
Each vial of concentrated solution contains:
Docetaxel in 0,5 ml polysorbate ………………………………. 20 mg
Each solvent vial contains:
13% (w/w) solution of ethanol in water for injection…….1,83 ml
Concentrated solution for infusion.
Box of a vial of concentrated solution and a vial of solvent
Treatment of locally advanced or metastatic cancer including: breast cancer; non-small cell lung cancer; head and neck cancer; prostate cancer; ovarian cancer and cervical cancer; gastric cancer
Please read carefully the leaflet before using.
*Administration: Concentrate solution of docetaxel must be diluted before administration with 5% glucose solution or 0,9 % sodium chloride solution to obtain a solution containing not exceeding 0,74 mg/ml.
*Dosage: The recommended dosage of docetaxel is 75-100 mg/m² administered by IV infution in 1 hour every 3 weeks.
– Premedication:
Patients should be premedicated with oral corticosteroids such as dexamethasone 8 mg twice daily for 3-5 days if have no contraindication, before 1 day starting to docetaxel administration, in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity.
– Dose adjustments during treatment:
Docetaxel should be administered when the neutrophil count is ≥ 1,500 /mm³. Patients who are dosed initially at 100 mg/m², if occurring febrile neutropenia or neutrophils <500 /mm³ for more than 1 week or severe peripheral nervous system disease during docetaxel therapy should have the dosage adjusted to 60-75 mg/m². If the patient continues to experience these reactions, the dosage should either be decreased to 55 mg/m² or the treatment should be discontinued.
– Special cases:
Hepatic impairment: Depending on pharmacokinetic data, in patients with transaminase (ALT, AST) concentrations exceeding 1,5 time the upper limit of normal (ULN) simultaneously alkaline phosphatase concentrations exceeding 2,5 times the ULN, the recommended dosage of docetaxel is 75 mg/m²
Patients with serum bilirubin concentrations exceeding the ULN and/or serum AST, ALT concentrations exceeding 3,5 times simultaneously alkaline phosphatase concentrations exceeding 6 times the ULN, should not use Docetaxel unless have accurate indication.
Pediatric: The safety and efficacy of Docetaxel have not been established in children.
At dry place, not exceeding 25°C, protect from light.