Abitaxel - instructions for use of the drug, structure, Contraindications
Abitaxel - anticancer drug. Is an inhibitor of mitosis.
Abitaxel: indications and dosage
The main indications for the use of Abitaxel are:
- Cancer ovary (incl. with the ineffectiveness of platinum drugs) – primary, secondary or metastatic tumor lesion of female hormone-producing gonads - ovaries,
- mammary cancer - a malignant tumor of the glandular tissue of the breast.,
- lung cancer (bronchogenic cancer, bronhogennaâ cancer) - malignant neoplasm of lung, originating from the epithelial tissue of the bronchi of various calibers.,
- esophageal carcinoma is an oncological disease, in which a malignant tumor appears on the wall of the esophagus.,
- head and neck cancer – a heterogeneous group of various intracranial neoplasms, benign or malignant, arising from the launch of the process of abnormal uncontrolled cell division, which in the past were normal constituents of brain tissue itself,
- bladder cancer - disease, in which malignant neoplasms occur in the mucous membrane or in the wall of the bladder.
The dosage of Abitaxel is set individually, depending on factors such as:
- indications and stage of the disease,
- state of the hematopoietic system,
- antitumor therapy regimen.
Treatment with Abitaxel should be carried out under the supervision of a qualified oncologist.. Since serious hypersensitivity reactions are possible, appropriate resuscitation equipment must be available.
All patients should receive corticosteroid premedication., antihistamines and H2 receptor antagonists, eg, as follows:
| Preparation | Dose | Time of receipt |
| Dexamethasone | 20 mg orally or (8-20 mg orally for Kaposi's sarcoma) | If ingestion: approximately 12 and for 6 hours before the introduction of Abitaxel. When administered intravenously: for 30-60 minutes before the introduction of Abitaxel. |
| Difengidramin (or an analog antihistamine) | 50 mg infusion | Half an hour or an hour before the introduction of Abitaxel |
| Cimetidine or Ranitidine | 300 mg IV 50 mg IV | Half an hour or an hour before the introduction of Abitaxel |
Also, the dosage and scheme of oncotherapy can be prescribed depending on the patient's disease.. Appointment details are shown in the table below.
| Type of disease | Combination of drugs | Recommended dosage |
| First stage chemotherapy for ovarian cancer. | Abitaxel and Cisplatin | Abitaxel - 135 mg / m2 during daily intravenous infusions, then inject Cisplatin - 75 mg / m on the surface of the body. Break between treatments – 3 of the week. |
| Second stage chemotherapy for ovarian cancer. | Abitaxel | 175 mg / m2 with a 3-hour infusion. Break between treatments – 3 of the week. |
| Preventive chemotherapy for breast cancer. | Abitaxel is prescribed after chemotherapy with anthracyclines and cyclophosphamide. | 175 mg / m on the surface of the body by using a 3-hour infusion, total number 4 course with 1-week breaks between them. |
| First stage chemotherapy for breast cancer. | Combined use with doxorubicin (dose 50 mg / m of body surface) Abitaxel must be administered through 24 hours after doxorubicin. | 175 mg / m2 when administered via 3-hour infusion. Break between treatments – 3 of the week. |
| First stage chemotherapy for breast cancer. | Combined use of Abitaxel with Trastuzumab | 175 mg / m2 with 3-hour infusions with 1-week breaks between courses. Abitaxel can be administered the day after the first dose of trastuzumab or immediately after subsequent doses, if previous injections of trastuzumab were taken normally by the body. |
| Second stage chemotherapy for breast cancer. | Abitaxel | 175 mg / m of body surface with a 3-hour infusion. Break between treatments – 3 of the week. |
| Chemotherapy for non-small cell lung cancer (NMKRL). | Abitaxel and Cisplatin | 175 mg / m of body surface with a 3-hour infusion, then inject Cisplatin - 80 mg / m2. Break between treatments – 3 of the week. |
| Chemotherapy for Kaposi's sarcoma in patients with AIDS. | Abitaxel | 135 mg / m2 with 3-hour infusions at intervals 3 weeks or per dose 100 mg / m on the surface of the body with a 3-hour infusion. Break between treatments – 2 of the week. |
Treatment of patients with liver disease of varying degrees. Studies on the use of the drug Abitaxel in patients with mild and moderate liver dysfunction have not been conducted.. Therefore, patients with severe liver dysfunction are prohibited from prescribing Abitaxel..
Abitaxel: preparation of solution for infusion
The drug Abitaxel for the preparation of an infusion solution must be diluted under sterile conditions with the addition of the following substances:
- 0,9% sodium chloride solution,
- 5% glucose,
- 5% glucose solution in 0,9% sodium chloride or 5% glucose solution in Ringer's solution to a final concentration 0,3-1,2 mg / ml.
When the drug is taken from the vial again, the concentrate for the drug infusion solution retains microbiological, physical and chemical properties during 28 days at room temperature 25 ° C. Prepared solutions should not be refrigerated..
The finished solution may precipitate due to the presence of a carrier base in the dosage form of Abitaxel, in addition, after filtration, the precipitate of the solution remains.
Therefore, Abitaxel should be administered to the body through a special system with a membrane filter. (pore diameter no more 0,22 m). During clinical trials, the solution, administered through an intravenous infusion tube and with a filter did not lose its therapeutic properties.
To minimize the ingestion of di (2-ethylhexyl) phthalate (DEGF), which may have a tin-plated reaction from infusion bags, systems or other medical equipment from plasticized PVC (PVC), solutions for infusion should be stored in containers made of materials, PVC-free (glass or polypropylene bottles, polypropylene or polyolefin bags) and administered through infusion systems, lined with polyethylene. When connecting filters (eg, IVEX-2®) no significant leaching of DEHF occurs with short PVC tubes.
Abitaxel: overdose
There is no antidote for use in case of an overdose of Abitaxel. The main expected complications of overdose:
- suppression of bone marrow function,
- peripheral neurotoxicity
- mukozit.
In this case, you should immediately stop the administration of the drug and carry out symptomatic treatment with the control of the content of blood cells and the state of the functions of vital organs..
Abitaxel: side effects
From the hematopoietic system:
- leukopenia -the State of, characterized by a decrease in the number of leukocytes below 4,0 * 109/l.),
- thrombocytopenia -the State of, characterized by a low platelet count (less than 150х10⁹/l),
- anemia - syndrome, It is characterized by a decrease in the concentration of hemoglobin in the blood, the decline in the number of red blood cells.
From the digestive system:
- nausea,
- vomiting,
- diarrhea,
- mucositis,
- poor appetite,
- constipation (rarely – symptoms of intestinal obstruction),
- increased blood levels of liver enzymes and bilirubin levels.
Allergic reactions:
- skin rash,
- angioedema - acute local allergic edema of the mucous membrane, skin, subcutaneous tissue,
- bronchospasm (rarely) - acute condition, arising from the contraction of the muscles of the bronchi and the narrowing of their lumen.
Cardio-vascular system:
- hypotension - characterized by systolic pressure below 100 mm Hg. Art., diastolic pressure – below 60 mm Hg. Art.,
- bradycardia - a type of arrhythmia, at which the heart rate is less than 60 beats per minute.,
- conduction disorders - arrhythmia, which occurs as a result of dysfunction of automatism, excitability, conductivity and contractility.,
- peripheral edema - condition of limbs, characteristic accumulation of fluid in soft tissues.
Other:
- arthralgia - a symptom of joint pain, characteristic of one or several joints at the same time,
- myalgia - pathology, characterized by severe muscle pain, often accompanied by weakness and swelling,
- perifericheskaya neuropathy - a group of dystrophic lesions of peripheral nerves, caused by various reasons (intoxication, vitamin deficiency, autoimmune processes, tumors, etc.).
Local reactions:
- tromboflebit - inflammation of the internal venous wall with the formation of a thrombus,
- necrosis (when extravasation) - pathological process, expressed in local tissue death in a living organism as a result of any exo- or endogenous damage.
Abitaxel: Contraindications
The main contraindications to the use of Abitaxel are:
- severe neutropenia (less than 1500/MKL),
- hypersensitivity to the drug.
Abitaxel is not recommended for use in children., because its toxicity and efficacy have not been studied in this group of patients.
Abitaxel: use of the drug during pregnancy and lactation
Abitaxel is not approved for use during pregnancy and breastfeeding.. Due to animal data, who showed, that Abitaxel is embryotoxic and fetotoxic in rabbits, and also adversely affects the fertility of rats. Therefore, like other cytotoxic drugs, Abitaxel may be harmful to the fetus. Patients should take measures to prevent pregnancy during treatment with Abitaxel and immediately inform the doctor about a possible pregnancy..
Special Security Measures
When working with Abitaxel, like other antineoplastic drugs, caution. It is necessary to dilute the drug under aseptic conditions in a specially designated room.. This should be done by trained personnel.. It is necessary to take all measures to prevent Abitaxel solutions from getting on the skin. and mucous membranes, especially wear protective clothing (dressing gowns, caps, masks, goggles and disposable gloves). In case of contact with the skin (while local reactions such as tingling are possible, burning and redness of the skin) wash affected area with soap and water. If the drug gets on the mucous membranes, rinse them thoroughly with plenty of water.. The following manifestations have been reported with inhalation of sprayed solutions of Abitaxel:
- breathlessness,
- chest pain,
- burning in the throat
- nausea.
When unopened vials are cooled, a precipitate may form in the preparation., which dissolves with gentle shaking or even without stirring when room temperature is reached. This phenomenon does not affect the quality of the drug.. If the solution remains cloudy or an insoluble precipitate is present, the product must not be used and the vial must be disposed of in accordance with the established procedure for the disposal of hazardous waste.
Disposal of Abitaxel residues
Unused solutions and all tools and materials, who had contact with Abitaxela, should be disposed of in accordance with standard hospital waste disposal procedures for cytotoxic substances, taking into account the current regulations for the destruction of hazardous waste.
Interaction with other drugs and alcohol
When conducting laboratory studies in patients, receiving sequential infusions of Abitaxel and Cisplatin, a more pronounced myelotoxic effect was revealed with the introduction of the drug Abitaxel after cisplatin; while the average values of the total clearance of Abitaxel decreased by approximately 20%.
Previous intake of cimetidine does not affect the average values of the total clearance of the drug Abitaxel.
Based on, obtained in vivo and in vitro, We can assume, that patients, treated with ketoconazole, inhibition of paclitaxel metabolism is observed.
Abitaxel: composition and properties
Abitaxel 6 mg excipients: polyoxyethylated castor oil; Ethanol absolute; acetic acid glacial
Product form
In vials of 5 or 16,7 ml; in a cardboard box 1 bottle.
Pharmacological action
Paclitaxel binds specifically to microtubule beta-tubulin., disrupting the depolymerization process of this key protein, which leads to suppression of the normal dynamic reorganization of the microtubule network, which plays a decisive role during interphase and without which it is impossible to carry out cellular functions in the phase of mitosis. Besides, paclitaxel induces the formation of abnormal microtubule bundles throughout the cell cycle and the formation of multiple centrioles during mitosis.
Storage conditions
Temperatures up to +25 ° C, in a place protected from light and out of the reach of children.
Abitaxel: general information
- Sales form: on prescription
- Current in-about: Paclitaxel
- Manufacturer: TEVA Pharmaceutical Industries Ltd, Israel
- Farm. Group: Antineoplastic agents. Anticancer antibiotics and related drugs
