Usage and dosage of paclitaxel injection

Note: It is not recommended to contact undiluted concentrated liquid medicine with polyvinyl chloride (PVC) container to prepare drip. In order to reduce patients' exposure to DEHP plastic substances [2-(2- ethylhexyl) phthalate, di -(2- ethylhexyl) phthalate], these substances may be released from PVC drip bags or other devices. The diluted paclitaxel solution should be stored in glass bottles, polypropylene bottles or plastic bags and dripped with polyethylene-lined drug delivery equipment. Prophylactic drugs: In order to prevent severe allergic reactions, all patients receiving paclitaxel should take preventive drugs in advance. Dexamethasone 20mg can be taken orally, generally 12 and 6 hours before paclitaxel, diphenhydramine (or its similar drugs) 50mg can be injected intravenously 30-60 minutes before paclitaxel injection, and cimetidine (300mg) can be injected intravenously 30-60 minutes before paclitaxel injection. Dosage: For patients with ovarian cancer, the following therapies are recommended: 1) For patients with untreated severe ovarian cancer, the following therapies are recommended once every three weeks. A. intravenous injection of paclitaxel175mg/㎡ for more than 3 hours and cisplatin for 75mg/㎡, or b. intravenous injection of paclitaxel for more than 24 hours and cisplatin for 75 mg/㎡. 2) The patient received chemotherapy for ovarian cancer. Paclitaxel was used in multiple doses and regimens, but the optimal dosage regimen was not clear. The recommended treatment plan is: intravenous injection of paclitaxel 135mg/㎡ or 175mg/㎡, once every three weeks for more than 3 hours each time. For patients with breast cancer, the following therapies are recommended: 1) The adjuvant treatment scheme for lymph node positive breast cancer is: paclitaxel is injected intravenously once every three weeks for more than 3 hours, and the dose is 175mg/㎡, and adriamycin is used in combination chemotherapy. 2) The adjuvant treatment scheme for patients who failed in initial chemotherapy and had metastasis or recurrence within 6 months is: once every three weeks, intravenous injection of paclitaxel175 mg/㎡ for more than 3 hours, which proved to be effective. The recommended regimen for patients with non-small cell lung cancer is to give paclitaxel 175mg/㎡ intravenous injection once every three weeks for more than 3 hours each time. For AIDS-related Sarcoma Carinii, the recommended treatment plan is: once every three weeks, intravenous injection of paclitaxel135 mg/m2 for more than 3 hours, or once every two weeks, intravenous injection of paclitaxel100 mg/m2 for more than 3 hours (dose intensity is 45-50m g/m2/ week). Paclitaxel 135mg/㎡ is injected intravenously once every three weeks, and the toxicity is greater than the latter if the injection time exceeds 3 hours. In addition, all patients who used the latter (paclitaxel100 mg/m ㎡ once every two weeks for more than 3 hours) had low curative effect. In view of the immunosuppression of patients with advanced HIV, an improved scheme is recommended for such patients: 1) reduce the dosage of dexamethasone in the three prodrugs, and the dosage is 10mg (instead of 20 mg) orally; 2) Only when the neutrophil count is at least 1000 /mm3 can paclitaxel be used for the first time or again; 3) For patients with neutropenia (neutrophils below 500 /mm3), the dosage of paclitaxel will be reduced by 20% in the later stage of treatment. 4) It is suggested that G-CSF should be used to treat patients with solid tumors (ovary, breast, non-small cell lung cancer) at the initial stage, only when neutrophils are at least 65,438+500 /mm3 and platelets are at least 65,438+0,000. Patients with severe neutropenia (neutrophils below 500 /mm3 for more than a week or more) or peripheral nerve diseases during paclitaxel treatment should reduce the dosage of paclitaxel by 20% in the subsequent treatment. The incidence of neurotoxicity and severe neutropenia increased with the increase of paclitaxel dose. The toxicity risk of patients with impaired liver function may be increased, especially the risk of ⅲ-ⅳ bone marrow suppression. For 3-hour infusion and 24-hour infusion, the recommended dose control method for the first course of treatment is shown in Table 1, and whether to further reduce the dose for subsequent courses depends on personal tolerance. It is necessary to closely monitor whether the patient has deep bone marrow suppression. Table 1: according to clinical trial data, the recommended dose for patients with impaired liver function. A liver function damage, transaminase level, bilirubin level, recommended dose of paclitaxel, c 24-hour infusion < < 2×ULN and ≤1.5 mg/dl135 mg/M22-<10× ULN and ≤1.5 mg/. The recommended dosage above 0×ULN and 1.6-7.5mg/dl 55 is based on the dosage of patients without liver damage (135 mg/m2, infusion time is more than 24 hours or 175 mg/m2, infusion time is more than 3 hours); There are no clinical data of other dose-adjusted treatment schemes (such as AIDS-related sarcoma). There is a difference in bilirubin levels between b3-hour infusion and 24-hour infusion, which is caused by the difference in clinical trial design. C This is a dose suggestion for 1 course of treatment: whether to further reduce the dose in the future course of treatment should be judged according to the individual's tolerance. Course of treatment: determined by the doctor according to the condition. Description: Paclitaxel concentrated injection must be diluted before drip. Paclitaxel should be diluted in 0.9% sodium chloride injection (USP), or 5% glucose injection (USP), or 5% glucose plus 0.9% sodium chloride injection (USP) or 5% glucose rennet solution, and added to the final concentration of 0.3 to 1.2mg/ml. The physical and chemical properties of the product solution can be kept stable for 27 hours at ambient temperature (about 25℃) and indoor illumination. Before injecting this kind of drugs, we should check whether there are particles or color changes with the naked eye under the possible conditions of the solution and container. In the process of dilution preparation, fog may appear in the solution, which is caused by the prepared dilution solvent. When this solution flows through the intravenous drip pipeline connected to the filter (0.22 micron aperture), it has been proved that there is no obvious drop in titer. When the product was diluted in a polyvinyl chloride (PVC) container, the data collected from the existence of extractable di (2- ethylhexyl) phthalate (DEHP) showed that its content increased with time and concentration. Therefore, PVC containers and solution tubes are not suitable. For the preparation and storage of paclitaxel solution, glass containers, polypropylene containers or polyolefin containers should be used. The infusion tube should not contain PVC, but should contain polyethylene lining. Taxol droplets should first be filtered through a microporous membrane with a diameter not exceeding 0.22 micron connected in the system. All filtering equipment is connected with the short inlet and outlet of PVC, which will not cause obvious dissolution of DEHP plastic. Stability: The unopened concentrated paclitaxel injection is stable when stored at room temperature of 65438 05℃-30℃ and packaged as it is. Cold storage of this product will not have adverse effects. The components of paclitaxel may precipitate under cold storage conditions, but when it is raised to room temperature, it will dissolve again with little or no shaking. Under these conditions, there is no influence on the quality of the product. If the solution becomes blurred or insoluble precipitation occurs, the drug should be discarded. The liquid drops prepared according to the recommended conditions are stable under normal room temperature (about 25℃) and illumination conditions, and the stability reaches 27 hours. Blood transfusion should be completed within this time. It is reported that precipitation may occur when the infusion time is longer than the recommended 3 hours, but this report is rare. Violent agitation, vibration or shaking may cause precipitation, so don't do it. Before taking the medicine, the infusion set should be thoroughly washed with diluent, and there is no incompatibility.