Docetaxel Trihydrate 80mg/4ml injection

Ferron Par Pharmaceuticals

Ingredients in every 4 ml

Docetaxel Trihydrate 80 mg

Each package contains

1 vial of 4 ml

Other details

Dosage form:Injection
Flavour: None

W.H.O. classification

ATC Level 1: L - Antineoplastic and immunomodulating agents
ATC Level 2: L01 - Antineoplastic Agents
ATC Level 3: L01C - Plant Alkaloids and Other Natural Products; Antineoplastic Drugs

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

NOT SAFEThis item should not be used with alcohol.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution.

Available in

Indonesia

Dosage information

18 YEARS OLD AND ABOVE
Breast cancer
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m² in monotherapy. In the first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²).
In combination with trastuzumab, the recommended dose of docetaxel is 100 mg/m² every 3 weeks, with trastuzumab administered weekly. In the pivotal trial, the initial docetaxel infusion was started the day following the first dose of trastuzumab. The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated. For trastuzumab dose and administration, see summary of product characteristics.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m² every 3 weeks, combined with capecitabine at 1,250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period. For capecitabine dose calculation according to body surface area, see capecitabine summary product characteristics.

Non-small cell lung cancer
In chemotherapy-naïve patients, the recommended dose of docetaxel is 75 mg/m² administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m² over 30-60 minutes every 3 weeks. For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.

Ovarian cancer
The recommended dose of docetaxel is 75-100 mg/m² administered as 1-hour infusion every 3 weeks. A dose of 100 mg/m² has been shown to result in a moderate increase in response rates compared with 75 mg/m² but is associated with greater toxicity.

Hormone refractory prostate cancer
The recommended dose of docetaxel is 75 mg/m². Prednisone or prednisolone 5 mg orally twice daily is administered continuously.

Gastric adenocarcinoma
The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1 to 3 hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every 3 weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration. Prophylactic G-CSF should be used to mitigate the risk of hematological toxicities.

Squamous cell carcinoma of the head and neck cancer
Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration). Prophylactic G-CSf should be used to mitigate the risk of hematological toxicities.
– Induction chemotherapy followed by radiotherapy (TAX 323)
For the induction treatment of inoperable locally advanced Squamous cell carcinoma of the head and neck cancer, the recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion followed by cisplatin 75 mg/m² over 1 hour, on day 1, followed by 5-fluorouracil as a continuous infusion at 750 mg/m² per day for 5 days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy.
– Induction chemotherapy followed by chemoradiotherapy (TAX 324)
For the induction treatment of locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) Squamous cell carcinoma of the head and neck cancer, the recommended dose of docetaxel is 75 mg/m² as a 1-hour intravenous infusion, followed by cisplatin 100 mg/m² administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy."

OTHER DETAILS
ELDERLY
In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients. There are no special instructions for use in the elderly. In combination with capecitabine, for patients 60 years of age or more. A starting dose reduction of capecitabine to 75% is recommended

PREMEDICATION
Unless contraindicated, all patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration.
For prostate cancer, given the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion. Docetaxel is administered as a one-hour infusion every three weeks.

Indication

Breast cancer
1. Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive and 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.
2. Docetaxel 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.
3. Docetaxel 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.
4. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors over express HER2 and who previously have not received chemotherapy for metastatic disease.
5. Docetaxel in combination with capecitabine is 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
1. Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
2. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition.
3. Docetaxel in combination with carboplatin represents a treatment option to cisplatin based therapy.

Ovarian cancer
Docetaxel is indicated for the treatment of patients with metastatic carcinoma of the ovarian after failure of first line or subsequent chemotherapy.

Hormone refractory prostate cancer
Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.

Gastric adenocarcinoma
Docetaxel in combination with cisplatin and 5-fluorouracil 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.

Squamous cell carcinoma of the head and neck cancer
Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for induction treatment of locally advanced Squamous cell carcinoma of the head and neck cancer.

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