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As a new dual inhibitor of ALK and EGFR, brigatinib significantly enhances its binding force with ALK protein through its unique dimethylphosphorus oxide (DMPO) structure, thereby improving drug activity.
1. Generic name: Brigatinib
2. Trade name: ALUNBRIG
1. For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), and the following conditions must be met:
2. Disease progression or intolerance after previous treatment with crizotinib.
3. This indication is subject to accelerated approval based on tumor response rate and response duration, and clinical benefit may need to be verified in the future.
180mg tablet , 90mg tablet .
1. Active ingredient: Brigatinib
2. Excipients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl starch, magnesium stearate, hydrophobic colloidal silica; coating contains talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.
1. Initial dose of : 90 mg orally, once a day for 7 consecutive days.
2. Increase after tolerance: If tolerated well, increase to 180mg once a day from the 8th day.
3. How to take : Swallow the tablet whole, do not crush or chew it; it can be taken with food or on an empty stomach.
1. Missed dose or vomiting of : No need to take a supplementary dose, take the next dose according to the original plan.
2. Adjust for adverse reactions: suspend, reduce the dose or permanently discontinue the drug according to the severity (such as ILD/pneumonia needs to be reduced to 60mg, hypertension needs to be reduced to 120mg, etc.).
3. When strong CYP3A inhibitor is used in combination with : the dose needs to be reduced by about 50% (such as from 180mg to 90mg).
1. Influence of diet : not affected by food, but avoid grapefruit/juice (may increase blood concentration).
2. Special reminder : Respiratory symptoms (ILD risk) need to be closely monitored in the first week of treatment; blood pressure, heart rate, CPK, pancreatic enzymes and blood sugar should be measured regularly.
1. Pregnant women : contraindicated, may cause fetal malformation, non-hormonal contraceptive measures are required (for women during the medication and 4 months after discontinuation of medication, and for males 3 months after discontinuation of medication).
2. Lactation period : Breastfeeding is prohibited during medication and within 1 week of discontinuation of medication.
3. Hepatic/renal insufficiency : Mild to moderate, no adjustment is required; severe renal impairment (CLcr<30mL/min) requires a dose reduction to 30mg once a day.
1. Common (≥25%) : nausea, diarrhea, fatigue, cough, headache.
2. Severe reactions : ILD/pneumonia (9.1%), hypertension (21%), bradycardia, visual impairment, elevated CPK, pancreatitis, hyperglycemia.
There are no clear contraindications, but it is prohibited for those who are allergic to this product or excipients.
1. Avoid combined use of : strong CYP3A inhibitors (such as ketoconazole), strong CYP3A inducers (such as rifampicin).
2. Note : It may reduce the effectiveness of hormonal contraceptives, so you need to switch to non-hormonal contraceptives.
Save at room temperature (20°C-25°C), short-term storage at 15°C-30°C is allowed.