As a novel dual inhibitor of ALK and EGFR, brigatinib significantly enhances its binding affinity with ALK protein through its unique DMPO structure, thereby improving drug activity.

1、 Drug name

1. Common name: Brigatinib

2. Product Name: ALUNBRIG

2、 Indications

1. Used to treat adult patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer (NSCLC), and must meet the following conditions:

2. Disease progression or intolerance after previous treatment with crizotinib.

3. This indication is approved based on accelerated tumor response rate and duration of response, and clinical benefits may need to be validated in the future.

3、 Specifications and characteristics

180mg tablets, 90mg tablets.

4、 Main components

1. Active ingredient: Brigatinib

2. Accessories: lactose monohydrate, microcrystalline cellulose, hydroxypropyl starch, magnesium stearate, hydrophobic colloidal silica; The coating contains talcum powder, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.

5、 Usage and dosage

1. Initial dose: 90mg orally, once daily for 7 consecutive days.

2. Incremental tolerance: If well tolerated, increase to 180mg once daily from the 8th day onwards.

3. Usage: Swallow the whole tablet, do not crush or chew it; Can be taken with food or on an empty stomach.

6、 Dose adjustment

1. Omission or vomiting: No need to supplement, take the next dose according to the original plan.

2. Adverse reaction adjustment: Suspend, reduce or permanently discontinue medication based on severity (such as reducing ILD/pneumonia to 60mg, hypertension to 120mg, etc.).

3. Combination use of strong CYP3A inhibitors: The dosage needs to be reduced by about 50% (such as from 180mg to 90mg).

7、 Medication precautions

1. Dietary impact: Not affected by food, but avoid grapefruit/juice (which may increase blood drug concentration).

2. Special Reminder: Close monitoring of respiratory symptoms (ILD risk) is required during the first week of treatment; Regularly monitor blood pressure, heart rate CPK、 Pancreatic enzymes and blood glucose.

8、 Medication for special populations

1. Pregnant women: Prohibited, may cause fetal malformation, non hormonal contraceptive measures should be taken (during and 4 months after discontinuation of medication for women, and 3 months after discontinuation of medication for men).

2. Breastfeeding period: Breastfeeding is prohibited during the medication period and within one week of discontinuation.

3. Liver/kidney dysfunction: mild to moderate without adjustment; Severe kidney damage (CLcr<30mL/min) requires a reduction to 30mg once daily.

9、 Adverse reactions

1. Common (≥ 25%): Nausea, diarrhea, fatigue, cough, headache.

2. Serious reactions: ILD/pneumonia (9.1%), hypertension (21%), bradycardia, visual impairment, elevated CPK, pancreatitis, hyperglycemia.

10、 Contraindications

There are no clear contraindications, but it is contraindicated for those who are allergic to this product or excipients.

11、 Drug interactions

1. Avoid combination use: strong CYP3A inhibitors (such as ketoconazole), strong CYP3A inducers (such as rifampicin).

2. Attention: It may reduce the effectiveness of hormonal contraceptives and non hormonal contraception should be used instead.

12、 Storage method

Store at room temperature (20 ° C-25 ° C) and allow short-term storage at 15 ° C-30 ° C.

Alunbriginformation