Among drugs that are used to treat malignant tumors of the breast, a drug with a rather high efficiency is docetaxel.
Form, Composition and Packing
A concentrated concentrate for the preparation of a solution for infusion, complete with a solvent bottle.
Depending on the manufacturer, the concentrate bottle may contain 20 mg / ml, 40 mg / ml or 10 mg / ml. One bottle can contain 0.5 ml, 1 ml, 2 ml, 3 ml, 4 ml, 7 ml, 8 ml.
The concentrate contains:
- Docetaxel, which is an antitumor semisynthetic agent of plant origin. Natural raw materials for the production of the drug are yew yew needle European. The powder obtained by means of chemical synthesis is almost insoluble in water.
- Acid lemon anhydrate( is a natural preservative).
- Ethanol anhydrous is a stabilizer that preserves the physico-chemical properties of the drug.
- Polysorbate 80 is a surfactant that promotes the solubility of poorly soluble drugs.
Excipients may also include povidone or macrogol 300.
The solvent is a solution of 13% ethanol.
The solution is characterized by a clear oily or light yellow hue. The bottles are glass transparent, the preparation is packed with a pack of cardboard.
Manufacturer
Docetaxel( Docetaxel) is the non-proprietary international name of the drug, which is docetaxel produced by the Belarusian pharmaceutical company Pharmtechnology LLC, as well as the Ukrainian pharmaceutical company ZAT Biolik.
The international pharmaceutical company Aktavis Itali SpA issues a drug called Docetaxel-Teva( Italy / Israel), as well as Docetaxel-Vista( Italy / United Kingdom).
Indications for use
Docetaxel is used for:
- Breast cancer( an operable form in which lymph nodes can be affected or not affected).It is used as an adjuvant treatment with surgical and radiotherapy in combination with cyclophosphamide and doxorubicin. In the operable stage of cancer, which is not accompanied by a lesion of the lymph nodes, docetaxel is prescribed only when, according to the international criteria for conducting primary therapy for this disease, it is possible to use chemotherapy.
Monotherapy with docetaxel is given to patients with no cytotoxic therapy.
In metastatic or locally advanced breast cancer, which is accompanied by increased expression of HER2 tumor cells, docetaxel is administered in combination with trastuzumab if patients are not receiving chemotherapy.
- Non-small-cell lung cancer( appointed with ineffective chemotherapy for locally advanced or metastatic type of this type of cancer).
- Prostate cancer. Assigned in conjunction with the use of prednisolone or prednisone, if the patient has a hormone-resistant metastatic type of cancer.
- Metastatic adenocarcinoma of the stomach, adenocarcinoma of the esophageal-gastric junction. It is prescribed in combination with 5-fluorouracil and cisplatin in those patients who did not previously undergo chemotherapy.
- Squamous cell local and progressive carcinoma of the head and neck. Assigned in combination with 5-fluorouracil and cisplatin.
Contraindications
Docetaxel is contraindicated in patients:
- with a different hypersensitivity to any component of the drug;
- in which the baseline level of neutrophils is less than 1500 cells / mm 3;
- for liver pathologies expressed in severe degree;
- for pregnant and lactating women.
In childhood, the drug is administered with caution because of insufficient knowledge of the safety of use.
Mechanism of Action
Docetaxel refers to antitumor drugs whose effects are based on the promotion of combining tubulin( the protein from which the microtubules of the cytoskeleton is constructed) into stable microtubules and preventing their disintegration.
Disruption of microtubule disruption leads to disruption of the process of indirect division of tumor cells. Binding of docetaxel and microtubules does not change the amount of protofilament( threadlike structures that consist of special proteins and belong to the three main components of the cytoskeleton cells).
Docetaxel:
- Cytotoxic to different lines of tumor cells.
- Promotes high cell life span.
- It is not depending on the mode of application and it has a significant spectrum of antitumor activity.
- For a long time is present in cells in a high concentration.
75% of the drug is excreted with feces( most in the form of metabolites), about 4% of the kidneys are excreted.
Instructions for use Docetaxel: dosage
Docetaxel is used only in hospital settings under the supervision of a therapist who specializes in cytotoxic chemotherapy.
The use of granulocyte colony-stimulated factor, which reduces the risk of toxicity manifestations of hematological docetaxel, is also possible.
For the recommended treatment of breast cancer, the recommended dose is 75 mg / m2.The drug is administered an hour after the administration of cyclophosphamide and doxorubicin for 6 cycles.
For monotherapy in patients with locally advanced or metastatic type of cancer, the recommended dose is 100 mg / m2.As first-line therapy at a dose of 75 mg / m2 is used in conjunction with doxorubicin( 50 mg / m2).
In case of non-small cell lung cancer, the recommended dose is 75 mg / m2( if the patient did not previously undergo chemotherapy, cisplatin is administered immediately after docetaxel administration).
In gastric adenocarcinoma after administration of docetaxel( 75 mg / m2) for 1-3 hours is introduced on the first day of the cisplatin cycle, and then begin a 5-day continuous infusion of 5-fluorouracil( 750 mg / m2 / day).It is important for patients to consume enough fluids.
Preliminary drug preparation for the treatment of prostate cancer should consider simultaneous use of prednisolone or prednisone. The recommended dose is 75 mg / m2.Docetaxel is administered for one hour with the help of droppers( infusion therapy) every 3 weeks.
Side effects of
- Cardiovascular system, hematopoiesis : very often neutropenia is observed( it is characterized by reversible character) and anemia, often thrombocytopenia, cardiac rhythm disturbance, changes in blood pressure, sometimes myocardial infarction and venous thromboembolism.
- Gastrointestinal organs : In most cases, nausea, vomiting, diarrhea / constipation, as well as stomatitis, gastric pain, esophagitis and taste disorders are observed, sometimes an increased level of AST, ALT, APF and hyperbilirubinemia is observed, rarely accompanied by gastrointestinalbleeding.
- Skin covers : very often there is alopecia and itchy rash, hypo- or hyperpigmentation of the nail plates, possibly exfoliation of the nails.
- Immune system: hypersensitivity( slight or moderate degree), severe reactions( bronchospasm, generalized rash) are possible.
- Nervous system : observed in many cases peripheral sensory neuropathy and dysgeusia, often - peripheral motor neuropathy.
- Respiratory system : often observe shortness of breath, nosebleed, cough.
If other docetaxel drugs are used, the severity of side effects may increase.
Overdose
There is no specific antidote, the patient is hospitalized and symptomatic therapy is performed.
Special instructions
Because complications are possible, therapy is performed only by an experienced specialist in a specialized hospital.
To prevent allergic reactions and fluid retention, pre-administration of docetaxel is preceded by glucocorticoids.
During the therapy, the peripheral blood parameters are checked regularly. During treatment and 3 months after it, patients should be careful about contraception.
The solution is prepared in gloves, when the drug contacts the skin or mucous membranes, this area is thoroughly washed with water.
Drug Interaction
The combined use of docetaxel and erythromycin, cyclosporine and other substances that affect the isoenzyme CYP3A, can alter the metabolism of docetaxel.
The use of docetaxel together with doxorubicin increases the clearance of docetaxel( efficacy does not change).
Reviews
Irina, 38 years old.
After surgery, several chemotherapy courses with docetaxel have been prescribed.2 courses passed, my fingertips hurt, and my feet are not felt. The mood is optimistic - you can survive this kind of pain( paracetamol helps with pain, I take it on the advice of a doctor).
Olga, 45 years old.
The first chemistry with docetaxel was normal, but then the white blood cells dropped sharply. Now after each dropper they put a leech injection 480.
How much is the medicine in Moscow?
Price of docetaxel depends on the manufacturer and dosage( varies from 2861 to 23 938 rubles).
Where to buy?
You can find docetaxel in the correct dosage in a pharmacy conveniently located for you using the drug search site.
Analogues Docetaxel
- Docet
- Dosage
- Novotax
- Oncodocel
- Taxotere
- Tautax
Synonyms
None.
Terms of dispensing from pharmacies
Sold only by prescription.
Storage Conditions and Shelf Life
Shelf life of the concentrate is 18 months at 2-8 ° C.The finished solution is used for 6 hours from the time of preparation at a temperature of up to 25 ° C.