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Generic name: Tigeo Capsules
Trade name: Suri
All names: Tigeo Capsules, Suri, Viconda, Esvan, Tegafur, Gimeracil and Oteracil Potassium Capsules
Indications:
Unresectable locally advanced or metastatic gastric cancer.
Usage and dosage:
Tigeol capsules combined with cisplatin are used to treat patients with unresectable locally advanced or metastatic gastric cancer:
Generally, the first dose for adults is determined according to the following table based on body surface area.
The dosage is to take it orally twice a day, after breakfast and dinner, for 28 consecutive days, followed by a 14-day break, which is a treatment cycle. Administer until patient's condition worsens or intolerable.
Body surface area (m2) First dose (based on tegafur)
<1.25 40mg each time
≥1.25~<1.5 50mg each time
≥1.5 60mg each time
The dosage can be increased or decreased according to the patient's condition. The dosage of each dose is increased or decreased sequentially according to the four dosage levels of 40mg, 50mg, 60mg and 75mg. If there are no safety issues such as abnormal laboratory tests (blood routine, liver and kidney function) and gastrointestinal symptoms caused by this drug, and if the doctor judges that an increase is necessary, the dose can be increased by one level in the above order, with the upper limit being 75mg/time. If you need to reduce the dose, reduce it according to the dose level, with the lower limit being 40mg/time. The drug was taken orally for 21 consecutive days and rested for 14 days. On the 8th day of administration, cisplatin 60 mg/m2 was injected intravenously, which constituted a treatment cycle. Administer until patient's condition worsens or intolerable.
Adverse reactions:
Obvious gastrointestinal symptoms such as loss of appetite, nausea, vomiting, diarrhea, leukopenia, neutropenia, hemoglobinopenia, thrombocytopenia, general fatigue, pigmentation
Contraindications:
Patients with a history of severe allergies to the ingredients of this product.
Patients with severe myelosuppression (may lead to worsening of symptoms).
Patients with severe renal dysfunction.
Patients with severe liver dysfunction.
Patients who are taking other fluorouracil antineoplastic drugs (including combination chemotherapy with these drugs).
Patients taking flucytosine.
Pregnant women and women of childbearing age.
Generally, most elderly people have low physiological functions. The patient's condition should be observed and this product should be used with caution.
Precautions:
Precautions related to usage and dosage:
(1) During the treatment process, if the withdrawal period must be shortened due to treatment needs, it must be confirmed that there are no abnormal clinical test values (hematology tests, liver and kidney function tests) and gastrointestinal symptoms related to this product, and there are no safety issues. The drug withdrawal period shall not be less than 7 days. The safety of shortened drug-free periods in patients with inoperable or recurrent breast cancer has not been established (no experience with use).
(2) In order to avoid serious side effects such as bone marrow suppression and severe hepatitis, clinical examinations (hematology tests, liver and kidney function tests, etc.) should be performed at least once every 2 weeks before the start of each cycle and during the administration period, and the patient's status should be closely observed. If abnormal conditions are found, appropriate measures such as extending the withdrawal time, reducing the dose, and suspending the medication should be taken. Frequent clinical examinations should be performed especially during cycle 1 and when increasing doses.
(3) Basic research shows that the bioavailability of oteracil potassium changes greatly when administered to rats on an empty stomach, which can inhibit the phosphorylation of 5-FU and weaken the anti-tumor effect. Therefore, this product should be taken after meals.
(4) In patients with non-small cell carcinoma, the effectiveness and safety of exceeding the usage and dosage in the phase II clinical late-stage study (taking this product orally for 21 consecutive days, and giving cisplatin 60 mg/m2 on the 8th day) have not yet been established.
(5) The effectiveness and safety of this product combined with chest and abdominal radiotherapy have not yet been established.
The following patients should use with caution:
Myelosuppressed patients. Patients with renal dysfunction. Patients with liver dysfunction. Patients with co-infections. Patients with impaired glucose tolerance. Patients with interstitial pneumonia or a history of interstitial pneumonia. People with heart disease or those with a history of heart disease. Patients with peptic ulcer or bleeding.
Important precautions:
(1) After discontinuing this product, give other fluorouracil antitumor drugs or antifungal drug flucytosine at least 7 days apart.
(2) After discontinuing fluorouracil antitumor drugs or antifungal drug flucytosine, it is also necessary to give this product at an appropriate interval.
(3) It has been reported that severe infection (sepsis) due to bone marrow suppression may lead to septic shock or disseminated intravascular coagulation or even death. Therefore, attention must be paid to the emergence or worsening of symptoms such as infection and bleeding tendency.
(4) When administering medication to patients of childbearing age, the impact on the gonads should be considered.
(5) It has been reported that this product may cause worsening of interstitial pneumonia or even death. Therefore, when using this product, it is necessary to confirm whether there is interstitial pneumonia. During the medication, respiratory status should be closely observed, whether there are clinical symptoms such as cough and fever, and chest X-ray examination should be performed. Watch for the emergence and worsening of interstitial pneumonia. If abnormalities are found, the medication should be discontinued and appropriate measures should be taken. [Especially for patients with non-small cell lung cancer, the possibility of developing lung function damage such as interstitial pneumonia is greater than that of patients with other tumors. ]
Storage:
Store at room temperature and airtight.
Mechanism of action:
This product is a compound preparation composed of tegafur, gimelazine, and oteracil potassium. After oral administration, tegafur is slowly converted into 5-FU in the body to exert anti-tumor effects.
Gemmepyrimidine is mainly distributed in the liver and has a selective antagonistic effect on the 5-FU catabolic enzyme DPD, thereby increasing the concentration of tegafur converted into 5-FU. This in turn causes the phosphorylated metabolite of 5-FU, 5-FUMP, to persist at a high concentration in the tumor, 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 into 5-FUMP. As a result of the above effects, the anti-tumor effect of this product is enhanced after oral administration, but the gastrointestinal toxicity is reduced.
Safety and efficacy:
Domestic clinical studies have confirmed that Tigeo capsules have significant efficacy on advanced gastric cancer and are a safe and effective oral anti-cancer drug. The emergence of Tigeo capsules has brought new hope to domestic patients with advanced gastric cancer. It breaks through the tradition and is a brand new anti-metabolite chemotherapy drug. It is the latest high-potency antimetabolite compound preparation in China for the treatment of advanced gastric cancer. It is a new compound drug for the treatment of advanced gastric cancer. Its unique tablet dosage form has the characteristics of easy taking, significant efficacy and few side effects.
After entering the blood, Tigeol capsules can maintain high blood concentration for a long time, improve anti-cancer activity, and reduce gastrointestinal toxicity to a greater extent. Single drug is highly effective in treating advanced gastric cancer and reduces the risk of death by 38% compared to surgery alone.