Docetaxel Injection

Pharmacological action: Docetaxel is a paclitaxel anti-tumor drug that plays an anti-tumor role by interfering with the microtubule network necessary for cell mitosis and interphase cell function. Docetaxel can bind to free tubulin, promote tubulin assembly into stable microtubules, and inhibit its depolymerization, resulting in the production of microtubule bundles that have lost their normal functions and the fixation of microtubules, thereby inhibiting cell mitosis. The binding of docetaxel to microtubules does not change the number of protofilaments, which is different from most spindle toxic drugs currently used in clinical practice. Toxicological studies: Genotoxicity, docetaxel showed a breaking effect in the CHO-KI cell chromosome aberration test and the mouse bone marrow nuclear test. However, no mutagenic effect was observed in the Ames test and the CHO/HGPRT gene mutation test. Reproductive toxicity: In rats, intravenous injection of docetaxel at 0.3 mg/kg (about 1/50 of the clinically recommended dose based on body surface area) did not cause damage to fertility, but it could cause testicular weight loss; this result was correlated with the results of repeated administration of 10 cycles (administered once every 21 days for 6 consecutive months) in rats and dogs; rats and dogs were injected intravenously with doses of 5 mg/kg and 0.375 mg/kg, respectively (about 1/3 and 1/15 of the clinically recommended dose based on body surface area), and testicular atrophy and degeneration were observed. Rats also showed similar effects when the number of doses was increased at low doses. Docetaxel use during pregnancy can cause fetal damage. Embryotoxicity and fetotoxicity (manifested as intrauterine death, increased fetal resorption, fetal weight loss and delayed bone formation) were observed in rats and rabbits given docetaxel ≥ 0.3 mg/kg/day and 0.03 mg/kg/day, respectively, during the period of organogenesis (based on body surface area, equivalent to 1/50 and 1/300 of the clinical recommended daily dose, respectively). The above doses can also cause maternal toxicity. There is currently 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 to the fetus and the potential risk of miscarriage. Women of childbearing potential should avoid pregnancy during treatment with this product. It is not clear whether docetaxel is excreted from human milk. Given that many drugs can be excreted from human milk and docetaxel may cause serious adverse reactions in breastfeeding infants, mothers should stop breastfeeding before using this product.

The main ingredient of this product is docetaxel.

1. Docetaxel is suitable for the treatment of advanced or metastatic breast cancer after failure of previous chemotherapy. Unless it is clinically contraindicated, previous treatment should include anthracycline anticancer drugs. 2. Docetaxel is suitable for the treatment of advanced or metastatic non-small cell lung cancer after failure of chemotherapy based on cisplatin.

Docetaxel can only be used for intravenous infusion. All patients must take oral glucocorticoids, such as dexamethasone, before receiving docetaxel treatment, one day before docetaxel infusion. 16 mg per day, for at least 3 days, to prevent allergic reactions and fluid retention. Before use, inhale all the solvent corresponding to docetaxel into the corresponding solution, shake gently to mix evenly, leave the mixed bottle at room temperature for 5 minutes, then check whether the solution is uniform and clear, and according to the calculated amount of medicine used by the patient, inhale the mixture with a syringe, inject it into the injection bottle or injection bag of 5% glucose injection or 0.9% sodium chloride injection, shake gently, mix evenly, and the final concentration shall not exceed 0.9 mg/ml. The recommended dose of docetaxel is 75 mg/m2 drip for one hour, once every three weeks

1 Bone marrow suppression and neutropenia are the most common side effects and are usually severe (less than 500/mm3), reversible and non-accumulative. 2 Allergic reactions: Severe allergic reactions may occur in some cases, characterized by hypotension and bronchospasm, requiring interruption of treatment. The patient can return to normal after stopping the infusion and immediate treatment. Mild allergic reactions may also occur in some cases. Such as flushing, erythema with or without itching, chest tightness, back pain, dyspnea, drug fever or chills. 3 Skin reactions often manifest as erythema, mainly seen on the hands and feet, and may also occur in local rashes on the arms, face and chest, sometimes accompanied by itching. Peeling after the rash rarely occurs. Nail lesions may occur. Characterized by pigmentation or lightening, sometimes pain and

The following patients are contraindicated: 1. Patients with a history of severe allergic reaction to docetaxel or Tween-80; 2. Patients with a white blood cell count of less than 1500/mm3; 3. Patients with severe liver damage.

In vitro studies have shown that CYP3A4 inhibitors may interfere with the metabolism of this product, so extreme caution should be exercised when it is used simultaneously with such drugs (such as ketoconazole, erythromycin, cyclosporine, etc.).

Keep in a dark and airtight container at 2-8℃.

2.0 ml: 80 mg