Paclitaxel-Ebeve concentrate 6mg ml 5ml N1fl
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Active ingredients
Paclitaxel
Release form
Concentrate
Composition
1 ml paclitaxel 6 mg.
Pharmacological effect
An antitumor drug of natural origin, obtained in a semi-synthetic way from the plant Taxus baccata. The mechanism of action is associated with the ability to stimulate the assembly of microtubules from dimeric tubulin molecules, to stabilize their structure and inhibit dynamic reorganization in the interphase, which disrupts the mitotic function of the cell. Causes dose-dependent inhibition of bone marrow hematopoiesis.
Indications
- ovarian cancer (first-line therapy in combination with platinum preparations and second-line therapy for metastases after standard therapy, which did not give a positive result). - breast cancer (as a first and second line therapy, as well as an adjuvant treatment). - non-small cell lung cancer (first-line therapy for patients who are not planning surgical treatment and / or radiation therapy / in combination with cisplatin /). - Kaposi's sarcoma in AIDS patients (second-line therapy, after ineffective therapy with liposomal anthracyclines).
Contraindications
- hypersensitivity to the components of the drug - hypersensitivity to other drugs, the dosage form of which includes polyoxyethylated castor oil - the initial neutrophil content is less than 1500 / μl in patients with solid tumors - the initial (or registered during the treatment process) neutrophil content is less than 1000 / μl for sarcoma Kaposhi patients with AIDS - pregnancy - lactation (breastfeeding) - children's age (safety and efficacy not established). It is used with caution in patients with oppression of bone marrow hematopoiesis (including after chemotherapy or radiation therapy), liver failure, acute infectious diseases (including shingles, chicken pox, herpes), severe IHD, with myocardial myocardium in history, with arrhythmias.
Use during pregnancy and lactation
Controlled studies of the use of paclitaxel in pregnant women have not been conducted. Animal studies have shown embryotoxic, teratogenic and mutagenic effects of paclitaxel. Therefore, during pregnancy, paclitaxel should not be used.It is not known whether paclitaxel is excreted in breast milk, so in order to avoid the toxic effect of the drug on an infant, breastfeeding should be stopped during treatment. Patients during treatment with Paclitaxel-Ebev and for at least 3 months after the end of therapy should use reliable contraceptive methods.
Dosage and administration
Enter in / in. Paclitaxel can be used both as a monotherapy and in combination with other anticancer drugs. The dose and regimen of the drug is selected individually. To prevent severe hypersensitivity reactions, all patients should be premedicated using corticosteroids, histamine H1 and H2 receptor blockers. The recommended premedication scheme is 20 mg of dexamethasone (or its equivalent) orally for approximately 12 hours and 6 hours before the administration of paclitaxel-Ebeve, 50 mg of diphenhydramine (or its equivalent) in / and 300 mg of cimetidine or 50 mg of ranitidine / in 30-60 minutes before the introduction of the drug Paclitaxel-Ebeve. First-line chemotherapy for ovarian cancer A combination regimen of paclitaxel and cisplatin is recommended. Paclitaxel is administered at a dose of 175 mg / m2 of body surface during a 3-hour intravenous infusion or at a dose of 135 mg / m2 over a 24-hour intravenous infusion, after which cisplatin is administered at a dose of 75 mg / m2. Intervals between courses - 3 weeks. Chemotherapy for second-line ovarian cancer Paclitaxel is recommended to be administered at a dose of 175 mg / m2 of body surface by 3-hour intravenous infusion. Intervals between courses - 3 weeks. Adjuvant chemotherapy for breast cancer. Paclitaxel is prescribed after chemotherapy with anthracyclines and cyclophosphamide. Paclitaxel is recommended to be administered at a dose of 175 mg / m2 IV for 3 hours. 4 courses with intervals between courses of 3 weeks. First-line chemotherapy for breast cancer In the case of combined use with doxorubicin (50 mg / m2 body surface), paclitaxel must be administered 24 hours after doxorubicin. The recommended dose of paclitaxel is 220 mg / m2 of body surface when administered by 3-hour IV infusion. Intervals between courses - 3 weeks. In the case of combined use with trastuzumab, paclitaxel is recommended to be administered at a dose of 175 mg / m2 of body surface via a 3-hour IV infusion with an interval between courses of 3 weeks.Paclitaxel can be administered the next day after the first dose of trastuzumab or immediately after the subsequent doses, if the previous dose of trastuzumab was well tolerated. Chemotherapy for second-line breast cancer, paclitaxel is recommended to be administered at a dose of 175 mg / m2 by 3-hour intravenous infusion. Intervals between courses - 3 weeks. Chemotherapy for advanced non-small cell lung cancer A combination regimen for paclitaxel and cisplatin is recommended. Paclitaxel is administered at a dose of 175 mg / m2 body surface via a 3-hour w / w infusion, then cisplatin is administered at a dose of 80 mg / m2. Intervals between courses - 3 weeks. Chemotherapy of Kaposi's sarcoma with AIDS. Paclitaxel is recommended to be administered at a dose of 100 mg / m2 by 3-hour IV infusion. Intervals between courses - 2 weeks. Subsequent doses of paclitaxel are determined individually, depending on the tolerance of therapy. The next dose of paclitaxel can be administered only after increasing the number of neutrophils to the level of & # 8805 .1500 cells / mcl (& # 8805 .1000 cells / mcl in the case of Kaposi's sarcoma), and platelets - to the level of> 100000 cells / mm3 (> 75000 cells / mm3 in the case of Kaposi's sarcoma). Patients who have experienced severe neutropenia (neutrophil count less than 500 cells / mcl for 7 days or more) or severe peripheral neuropathy, reduce the following doses by 20% (25% in the case of Kaposi's sarcoma). Currently, there is insufficient data to make recommendations for dose adjustment for patients with mild or moderately impaired liver function. Patients with severely impaired liver function should not be given paclitaxel. Terms of preparation of the solution for infusion In the preparation, storage and administration of the drug Paclitaxel-Ebeve, you should use equipment that does not contain PVC: for example, from glass, polypropylene or polyolefin. A solution of the drug is prepared by diluting the concentrate to a final concentration of paclitaxel from 0.3 to 1.2 mg / ml. As a diluting solution can be used: 0.9% sodium chloride solution, 5% dextrose solution, 5% dextrose solution in 0.9% sodium chloride solution, 5% dextrose solution in Ringer's solution. Prepared solutions may opalesce due to the presence of the base carrier in the formulation.With the introduction of the drug should use a system with a membrane filter (pore size not more than 0.22 microns). Solutions for infusions prepared by diluting Paclitaxel-Ebeve with a 0.9% solution of sodium chloride or 5% dextrose are physically and chemically stable for 51 hours when stored at 25 ° C and 14 days when stored at 5 ° C. From a microbiological point of view, the solution for infusion should be administered immediately after preparation. If the solution is not used immediately after preparation, the storage time should not exceed 24 hours at a temperature between 2 ° and 8 ° C, unless the solution has been prepared under controlled aseptic conditions. To reduce the risk of sediment formation, the infusion solution must be injected immediately after dilution and excessive shaking, vibrations and agitation should be avoided. The infusion system must be thoroughly flushed before use. In the process of introduction, it is necessary to regularly monitor the appearance of the solution and stop the infusion if sediment is detected.
Side effects
The frequency and severity of side effects are dose-dependent. Determination of the frequency of side effects: very often -> 10%, often - from 1 to 10%, infrequently - from 0.1% to 1%, rarely - from 0.01 to 0.1%, very rarely - less than 0.01%. On the part of the hematopoietic system: very often - myelosuppression, neutropenia, thrombocytopenia, anemia, leukopenia, bleeding. rarely febrile neutropenia. very rarely, acute myeloid leukemia, myelodysplastic syndrome. On the part of the nervous system: very often - neurotoxic effects (mainly peripheral neuropathy), paresthesia. rarely, motor neuropathy (moderately pronounced weakness of the distal muscles, difficulty in performing precise movements). very rarely - autonomic neuropathy (leading to paralytic ileus and orthostatic hypotension), major epileptic seizures (grand mal), convulsions, encephalopathy, dizziness, headache, confusion, ataxia. Since the cardiovascular system: often - bradycardia, lower blood pressure. infrequently - cardiomyopathy, asymptomatic ventricular tachycardia, AV-blockade, syncope, increased blood pressure, myocardial infarction, vascular thrombosis, thrombophlebitis. very rare - atrial fibrillation, supraventricular tachycardia, shock.On the part of the senses: very rarely - lesions of the optic nerve and / or visual impairment (atrial scotoma), hearing loss, tinnitus, dizziness. On the part of the respiratory system: rarely - shortness of breath, pleural effusion, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism, respiratory failure, radiation pneumonitis in patients simultaneously undergoing radiation therapy. very rare - cough. On the part of the digestive system: very frequent - nausea, vomiting, diarrhea, inflammation of the mucous membranes. rarely - pancreatitis, intestinal perforation, ischemic colitis. very rarely - anorexia, constipation, mesenteric thrombosis, pseudomembranous colitis, esophagitis, ascites, neutropenic colitis, hepatic necrosis, hepatic encephalopathy (there are single reports of fatal outcome). On the part of the skin and skin appendages: very often - alopecia. often - transient small changes in nails and skin (pigmentation, discoloration of the nail bed). rarely - itching of the skin, rash, erythema. very rarely - Stevens-Johnson syndrome (ulceration of the oral mucosa, throat, eyes, genitals, other skin and mucous membranes), epidermal necrolysis, erythema multiforme, exfoliative dermatitis, urticaria, onycholysis. From the musculoskeletal system: very often - arthralgia, myalgia. On the part of the immune system: very frequent infections (mainly the urinary tract and upper respiratory tract). infrequently - serious hypersensitivity reactions requiring therapeutic measures (namely, lowering blood pressure, angioedema, respiratory distress syndrome, generalized urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in the extremities, pronounced sweating, increase in blood pressure). rarely - anaphilatoid reactions. From the laboratory parameters: often - an increase in the activity of hepatic transaminases, an increase in the concentration of alkaline phosphatase, bilirubin, creatinine in the blood serum. Local reactions: often - pain, localized edema, erythema, induration and skin pigmentation at the injection site. extravasation may cause inflammation and necrosis of the subcutaneous tissue. Other: rarely - asthenia, fever, dehydration, general weakness.
special instructions
The frequency and severity of side effects are dose-dependent. Determination of the frequency of side effects: very often -> 10%, often - from 1 to 10%, infrequently - from 0.1% to 1%, rarely - from 0.01 to 0.1%, very rarely - less than 0.01%. On the part of the hematopoietic system: very often - myelosuppression, neutropenia, thrombocytopenia, anemia, leukopenia, bleeding. rarely febrile neutropenia. very rarely, acute myeloid leukemia, myelodysplastic syndrome. On the part of the nervous system: very often - neurotoxic effects (mainly peripheral neuropathy), paresthesia. rarely, motor neuropathy (moderately pronounced weakness of the distal muscles, difficulty in performing precise movements). very rarely - autonomic neuropathy (leading to paralytic ileus and orthostatic hypotension), major epileptic seizures (grand mal), convulsions, encephalopathy, dizziness, headache, confusion, ataxia. Since the cardiovascular system: often - bradycardia, lower blood pressure. infrequently - cardiomyopathy, asymptomatic ventricular tachycardia, AV-blockade, syncope, increased blood pressure, myocardial infarction, vascular thrombosis, thrombophlebitis. very rare - atrial fibrillation, supraventricular tachycardia, shock. On the part of the senses: very rarely - lesions of the optic nerve and / or visual impairment (atrial scotoma), hearing loss, tinnitus, dizziness. On the part of the respiratory system: rarely - shortness of breath, pleural effusion, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism, respiratory failure, radiation pneumonitis in patients simultaneously undergoing radiation therapy. very rare - cough. On the part of the digestive system: very frequent - nausea, vomiting, diarrhea, inflammation of the mucous membranes. rarely - pancreatitis, intestinal perforation, ischemic colitis. very rarely - anorexia, constipation, mesenteric thrombosis, pseudomembranous colitis, esophagitis, ascites, neutropenic colitis, hepatic necrosis, hepatic encephalopathy (there are single reports of fatal outcome). On the part of the skin and skin appendages: very often - alopecia. often - transient small changes in nails and skin (pigmentation, discoloration of the nail bed). rarely - itching of the skin, rash, erythema. very rarely - Stevens-Johnson syndrome (ulceration of the oral mucosa, throat, eyes, genitals, other skin and mucous membranes), epidermal necrolysis, erythema multiforme, exfoliative dermatitis, urticaria, onycholysis.From the musculoskeletal system: very often - arthralgia, myalgia. On the part of the immune system: very frequent infections (mainly the urinary tract and upper respiratory tract). infrequently - serious hypersensitivity reactions requiring therapeutic measures (namely, lowering blood pressure, angioedema, respiratory distress syndrome, generalized urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in the extremities, pronounced sweating, increase in blood pressure). rarely - anaphilatoid reactions. From the laboratory parameters: often - an increase in the activity of hepatic transaminases, an increase in the concentration of alkaline phosphatase, bilirubin, creatinine in the blood serum. Local reactions: often - pain, localized edema, erythema, induration and skin pigmentation at the injection site. extravasation may cause inflammation and necrosis of the subcutaneous tissue. Other: rarely - asthenia, fever, dehydration, general weakness.