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India's Tarceva Erlotinib single agent is suitable for locally advanced or metastatic non-small cell lung disease after failure of at least one previous chemotherapy regimen. In two multi-center randomized placebo-controlled phase III trials, the results showed that erlotinib combined with platinum-containing chemotherapy regimen carboplatin + paclitaxel or gemcitabine + cisplatin was used as first-line treatment for patients with locally advanced or metastatic disease, compared with platinum-containing chemotherapy alone. There is no added clinical benefit and therefore it is not recommended as first-line treatment in these conditions.
*The latest biological targeted therapy drug for lung cancer
*Clinical studies have proven that it can significantly prolong the survival of lung cancer patients
*The only drug currently approved for marketing in the United States, Canada, Australia and the European Union Epidermal growth factor receptor tyrosine kinase inhibitor
The generic name of Tarceva in India is Erlotinib Hydrochloride Tablets, English trade name, English common name b
Molecular structure name Erlotinib Hydrochloride Tablets< [Ingredients] Each tablet contains erlotinib in the form of erlotinib hydrochloride [Characteristics] Round biconvex white coated tablets, with brown and printed on one side and blank on the other side.
[Mechanism of Action]
The anti-tumor mechanism of Tarceva R is mainly to inhibit the intracellular phosphorylation of epidermal growth factor R tyrosine kinase.
[Pharmacokinetics]
It is absorbed after oral administration, with a half-life of about an hour and is mainly eliminated by metabolism. The bioavailability of r after oral administration is approximately 1 hour, reaching peak plasma concentration. Pharmacokinetic analysis of the patient treated with a single drug r showed that it took days to reach stable blood concentration. The patient's age, weight, and gender had no significant relationship with the clearance rate of the drug. Smoking can increase the clearance rate of the drug.
[Indications]
For third-line treatment of locally advanced or metastatic non-small cell lung cancer that has failed two or more chemotherapy regimens.
【Contraindications】Contraindicated for those allergic to this product and its ingredients.
India’s Tarceva is a small molecule compound that can inhibit the signaling pathway of human epidermal growth factor receptor R. This mode of action is completely different from traditional chemotherapy, so it will not cause common adverse reactions in chemotherapy. It is only contraindicated for patients who are severely allergic to Tarceva and its excipients. The United States approved Tarceva on 2019 for the treatment of patients with locally progressive or metastatic disease who have failed previous chemotherapy. Approved in China on the year, month and day
Common adverse reactions
The most common adverse reactions of Tarceva erlotinib in India are rash and diarrhea, the incidence of rash and diarrhea is and, respectively The median onset time of diarrhea was days. The most common adverse reactions include rash, diarrhea, decreased appetite, fatigue, difficulty breathing, cough, nausea, infection, vomiting, stomatitis, itching, dry skin, conjunctivitis, keratoconjunctivitis, and abdominal pain.
Pulmonary Toxicity
There are rare reports suggesting that severe interstitial lung disease, even leading to death, may occur in patients treated with r or in patients with other solid tumors. In the randomized controlled study, the incidence was , and this incidence was the same in the r treatment group and the placebo group. Reported include pneumonia, interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, acute respiratory stress syndrome, and pulmonary effusion. Symptoms occurred from the day after treatment to more than one month, with a median onset time of days. Most patients often have confounding factors, such as previous chemotherapy/radiotherapy, pulmonary metastasis from existing solid lung disease, or pulmonary infection. When there are new unexplained pulmonary symptoms, such as difficulty breathing, cough, fever, etc., examination and evaluation are required. Once diagnosed, continued use should be stopped and appropriate treatment should be taken.
Hepatotoxicity
Treatment can cause asymptomatic increases in liver transaminases. Therefore, liver function should be reviewed regularly during treatment, including transaminases, bilirubin alkaline phosphatase, etc. If liver function damage is severe, the dose should be reduced. or discontinue medication. Liver damage is often temporary or accompanied by liver metastasis. Gastrointestinal bleeding is rarely reported and often occurs in patients taking warfarin at the same time. Therefore, patients taking warfarin or other anticoagulants at the same time should monitor their prothrombin time.
Elderly patients
There is no significant difference in safety and pharmacokinetics between young and elderly patients. Therefore, dose adjustment is not recommended when used in elderly patients.
[Pulmonary Toxicity]
There are few reports suggesting that severe interstitial lung disease may occur in patients treated with r or in patients with other solid tumors, and may even lead to death. In the randomized controlled study, the incidence was , and this incidence was the same in the r treatment group and the placebo group. Reported include pneumonia, interstitial lung disease, bronchiolitis obliterans, pulmonary fibrosis, acute respiratory stress syndrome, and pulmonary effusion. Symptoms occurred from the day after treatment to more than one month, with a median onset time of days. Most patients often have confounding factors, such as previous chemotherapy/radiotherapy, pulmonary metastasis from existing solid lung disease, or pulmonary infection. When there are new unexplained pulmonary symptoms, such as difficulty breathing, cough, fever, etc., examination and evaluation are required. Once diagnosed, continued use should be stopped and appropriate treatment should be taken.
[Hepatotoxicity]
Tercevail treatment can cause asymptomatic increases in liver transaminases. Therefore, liver function should be reviewed regularly during treatment, including transaminases, bilirubin alkaline phosphatase, etc. If liver If the functional impairment is severe, the dosage should be reduced or discontinued. Liver damage is often temporary or accompanied by liver metastasis. Gastrointestinal bleeding is rarely reported and often occurs in patients taking warfarin at the same time. Therefore, patients taking warfarin or other anticoagulants at the same time should monitor their prothrombin time.
[Elderly patients]
There is no significant difference in safety and pharmacokinetics between young and elderly patients. Therefore, dose adjustment is not recommended when used in elderly patients.
Precautions
This product must be used under the guidance of doctors with experience in the use of such drugs, and can only be used in the national oncology drug clinical trial base or tertiary A hospitals.
Usage and Dosage
This product must be used under the guidance of doctors with experience in using such drugs, and can only be used in the national tumor drug clinical trial base or tertiary A hospitals. The recommended dose of erlotinib monotherapy for non-small cell lung cancer is /day, taken at least one hour before or one hour after eating. Continue taking medication.
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