INDICATIONS

Breast cancer

TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:

· operable node-positive breast cancer.

· operable node-negative breast cancer.

For patients with operable node negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.

TAXOTERE in combination with capecitabine indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non small cell lung cancer

TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

TAXOTERE in combination with carboplatin represents a treatment option to cisplatin based therapy.

Prostate cancer: TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic prostate cancer.

Gastric adenocarcinoma: TAXOTERE in combination with cisplatin and 5-fluorourasil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer: TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Ovarian cancer: TAXOTERE is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of fist line or subsequent chemotherapy.

POSOLOGY AND METHOD OF ADMINISTRATION

Recommended dose for breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used. For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy. For Ovarian cancer, The recommended dose of TAXOTERE is 75 to 100 mg/m² administered as one-hour infusion every three weeks.

Generally, the dose of docetaxel should be reduced from 100 mg/m² to 75 mg/m² , and/or from 75 mg/m² to 60 mg/m², when the patient has febrile neutropenia, neutrophil < 500 cells/mm³for more than one week, etc . Taxotere (docetaxel) is not recommended for children and no special instructions for use in the elderly. For patients with hepatic impairment, the recommended dose of docetaxel is 75 mg/m².

TAXOTERE must be administered intravenously it is extremely important that the intravenous people or catheter be properly positioned before any TAXOTERE is injected. If extravasation occurs, the injection should be discontinued immediately and any remaining portion of the dose should be introduced into another vein.

CONTRAINDICATIONS

Hypersensitivity reactions to the active substance or to any of the excipients. Patients with baseline neutrophil count of < 1,500 cells/mm³, Patients with severe liver impairment, and Contraindications for other medicinal products also apply when combined with docetaxel.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE:

For breast and non-small cell lung cancers, the recommended premedication can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Neutropenia is the most frequent adverse reaction of docetaxel. Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm³. Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications.

Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions. Patients who have developed severe hypersensitivity reactions should not be re-challenged with docetaxel. Patients who have experienced a hypersensitivity reaction to paclitaxel may be at risk to develop hypersensitivity reaction to docetaxel, including more severe hypersensitivity reaction. Heart failure has been observed in patients receiving docetaxel in combination with trastuzumab, particulary following anthracycline containing chemotherapy.

Patients should be informed about the signs and symptoms of serious skin manifestations and closely monitored. In patients treated with docetaxel at 100 mg/m² as single agent who have serum transaminase levels greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths, febrile neutropenia, infections, etc.

The concomitant use of Taxotere with strong CYP3A4 inhibitors should be avoided. The amount of ethanol in Taxotere may be harmful in patients suffering from alcoholism and may impair the ability to drive or use machines. Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy.

INTERACTIONS:

Docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolized by cytochrome P450-3A such as ciclosporine, terfenadine, etc. The coadministration of docetaxel with the strong CYP3A4 inhibitor ketoconazole leads to a significant decrease in docetaxel clearance by 49%. Docetaxel is highly protein bound (> 95%). Increase in docetaxel toxicity were reported when it was combined with ritonavir. The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir. For other interactions : see full PI.

PREGNANCY AND LACTATION:

Docetaxel may cause foetal harm when administered to pregnant women, therefore, docetaxel must not be used during pregnancy unless clearly indicated.

Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur. Because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.

UNDESIRABLE EFFECTS:

The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.

Very common : neutropenia, anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea, and

asthenia, infections, febrile neutropenia, hypersensitivity, anorexia,

Dyspnoea, skin reactions, Fluid retention, myalgia, nail disorders, etc.

Common : Infection associated with G4 neutropenia, Thrombocytopenia, Arrhythmia,

Hypotension, Hypertension, Haemorrhage, Constipation, Arthralgia, etc.

For other undesirable effect Taxotere in combination : See full PI.

OVERDOSE:

The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. here is no known antidote for docetaxel overdose. Other appropriate symptomatic measures should be taken, as needed.

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Taxanes, ATC Code: L01CD 02

Presentation :

Each blister carton of TAXOTERE 20 mg/1 ml for solution for infusion contains one vial

7 ml clear glass (type I) vial with a green aluminum seal and a green plastic flip-off cap containing 1 ml of concentrate.

Reg. No. DKI1459202749B1

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst

65926 Frankfurt am Main Allemagne – Germany

More detailed Information on request:

PT Aventis Pharma

Jl. Jend. Ahmad Yani, Pulomas, Jakarta 13210

(021) 4892208 - 4895608

Date of revision: 10-Mar-2022 (based on BPOM approval 07-June-2020)

This information is intended for Health Care Professional only. See local product information for full details information.