Paclitaxel Liposomal Injection

Pharmacological action: This product is a cytotoxic antitumor drug that can promote the assembly of microtubule dimers and prevent their disassembly. It can also lead to abnormal arrangement of microtubules throughout the cell cycle and the production of microtubule astrocytes during cell division, thereby hindering cell division and inhibiting tumor growth. Toxicological studies: Genetic toxicity: In vitro (human lymphocyte chromosome aberration test) and in vivo (mouse micronucleus test) tests showed that paclitaxel is a clastogen, but it was not found to be mutagenic in the Ames test and CHO/HGPRT gene mutation test. Reproductive toxicity: When paclitaxel is given to rats before and during mating at a dose of 1 mg/kg/day (about 0.04 times the maximum recommended daily dose in clinical practice based on body surface area) or more, it can cause fertility damage in female and male rats. At this dose, this product causes a decrease in fertility and reproductive indexes and an increase in embryotoxicity. When rabbits were given paclitaxel at 3 mg/kg/day during the organogenesis period (about 0.2 times the maximum recommended daily dose in clinical practice, based on body surface area), it could cause embryonic and fetal toxicity such as intrauterine death, increased fetal absorption, and increased fetal death, and maternal toxicity was also observed. When the dose was 1 mg/kg/day (about 1/15 of the maximum recommended daily dose in clinical practice, based on body surface area), no teratogenic effect was observed. At higher doses, due to the large number of fetal deaths, the teratogenicity of this product could not be evaluated. There is no sufficient and strictly controlled clinical research data on pregnant women. If patients use this product during pregnancy, or become pregnant while using this product, they should be informed of the potential harm of this product to the fetus. Women of childbearing age who receive this product should avoid pregnancy. It is not clear whether this product is excreted from human milk. When rats were given carbon-14 labeled paclitaxel intravenously 9-10 days after delivery, the radioactive concentration in their milk was higher than that in plasma, and decayed in parallel with the plasma concentration. Given that many drugs are excreted in human milk and that this product may cause serious adverse reactions in nursing infants, it is recommended to stop breastfeeding while receiving treatment with this product.

Paclitaxel. Excipients: lecithin, cholesterol, threonine, glucose.

This product is for injection

1. This product can be used for first-line chemotherapy of ovarian cancer and the treatment of ovarian metastatic cancer in the future. As first-line chemotherapy, this product can also be used in combination with cisplatin. 2. This product can also be used for follow-up treatment of breast cancer patients who have used standard chemotherapy containing doxorubicin or for the treatment of recurrent patients. 3. This product can be combined with cisplatin as first-line chemotherapy for patients with non-small cell lung cancer who cannot undergo surgery or radiotherapy.

The common dose is 135-175mg/m2. Before use, add 10ml 5% glucose solution to the bottle, place it on a special oscillator (oscillation frequency 20Hz, amplitude: 7cm in the X-axis direction, 7cm in the Y-axis direction, 4cm in the Z-axis direction) and shake it for 5 minutes. After it is completely dissolved, inject it into 250-500ml 5% glucose solution and use a disposable infusion set that meets national standards for intravenous drip for 3 hours. To prevent possible allergic reactions to paclitaxel, please perform the following pretreatment 30 minutes before using this product: intravenous injection of dexamethasone 5-10mg; intramuscular injection of diphenhydramine 50mg; intravenous injection of cimetidine 300mg.

1. Allergic reactions: manifested as flushing, rash, dyspnea, hypotension and tachycardia. If a severe allergic reaction occurs, the drug should be discontinued and treatment should be initiated. Patients who have had an allergic reaction should not use this product again. 2. Bone marrow suppression: It is the main dose-limiting toxicity, manifested as neutropenia, and thrombocytopenia is rare. It usually occurs 8-10 days after medication. The incidence of severe neutropenia is 47%, the incidence of severe thrombocytopenia is 5%, and anemia is more common. 3. Neurotoxicity: The incidence of peripheral neuropathy is 62%, the most common manifestations are mild numbness and paresthesia, and the incidence of severe neurotoxicity is 6%. 4. Cardiovascular toxicity: There may be hypotension and asymptomatic short-term bradycardia, muscle and joint pain, with an incidence of 55%, and the incidence of

Precautions for children: There is no clinical experience for children, so use with caution. Precautions for pregnancy and lactation: No systematic studies have been conducted on pregnant women. If it is used for pregnant women or the patient becomes pregnant during the use of this product, the patient should be informed of the potential risks immediately. If a lactating woman uses this product, she must stop breastfeeding. Precautions for the elderly: No relevant experiments have been conducted and there are no reliable references.

Pharmacokinetic data show that the clearance of this product is reduced by about 30% when it is given after cisplatin. Bone marrow toxicity is more serious. The simultaneous use of ketoconazole affects the metabolism of this product.

Sealed and moisture-proof

30mg

18 months

Nanjing Sike Medicine Industry Co., Ltd.

• Founded in:

  2002-02-22

• Address:

  No. 28, Gaoxin Road, Nanjing High-tech Development Zone

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  91320100745351171H

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