S-1 tablets

Pharmacological action: 1. Anti-tumor effect This product has the effect of inhibiting tumor proliferation in various subcutaneous transplanted tumors such as Yoshida's sarcoma, AH-130 ascites liver cancer, Sato's lung cancer (rats), S-180 sarcoma, Lewis lung cancer, Colon26 (mice), and subcutaneous transplanted tumors (nude mice) of human gastric cancer, colorectal cancer, breast cancer, lung cancer, pancreatic cancer, and kidney cancer. In addition, this product has the effect of prolonging the survival period of Lewis lung cancer lung metastasis model and L5178Y liver metastasis model (mice), and has the effect of inhibiting tumor proliferation in human gastric cancer and colorectal cancer cell transplantation models (nude mice). 2. Mechanism of action This product is a compound preparation composed of tegafur, gimeracil, and oteracil potassium. After oral administration, tegafur is slowly converted into 5-FU in the body to exert anti-tumor effects. Gimeracil is mainly distributed in the liver and has a selective antagonistic effect on the 5-FU decomposition enzyme DPD, thereby increasing the concentration of 5-FU converted from tegafur, and then causing the phosphorylated metabolite 5-FUMP of 5-FU in the tumor to persist at a high concentration, enhancing the anti-tumor effect. After oral administration, oteracil potassium mainly has a selective antagonistic effect on orotate phosphoribosyltransferase distributed in the digestive tract, thereby selectively inhibiting the conversion of 5-FU to 5-FUMP. As a result of the above effects, the anti-tumor effect of this product is enhanced after oral administration, but the digestive tract toxicity is reduced. Toxicology study: The results of acute toxicity tests showed that the LD50 of mice was 441-551 mg/kg, and the LD50 of Beagle dogs was 53 mg/kg. The results of long-term toxicity tests showed that the main toxic target organ of this product for continuous oral administration of SD rats and Beagle dogs for 13-52 weeks was bone marrow hematopoietic stem cells.

This product is a compound preparation, its components are: tegafur, gimeracil and oteracil potassium. Chemical name: furazolidinone 5-chloro-2,4-dihydroxypyridine, oxazolidinone potassium (OXO plant growth inhibitor), tegafur

This product is white tablets.

Unresectable locally advanced or metastatic gastric cancer.

Single medication: Usually, the baseline dose for the first dose for adults (1 dose) should be calculated based on the body surface area in the table below. Take the drug twice a day, once after breakfast and once after dinner, for 28 consecutive days, and then stop the drug for 14 days. This is one cycle and can be repeated. The baseline dose for the first dose based on body surface area (in terms of tegafur) [1.25m[sup]2[/sup]40mg/time 1.25[1.5m[sup]2[/sup]50mg/time] 1.5m[sup]2[/sup]60mg/time The dosage can be appropriately increased or decreased according to the patient's condition, and the dosage is set at 40, 50, 60, or 75mg/time. When the dose needs to be increased, if there are no abnormalities in clinical test values (hematological tests, liver and kidney function tests) related to this product and there are no signs of consumption

The results of foreign clinical trials show that: 1. Single administration In clinical trials of single administration (except for patients with breast cancer, pancreatic cancer and biliary tract cancer who have been treated before), there were 578 cases that could be evaluated for side effects, and the incidence of side effects was 87.2% (504 cases). The incidence of side effects in patients with breast cancer (including inoperable breast cancer or recurrent breast cancer (excluding breast cancer treated previously)), pancreatic cancer, and biliary tract cancer who had been treated with (taxane anti-tumor drugs) was 96.4%, 98.3%, and 94.9%, respectively, which is higher than the incidence of other tumors. In patients with pancreatic cancer, the incidence of severe side effects is high, especially gastrointestinal symptoms such as loss of appetite, nausea, vomiting, and diarrhea. Note: (1) Patients with previously treated breast cancer, pancreatic cancer and biliary tract cancer are excluded (2) Classification: Statistics are based on the standards of NCI-CTC or the Japanese Cancer Treatment Association (3) Including fatigue 2. Combination therapy In a late-stage Phase II clinical trial of combination therapy in patients with non-small cell lung cancer, this product was taken orally for 21 consecutive days, and cisplatin 60 mg/m2 was given on the 8th day. A total of 55 cases were evaluated for side effects, and side effects were found in all cases. The clinically important side effects are shown in the table below: Note: 1. Classification: Statistics are based on NCI-CTC. The results of domestic clinical trials showed that the incidence of adverse reactions related to this product was 83.78%, of which the main adverse reactions were 68.47% in the blood system (the incidence of leukopenia was 45.05%, the incidence of thrombocytopenia was 20.72%, and most of them were grade I and II decreases), 46.85% in the digestive system (39.64% for nausea and vomiting, 7.21% for diarrhea), and 14.41% for others. The adverse reactions of this product in the blood system are comparable to those of Tegafur, but its gastrointestinal reactions are significantly better than those of Tegafur. The incidence of adverse events related to this product is 2.70%, mainly manifested as mild gastrointestinal bleeding and decreased red blood cells, and the incidence is lower than that of Tegafur (3.48%).

1. Patients with a history of severe allergies to the ingredients of this product. 2. Patients with severe bone marrow suppression (may cause worsening of symptoms). 3. Patients with severe renal dysfunction. 4. Patients with severe liver dysfunction. 5. Patients who are currently taking other fluorouracil anti-tumor drugs (including combined chemotherapy with these drugs). 6. Patients who are currently taking flucytosine.

Precautions for children: The safety of this product for low birth weight infants, newborns, infants and children has not been established. Precautions for pregnancy and lactation: 1. Pregnant women and women of childbearing age are prohibited from using this product. 2. Lactating women should stop breastfeeding if they need to use the drug. Precautions for the elderly: Generally, most elderly people have low physiological functions, so the patient's condition should be observed and this product should be used with caution.

Drug interactions may occur if used with other drugs. Please consult your doctor or pharmacist for details.

Keep sealed and stored in a dry place.

Tegafur 20mg, Gimeracil 5.8mg, Oteracil Potassium 19.6mg

24 months

Fuzhou FU Yao Pharmaceutical Co., Ltd.

• Founded in:

  2001-06-07

• Address:

  No. 279, Zhongxia, Gushan Town, Jin'an District, Fuzhou City

• Tax NO.:

  91350100727934373D

• Registered Funds:

  30 million yuan

• Website:

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