ak, confusion, change in your speech, or a headache that lasts a long time. Your risk of bleeding may increase if you are also taking a blood thinner medicine.
Infections can happen during treatment with IMBRUVICA™. Infections can be serious and may lead to death. Tell your healthcare provider if you have fever, chills, or any other signs or symptoms of an infection while taking IMBRUVICA™.
Decrease in blood cell counts. Your healthcare provider should do monthly blood tests to check your blood counts.
Kidney problems. Kidney failure and death have happened with IMBRUVICA™ treatment. Drink fluids during treatment with IMBRUVICA™ to help prevent too much fluid loss (dehydration). Your healthcare provider should do blood tests to check how well your kidneys are working.
Second primary cancers. New cancers have happened in people who have been treated with IMBRUVICA™, including cancers of the skin or other organs.
The most common side effects of IMBRUVICA™ in MCL include: low blood platelet count, diarrhea, low white blood cell count, low red blood cell count, fatigue, muscle and bone pain, swelling of legs and feet, upper respiratory tract infection, nausea, bruising, shortness of breath, constipation, rash, stomach (abdomen) pain, vomiting, and decreased appetite.
The most common side effects of IMBRUVICA™ in CLL include: low blood platelet count, diarrhea, bruising, low white blood cell count, low red blood cell count, upper respiratory tract infection, fatigue, muscle and bone pain, rash, fever, constipation, swelling of legs and feet, joint pain, nausea, mouth sores, sinus infection, and dizziness.
Diarrhea is a common side effect in people who take IMBRUVICA™. Tell your healthcare provider if you have diarrhea that does not go away
General information about the safe and effective use of IMBRUVICA™
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA™ for a condition for which it was not prescribed. Do not give IMBRUVICA™ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA™ that is written for health professionals.
These are not all the possible side effects of IMBRUVICA™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please review the full Important Product Information by clicking here.
美国FDA批准Imbruvica治疗慢性淋巴细胞性白血病
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm385764.htm
2014年2月12日美国食品药品监督管理局(FDA)扩展Imbruvica(拉铁尼伯[ibrutinib])为曾接受至少一次既往治疗慢性淋巴细胞性白血病(CLL)患者的批准使用。.
CLL是一种罕见血液和骨髓疾病that 通常随时间缓慢变坏，引起被称为B淋巴细胞，或B细胞的白细胞逐渐增加。美国国立癌症研究所估计在2013年15,680美国人被诊断和4,580死于此病。
Imbruvica通过阻断允许癌细胞生长和分裂酶起作用。在2013年11月，FDA授予Imbruvica 加速批准治疗有套细胞淋巴瘤患者，一种罕见和侵袭类型血癌，如那些患者既往接受至少一次治疗。
FDA的药物评价和研究中心血液学和肿瘤产品室主任Richard Pazdur，医学博士说“今天的批准为尽管正在进行以前治疗癌症已进展的CLL患者提供一种重要的新治疗选择，”“FDA 在监管局的加速批准过程下完成Imbruvica的新适应证审评，这在使最需要此药患者迅速得到这个新治疗中起至关重要的作用。”
在监管局的加速批准过程，FDA可根据一个替代指标或合理预测临床获益的中间终点批准一个药物
