetrates into the pleural fluid, is determined in saliva, liver, spleen, kidneys, myometrium, in brain tissues. The minimum amount of the drug enters the bile. Etoposide poorly penetrates the blood-brain barrier (the concentration of etoposide in the cerebrospinal fluid usually ranges from an undetectable amount to less than 5% of the plasma concentration within the first 24 hours after administration). Etoposide to a large extent (98%) binds to blood plasma proteins.
The drug is metabolized in the liver with the formation of an inactive hydroxy acid, as well as glucuronides and sulfates (5-22%), which have minimal cytotoxic activity. It is excreted mainly in the urine, in a smaller amount (about 6%) in the bile. The average renal clearance of etoposide is 7-10 ml / min, or approximately 35% of the total clearance when the drug is prescribed at a dose of 80-600 mg / m 2.
Small cell lung carcinoma. Nonseminoma testicular carcinoma. Acute myelomonocytic and myelocytic leukemia (AML, subtypes M4 or M5 according to the FAB classification), as part of combination therapy with ineffective induction therapy. Palliative therapy for non-small cell lung cancer, re-induction therapy for Hodgkin’s disease, induction therapy for non-Hodgkin’s lymphoma and acute myelocytic leukemia, and induction and re-induction therapy for choriocarcinoma.
Hypersensitivity to etoposide or other components of the drug.
Etoposide should not be administered into or intracavitary (into the pleural, abdominal or other cavities).
Special security measures
When working with the drug, it is necessary to follow the general safety rules when handling cytotoxic substances.
Solutions for infusion should be prepared in an insulated box or fume hood for working with cytotoxic drugs. It is necessary to use protective clothing (disposable gloves, masks, goggles, gowns and hats or overalls). Measures must be taken to prevent contact of etoposide solutions on the skin and mucous membranes. If the drug nevertheless gets on the skin or mucous membranes, the affected area should be immediately washed with plenty of water or isotonic solution.