Docetaxel Injection

Pharmacological action: Docetaxel is a taxane that promotes the assembly of microtubule dimers into microtubules and stabilizes microtubules by preventing the depolymerization process, thereby blocking cells in the G2 and M phases and inhibiting the mitosis and proliferation of cancer cells. The pharmacological action of docetaxel is stronger than that of paclitaxel, with an intracellular concentration three times higher than that of paclitaxel and a longer intracellular retention time. Its affinity for microtubules is twice that of paclitaxel; as a microtubule stabilizer and assembly promoter, its activity is twice that of paclitaxel; as a microtubule depolymerization inhibitor, its activity is twice that of paclitaxel. In in vitro antitumor activity tests, it has been confirmed that the antitumor activity of docetaxel is 1.3 to 12 times that of paclitaxel. Clinical studies have shown that docetaxel has a higher efficacy than paclitaxel for anthracycline-resistant breast cancer. Docetaxel is the most effective drug for the second-line treatment of anthracycline-resistant breast cancer so far; in monotherapy and combination chemotherapy for non-small cell lung cancer, docetaxel is one of the most effective drugs. Genotoxicity: Docetaxel showed clastogenic effects in the CHO-K1 cell chromosome aberration test and the mouse bone marrow micronucleus test, but no mutagenic effects were 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 reduction. This result is correlated with the results of repeated dosing tests in rats and dogs for 10 cycles (administered once every 21 days for 6 consecutive months); when 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, respectively, based on body surface area), testicular atrophy and degeneration were observed, and rats showed similar effects when the number of doses was increased at low doses. The use of docetaxel during pregnancy can cause fetal damage. When rats and rabbits were given docetaxel ≥ 0.3 mg/kg/day and 0.03 mg/kg/day (equivalent to 1/50 and 1/300 of the clinical recommended daily dose, respectively, based on body surface area) during the period of organogenesis, embryotoxicity and fetotoxicity (manifested as intrauterine death, increased fetal resorption, fetal weight loss and delayed ossification) were observed. 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 in 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. Chemical name: {2Ar-[2aalpha;, 4beta;, 4abeta;, 6beta;, 9alpha; (alpha; R*, Beta; s*), 11alpha;, 12alpha;, 12aalpha;, 12balpha;]}-beta;-{[(1,1-dimethylethoxy)carbonyl]amino}-alpha;-hydroxyphenylpropionic acid [12b-acetoxybenzoyloxy-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-twelve hydrogen-4, 6, 11-trihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7, 11-methylene-1H-cyclodecene pentaenol [3, 4] benzo [1, 2-b] oxabutane-9-yl] ester. Molecular formula: C43H53NO14 Molecular weight: 807.88

This product is a light orange-yellow to orange-yellow clear liquid.

1. It is suitable for the treatment of locally advanced or metastatic breast cancer. 2. It is suitable for the treatment of locally advanced or metastatic non-small cell lung cancer, even after the failure of cisplatin-based chemotherapy.

Docetaxel can only be used for intravenous infusion. All patients must take oral glucocorticoids, such as dexamethasone, before receiving docetaxel treatment. Take it one day before docetaxel infusion, 16 mg per day, for at least 3 days to prevent allergic reactions and fluid retention. The recommended dose of docetaxel is 70-75 mg/m2, intravenous infusion for one hour, once every three weeks. According to the calculated amount of medication for the patient, draw the required dose with a syringe, dilute it into 5% glucose injection or 0.9% sodium chloride injection, shake it gently, mix it evenly, and the final concentration does not exceed 0.74 mg/ml.

1. Bone marrow suppression: Neutropenia is the most common adverse reaction and is usually severe (less than 500/mm3). It is reversible and does not accumulate. According to literature reports, fever and infection associated with neutropenia have occurred. Anemia is seen in most cases, and severe thrombocytopenia occurs in a few cases. 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, difficulty breathing, 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

1. Patients with a history of severe allergy to docetaxel or Tween-80; 2. Patients with a white blood cell count 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 ketoazole, erythromycin, cyclosporine, etc.).

Store at 15-30℃ away from light.

1ml:40mg

Qilu Pharmaceutical Co., Ltd.

• Founded in:

  1992-08-21

• Address:

  No. 317, Xinluo Street, High-tech Zone, Jinan City, Shandong Province

• Tax NO.:

  91370000614073351Q

• Registered Funds:

  600 million yuan

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