Epirubicin Amaxa (epirubicin) solution for injections 2 mg/ml. 10 ml. vial №1


Manufacturer: Germany

Epirubicin is indicated for the treatment of a wide range of neoplasms, including: breast cancer; malignant lymphoma; soft tissue sarcoma cancer of the stomach, liver, pancreas, rectum; cancer of the cervical-facial region; lung cancer; ovarian cancer; leukemia. Intravesical administration of epirubicin is indicated: in the treatment of superficial bladder cancer (transitional cell cancer, carcinoma in situ ) to prevent relapse after transurethral resection.



Epirubicin Amaxa 10 ml. Storage
active substance: epirubicin hydrochloride;

1 ml of solution contains 2 mg of epirubicin hydrochloride;

Epirubicin Amaxa Excipients: sodium chloride, sodium (S) -lactate solution (50%), hydrochloric acid (1 M solution), water for injections.

Epirubicin Amaxa 10 ml. Dosage form
Solution for injection.

Main physical and chemical properties: clear solution of dark red color, free from visible suspicious particles.

Pharmacotherapeutic group
Anthracyclines and related compounds.

ATX code L01D B03.

Pharmacological properties


Epirubicin is a 4′-epimer of the anthracycline antibiotic doxorubicin. Its pharmacological properties correspond to the properties of other anthracyclines. Epirubicin is active in all phases of the cell cycle and demonstrates maximal cytotoxic effects in phase S and G2 of the cell cycle. The exact mechanism of antitumor action is not fully known, but it is likely related to its ability to bind to DNA by intercalation between pairs of DNA bases. This leads to steric inhibition of DNA and RNA synthesis.

Epirubicin intercalation also inhibits DNA topoisomerase of the “rapidly cleavable complex.” Further mechanisms of action are the formation of free radicals, direct effect on the membrane, as well as the formation of chelated compounds with metal ions.

Epirubicin is active in a wide range of experimental tumors, including leukemias L1210 and P388, sarcomas SA180 (solid and ascetic forms), melanoma B16, breast carcinoma, Lewis lung carcinoma, and colon carcinoma 38. Efficacy has also been demonstrated in transplanted “Naked” mice (melanoma, breast cancer, lung cancer, prostate and ovarian cancer).

Epirubicin Amaxa 10 ml. Indication
Intravenous administration:

breast cancer;
progressive ovarian cancer;
progressive gastric cancer;
progressive small cell lung cancer;
progressive soft tissue sarcoma.
In addition, intravesical administration of epirubicin hydrochloride is indicated for:

prevention of recurrence (adjuvant therapy) of superficial bladder carcinoma (Ta, T1) after transurethral resection.

Hypersensitivity to epirubicin hydrochloride, other anthracyclines / anthracenediones or to any of the excipients.
Breastfeeding period (see section “Use during pregnancy or breastfeeding”).
Intravenous administration of epirubicin hydrochloride is contraindicated in:

persistent myelosuppression;
severe liver damage;
severe heart failure, myocardial infarction, recent myocardial infarction;
severe arrhythmias;
previous treatment with maximum cumulative doses of epirubicin and / or other anthracyclines and anthracendiones (see section “Peculiarities”);
acute systemic infections;
unstable angina.
Intravesical administration of epirubicin hydrochloride is contraindicated in:

urinary tract infections;
inflammation of the bladder;
large amounts of residual urine;
wrinkled bladder;
invasive tumors that grow into the bladder wall;
difficulties of catheterization.
Constant monitoring of renal function is required if there is a reverse flow of urine from the bladder to the renal pelvis (vesicoureteral reflux).