Concentrate for solution for infusion "Paclitaxel" Ebewe "is used for the following indications:
ovarian cancer (first-line chemotherapy for the treatment of ovarian cancer, as well as in combination with cisplatin for advanced disease or residual tumors (larger than 1 cm) after laparotomy; second-line chemotherapy for metastatic ovarian cancer when standard platinum therapy is ineffective); breast cancer (adjuvant chemotherapy of patients with lymph node involvement after standard combination therapy with anthracyclines or cyclophosphamide, primary chemotherapy of locally advanced or metastatic breast cancer in combination with anthracyclines or in combination with trastuzumab in case of immunohistochemical overexpression of HER-2 oncoproteins (3+) or in case of contraindications to anthracycline therapy; monotherapy of metastatic breast cancer in patients who are not candidates for standard anthracycline therapy or in case of ineffectiveness of previous anthracycline therapy); advanced non-small cell lung cancer (NSCLC) (combined chemotherapy with cisplatin in case of impossibility of surgical treatment and/or radiotherapy); Kaposi's sarcoma in AIDS patients (second-line therapy of advanced Kaposi's sarcoma in case of ineffectiveness of previous therapy with liposomal anthracyclines).
Composition
The active substance is paclitaxel (1 ml of concentrate contains 6 mg of paclitaxel).
Excipients: polyethoxylated castor oil, anhydrous ethanol.
Contraindication
Hypersensitivity to paclitaxel or other components of the drug, especially to polyethoxylated castor oil; pregnancy and lactation; neutropenia before the start of treatment (initial neutrophil count <1.5 × '10 9 / l, in the case of Kaposi's sarcoma in AIDS patients, the neutrophil count <1 × '10 9 / l), thrombocytopenia (<100 × '10 9 / l); concomitant severe uncontrolled infections in patients with Kaposi's sarcoma; severe liver dysfunction.
Method of application
Before starting treatment with the drug, all patients should receive premedication with corticosteroids, antihistamines, and H2-receptor antagonists.
Paclitaxel solution should be administered intravenously via infusion systems with built-in membrane filters with a pore size ≤ 0.22 μm.
First-line chemotherapy for ovarian cancer
A combination regimen of paclitaxel and cisplatin is recommended. Two doses of paclitaxel are recommended, depending on the duration of infusion:
Paclitaxel at a dose of 175 mg/m2 should be administered by intravenous infusion over 3 hours, followed by cisplatin at a dose of 75 mg/m2; Paclitaxel at a dose of 135 mg/m2 should be administered as a 24-hour infusion, followed by cisplatin at a dose of 75 mg/m2.
The intervals between treatment courses are 3 weeks.
Second-line chemotherapy for ovarian cancer
Paclitaxel is recommended to be administered at a dose of 175 mg/m2 by 3-hour infusion. Usually, no more than 4 courses are prescribed at 3-week intervals.
Adjuvant chemotherapy for breast cancer
Paclitaxel is administered after chemotherapy with anthracyclines or cyclophosphamide. Paclitaxel is recommended to be administered at a dose of 175 mg/m2 by 3-hour infusion. Usually 4 courses are prescribed with intervals of 3 weeks between them.
First-line chemotherapy for breast cancer
When used in combination with doxorubicin (50 mg/m2), paclitaxel should be administered 24 hours after doxorubicin. The recommended dose of paclitaxel is 220 mg/m2 administered as a 3-hour infusion. The interval between courses of treatment is 3 weeks.
When used in combination with trastuzumab, paclitaxel is recommended to be administered at a dose of 175 mg/m2 by 3-hour infusions with intervals between courses of 3 weeks. Paclitaxel can be administered the day after the first dose of trastuzumab or immediately after subsequent doses of trastuzumab if the previous doses were well tolerated.
Second-line chemotherapy for breast cancer
Paclitaxel is recommended to be administered at a dose of 175 mg/m2 by 3-hour infusion. The intervals between treatment courses are 3 weeks.
Chemotherapy for advanced non-small cell lung cancer (NSCLC)
A combination regimen of paclitaxel and cisplatin is recommended. Paclitaxel should be administered at a dose of 175 mg/m2 as a 3-hour infusion, followed by cisplatin at a dose of 80 mg/m2. The intervals between courses of treatment are 3 weeks.
Chemotherapy for Kaposi's sarcoma in AIDS patients
Paclitaxel is recommended to be administered at a dose of 100 mg/m2 by 3-hour infusions. The intervals between treatment courses are 2 weeks.
Application features
Pregnant women
There is no information on the use of paclitaxel in pregnant women. As with other cytotoxic drugs, paclitaxel may cause fetal harm and should not be used during pregnancy. Women and men should use contraception to prevent pregnancy during treatment with paclitaxel and for at least 6 months after treatment with paclitaxel, and should inform their doctor immediately if pregnancy occurs. Breastfeeding should be discontinued during treatment with paclitaxel.
If necessary, cryopreservation of sperm in men should be performed before starting paclitaxel treatment due to the possible development of infertility.
The safety and efficacy of paclitaxel in children have not been established, therefore paclitaxel is not recommended for use in this category of patients.
Drivers
During treatment with paclitaxel, one should refrain from potentially hazardous activities that require increased concentration and quick reactions. It should be borne in mind that the drug contains ethanol, and some side effects may adversely affect the ability to drive vehicles or operate complex mechanisms.
Overdose
Symptoms
The main expected complications of overdose are bone marrow suppression, peripheral neuropathy, and inflammation of the mucous membranes.
Treatment
In case of overdose, the drug should be discontinued immediately and symptomatic treatment should be carried out with monitoring of the blood cell count and vital organ function. There is no known antidote for paclitaxel.
Side effects
The most common side effect of paclitaxel treatment is bone marrow suppression.
Storage conditions
Keep out of reach of children. No special storage conditions required.
Shelf life - 3 years.
