Imbruvica(Ibrutinib Capsules)依鲁替尼胶囊

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CLLPREVIOUSLY TREATED
CHRONIC LYMPHOCYTIC LEUKEMIA MCLPREVIOUSLY TREATED
MANTLE CELL LYMPHOMA
These indications are based on overall response rate. Improvements in survival or disease-related symptoms have not been established.
WHAT IS IMBRUVICA™?
IMBRUVICA™ is a prescription medicine used to treat people with:
Mantle cell lymphoma (MCL) who have received at least one prior treatment
Chronic lymphocytic leukemia (CLL) who have received at least one prior treatment
It is not known if IMBRUVICA™ is safe and effective in children.
What should I tell my healthcare provider before taking IMBRUVICA™?
Before you take IMBRUVICA™, tell your healthcare provider about all of your medical conditions, including if you:
had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA™ for any planned medical, surgical, or dental procedure.
have bleeding problems
have liver problems
are pregnant or plan to become pregnant. IMBRUVICA™ can harm your unborn baby. You should not become pregnant while taking IMBRUVICA™.
are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take IMBRUVICA™ or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA™ with certain other medicines may affect how IMBRUVICA™ works and can cause side effects.
How should I take IMBRUVICA™?
Take IMBRUVICA™ exactly as your healthcare provider tells you to take it.
Take IMBRUVICA™ 1 time a day.
Swallow IMBRUVICA™ capsules whole with a glass of water. Do not open, break, or chew IMBRUVICA™ capsules.
Take IMBRUVICA™ at about the same time each day.
If you miss a dose of IMBRUVICA™ take it as soon as you remember on the same day. Take your next dose of IMBRUVICA™ at your regular time on the next day. Do not take 2 doses of IMBRUVICA™ on the same day to make up for a missed dose.
What should I avoid while taking IMBRUVICA™?
You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) while you are taking IMBRUVICA™. These products may increase the amount of IMBRUVICA™ in your blood.
What are the possible side effects of IMBRUVICA™?
IMBRUVICA™ may cause serious side effects, including:
Bleeding problems can happen during treatment with IMBRUVICA™ that can be serious. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, feel dizzy or weak, 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.

2013年11月13日，美国食品药品管理局（FDA)加速批准了Pharmacyclics公司和强生的Imbruvica（通用名：Ibrutinib，依鲁替尼）上市，用于治疗一种罕见的侵袭性血癌——套细胞淋巴瘤（MCL）。2014年2月12日，美国食品药品管理局（FDA)又批准了Pharmacyclics公司和强生的Imbruvica（通用名：Ibrutinib，依鲁替尼）上市，用于治疗慢性淋巴细胞白血病（CLL）。临床试验中，111例既往至 少接受过一项治疗的患者经依鲁替尼治疗后，总应答率为65.8%（完全应答17.1%+部分应答48.6%），中位持续应答时间为17.5个月
依鲁替尼（Ibrutinib）
适应症：
慢性淋巴细胞白血病和套细胞淋巴瘤患者治疗。作用机理：作为一种Bruton’s酪氨酸激酶（BTK）抑制剂，抗肿瘤药Ibrutinib是该治疗机制的首个新药。作为细胞生理活动中的重要蛋白，BTK参与B细胞成熟/生存信号通路的调控。该信号通路在恶性B细胞中被过度表达。Ibrutinib能够以强力共价键的形式与BTK相契合，从而抑制细胞生存信号的过度表达，最终抑制肿瘤生长和转移。
药物分类：孤儿药，
特点:
抗肿瘤药Ibrutinib早先由Pharmacyclics公司单独开发。2011年，强生（JNJ）旗下子公司杨森制药（Jassen）通过先期支付1.5亿美元而获得与Pharma-cyclics公司合作开发的权利。这款药物于今年2月份已被FDA授予突破性治疗药物资格（突破性疗法称号是2012年FDA安全和创新法案中制定的部分内容，目的是帮助加快用于严重致命疾病的潜在新药的开发进度，这些药物的临床前研究就已显示比现有的治疗药物在一项或多项临床指标上具有明显改进。）。杨森制药于7月份向FDA提交了这款药物的上市申请，该药物用于治疗两种B细胞恶性肿瘤，即作为二线治疗药物用于慢性淋巴细胞性白血病(CLL)/小淋巴细胞淋巴瘤(SLL)和套细胞淋巴癌(MCL)治疗。10月份，杨森制药再次宣布，已向欧洲药品管理局（EMA）提交了抗肿瘤药Ibrutinib的上市许可申请（MAA），寻求批准用于上述三种血液性肿瘤的治疗。