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布吉他滨Alunbrig,布吉他滨说明书,布吉他滨价格,香港布吉他滨价格,香港布吉他滨规格
【通用名称】 布吉他滨Alunbrig
【英文名称】 Alunbrig（brigatinib Tablet）
【中文名称】 布吉他滨
【生产厂家】 ARIAD公司
【经 销 商】香港华特药房咨询：137-255-387-85.
部份英文Alunbrig资料（仅供参考）
Alunbrig will be available as 30mg strength tablets in 21- and 180-count bottles and as 90mg strength tablets in 7- and 30-count bottles.
ALUNBRIG (Brigatinib) Approved For The Treatment Of ALK+ Metastatic Non-Small Cell Lung Cancer.
Approval Date: April 28, 2017 Company: Takeda Pharmaceutical Company: Limited
ALUNBRIG(TM) (brigatinib) tablets, for oral use&
Initial U.S. Approval: 2017
Mechanism of Action
Brigatinib is a tyrosine kinase inhibitor with in vitro activity at clinically achievable concentrations against multiple kinases including ALK, ROS1, insulin-like growth factor-1 receptor (IGF-1R), and FLT-3 as well as EGFR deletion and point mutations. Brigatinib inhibited autophosphorylation of ALK and ALK-mediated phosphorylation of the downstream signaling proteins STAT3, AKT, ERK1/2, and S6 in in vitro and in vivo assays. Brigatinib also inhibited the in vitro proliferation of cell lines expressing EML4-ALK and NPM-ALK fusion proteins and demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice.
At clinically achievable concentrations (≤ 500 nM), brigatinib inhibited the in vitro viability of cells expressing EML4-ALK and 17 mutant forms associated with resistance to ALK inhibitors including crizotinib, as well as EGFR-Del (E746-A750), ROS1-L2026M, FLT3-F691L, and FLT3-D835Y. Brigatinib exhibited in vivo anti-tumor activity against 4 mutant forms of EML4-ALK, including G1202R and L1196M mutants identified in NSCLC tumors in patients who have progressed on crizotinib. Brigatinib also reduced tumor burden and prolonged survival in mice implanted intracranially with an ALK-driven tumor cell line.
INDICATIONS AND USAGE
ALUNBRIG is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive static non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval d on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and deion of clinical benefit in a confirmatory trial.&
DOSAGE AND ADMINISTRATION
90 mg orally once daily for the first 7 if tolerated, increase to 180 mg orally once daily. May be taken with or without food.&
DOSAGE FORMS AND STRENGTHS
Tablets: 30 mg and 90 mg&
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 9.1% of patients at the recommended dose. Monitor for new or worsening respiratory symptoms, particularly during the first week of treatment. Withhold ALUNBRIG for new or worsening respiratory symptoms and promptly evaluate for ILD/pneumonitis. Upon recovery, either dose reduce or permanently discontinue ALUNBRIG.&
Hypertension: Monitor blood pressure after 2 weeks and then at least monthly during treatment. For severe hypertension, withhold ALUNBRIG, then dose reduce or permanently discontinue.
Bradycardia: Monitor heart rate and blood pressure regularly during treatment. If symptomatic, withhold ALUNBRIG, then dose reduce or permanently discontinue.&
Visual Disturbance: Advise patients to report visual symptoms. Withhold ALUNBRIG and obtain ophthalmologic evaluation, then dose reduce or permanently discontinue ALUNBRIG.&
Creatine Phosphokinase (CPK) Elevation: Monitor CPK levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose.&
Pancreatic Enzyme Elevation: Monitor lipase and amylase levels regularly during treatment. Based on the severity, withhold ALUNBRIG, then resume or reduce dose.&
Hyperglycemia: Assess fasting serum glucose prior to starting ALUNBRIG and regularly during treatment. If not adequately controlled with optimal medical management, withhold ALUNBRIG, then consider dose reduction or permanently discontinue, d on severity.&
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use a non-hormonal method of effective contraception.&
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Alunbrig(brigatinib)
批准日期：4月28，2017
公司：Takeda
Pharmaceutical
美国初次批准：2017
适应证和用途
ALUNBRIG是一种激酶抑制剂适用为有间变性淋巴瘤激酶(ALK)-阳性转移非小细胞肺癌(NSCLC)患者对用克里唑蒂尼[crizotinib]已进展或是不能耐受患者的治疗。这个适应证是根据肿瘤反应率和反应时间在加快批准[accelerated
approval]。对这个适应证继续批准可能取决于在验证性试验的确证和临床获益的描述。
剂量和给药方法
对头7天90 mg口服每天1次，如耐受，增加至180
mg口服每天1次。可能有或无食物服用。
剂型和规格
片：30 mg和90
警告和注意事项
间质性肺病(ILD)/肺炎：在推荐剂量时发生在9.1%的患者。监视对新或变坏的呼吸症状，尤其是在治疗的第一周。对新或变坏的呼吸症状不给ALUNBRIG和及时对ILD/肺炎评价。恢复时，或减低剂量或永久地终止ALUNBRIG。
高血压：治疗期间监视血压2周后和然后至少每月。对严重高血压，不给ALUNBRIG，然后剂量减低或永久地终止。
心动过缓：治疗期间有规律地监视心率和血压。如症状性，不给ALUNBRIG，然后剂量减低或永久地终止。
视力障碍：建议患者报告视力症状。不给ALUNBRIG和得到眼科评价，然后减低剂量或永久地终止ALUNBRIG&
肌酸磷酸激酶(CPK)升高：治疗期间有规律地监视CPK水平。根据严重程度，不给ALUNBRIG，然后恢复或减低剂量。
胰酶升高：治疗期间有规律地监视脂肪酶和淀粉酶水平。根据严重程度，不给ALUNBRIG，然后恢复或减低剂量。
高血糖：ALUNBRIG开始前和治疗期间常规地评估空腹血清葡萄糖。如不能用最优药物处理控制，不给ALUNBRIG，然后，根据严重程度考虑剂量减低或永久地终止。
胚胎胎儿毒性：可能致胎儿危害。
忠告有生殖潜能女性对胎儿潜在风险。和使用非激素有效避孕方法。&
用ALUNBRIG最常见不良反应(≥25%)为恶心，腹泻，疲乏，咳嗽，和头痛。
药物相互作用
CYP3A抑制剂：避免ALUNBRIG与强CYP3A抑制剂的同时使用。如一种强CYP3A抑制剂的同时使用是不能避免。减低ALUNBRIG的剂量。
CYP3A诱导剂：避免ALUNBRIG与强CYP3A
诱导剂的同时使用。
CYP3A底物：激素避孕药可能是无效由于减低暴露。
在特殊人群中使用
哺乳：建议不哺乳喂养。
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