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Glumetinib features good oral absorption and stable metabolism in vivo, and it can easily penetrate the blood-brain barrier, making it suitable for patients with brain metastases.
AuthenticGuaranteeFast DeliveryPrivacy Glumetinib was granted conditional approval in China in March 2023 and approved for marketing in Japan in June 2024, making it the first innovative drug approved in Japan through an application filed primarily by a Chinese pharmaceutical enterprise.
This product is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping alterations.
The above indication was granted conditional approval based on the results of a single-arm clinical trial. The full approval of this indication will be contingent upon the clinical benefit demonstrated by subsequent confirmatory trials.
Glumetinib is administered orally on an empty stomach (fasting is required for at least 2 hours before administration and 1 hour after administration; drinking water is allowed during this period). The recommended dose is 300 mg once daily, taken continuously until disease progression or unacceptable adverse reactions occur.
It is advisable to take the medication at approximately the same time each day. The tablets should be swallowed whole and must not be chewed or crushed. Missed doses during the treatment course cannot be supplemented. If vomiting occurs after administration leading to insufficient drug dosage, no supplementary dose is needed, and the prescribed dose should be resumed the next day as scheduled.
This product is contraindicated in patients with severe hypersensitivity to this product or any of its inactive ingredients.
It is contraindicated in pregnant or lactating women.
The possible adverse reactions of the body are classified into two categories:
Severe adverse reactions include: peripheral edema, liver function impairment, neutropenia (reduction of an important type of white blood cells), hypoalbuminemia (insufficient protein in the blood), hypokalemia (deficiency of potassium in the body), leukopenia, dyspnea complicated with pleural effusion, interstitial lung disease (a disorder affecting the normal structure of the lungs), and QT interval prolongation (abnormal cardiac electrical activity shown on electrocardiogram).
Mild adverse reactions include: vomiting, headache, general malaise, skin rash, fatigue, decreased appetite, nausea, dizziness, and back pain.
Patients with mild hepatic impairment (total bilirubin < upper limit of normal [ULN] and alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > ULN; or ULN < total bilirubin < 1.5×ULN and any levels of AST or ALT) do not require adjustment of the initial dose of this product.
Currently, there is only limited research data available for patients with moderate hepatic impairment, and no research data exists for patients with severe hepatic impairment. Therefore, patients with moderate to severe hepatic impairment should take this product with caution under the guidance of a physician, and their liver function should be closely monitored.
Patients with mild to moderate renal impairment (creatinine clearance [CLcr] estimated by the Cockcroft-Gault formula: 30 to < 90 mL/min) do not require adjustment of the initial dose of this product.
Currently, no research data exists for patients with severe renal impairment. Patients with severe renal impairment should take this product with caution under the guidance of a physician, and their renal function should be closely monitored.
No clinical data are available on the use of this product in pediatric or adolescent patients under 18 years of age.
No adjustment of the initial dose is required for geriatric patients.
For more detailed drug information, please consult the official package leaflet.
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No. If the drug is found to be expired or its outer packaging is damaged, you shall go to the hospital for a new prescription.
No. This is to avoid drug accumulation and the occurrence of unnecessary adverse drug reactions. Please follow your doctor’s advice.
This product should be stored in a sealed container at a temperature not exceeding 30°C.
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