Doxorubicin Hydrochloride for Injection

Doxorubicin has a strong anti-tumor effect because its structure contains both fat-soluble anthracene ring ligands and water-soluble daunorubicin; and it has acidic phenolic hydroxyl and basic amino groups. As a non-specific anti-tumor chemotherapy drug, this product has effects on cells in all phases, but is most sensitive to the early S phase, followed by the M phase, and has a delaying effect on the G1, S and G2 phases. Its mechanism of action is that it can directly act on DNA synthesis, insert into the double helix chain of DNA, unwind the latter, change the template properties of DNA, inhibit DNA polymerase, and thus inhibit both DNA synthesis and RNA synthesis. In addition, this product has the function of forming superoxide free radicals and has a special effect of destroying the structure and function of cell membranes. This product has a strong cytotoxic effect, has a tumorigenic effect in animals, and has potential mutagenic and tumorigenic effects in humans. This product has a significant effect on the reproductive function of animals, but in humans, its inhibitory effect is greatly reduced compared with the large white mouse experiment.

Doxorubicin hydrochloride.

This product is an orange-red loose mass or powder, easily soluble in water. This product can be used in combination with glucose and sodium chloride infusion, and can also be used in combination with certain anti-tumor drugs.

It is suitable for the treatment of acute leukemia (lymphocytic and granulocytic), malignant lymphoma, breast cancer, lung cancer (small cell and non-small cell lung cancer), ovarian cancer, bone and soft tissue sarcoma, Wilms' tumor, neuroblastoma, bladder cancer, thyroid cancer, prostate cancer, head and neck squamous cell carcinoma, testicular cancer, gastric cancer, liver cancer, etc.

Intravenous infusion, intravenous drip or arterial injection. Dissolve with sterile water for injection before use, the concentration is generally 2mg/ml. The common dosage for adults is 50~60mg/m2 once every 3~4 weeks or 20mg/m2 per day for 3 consecutive days, and repeat after 2~3 weeks of discontinuation. The myocardial toxicity, bone marrow suppression and gastrointestinal reactions (including oral ulcers) of divided medication are milder than those of medication once every 3 weeks. The combined medication is 40mg/m2 once every 3 weeks or 25mg/m2 once a week for 2 consecutive weeks, and repeated for 3 weeks. The total dose should not exceed 400mg/m2 based on body surface area.

1. Bone marrow suppression and oral ulcers. Do not reuse this product when there is bone marrow suppression and oral ulcers. The latter may have a precursor symptom of oral burning sensation, and should not be used when symptoms occur. Obvious bone marrow suppression may occur about 10 days after the use of doxorubicin, so blood counts should be routinely monitored regardless of whether the patient has a blood disease or a non-blood disease. 2. Cardiotoxicity. Cardiotoxicity can manifest as bradycardia, including supraventricular bradycardia and electrocardiogram changes. It is recommended to routinely monitor the electrocardiogram. Patients with existing heart function damage should be particularly careful. When the cumulative dose exceeds 450-500mg/m2, special care should be taken. When this dose level is exceeded, the risk of irreversible congestive heart failure is greatly increased. When considering the total amount of doxorubicin used, a comprehensive assessment should be made of the patient's previous or concurrent use of other drugs with obvious cardiotoxicity, such as high-dose intravenous cyclophosphamide, mediastinal radiotherapy, or related anthracycline compounds such as daunorubicin. It has been shown that weekly doxorubicin has lower cardiotoxicity than doxorubicin every three weeks, which allows patients to receive higher cumulative doses of treatment. It must be noted that heart failure can occur a few weeks after medication and may not respond to treatment. It is recommended to test the baseline electrocardiogram and follow up with an electrocardiogram during and immediately after medication. Transient electrocardiogram changes, such as flat T waves, S-T segment depression, and arrhythmias, are not considered an indication for stopping the drug. It is now believed that QRS wave reduction is a more specific manifestation of cardiotoxicity. If this change occurs, the benefit of continuing medication treatment and the risk of irreversible heart damage must be carefully weighed. Severe heart failure can occur suddenly without prior electrocardiogram changes. 3. Rapid-dissolving doxorubicin hydrochloride for injection can make urine red, especially the first urine after injection. Patients should be informed not to panic. 4. Gastrointestinal reactions: vomiting, nausea, and diarrhea may also occur. 5. Others: Abnormal liver and kidney function and hair loss are also common phenomena, including interference with beard growth. However, all hair can resume normal growth after stopping the drug.

1 Bone marrow suppression: It is the main side effect of doxorubicin. White blood cells drop to the lowest point about 10 to 14 days after medication, and most of them gradually return to normal levels within three weeks. Anemia and thrombocytopenia are generally not serious. 2 Cardiotoxicity: Transient electrocardiogram changes may occur, manifested as supraventricular tachycardia, premature ventricular contractions and ST-T changes, which generally do not affect treatment. A small number of patients may develop delayed and progressive myocardial lesions, manifested as acute congestive heart failure, which is closely related to the cumulative dose. Most of them occur in patients with a total dose of 400 mg/m2. These conditions may occasionally occur suddenly without abnormal signs in routine electrocardiograms. Doxorubicin-induced heart disease often occurs 1 to 6 months after discontinuation of medication. Cardiotoxicity may be aggravated by the combined use of other drugs. 3 Gastrointestinal reactions: Manifested as loss of appetite, nausea, vomiting, and oral mucosal erythema, ulcers, esophagitis, and gastritis. 4 Hair loss: The incidence rate is over 90%, and growth can generally resume after discontinuation of medication for 1 to 2 months. 5 Local reactions: Extravasation of drugs at the injection site can cause tissue ulcers and necrosis. Excessive drug concentration can cause phlebitis. 6 Others: A small number of patients have fever, hemorrhagic erythema, abnormal liver function hives, allergic reactions, conjunctivitis, and tearing. In addition, doxorubicin can also increase the toxicity of radiotherapy and some anticancer drugs. 7 When patients with leukemia and malignant lymphoma use this product, especially those who use doxorubicin for the first time, hyperuricemia may be caused by the massive destruction of tumor cells, leading to joint pain or renal damage.

Precautions for children: Use with caution in children under 2 years old. Precautions for pregnancy and lactation: This product can cross the placenta and may cause miscarriage, so it is strictly forbidden to use doxorubicin within 3 months of the first trimester of pregnancy. After pregnant women use this product, toxic reactions to the fetus may sometimes take several years to appear, so it is forbidden for lactating women. Precautions for the elderly: Use with caution in elderly patients.

1 Various bone marrow suppressive cytotoxic drugs, especially nitrosoureas, high-dose cyclophosphamide or methotrexate, mitomycin or radiotherapy, if used with doxorubicin, the latter's single dose and total dose should be reduced as appropriate. 2 If doxorubicin is used with streptozocin, the latter can prolong the half-life of doxorubicin, so the dose of the former should be reduced as appropriate. 3 Any drug that may cause liver damage, if used with this product, can increase the hepatotoxicity of doxorubicin; use with cytarabine can cause necrotizing colitis; mixed use with heparin, cephalosporin, etc. is prone to precipitation. 4 This product is cross-resistant to daunorubicin. It is not cross-resistant with methotrexate, fluorouracil, cytarabine, nitrogen mustard, mitomycin, bleomycin, cyclophosphamide and nitrosoureas, and has varying degrees of synergistic effects when used in combination with cyclophosphamide, fluorouracil, methotrexate, cisplatin and nitrosoureas. 5. Use live virus vaccines with caution during medication.

Sealed, stored in a cool, dark and dry place.

10mg

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

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  1852.03035908 yuan

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