LuciBriga 90 brigatinib Tablets

Product Name: LuciBriga

English Name: Brigatinib

Specifications: 90 mg/tablet, 30 tablets/bottle. 

180 mg/tablet, 30 tablets/bottle.

[Overview]

Brigatinib is a second-generation ALK-targeted therapy drug. It is currently the first drug demonstrated to provide a progression-free survival (PFS) duration exceeding one year in patients who have developed resistance to crizotinib treatment. In a patient population comprising both those previously treated with crizotinib and those who have not received prior ALK inhibitor therapy, the overall response rate (ORR) for Brigatinib reaches as high as 73%.

[Indications]

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

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F).

[Dosage and Administration]

Take 90 mg orally once daily for the first 7 days;

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

[Adverse Reactions]

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

[Warnings and Precautions]

1. Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 9.1% of patients at the recommended dosage. Monitor for new or worsening respiratory symptoms, particularly 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 during treatment, after 2 weeks, and then at least monthly thereafter. For severe hypertension, withhold Brigatinib, then either reduce the dose or permanently discontinue the drug. 3. Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold Brigatinib; then, either reduce the dose or permanently discontinue the drug.

4. Visual Disturbances: Advise patients to report any visual symptoms. Withhold Brigatinib and obtain an ophthalmologic evaluation; then, either reduce the dose or permanently discontinue Brigatinib.

5. Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Depending on the severity, withhold Brigatinib; then, either resume treatment or reduce the dose.

6. Pancreatic Enzyme Elevation: Monitor lipase and amylase levels regularly during treatment. Depending on the severity, withhold Brigatinib; then, either resume treatment or reduce the dose.

7. Hyperglycemia: Assess fasting serum glucose routinely prior to initiating Brigatinib and periodically during treatment. If hyperglycemia cannot be controlled with optimal medical management, withhold Brigatinib; then, depending on the severity, consider dose reduction or permanent discontinuation.

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

[Drug Interactions]

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

CYP3A Inducers: Avoid the concomitant use of Brigatinib with strong CYP3A inducers.

CYP3A Substrates: Hormonal contraceptives may be ineffective due to reduced exposure.