Docetaxel
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Clinical Pharmacology
Antitumor drug of plant origin (from the group of taxoids). It accumulates tubulin in microtubules, prevents their disintegration, which disrupts the phase of mitosis and interfacial processes in tumor cells. Docetaxel is stored for a long time in cells, where its concentration reaches high values. Active against some, but not all, of the cells that produce in excess P-glycoprotein, which is encoded by the gene for multiple resistance to chemotherapeutic drugs.
Indications
As a means of line 1 in breast cancer, as well as with the ineffectiveness of therapy with anthracycline drugs; non-small cell lung cancer (including with the ineffectiveness of other anticancer drugs); malignant tumors of the head and neck; ovarian cancer.
Composition
1 ml of concentrate contains
active substance: docetaxel (anhydrous) 10.0 mg;
Excipients: polysorbate 80 80,000 mg, macrogol 300 648,000 mg, anhydrous citric acid 4,000 mg, ethanol 96% 275,900 mg.
Docetaxel is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Docetaxel Sandoz | Ebeve Pharma | Austria | solution concentrate |
Taxotere® | Other | ||
Tautax® | Lance farm | Russia | bottle |
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Dosage and Administration
Dosage should be determined individually, depending on the evidence and the stage of the disease, the state of the hematopoietic system, the scheme of antitumor therapy.
Adverse reactions
From the hemopoietic system:neutropenia, thrombocytopenia, anemia.
From the digestive system: nausea, vomiting, diarrhea, increased serum levels of transaminases and bilirubin; rarely stomatitis.
From the nervous system: paresthesia, hyperesthesia.
From the musculoskeletal system:arthralgia, myalgia.
Allergic reactions:skin manifestations are possible; rarely - bronchospasm.
Dermatological reactions:skin rash, mainly in the area of the feet, palms, and also in the area of the upper extremities, face, chest, often accompanied by itching, sometimes with subsequent desquamation; hypo or hyperpigmentation of the nails and onycholysis; alopecia.
From the water and electrolyte exchange:fluid retention, incl. ascites, peripheral edema.
Since the cardiovascular system:arterial hypotension, cardiac arrhythmias.
Contraindications
Neutropenia less than 1500 / mcl, sensitivity to docetaxel in history, pregnancy, lactation.
Drug interactions
In vitro studies have shown that the biotransformation of the drug may change with the simultaneous use of other drugs that induce, inhibit or metabolize the cytochrome CYP3A isoenzyme, such as cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin. In this regard, care must be taken with the simultaneous use of such drugs, given the possibility of pronounced interaction.
With simultaneous use of docetaxel with inhibitors of the isoenzyme CYP3A4 may increase the risk of its adverse reactions. If it is necessary to use docetaxel concomitantly with strong inhibitors of the CYP3A4 isoenzyme (ketoconazole, itraconazole, clarithromycin, indinavir, nefadozone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole), caution is needed, dose correction of doctareone, saquinavir, telithromycin, voriconazole should be used;
Studies in patients who received docetaxel and ketoconazole at the same time showed that docetaxel clearance decreased by 49%, apparently due to the fact that the main pathway of docetaxel metabolism is its metabolism using the CYPP3A4 isoenzyme. In this case, even with the use of lower doses of docetaxel, its tolerance may deteriorate.
In vitro drugs strongly binding to plasma proteins, such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylates, sulfamethoxazole, and valproic acid, did not affect the binding of docetaxel to plasma proteins. Dexamethasone also does not affect the degree of binding of docetaxel to plasma proteins. Docetaxel does not affect communication with plasma proteins of digitoxin. The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide did not change when they were used together.
The pharmacokinetics of docetaxel in the presence of prednisone was studied in patients with metastatic prostate cancer, although docetaxel is metabolized by the CYP3A4 isoenzyme, and prednisone is an inducer of the CYP3A4 isoenzyme, no statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
There is information about the interaction of docetaxel and carboplatin. When a combination of carboplatin and docetaxel is used, the clearance of carboplatin is increased by 50% compared with carboplatin monotherapy.
Pregnancy and Lactation
Contraindicated for use during pregnancy and lactation.
Women of childbearing age should use reliable methods of contraception during docetaxel therapy.
Special instructions
Docetaxel is not used when the content of bilirubin more than VGN in combination with the activity of hepatic transaminases, 1.5 times more than VGN, and ALP, 2.5 times more than VGN.
Before starting therapy, patients are prescribed GCS inside. The likelihood of developing allergic reactions and the occurrence of edema is significantly increased in patients who have not previously been given such therapy.
During the period of treatment, systematic monitoring of the pattern of peripheral blood is necessary in order to identify the degree of myelodepression.
Overdosage
Symptoms: oppression of bone marrow function, peripheral neuropathy and inflammation of the mucous membranes.
Treatment: hospitalization of the patient, careful control of the functions of vital organs, prophylactic use of G-CSF, symptomatic therapy. The antidote to docetaxel is currently unknown.
- Brand name: Docetaxel Sandoz
- Active ingredient: Docetaxel
- Dosage form: Concentrate for solution for infusion
- Manufacturer: Ebeve Pharma
- Country of Origin: Austria
Studies and clinical trials of Docetaxel (Click to expand)
- Complete regression of choroidal metastases from breast cancer after docetaxel-based systemic chemotherapy
- Carboplatin–paclitaxel- and carboplatin–docetaxel-induced cytotoxic effect in epithelial ovarian carcinoma in vitro
- A phase I study of gemcitabine and docetaxel in patients with metastatic solid tumors
- Phase I trial of docetaxel and vinorelbine in patients with advanced nonsmall cell lung carcinoma
- Cutaneous fibrosis induced by docetaxel : A case report
- Enhancement of radiation effects by combined docetaxel and carboplatin treatment in vitro
- Treatment of androgen-independent prostate cancer using antimicrotubule agents docetaxel and estramustine in combination: an experimental study
- Phase II trial of a 75-mg/m2 dose of docetaxel with prednisone premedication for patients with advanced non-small cell lung cancer
- Docetaxel (Taxotere) associated scleroderma-like changes of the lower extremities. A report of three cases
- Weekly docetaxel in the treatment of elderly patients with advanced nonsmall cell lung carcinoma : A Minnie Pearl Cancer Research Network Phase II Trial
- Treatment of patients with advanced nonsmall cell lung carcinoma using docetaxel and gemcitabine plus granulocyte-colony stimulating factor
- Comparison of 2-methoxyestradiol-induced, docetaxel-induced, and paclitaxel-induced apoptosis in hepatoma cells and its correlation with reactive oxygen species
- Docetaxel-induced lymphopenia in patients with solid tumors : A prospective phenotypic analysis
- Phase I clinical trial of weekly combined paclitaxel plus docetaxel in patients with solid tumors
- Phase II trial of weekly docetaxel in second-line therapy for nonsmall cell lung carcinoma
- Weekly docetaxel with either gemcitabine or vinorelbine as second-line treatment in patients with advanced nonsmall cell lung carcinoma : Phase II trials of the Minnie Pearl Cancer Research Network
- Gemcitabine and docetaxel as second-line chemotherapy for patients with nonsmall cell lung carcinoma who fail prior paclitaxel plus platinum-based regimens
- Effects of docetaxel in combination with radiation on human head and neck cancer cells (ZMK-1) and cervical squamous cell carcinoma cells (CaSki )
- Decreased expression of BRCA2 mRNA predicts favorable response to docetaxel in breast cancer
- Synthesis of New Analogs of the C-13 Docetaxel Side Chain By Asymmetric Aminohydroxylation
- A biodegradable diblcok copolymer poly(ethylene glycol)-block-poly(L-lactide-co-2-methyl-2-carboxyl-propylene carbonate): Docetaxel and RGD conjugation
- Quantitative analysis of docetaxel in human plasma using liquid chromatography coupled with tandem mass spectrometry
- The effect of alkylamine additives on the sensitivity of detection for paclitaxel and docetaxel and analysis in plasma of paclitaxel by liquid chromatography–tandem mass spectrometry
- Selective Recognition of Co-assembled Thrombin Aptamer and Docetaxel on Mesoporous Silica Nanoparticles against Tumor Cell Proliferation