Paclitaxel - instructions for use, analogs, testimonials and release forms (solution for infusions, injections or droppers Teva, Ebwee) a drug for the treatment of breast, ovarian, lung cancer in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Paclitaxel. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Paclitaxel in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Paclitaxel in the presence of existing structural analogs.Use for the treatment of breast, ovarian, lung cancer in adults, children, as well as in pregnancy and lactation. Composition of the preparation.

Paclitaxel antitumor agent. It is a mitotic inhibitor. Paclitaxel specifically binds to the beta tubuline of microtubules, disrupting the depolymerization 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 perform cellular functions in the mitosis phase. In addition, paclitaxel causes the formation of abnormal microtubule beams throughout the entire cell cycle and the formation of several centrioles during mitosis.

Composition

Paclitaxel + auxiliary substances.

Pharmacokinetics

Binding to plasma proteins is 89-98%. Biotransformiruetsya mainly in the liver. It is excreted as kidneys in unchanged form, and with bile (both unchanged and in the form of metabolites).

Indications

• ovarian cancer (including with ineffectiveness of platinum drugs);
• mammary cancer;
• cancer of the lungs and bronchi;
• esophageal carcinoma;
• cancer of the head and neck;
• cancer of the bladder.

Forms of release

Concentrate for the preparation of a solution for infusions (injections in ampoules for injections or droppers) 300 mg in a 50 ml bottle.

There are no other dosage forms, be it capsules or tablets.

Instructions for use and dosing regimen

Intravenously in the form of a 3- or 24-hour infusion (droppers) at a dose of 135-175 mg / m2 with an interval between courses of 3 weeks.

To prevent severe reactions of hypersensitivity, all patients should undergo premedication with glucocorticosteroids (GCS), antihistamines and antagonists of histamine H2 receptors. For example, 20 mg Dexamethasone (or its equivalent) orally - approximately 12 and 6 hours before the administration of the drug Paclitaxel; 50 mg of Diphenhydramine (or its equivalent) intravenously and 300 mg of cimetidine or 50 mg of Ranitidine intravenously 30-60 minutes before the administration of Paclitaxel.

When choosing the regimen and doses in each individual case, one should be guided by the literature data.

Paclitaxel is used as a monotherapy or in combination with Cisplatin (ovarian cancer and non-small cell lung cancer) or doxorubicin (breast cancer).

The recommended dose of Paclitaxel for the treatment of Kaposi's sarcoma in patients with AIDS is 100 mg / m2 as a 3-hour infusion every 2 weeks.

Administration of the drug Paclitaxel should not be repeated until the neutrophil count is at least 1500 / μL of blood, and the platelet count is at least 100,000 / μL of blood. Patients who had severe neutropenia (neutrophil count less than 500 / mm3 blood for 7 days or longer) or severe peripheral neuropathy after treatment with Paclitaxel should be reduced by 20% during subsequent courses of treatment.

The drug solution is prepared immediately before administration, diluting the concentrate with 0.9% sodium chloride solution, or 5% Dextrose solution, or 5% dextrose solution in a 0.9% solution of sodium chloride for injection, or 5% dextrose solution in Ringer's solution to a final concentration from 0.3 to 1.2 mg / ml. The prepared solutions may be opalescent due to the carrier base present in the formulation, after which the opalescence of the solution is retained.

When preparing, storing and administering Paclitaxel, you should use equipment that does not contain PVC parts.

Paclitaxel should be administered via a system with an integrated membrane filter (pore size not more than 0.22 microns).

Side effect

• leukopenia, thrombocytopenia, anemia;
• nausea, vomiting;
• diarrhea, constipation;
• mucositis;
• deterioration of appetite;
• the phenomena of intestinal obstruction;
• increase in the blood activity of hepatic enzymes and bilirubin levels;
• skin rash;
• angioedema;
• bronchospasm;
• arterial hypotension;
• bradycardia;
• conduction disorders;
• peripheral edema;
• arthralgia;
• myalgia;
• peripheral neuropathy;
• thrombophlebitis;
• necrosis (with extravasation).

Contraindications

• severe neutropenia (less than 1500 / μl);
• pregnancy;
• hypersensitivity to paclitaxel.

Application in pregnancy and lactation

Paclitaxel is contraindicated in pregnancy. If it is necessary to use lactation, breastfeeding should be discontinued.

Women of childbearing age should apply reliable contraceptive methods during the use of paclitaxel.

In experimental studies, it has been established that paclitaxel has a teratogenic and embryotoxic effect.

special instructions

With caution use paclitaxel in patients with angina pectoris, rhythm and conduction disorders, chronic heart failure, with chickenpox (including recently transferred or after contact with the sick), herpes zoster and other acute infectious diseases, and within 6 months after a recent myocardial infarction.

When using paclitaxel in patients with impaired liver function, a dosage regimen may need to be adjusted.

To prevent the occurrence of hypersensitivity reactions, all patients should undergo premedication (glucocorticosteroids (GCS), histamine H1 and H2 receptor blockers).

In the process of treatment, a systematic control of the peripheral blood pattern, control of blood pressure, ECG is necessary. Do not take another infusion of paclitaxel until the number of neutrophils exceeds 1500 / μl, and the platelet count is 100,000 / μL.

When using paclitaxel in patients with impaired liver function, a dosage regimen may need to be adjusted.

Do not recommend the vaccination of patients and their families.

When preparing and introducing a solution of paclitaxel, you should not use PVC infusion systems.

In experimental studies, it has been established that paclitaxel has a mutagenic effect.

Patients should be provided with reliable contraceptive methods during treatment with paclitaxel and at least 3 months after the end of therapy.

Drug Interactions

When conducting laboratory studies in patients who received consistent infusions of paclitaxel and cisplatin, a more pronounced myelotoxic effect was found when paclitaxel was administered after cisplatin; mean values ​​of total clearance of paclitaxel decreased by approximately 20%.

The previous administration of cimetidine does not affect the average values ​​of total clearance of paclitaxel.

Based on the data obtained in vivo and in vitro, it can be assumed that in patients receiving ketoconazole, suppression of paclitaxel metabolism is observed.

Analogues of the drug Paclitaxel

Structural analogs for the active substance:

• Abitaxel;
• Intaksel;
• Kanataksen;
• Mitotax;
• The paclikal;
• Paclitaxel is semisynthetic;
• Paclitaxel LENS;
• Paclitaxel Teva;
• Paclitaxel Phylaxis;
• Paclitaxel Ebwe;
• Pacifier;
• Paxen;
• Pactalek;
• Sindaxel;
• Taxiade;
• Taxol;
• Yutaksan.

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