Index of drugs

Breast cancer, advanced stages of ovarian cancer, stomach cancer, small cell lung cancer. Bladder: papillary papillary tumor of transitional epithelium, cancerin situ bladder, prophylaxis of recurrences after transurethral resection of bladder cancer.

1 ml solution for injection contains 2 mg epirubicin hydrochloride.

A drug with anticancer activity. The mechanism of action of epirubicin is the binding of DNA, thus inhibiting replication and transcription. After intravenous administration, epirubicin undergoes three-phase elimination from plasma, a very rapid initial phase followed by a slow terminal phase. T_0,5 is on average 40 hours. Epirubicin is extensively distributed to tissues. It is metabolized to glucuronides and epirubicinol, mainly excreted in the bile.

Hypersensitivity to the drug or other ingredients of the preparation. Hypersensitivity to other anthracyclines or anthracenediones. Increased bone marrow suppression caused by previous anticancer treatment or radiotherapy. Prior treatment with maximum cumulative doses of epirubicin and / or other anthracyclines (e.g., doxorubicin or daunorubicin) and anthracenediones. Past or active myocardial dysfunction, acute myocardial infarction and previous myocardial infarction resulting in NYHA class III or IV heart failure, acute cardiac inflammatory disease, cardiac arrhythmias with severe haemodynamic consequences. Unstable angina. Cardiomyopathy. Acute generalized infection. Severe liver dysfunction. Breastfeeding period. In intravesical use, contraindications are urinary tract infections, hematuria, invasive tumors that penetrate the bladder wall, problems with catheterization, inflammation of the urinary bladder.

Exceeding the total dose of epirubicin (900 mg / m² pc.) significantly increases the risk of congestive heart failure. ECG changes such as flattening or inversion of the T wave, ST segment depression or arrhythmia are not indications for discontinuation of therapy; persistent reduction of QRS amplitude, prolongation of the systolic period and reduction of the ejection fraction are considered to be strongly indicative of cardiotoxic effects. The risk of cardiotoxicity is greater in patients who have undergone mediastinal irradiation, received other cardiotoxic drugs, in patients with a history of cardiac disease. Caution should be exercised in patients with impaired hepatic function. The red urine may appear 1-2 days after the medicine. If extravasation occurs, the injection should be stopped immediately. There are no data on the use of the preparation in children.

If epirubicin is used during pregnancy or if the patient continues to take while taking the medicine, the patient should be informed about the potential risk to the fetus and the possibility of genetic consultation should be considered. Do not use during pregnancy and in women of childbearing potential, unless the potential benefit to the mother outweighs the potential risk to the fetus. Men and women should use effective contraception during and for at least 6 months after stopping treatment with the product. Breast-feeding should be discontinued prior to initiation of treatment with the preparation.

Very common: myelosuppression (leucopenia, granulocytopenia and neutropenia, anemia and febrile neutropenia), alopecia (usually reversible) occurring in 60-90% of patients, inhibition of beard growth in men; red urine color 1-2 days after drug administration. Common: infection, allergic reactions during intravesical administration; anorexia, hot flushes; nausea, vomiting, diarrhea which can lead to dehydration; loss of appetite, abdominal pain; mucositis (may occur 5-10 days after the start of treatment and usually includes inflammation of the mouth with areas of painful erosion, ulceration and bleeding, mainly on the sides of the tongue and sublingual mucosa), stomatitis, inflammation of the esophagus, discoloration of the oral mucosa ; redness along the vein to which the medicine is administered; local phlebitis, induration of veins; local pain and tissue necrosis (after accidental administration of the drug outside the vein); chemical cystitis, in some cases hemorrhagic, occurring after administration to the bladder.Uncommon: thrombocytopenia; Headache; phlebitis, thrombophlebitis; discoloration of the skin and nails, redness of the skin, hypersensitivity to light, hypersensitivity of the skin in the case of radiotherapy. Rare: secondary myeloblastic leukemia with or without a leukaemic phase when co-administered with DNA-damaging cytostatics; anaphylaxis (anaphylactic or anaphylactoid reactions with or without shock, including skin rash, pruritus, fever and chills); hyperuricemia (as a result of the rapid breakdown of tumor cells), dizziness; cardiotoxicity (ECG changes, tachycardia, arrhythmia, cardiomyopathy, congestive heart failure (dyspnoea, edema, enlargement of the liver, ascites, pulmonary edema, pleural effusion, gallium rhythm), ventricular tachycardia, bradycardia, atrioventricular block, bundle branch block urticaria, lack of menstruation, lack of sperm in sperm, fever, chills, dizziness, high fever, malaise, weakness, increase in transaminases. result of myelosuppression) conjunctivitis, keratitis, thromboembolic events, including pulmonary embolism (also with fatal outcome), pain and / or burning in the mouth, local toxicity, rash, skin changes, severe tissue inflammation total, asymptomatic reduction of ejection fraction left k omory.

The drug can be administered intravenously as an infusion in physiological saline and intravesically. Adults in monotherapy: intravenously 60-90 mg / m² pc. within 3-5 min every 3 weeks; in lung cancer: 120 mg / m² on the 1st day, every 3 weeks in an intravenous bolus for 3-5 min. or in 30 min. infusion. In complementary chemotherapy for breast cancer with nodal metastases, a dose of 100-120 mg / m² pc. on days 1 and 8 in 2 divided doses every 3 to 4 weeks. In patients with bone marrow dysfunction (elderly, after previous treatment or as a result of neoplastic infiltration) a smaller dose - 60-75 mg / m² pc. in standard therapy and 105-120 mg / m² pc. in the treatment of high doses. This dose can be given once or divided into single lower doses given for 2-3 days. Advanced ovarian cancer in monotherapy: 60-90 mg / m² pc., in combination treatment: 50-100 mg / m² pc .; gastric cancer in monotherapy: 60-90 mg / m² pc., in combination treatment: 50 mg / m² pc. In the liver impairment at SGOT 2-5xGGN half dose is administered, while at SGOT> 5xGGN 25% of the dose is given. Intravesical administration: bladder cell carcinoma - intravesical infusion 50 mg after dissolving in 50 ml of 0.9% NaCl solution or sterile water once a week for 8 weeks (the dose should be reduced to 30 mg / 50 ml for local side effects);carcinoma in situ - 80 mg / 50 ml infusion; prophylaxis of recurrent bladder cancer after transurethral resection - 50 mg / 50 ml once a week for 4 weeks and then once a month for 11 months. The patient should maintain urine in the bladder for 1-2 h.