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BESTDOCEL 80


Composition:
Each vial of concentrated solution contains:
Docetaxel in 2 ml polysorbate................................................. 80 mg

Each solvent vial contains: 
13% (w/w) solution of ethanol in water for injection ............. 7,33 ml

Dosage forms: Concentrated solution for infusion.
Packaging: Box of a vial of concentrated solution and a vial of solvent

Pharmacology:
- Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine, N-tert-butylester, 13-ester with 5β-20-epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4-acetate 2-benzoate. 
- Docetaxel binds to free tubulin, promotes the assembly of tubulin into stable microtubules and simultaneously inhibits their disassembly, resulting in the inhibition of mitosis in cells. In vitro test, Docetaxel doesn’t inhibit the synthesis of DNA, RNA or protein in cells. 

Pharmacokinetics:
Absorption and Distribution:
- Docetaxel is rapidly absorbed and distributed via intravenous infusion. Docetaxel's pharmacokinetic property  is stable , half-lives for the α, β, and γ phases of 4 min, 36 min, and 11,1 hr. Peak plasma concentration of docetaxel was 3,7 µg/ml, The area under the curve (AUC) was 4,6 µg/ml/h, after infusing a dose of 100 mg/m² in 1 hour.
- Mean steady-state volume of distribution was 113 liters, clearance was 21 L/h/m², regardless of dose. Docetaxel is widely distributed to most tissues except the central nervous system.
- In vitro, greater than 90% of docetaxel is bound to plasma proteins independent of  dose, mainly to albumin, α1 - acid glycoprotein, lipoprotein. Dexamethasone does not affect the protein binding of Docetaxel.  
Metabolism and Elimination:
- A study of 14C-docetaxel was conducted in cancer patients, within 7 days after IV administration, approximately 75% of the drug was excreted in the feces and 6% in the urine. About 80% of the radioactivity recovered in feces was excreted during the first 48 hours as 1 major and 3 minor metabolites with very small amounts (less than 8%) of unchanged drug. 
- The elimination of docetaxel may be significant for patients with hepatic impairment

Indications: 
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

Dosage and Administration: 
• 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.

Contraindications: Please read carefully the leaflet before using.

Storage: Cool place, below 25ºC, protect from light. 






 

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