Docetaxel 0.01/ml 8 ml bottle №1

Latin name

DOCETAXEL-SANDOZ

Release form

Concentrate for preparation of solution for infusions in the form of transparent liquid, from colorless to light yellow color.

Packaging

8 ml - bottles of colorless glass (1, 5, 10) - packs cardboard.

pharmachologic effect

antitumor agent - alkaloid

Indications

Breast Cancer (Breast Cancer)

Adjuvant Therapy:

- operable breast cancer (the drug Docetaxel Sandoz® in combination with doxorubicin and cyclophosphamide);

- resectable breast cancer with regional lymph nodes;

- resectable breast cancer without damage to regional lymph nodes in patients who have been shown to undergo Chemotherapy according to established international selection criteria for primary chemotherapy for early stages of breast cancer (if there are one or more factors at high risk for relapse: tumor size is more than 2 cm, negative estrogen and Progesterone receptor status, high degree of tumor malignancy (grade 2-3), age less than 35 years);

- operable breast cancer with tumor overexpression of HER2 (doxorubicin and cyclophosphamide followed by the use of the drug Docetaxel Sandoz® in combination with trastuzumab (AC-TN scheme));

Neoadjuvant Therapy:

- operable and locally advanced breast cancer (doxorubicin and cyclophosphamide, followed by the use of the drug Docetaxel Sandoz®).

Metastatic and / or locally advanced breast cancer:

- locally advanced or metastatic breast cancer (drug Docetaxel Sandoz® in combination with doxorubicin, 1st line therapy);

- metastatic breast cancer with tumor overexpression of HER2 (drug Docetaxel Sandoz® in combination with trastuzumab, 1st line therapy);

- locally advanced or metastatic breast cancer with the ineffectiveness of previous chemotherapy, which included anthracyclines or alkylating agents (Docetaxel Sandoz® in monotherapy);

- locally advanced or metastatic breast cancer with the ineffectiveness of previous chemotherapy, which included anthracyclines (Docetaxel Sandoz® in combination with capecitabine);

Non-small cell lung cancer (NSCLC)

- inoperable locally advanced or metastatic NSCLC in combination with Cisplatin or carboplatin as 1st line therapy;

- locally advanced or metastatic NSCLC in monotherapy as a 2nd-line therapy with the ineffectiveness of previous chemotherapy;

Ovarian cancer

- metastatic ovarian cancer as a 2nd line therapy with the ineffectiveness of previous 1st line therapy.

Head and Neck Cancer

- inoperable locally advanced squamous cell carcinoma of the head and neck (in combination with cisplatin and fluorouracil) as induction therapy.

Prostate cancer

- metastatic, hormone resistant prostate cancer (in combination with prednisone or prednisone).

Stomach cancer

- metastatic gastric cancer, including adenocarcinoma of the gastroesophageal compound (in combination with cisplatin and fluorouracil), as a 1st line therapy.

Contraindications

Increased individual sensitivity to docetaxel or other components of the drug;

- neutropenia (initial neutrophil count in peripheral blood <1500 / μl);

- severe liver dysfunction;

- pregnancy;

- breastfeeding period;

- children's age up to 18 years.

When using the drug Docetaxel Sandoz® in combination with other drugs, you should also take into account contraindications to their use.

With simultaneous use of drugs that induce or inhibit cytochrome isoenzymes R450-3A, ilimetaboliziruyuschihsya via cytochrome isoenzymes R450-3A such as cyclosporine, terfenadine, antifungals of the imidazoles group (ketoconazole, itraconazole, voriconazole), Erythromycin, troleandomycin, Clarithromycin, telithromycin, protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), as well as nefadozon.

Use during pregnancy and lactation

Data on the use of docetaxel during pregnancy are not available. The use of the drug during pregnancy is contraindicated.

Women with preserved childbearing potential should use reliable contraceptive measures during treatment, should they become pregnant during treatment, they should be urgently informed about this by their attending physician.

It is not known whether docetaxel is excreted in breast milk.Use of the drug Docetaxel Sandoz® during breastfeeding is contraindicated. Docetaxel has a genotoxic effect and may impair male fertility (ability to conceive). Men of reproductive age during therapy with Docetaxel Sandoz® and for at least 6 months after the end of treatment should use reliable methods of contraception; before starting treatment, the possibility of sperm preservation should be considered.

special instructions

Treatment with Docetaxel Sandoz® is carried out only under the supervision of a physician with experience in the use of anticancer drugs in a specialized hospital.

Neutropenia

Periodic monitoring of the complete blood count should be performed. With the development of severe neutropenia (the number of neutrophils less than 500 / μl for 7 days or more) during the course of therapy with Docetaxel Sandoz®, it is recommended to reduce the dose of the drug (see Dosage and Administration) on subsequent courses or to use adequate symptomatic measures. It is possible to continue treatment with Docetaxel Sandoz® after the neutrophil count has been restored to 1500 / µl.

In the case of receiving G-CSF by patients receiving docetaxel in combination with cisplatin and Fluorouracil, febrile neutropenia and / or neutropenic infections develop less frequently. Therefore, when using this combination, it is necessary with the prophylactic purpose of prescribing G-CSF to reduce the risk of developing complicated neutropenia (febrile neutropenia, prolonged neutropenia, neutropenic infection).The condition and laboratory parameters of patients receiving this chemotherapeutic regimen should be carefully monitored.

Hypersensitivity Reactions

In order to detect hypersensitivity reactions, patients should be carefully monitored, especially during the first and second infusions. The development of hypersensitivity reactions is possible in the very first minutes of the drug infusion. Manifestations of hypersensitivity, such as facial flushing or localized skin reactions, do not require interruption of drug administration. Severe hypersensitivity reactions (lowering blood pressure, bronchospasm, or generalized rash / erythema) require the immediate discontinuation of the administration of Docetaxel Sandoz® and the adoption of appropriate therapeutic measures. Repeated use of the drug Docetaxel Sandoz® in these patients is not allowed.

In patients receiving docetaxel monotherapy at a dose of 100 mg / m2 and with a high activity of "liver" transaminases, more than 1.5 times higher than VGN, combined with an increase in alkaline phosphatase activity more than 2.5 times higher than VGN, is extremely high the risk of severe side effects such as sepsis, Gastrointestinal bleeding, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia. In this regard, functional liver tests should be determined before the start of therapy and before each subsequent cycle of therapy with Docetaxel Sandoz®.In patients with elevated bilirubin concentration and / or liver transaminase activity (> 3.5 VGN) in combination with an increase in alkaline phosphatase activity of more than 6 times higher than VGN, Docetaxel Sandoz® is not recommended.

There are currently no data regarding the use of docetaxel in combination with other drugs in patients with impaired liver function.

Fluid retention

In connection with the possibility of fluid retention, careful monitoring of patients with effusion into the pleural cavity, pericardium, or those with ascites is necessary. With the appearance of edema, it is necessary to limit the salt and drinking regime and the appointment of diuretics.

Lesion of the respiratory system

Cases of acute respiratory distress syndrome, interstitial pneumonia / pneumonitis, interstitial pulmonary disease, pulmonary fibrosis and respiratory failure, including fatal outcomes, have been reported. Radiation therapy for pneumonitis has also been reported in concomitant radiation therapy.

When new or worsening symptoms of the respiratory system appear, patients should be under close medical supervision, symptomatic therapy is indicated. Docetaxel treatment should be suspended until the diagnosis is clarified. The question of the resumption of treatment with docetaxel should be resolved on the basis of a thorough assessment of the benefits of such treatment.

Leukemia

When using the combination of Docetaxel Sandoz® with doxorubicin and cyclophosphamide for non-metastatic resectable breast cancer, the risk of developing delayed myelodysplasia and / or myeloid leukemia requires hematological observation of patients.

Heart failure

During the period of treatment with docetaxel and in the follow-up period of observation, it is necessary to monitor the manifestations of symptoms of chronic heart failure (CHF). A higher risk of CHF in patients with breast cancer with damage to lymph nodes receiving chemotherapy under the TAS scheme is observed in the first year after completion of treatment.

Patients who received Docetaxel Sandoz in combination with trastuzumab for metastatic breast cancer with HER2 tumor overexpression, especially after chemotherapy containing anthracyclines (doxorubicin or epirubicin), may develop heart failure, may be moderate or severe, and cause death. When the patient is shown treatment with Docetaxel Sandoz® in combination with trastuzumab, she should undergo an initial cardiological examination. Every three months, cardiac function should be monitored, which allows to identify patients who may develop heart failure.

Violations by the organ of vision

The development of macular edema has been reported in patients taking docetaxel. In the event of a visual impairment, patients should undergo a full ophthalmologic examination. In the case of diagnosis of macular edema, the drug should be discontinued.

The need for contraception

Since preclinical studies have shown that docetaxel has a genotoxic effect and may impair male fertility (ability to conceive), men receiving docetaxel are advised not to conceive a child during treatment and for at least 6 months after the end of chemotherapy and advise before treatment to make the preservation of sperm.

Women in the event of their pregnancy during treatment should immediately inform your attending physician.

During and for at least 6 months after discontinuation of therapy, patients of both sexes should use reliable methods of contraception.

Neurotoxicity

The development of severe sensory neuropathy requires a dose reduction of the drug Docetaxel Sandoz®.

Elderly patients

Compared with patients younger than 60 years of age, patients aged 60 years and older who received docetaxel + Capecitabine combined chemotherapy increased the incidence of treatment-related adverse events of grade 3 and 4 associated with the treatment of serious adverse reactions (ADR) and early withdrawal. treatment due to the development of the NDP.

There are limited data on the use of a combination of docetaxel with doxorubicin and cyclophosphamide in patients over 70 years of age.

In patients 65 years and older who received drug treatment every 3 weeks for prostate cancer, the frequency of nail changes was ≥ 10% higher,than in younger patients, in patients 75 years and older, the frequency of fever, diarrhea, anorexia, and peripheral edema was ≥ 10% higher than in younger patients.

When using the combination of docetaxel with cisplatin and fluorouracil, the following adverse reactions (of all severity) were observed: lethargy (drowsiness, lethargy, torpor), stomatitis, neutropenic infections, in patients over 65 years of age were ≥10% more common than in younger patients . Therefore, patients over 65 years of age who receive this combination need to be carefully monitored.

Ethanol content

Docetaxel Sandoz® contains ethanol at a concentration of 27% by volume (108 / ml contains 0.28 g of ethanol in terms of the main substance). This should be taken into account when using the drug in patients with alcoholism and patients at risk (patients with liver disease and epilepsy).

Handling and precautions for handling the product

At application and preparation of solutions of the drug Docetaxel Sandoz® it is necessary to be careful. It is recommended to use gloves. If the concentrate or solution for infusion falls on the skin, it should be immediately washed thoroughly with soap and water. In case of contact with mucous membranes, they should be immediately washed thoroughly with water.

Special precautions when disposing of unused drugs

The remnants of the drug, all the tools and materials that are used