Gemcitabine Hydrochloride for Injection

This product is a cell cycle specific antimetabolite drug, which mainly acts on tumor cells in the DNA synthesis phase, that is, S phase cells. Under certain conditions, it can prevent the progression from G1 phase to S phase. It has obvious cytotoxic activity against various cultured human and mouse tumors. Its anticancer activity is related to the drug resistance mode. For example, daily administration will lead to animal death, while the anticancer activity is very small. When the drug is given once every 3 to 4 days, it has good anticancer activity against various tumors in mice at non-lethal doses. Gemcitabine is a prodrug and is a good substrate for deoxythymidine kinase phosphorylation in cells. It is converted into the following metabolites under the action of enzymes: gemcitabine monophosphate (dFdCMP), gemcitabine diphosphate (dFdCDP) and gemcitabine triphosphate (dFdCTP), of which dFdCDP and dFdCTP are active products. dFdCDP inhibits ribonucleotide reductase and reduces the amount of deoxynucleotides (especially dCTP) required for repair of DNA synthesis. Low levels of dCTP transfer normal negative feedback inhibition of deoxyside kinase, resulting in more accumulation of dFdCTP. At the same time, dFdCDP inhibits the deamination of dFdCMP by deoxycytidine aminoaminase induced by dCT, and dFdCTP directly inhibits deoxycytidine deamination, thereby converting more dFdCMP into active metabolites dFdCDP, dFd-CTP, and dFdCTP competes with dCTP to enter the DNA chain, insert into the site of deoxycytidine in the DNA chain, and allow guanosine to pair with it. The gemcitabine molecule is shielded by this guanosine to prevent it from being removed and repaired by ribonuclease exonuclease, and then DNA chain synthesis stops, leading to DNA breakage and cell death.

2-Deoxy-2,2-difluorodeoxycytidine hydrochloride

This product is white freeze-dried block.

Suitable for the treatment of intermediate and advanced non-small cell lung cancer.

The recommended dose of gemcitabine for adults is 1000 mg/m2 intravenous infusion for 30 minutes once a week for three consecutive weeks, followed by a one-week break, and repeated every four weeks. The dose is reduced accordingly based on the patient's toxicity. Elderly patients: Elderly patients over 65 years old can also tolerate it well. Although age has an effect on the clearance and half-life of gemcitabine, there is no evidence that elderly patients need to adjust the dose.

1. Blood system: bone marrow suppression, anemia, leukopenia and thrombocytopenia may occur. 2. Gastrointestinal tract: about 2/3 of patients have abnormal liver transaminase, mostly mild, non-progressive damage; about 1/3 of patients have nausea and vomiting reactions, and 20% of patients need drug treatment. 3. Kidney: about 1/2 of patients have mild proteinuria and hematuria, and some cases have unexplained renal failure. 4. Allergies: about 25% of patients have skin rashes, 10% of patients have itching, and less than 1% of patients may have bronchospasm. 5. Others: about 20% of patients have flu-like symptoms; the incidence of edema/peripheral edema is about 30%; the incidences of hair loss, lethargy, diarrhea, oral toxicity and constipation are 13%, 10%, 8%, 7% and 6% respectively.

1. Patients who are allergic to the ingredients of this product are prohibited from using it. 2. Pregnant women are prohibited from using it.

Precautions for children: Gemcitabine has not been studied in children, so it should be used with caution in children. Precautions for pregnancy and lactation: Pregnant women are prohibited from using this drug. Precautions for the elderly: There is no significant change in tolerance in elderly patients over 65 years old. Although age has an effect on the clearance and half-life of gemcitabine, there is no evidence that the dose needs to be adjusted in elderly patients.

In a trial for the treatment of non-small cell lung cancer, patients who were treated with 1000 mg/m2 of gemcitabine and given 6 weeks of continuous chest radiotherapy developed severe, even life-threatening toxic reactions, including esophagitis and pneumonia, especially when receiving high-dose radiotherapy. Currently, there is no suitable combination of gemcitabine and therapeutic dose radiotherapy for combined treatment.

Store at room temperature (15°C to 30°C)

0.2g

18 months

Harbin Reputation Scale Pharmaceutical Co., Ltd.

• Founded in:

  2016-09-09

• Address:

  No. 29, Beijing Road, Limin Development Zone, Harbin

• Tax NO.:

  91230111MA19000W9R

• Registered Funds:

  402.0892 million yuan

• Email:

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