Medicinal Products

EPIRUBICIN KABI 2 mg / ml Solution for infusion Box of 1 vial (glass) of 100 ml

Generic drug of Farmorubicin
Therapeutic class: Oncology and hematology
Active ingredients: Epirubicin
laboratory: Fresenius Kabi Oncology

Injection solution for IV infusion
All forms

Indication

Therapeutic indications are limited to:

· Mammary carcinomas,

· Ovarian cancer,

· Non-Hodgkin's malignant lymphoma, Hodgkin's disease,

· Microcellular cancers of the lung,

· Soft tissue sarcomas,

· Cancers of the esophagus, stomach, pancreas, hepatocellular cancers,

· Epidermoid cancers of the otolaryngological sphere.

Dosage EPIRUBICINE KABI 2 mg / ml Solution for infusion Box of 1 vial (glass) of 100 ml

Dosage

· 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, cycles being repeatable up to a maximum cumulative dose of 900 mg / m².

· The treatment cycles can be spaced out in case of toxic manifestations and in particular of haematological toxicity.

· In patients with hepatic impairment (bilirubinemia> 35 micromol / l), the dose administered will be reduced as follows:

Bilirubin (micromoles / l)

Dose to be administered (as a percentage of the theoretical dose)

> 50

0 (do not administer)

35-50

50

<35

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

Strict intravenous administration.

Slow injection into the tubing of an intravenous infusion of isotonic glucose solution.

Warning :

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.

Handling modalities

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 equipment suitable for handling including long-sleeved gowns, face masks, hood, safety 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 cytotoxic drugs. 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 may be envisaged within the framework of the oncology network (circular DGS / DH / 98 N ° 98/188 of 24 March 1998) in collaboration with any suitable and qualified structure.

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 yellow fever vaccine (see also section Interactions with other medicinal products and other forms of interaction ).

Adverse effects Epirubicin Kabi

Transient and reversible upon discontinuation of treatment:

· Bone marrow hypoplasia

· Digestive intolerance (anorexia, nausea, vomiting),

· Asthenia,

· Febrile access,

· Stomatitis,

· Amenorrhea, azoospermia,

· Alopecia.

Rare cardio-vascular complications: reduced ventricular ejection volume, heart failure. Heart failure usually occurs at cumulative doses above 900 mg / m 2 .

As with other DNA-damaging anticancer agents, myelodysplastic syndromes and acute myeloid leukemias have been observed following combination therapy including epirubicin.

With the 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 an early diagnosis and a treatment adapted to curative purpose (see section Special warnings and precautions for use ).

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