1. Indications and Usage
\nALK-Positive Non-Small Cell Lung Cancer (NSCLC):
\nIndicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
\nApproval Context:
\nPreviously treated patients (post-crizotinib).
\nTreatment-naive patients (first-line therapy).
\n2. Dosage and Administration
\nRecommended Dosage:
\nFirst-Line Therapy: 90 mg orally once daily for the first 7 days; if tolerated, increase to the recommended dose of 180 mg once daily thereafter.
\nPost-Crizotinib Therapy: 180 mg orally once daily.
\nAdministration Instructions:
\nAdminister orally with or without food.
\nSwallow tablets whole; do not crush, chew, or break.
\nDose Modifications:
\nDose reductions (to 120 mg, 90 mg, or 60 mg once daily) are recommended based on individual safety and tolerability (e.g., for hypertension, CPK elevation, or pulmonary toxicity).
\nIf the 180 mg dose is not tolerated, reduce to 120 mg; if 90 mg is not tolerated, reduce to 60 mg.
\n3. Mechanism of Action
\nALK Tyrosine Kinase Inhibitor:
\nBrigatinib is a kinase inhibitor of ALK, ROS1, and EGFR.
\nPhysiological Effect:
\nIt inhibits ALK-mediated phosphorylation of downstream signaling proteins (STAT3, AKT, ERK1\/2, S6) in cells expressing ALK fusion proteins (e.g., EML4-ALK).
\nIt exhibits potent anti-tumor activity against ALK mutations associated with resistance to crizotinib and demonstrates efficacy in reducing intracranial tumor burden.
\n4. Safety and Warnings
\nInterstitial Lung Disease (ILD)\/Pneumonitis:
\nSevere and fatal cases have been reported. Monitor for pulmonary symptoms (cough, dyspnea, hypoxia), especially during the first week of treatment. Withhold or discontinue based on severity.
\nHypertension:
\nOccurs in a significant percentage of patients. Monitor blood pressure 2 weeks after initiation and at least monthly thereafter.
\nBradycardia:
\nMonitor heart rate and blood pressure regularly.
\nElevated Creatine Phosphokinase (CPK):
\nMonitor CPK levels regularly. Withhold for unexplained CPK elevation.
\nPancreatic Enzyme Elevations:
\nMonitor serum lipase and amylase levels regularly.
\nHyperglycemia:
\nAssess fasting serum glucose prior to initiation and periodically thereafter.
\nVisual Disturbances:
\nCan occur. Withhold for moderate\/severe symptoms and evaluate ophthalmologically.
\nEmbryo-Fetal Toxicity:
\nCan cause fetal harm. Advise females of reproductive potential to use effective contraception.
\n5. Adverse Reactions
\nMost Common:
\nHypertension, increased CPK, diarrhea, rash, fatigue, increased lipase, cough, increased amylase, nausea, increased glucose, headache.
\n6. Drug Interactions
\nCYP3A Inhibitors:
\nConcomitant use with strong CYP3A inhibitors increases brigatinib exposure. Avoid concomitant use; if unavoidable, reduce the brigatinib dose.
\nCYP3A Inducers:
\nConcomitant use with strong CYP3A inducers significantly decreases brigatinib exposure. Avoid concomitant use.
\nP-gp Substrates:
\nBrigatinib is a P-gp inhibitor. Avoid co-administration of drugs with a narrow therapeutic index that are P-gp substrates.
\n7. Pharmaceutical Information
\nChemical Name:
\n5-[(2-Isopropyl-5-m-tolyl-1H-imidazol-4-yl)methoxy]-2-(2-morpholinoethoxy)aniline.
\nStorage:
\nStore at 25\u00b0C (77\u00b0F); excursions permitted to 15-30\u00b0C (59-86\u00b0F).<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u5b89\u4f2f\u745e\u00ae (Alunbrig\u00ae)
\nGeneric Name: Brigatinib
\nStrength: 90 mg per tablet, 28 tablets per box (7 tablets per blister, 4 blisters per box)
\nManufacturer: Penn Pharmaceutical Services Ltd. (UK)
\nMarketing Authorization Holder: Takeda Pharma A\/S\uff1b\u5883\u5185\u6301\u8bc1\uff1a\u6b66\u7530\uff08\u4e2d\u56fd\uff09\u56fd\u9645\u8d38\u6613\u6709\u9650\u516c\u53f8
\nApproval Date in China: March 22, 2022
\nRegistration Number:\u56fd\u836f\u51c6\u5b57 HJ20220020
\nStorage: Store at 20\u201325\u2103, short-term temperature fluctuation within 15\u201330\u2103 is acceptable; keep tightly sealed, avoid light and moisture, and place out of reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Brigatinib\uff08Alunbrig\uff09<\/p>\n","protected":false},"featured_media":3141,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[74],"product_cat":[27],"product_tag":[],"class_list":["post-3140","product","type-product","status-publish","has-post-thumbnail","product_brand-takeda","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n