Brigatinib INN equivalent to Brigatinib......... 90mg

Brigatinib Instructions

Product Name: Brigatinb

Manufacturer: Alliance Pharmaceuticals

Chinese name: brigatinib

English name: Brigatinib

Drug approval: 03 L 0954/23

【Summary】

Brigatinib is a second-generation ALK targeted therapy and is the first drug that can extend the disease-free survival (PFS) of patients with resistance to crizotinib treatment to more than one year. The overall efficacy of Brigatinib is as high as 73% for patients who have received crizotinib treatment and those who have not received ALK inhibitor treatment.

【Indications】

Brigatinib is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

【Specification】

90mg/tablet, 30 tablets/bottle.

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

【Usage and Dosage】

90 mg orally once a day for the first 7 days;

If 90 mg is tolerated within the first 7 days, increase the dose to 180 mg orally once daily.

【Adverse Reactions】

The most common adverse reactions (≥25%) were nausea, diarrhea, fatigue, cough, and headache.

【Warnings and Precautions】

1. Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 9.1% of patients at the recommended dose. Monitor for new or worsening respiratory symptoms, especially during the first week of treatment. Withhold brigatinib for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either reduce the dose or permanently discontinue brigatinib.

2. Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold brigatinib and then reduce the dose or permanently discontinue.

3. Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold brigatinib, then reduce the dose or permanently discontinue.

4. Visual Disturbance: Advise patients to report visual symptoms. Withhold brigatinib and obtain ophthalmologic evaluation, then reduce the dose or permanently discontinue brigatinib

5. Elevated creatine phosphokinase (CPK): Monitor CPK levels regularly during treatment. Depending on the severity, withhold brigatinib and then resume or reduce the dose.

6. Elevated pancreatic enzymes: Monitor lipase and amylase levels regularly during treatment. Depending on the severity, withhold brigatinib and then resume or reduce the dose.

7. Hyperglycemia: Assess fasting serum glucose prior to initiation of brigatinib and routinely during treatment. If not controlled with optimal medical management, withhold brigatinib and, based on severity, consider dose reduction or permanent discontinuation.

8. Embryo-fetal toxicity: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective non-hormonal contraceptive methods.

【Drug Interactions】

CYP3A Inhibitors: Avoid concomitant use of brigatinib with strong CYP3A inhibitors. If concomitant use of a strong CYP3A inhibitor cannot be avoided, reduce the dose of brigatinib.

CYP3A Inducers: Avoid concomitant use of brigatinib with strong CYP3A inducers.

CYP3A substrates: Hormonal contraceptives may be ineffective due to decreased exposure.

[Special Populations]

Breastfeeding: Breastfeeding is not recommended.