Description overdue on 08/12/2014

• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions on Paclitaxel (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Cautions
• Analogs
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

1 ml of concentrate contains 6 mg Paclitaxel . Additional components: anhydrous ethanol, purified makrogolglitserol ricinoleate nitrogen.

Product form

Paclitaxel is available in the form of a translucent yellow color concentrate for solution administered by infusion. Volumes glass vial: 5, 16.7, 25, 35, 41, 50 ml. Each bottle is packed in a pile of cardboard with the instructions supplied by the manufacturer.

Pharmacological action

Antitumor medication . The active substance is of vegetable origin, paclitaxel semi-synthetic methods obtained from a plant of Taxus Baccata. Active ingredient inhibits the process mitosis . The mechanism of action is based on specific binding to beta-tubulin in microtubules, which violates the basic depolymerization of the protein, resulting in depression of the dynamics of a functioning reorganization of the microtubule network plays an important role in interphase and mitosis. Paclitaxel promotes the formation of abnormally developed bundles of microtubules during the entire cell cycle.

The drug has the ability to dose-dependently inhibit bone marrow hematopoiesis . Experimentally it was shown that the medication has embryotoxic and mutagenic effects and suppresses the reproductive function of the body.

Pharmacodynamics and pharmacokinetics

Plasma protein binds to the active substance in the 89-98%. The biological transformation is carried out in the hepatic system. Active and inactive metabolites   displayed as a bile And through the renal system.

Indications

• ovarian cancer   (pervolineynaya therapy of patients with common form of cancers or with residual tumor larger than 10 mm) after laparotomy operations conducted jointly with cisplatin. Available second-line therapy in patients with metastatic disease diagnosed after a classical treatment scheme, which did not produce dramatically positive results;
• mammary cancer   (together with damage to the lymphatic system after the classic combination regimens - adjuvant therapy). The drug can also be used in relapsed within six months after adjuvant therapy. The drug is part of a second line regimen - with metastatic lesions;
• Kaposi's sarcoma   in patients suffering from AIDS . The drug is prescribed for treatment failure liposomal anthracyclines;
• non-small cell form Lung Cancer . Administered with cisplatin in patients who have not planned radiation therapy   and surgical treatment.

Contraindications

• neutrophils less than 1500 / ml in patients diagnosed with solid onkoobrazovaniyami;
• neutrophils less than 1000 / ml in patients suffering from AIDS, diagnosed with Kaposi's sarcoma;
• breast-feeding ;
• Individual hypersensitivity;
• pregnancy.

Conditions and diseases in which medication should be administered with caution:

• arrhythmia;
• myocardial infarction;
• liver disease;
• thrombocytopenia ;
• infectious disease in the acute phase ( herpes infection . chicken pox . shingles );
• severe course of CHD;
• diagnosed thrombocytopenia (number Platelet   less 100000 1 L).

Reliable information about the safety of the drug in pediatric practice there.

Side effects of Paclitaxel

Severity of adverse events is dose-dependent.

Side effects from the hematopoietic system :

• anemia;
• neutropenia ;
• reduction in the number of platelets.

Inactivation granulocyte germ   It is the main toxic effect, which does not allow to increase the dose of medication. In the 8-11 day anticancer therapy indicated maximum drop in the number of neutrophils. The index is normalized to 22 days.

Allergic responses :

• bronchospasm;
• angioedema ;
• itching , Rashes;
• drop blood pressure ;
• generalized form hives , Flushes the blood flow to the face.

In a few cases appear chest pain, back pain, chills.

Cardiovascular system:

• atrioventricular block;
• tachycardia   (rapid pulse);
• bradycardia   (urezhёnny pulse);
• thrombophlebitis and thrombosis ;
• rise or fall in blood pressure.

Respiratory tract:

• Radiation pneumonitis   after radiotherapy;
• pulmonary embolism;
• interstitial pneumonia;
• fibrosis of the lung tissue.

Nervous system:

• seizures by type of grand mal;
• paresthesia;
• autonomic neuropathy (orthostatic hypotension and ileus paralytic nature);
• encephalopathy ;
• ataxia;
• of the visual perception.

Musculoskeletal system:

• myalgia;
• arthralgia.

The digestive tract:

• mucositis;
• nausea;
• diarrheal syndrome ;
• constipation ;
• vomiting;
• anorexia ;
• ischemic colitis;
• intestinal perforation;
• acute intestinal obstruction;
• thrombosis of the superior mesenteric artery.

Liver:

• increase bilirubin and alkaline phosphatase in the blood;
• increase in ALT, AST;
• hepatic encephalopathy;
• gepatonekroz .

Local manifestations:

• erythema;
• puffiness;
• pigmentation of the skin;
• induration of the skin;
• pain;
• nekrotizirovanie subcutaneous tissue;
• inflammation after extravasation.

Other reactions:

• alopecia ;
• malaise;
• asthenia;
• change in color of the nail bed.

Instructions on Paclitaxel (method and dosage)

Intravenous Dexamethasone   in an amount of 20 mg before the infusion of anti-tumor agent to prevent negative allergic reactions .
Paclitaxel is intended for intravenous administration (3 or 24 hours) to translation at 3 week intervals. The drug can be assigned to monotherapy, but increasingly more effectively appoint additional Cisplatin   (with ovarian cancer and non-small cell lung cancer form), or Doxorubicin   (in the pathology of mammary glands).

When KS medicament is administered every two weeks for 3 hours at a dose of 100 mg / m2. Treatment is carried out as long as the level of neutrophils will not be 1500 / L, and the rate of platelet numbers reach 100,000 / microliter. When you register neutropenia immediately after infusion it is recommended to reduce next dose by 20%. The introduction of anti-tumor medication is carried out through a system equipped with a built-in membrane filter.

Overdose

Registers peripheral neuropathy,   aplasia of the bone marrow tissue , Mucositis. Specific antidote   It has not been developed. Held posindromnaya therapy.

Cooperation

Laboratory studies have shown that the sequential administration of paclitaxel and cisplatin increases the severity of the effect of myelotoxic. The total clearance Paclitaxel reduced by 20%.

Introduction Cimetidine does not affect the average total clearance. Suppression Paclitaxel metabolism observed in patients who have received at the same time Ketoconazole .

Terms of sale

Paclitaxel is sold in the pharmacy. Presenting a medical prescription form is mandatory.

Storage conditions

The drug belongs to the list recommended by the manufacturer B. temperature range: 15-25 degrees. Restrict uncontrolled admission of young children to the bottle with the solution.

Shelf life

2 years.

Cautions

The treatment can be administered and carried out only under the supervision of oncologist who has experience in treating cancer patients anticancer chemotherapeutic drugs.

Premedication   with corticosteroids and antihistamines appointment can prevent severe reactions in the drug intolerance. With the development of adverse reactions not described in the relevant section, the infusion of the drug is stopped and carried posindromnuyu therapy. Repeated infusions are strictly contraindicated. Storage, preparation and administration of the solution should be carried out using equipment which does not contain parts of PVC. Mandatory control of blood indicators, the level of blood pressure, pulse, respiratory rate, ECG. When registration is required atrioventricular conduction disorders Hour cardiomonitoring . In combination with cisplatin, paclitaxel, primarily administered paclitaxel. Be sure to use methods   Contraception .

The active component has a cytotoxic effect that requires special care: Use protective gloves, thorough washing of the skin and mucous membranes in contact with the solution.

Analogs

• Abitaksel;
• Paktalek;
• Intaksel;
• Taxol;
• Yutaksan .

During pregnancy (and lactation)

Requires the use of reliable contraceptive methods because the active ingredient has embryotoxic influence   and having teratogenic effects.   Lactation during anticancer therapy is stopped.

Reviews of paclitaxel

Health Forums thematic forums contain a variety of opinions about medications. The oncologists actively prescribe the drug in the treatment of cancer patients with ovarian cancer or breast cancer, indicates severe tolerability especially in the elderly. Doctors say a good performance after the anticancer therapy of paclitaxel.

Price paclitaxel where to buy

Paclitaxel / 5 mL (30 mg) costs 2000 rubles. Price paclitaxel 300 mg (50 ml) - 7000 rubles. Buy in Moscow can be in the pharmacy by presenting a prescription form from the oncologist.