Epirubicin Hydrochloride for Injection

The hydroxyl group at the 4' position changes from cis to trans. It is a non-specific drug for the cell cycle, and its main site of action is the cell nucleus. The mechanism of action of this product is related to its ability to bind to DNA. When this product is added to cells cultured in vitro, it can quickly penetrate into the cell, enter the cell nucleus and bind to DNA, thereby inhibiting nucleic acid synthesis and mitosis. It has been confirmed that epirubicin has a broad spectrum of anti-experimental tumor effects and also has an inhibitory effect on topoisomerase. The therapeutic effect is equal to or slightly higher than that of doxorubicin, while the toxicity, especially the cardiac toxicity, is lower than that of doxorubicin.

The main ingredient of this product is epirubicin hydrochloride.

This product is a bright red or orange-red freeze-dried mass; it is hygroscopic.

Treatment of malignant lymphoma, breast cancer, soft tissue sarcoma, esophageal cancer, gastric cancer, liver cancer, pancreatic cancer, melanoma, colorectal cancer, ovarian cancer, multiple myeloma, leukemia.

Conventional dose: When epirubicin is used alone, the adult dose is 60-90 mg/m2 body surface area, intravenous injection, injected into the body within 3-5 minutes. It can be repeated at intervals of 21 days according to the patient's blood picture. High dose: If epirubicin is used alone to treat lung cancer, it should be administered according to the following regimen: 120 mg/m2 body surface area/day for untreated small cell lung cancer, once every three weeks. Untreated non-small cell lung cancer (milliform epithelial cell lung cancer, large cell lung cancer or lung adenocarcinoma): 135 mg/m2 body surface area/day, once every three weeks; or 455 mg/m2 body surface area/day, once on the first, second and third days every three weeks. For patients who have undergone previous chemotherapy, radiotherapy, are old or have poor bone marrow hematopoietic function, a small dose (i.e., the conventional dose of 60-75 mg/m2 body surface area) can be used for treatment. The total amount of each course of treatment is used in 2-3 times. Since epirubicin is excreted through the hepatobiliary system, patients with liver dysfunction should reduce the dose to avoid accumulation and poisoning. For patients with moderate liver impairment (bilirubin 1.4-3mg/100ml or BPS retention 9-15%), the dosage should be reduced by 50%, and for patients with severe liver impairment (bilirubin>3mg/100ml or BPS retention>15%), the dosage should be reduced by 75%. Patients with moderate renal impairment do not need to reduce the dosage because only a small amount of the drug is excreted through the kidneys. The dosage is intravenous. It is recommended to inject normal saline first to check that the infusion tube and injection needle are indeed in the vein, and then administer the drug through this unobstructed infusion tube. This method can reduce the risk of drug spillage and ensure that the vein is flushed with saline after administration. Spillage during injection of epirubicin can cause severe tissue damage or even necrosis. Injection into a small vein or repeated injection into the same blood vessel can cause venous sclerosis. Epirubicin cannot be mixed with heparin because the chemical properties of the two are incompatible and precipitation reactions will occur at a certain concentration. Epirubicin can be used in combination with other anti-tumor drugs, but the dosage of epirubicin should be reduced and drugs should not be mixed in the same syringe.

1. In addition to the side effects of bone marrow suppression and cardiotoxicity, there are several other adverse reactions: 2. Hair loss, which can occur in 60-90% of cases and is generally reversible; men have suppressed beard growth. 3. Mucositis, which occurs on the 5th to 10th day of medication, usually on the side of the tongue and the sublingual mucosa. 4. High fever. 5. Allergic reactions such as gastrointestinal disorders, chills, and urticaria.

It is contraindicated in patients with significant bone marrow suppression due to chemotherapy or radiotherapy, patients who have received high doses of anthracyclines (such as doxorubicin or daunorubicin), and patients with a recent or past history of heart damage.

Precautions for children: There are no special requirements for children. Precautions for pregnancy and lactation: There is no conclusive data to show whether epirubicin has adverse effects on human fertility, teratogenicity or other harmful effects on the fetus. However, experimental data suggest that epirubicin, like most anti-tumor drugs and immunosuppressants, exhibits mutagenicity and carcinogenicity in animals under specific experimental conditions. It can reduce the survival rate of the fetus. Therefore, this product is not recommended for use during pregnancy and is contraindicated for breastfeeding women. Precautions for the elderly: Elderly patients with reduced heart function should use it with caution or reduce the dosage.

1. Epirubicin can be used in combination with other anti-tumor drugs, but the dosage of epirubicin should be reduced. When used in combination, they should not be used in the same syringe. 2. Epirubicin should not be mixed with heparin for injection, because the two are chemically incompatible and precipitation reactions will occur at a certain concentration.

Keep in a light-proof and airtight container.

50mg

24 months

Han Hui Pharmaceuticals Company Limited

• Founded in:

  2012-09-06

• Address:

  No. 2 Haizheng Road, Xukou Town, Fuyang District, Hangzhou City, Zhejiang Province

• Tax NO.:

  91330100053653670B

• Registered Funds:

  1852.03035908 yuan

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