Medicinal Products


Generic drug of Farmorubicin
Therapeutic class: Oncology and hematology
active ingredients: [Epirubicin hydrochloride, ]
laboratory: Mylan

Injection solution for IV infusion
Box of 1 bottle (glass) of 100 ml
All forms


Therapeutic indications are limited to:
- breast carcinomas,
- ovarian cancers,
- non-Hodgkin's malignant lymphoma, Hodgkin's disease,
- microcellular cancers of the lung,
- soft tissue sarcomas,
- cancers of the esophagus, stomach, pancreas, hepatocellular cancers,
- squamous cell carcinoma of the otorhinolaryngological sphere.

Dosage EPIRUBICINE MYLAN 2 mg / mL Solution for IV infusion Pack of 1 vial (glass) 100 ml

- Average dosage of 40 to 100 mg / m² per cycle, each cycle being separated from the previous one by a period of 3 to 4 weeks, the cycles being repeatable up to a maximum cumulative dose of 900 mg / m².
- The cycles of treatment can be spaced in case of toxic manifestations and in particular of hematological toxicity.
- In case of liver injury (bilirubinemia> 35 micromol / L), the dose administered will be reduced according to the following scheme:
Bilirubin: Dose to be administered (as a percentage of the theoretical dose).
. > 50 micromoles / L: Do not administer.
. 35-50 micromol / L: 50%.
. <35 micromol / L: 100%.
- In case of renal insufficiency, the dose administered will be reduced, taking into account the possibility of accumulation.
- Breast carcinomas: dosages up to 120 mg / m² per cycle in combination every 3 to 4 weeks have been evaluated especially in the 1st line treatment of metastatic breast carcinoma and suggest a favorable benefit / risk ratio.
Administration mode :
- Intravenous strict route.
- Slow injection into the tubing of an intravenous infusion of isotonic glucose solution.
- Attention:
It is extremely important to make sure the administration is intravenous. Extravasation may produce necrosis of surrounding tissue. In case of extravasation, the administration will be interrupted immediately .
How to handle:
- The preparation of injectable cytotoxic solutions must be carried out by specialized and trained personnel with knowledge of the drugs used, under conditions ensuring the protection of the environment and especially the protection of the personnel handling. It requires a preparation room reserved for this purpose. It is forbidden to smoke, eat, drink in this room. Manipulators must have a set of materials suitable for handling, including long-sleeved gowns, face masks, hood, goggles, sterile disposable gloves, worktop protection fields, containers and collection bags. garbage. Excreta and vomit must be handled with care. Pregnant women should be warned and avoid manipulation of cytotoxics. Any broken container must be treated with the same precautions and considered as contaminated waste. Disposal of contaminated waste is by incineration in rigid containers labeled for this purpose .
- These provisions can be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of March 24, 1998) in collaboration with any suitable and fulfilling the required conditions.

Against indications

This medicine is contraindicated in the following cases:
- pregnancy - breastfeeding (see section on pregnancy and lactation),
- its prescription should be avoided in subjects with cardiac disease with myocardial insufficiency,
- major cardiac toxicity induced by anthracyclines,
- in combination with the yellow fever vaccine (see section on interactions).
This medicinal product is not recommended with live attenuated vaccines (except the anti-yellow fever vaccine, see section contraindications), phenytoin or fosphenytoin (see section on interactions).

Adverse effects Epirubicin Mylan

- Transient and reversible upon discontinuation of treatment:
. medullary hypoplasia,
. digestive intolerance (anorexia, nausea, vomiting),
. asthenia,
. febrile access,
. stomatitis,
. amenorrhea, azoospermia,
. alopecia.
- Rare cardiovascular complications: reduced ventricular ejection volume, heart failure. Heart failure usually occurs at cumulative doses above 900 mg / m².
- As with other DNA-damaging anticancer agents, myelodysplastic syndromes and acute myeloid leukemias have been observed following combination therapy including epirubicin.
- With topoisomerase II inhibitors, there has been reported a higher than expected incidence of secondary leukaemias presenting as de novo leukemias LAM2, LAM3, LAM4. Such forms may have a short latency period (from 1 to 3 years). These forms, accessible to a curative treatment, require early diagnosis and treatment adapted to curative (see section warnings and precautions for use).

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