HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA.
IMBRUVICA™ (ibrutinib) capsules, for oral use
Initial U.S. Approval: 2013强生(JNJ)和Pharmacyclics 11月13日宣布，FDA已批准血癌药物ibrutinib(拟用商品名为Imbruvica)，用于既往已接受至少一种其他药物(如Celgene公司的Revlimid)治疗的套细胞淋巴瘤(mantle cell lymphoma，MCL)成人患者的治疗。该药成为获得FDA突破疗法认定并获批的第2个药物，ibrutinib将成为上市的首个BTK靶向药物。
FDA于本月早些时候批准了罗氏(Roche)的Gazyva，用于治疗慢性淋巴细胞白血病(CLL)，是首个获FDA突破疗法认定并获批的药物。
在美国，套细胞淋巴瘤(MCL)占到了非霍奇金淋巴瘤病例的6%，该病在确诊时，通常已扩散至淋巴结、骨骼和其他器官。
目前，ibrutinib也正在等待FDA批准用于CLL。一些分析人士原以为，FDA会同时批准ibrutinib用于MCL和CLL。
RBC资本市场分析师Michael Yee预计，ibrutinib的长期年度全球销售额将达到50亿美元。
Ibrutinib由杨森与Pharmacyclics合作开发，目前正调查用于数种类型血癌的治疗。
强生分别于今年7月10日和10月30日向FDA和欧洲药品管理局(EMA)提交了Ibrutinib的上市许可申请(MAA)，寻求批准用于复发性或难治性慢性淋巴细胞白血病(CLL)/小淋巴细胞白血病(SLL)或复发性或难治性套细胞淋巴瘤(MCL)成人患者的治疗。
CLL/SLL和MCL属于一组名为B细胞恶性肿瘤的血液癌症。许多患者在治疗后会复发，可能在治疗过程中使用数种药物。
关于Ibrutinib：
Ibrutinib是一种名为Bruton酪氨酸激酶(BTK)抑制剂的首创新药。BTK是一个重要的蛋白，参与介导调控B细胞成熟和生存的胞内信号通路。在恶性B细胞中，B细胞受体信号通路过度活跃，该信号通路即包括BTK。
Ibrutinib能够与BTK形成强有力的共价键，从而抑制恶性B细胞中过度活跃的细胞生存信号的传输。
INDICATIONS AND USAGE
IMBRUVICA is a kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (1).
This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established (14.1).
DOSAGE AND ADMINISTRATION
560 mg taken orally once daily (four 140 mg capsules once daily) (2.2).
Capsules should be taken orally with a glass of water. Do not open, break, or chew the capsules (2.1).
DOSAGE FORMS AND STRENGTHS
Capsule: 140 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Hemorrhage: Monitor for bleeding (5.1).
Infections: Monitor patients for fever and infections and eva luate promptly. (5.2).
Myelosuppression: Check complete blood counts monthly (5.3).
Renal Toxicity: Monitor renal function and maintain hydration (5.4).
Second Primary Malignancies: Other malignancies have occurred in patients, including skin cancers, and other carcinomas (5.5).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy while taking the drug (5.6).
ADVERSE REACTIONS
The most common adverse reactions (≥20%) in patients with MCL were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting and decreased appetite (6).
To report SUSPECTED ADVERSE REACTIONS, contact Pharmacyclics at 1-877-877-3536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
CYP3A Inhibitors: Avoid co-administration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce IMBRUVICA dose (2.4, 7.1).
CYP3A Inducers: Avoid co-administration with strong CYP3A inducers (7.2).
USE IN SPECIFIC POPULATIONS
Hepatic Impairment: Avoid use of IMBRUVICA in patients with baseline hepatic impairment (8.7).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2013
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