Docetaxel Ebeve concentrate for solution for infusion 80 mg vial 8 ml No. 1

Docetaxel Ebewe concentrate for infusion is indicated for:

Composition

Active ingredient: docetaxel;

1 ml of concentrate contains 10 mg of docetaxel;

Excipients: citric acid, polyethylene glycol 300, polysorbate 80, ethyl alcohol 96%.

Contraindication

Hypersensitivity to the active substance or to any of the excipients. Baseline neutrophil count <1500 cells/mm 3. Severe hepatic impairment. Pregnancy and breast-feeding.

Method of application

The use of the drug should be limited to departments specializing in cytotoxic chemotherapy and carried out exclusively under the supervision of a physician experienced in the use of anticancer chemotherapy.

Application features

Pregnant women

Should not be administered to women during pregnancy, except in cases of urgent need.

Children

The safety and efficacy of docetaxel for the treatment of nasopharyngeal carcinoma in children aged 1 month to 18 years have not yet been established.

Drivers

The alcohol contained in the drug may impair patients' ability to drive and operate machinery.

Overdose

There have been several reports of overdose with the drug. The antidote that could be used for docetaxel overdose is unknown. In case of overdose, the patient should be transferred to a specialized department and vital signs should be closely monitored. In case of overdose, an increase in adverse reactions can be expected. In particular, the development of disorders such as bone marrow suppression, peripheral neurotoxic disorders and inflammation of the mucous membranes is expected. After establishing the fact of overdose, the patient should be given therapeutic doses of G-CSF as soon as possible.

Side effects

General disorders and reactions at the injection site.

In TAX 316, among 119 patients with peripheral edema at the end of chemotherapy in the TAC arm, 19 patients had peripheral edema during follow-up; among 23 patients with peripheral edema at the end of chemotherapy in the FAC arm, 4 patients had peripheral edema during follow-up.

In the GEICAM 9805 study, among 5 patients with lymphedema observed at the end of chemotherapy, 4 patients had lymphedema persisting during the follow-up period.

Interaction

In vitro studies have shown that the metabolism of docetaxel may be altered by concomitant administration of drugs that induce, inhibit or are metabolised by cytochrome P450-3A (may inhibit the enzyme competitively), such as ciclosporin, terfenadine, ketoconazole, erythromycin and oleandomycin. Therefore, caution should be exercised when prescribing concomitant treatment with these drugs as there is a potential for significant interactions.

Storage conditions

Store in the original packaging to protect from light at a temperature not exceeding 25 °C.

Keep out of reach of children. Do not freeze.

Shelf life - 2 years.