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 详细处方信息以本药内容附件PDF文件（2011122123255618.PDF,2011122123255124.PDF）的“原文Priscribing Information”为准
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部分中文Arzerra处方资料（仅供参考）

慢性淋巴细胞白血病药Arzerra在欧洲再度获准
    欧洲药监局日前批准葛兰素史克和 Genmab出品的Arzerra上市销售，该药用于治疗难治型慢性淋巴细胞性白血病（CLL）。去年10月，Arzerra已通过了FDA的批准，此次再度获准在欧洲市场上市，但产品的销售有一定的前提条件，即适用患者范围有限，只能用于那些采用标准药物或化学疗法药氟达拉宾（fludarabine）治疗之后无应答的CLL患者，他们只占这类患者总人数的25%左右。
　　有条件销售批准主要针对那些疗效显著，但同时用药风险也相对较高的产品。通常这种药物能够满足特定患者的需求，但还没有足够的数据证实它给患者带来的益处大于潜在的风险，从而无法获得完全批准。根据相应要求，葛兰素史克在产品销售之后仍需向欧洲药监局递交补充数据。
　　分析师认为Arzerra的市场前景甚为乐观，到2013年该药的销售额将达到4.65亿美元左右。但罗氏/ Biogen上个月初在美国对这种药物进行起诉，认为它侵犯了抗癌药Rituxan的专利权，这也许会对产品的销售产生一定的影响。

慢性淋巴细胞白血病药Arzerra临床试验表现良好
    丹麦Genmab制药公司公布了其在研新药Arzerra在一项中期临床试验中获得的首批数据，该药主要用于从未接受过任何治疗的慢性淋巴细胞白血病（CLL）患者，由Genmab公司和GSK公司共同研发。
　　在上述试验中，研究者对61名受试CLL患者采用Arzerra+Fludarabine（氟达拉宾）+ Cyclophosphamide（环磷酰胺）进行治疗。试验结果发现，采用500毫克Arzerra治疗的患者病情完全缓解率为32%，而1000毫克剂量组患者的病情完全缓解率达到50%.此外，500毫克剂量组患者用药后的总体应答率为77%，1000毫克剂量组患者对药物的总体应答率为73%.
　　Genmab公司表示，在为期30天用药过程中未出现意料之外的安全性问题。该药最常见的副作用为嗜中性白细胞减少（出现几率为48%），其他常见不良反应（出现几率为15%）还包括恶心、呕吐、皮疹、发热、头痛和血小板减少。两个不同剂量受试组用药后出现上述不良反应的概率相当。
　　
用于非霍奇金淋巴瘤的Arzerra 介绍
    Genmab公司与葛兰素史克公司合作开发的靶向作用于B细胞上CD20的单克隆抗体Arzerra(通用名为ofatumumab)在与其他抗肿瘤药物联用治疗滤泡性非霍奇金淋巴瘤(NHL)的Ⅱ期临床试验中获得成功。
    该项试验考察了不同剂量的Arzerra与环磷酰胺、多柔比星、长春新碱和泼尼松联用治疗NHL 的疗效,每3周为1个疗程,共6个疗程, 58名患者被随机分为两组, 第1 个疗程中两组患者均注射 Arzerra 300 mg,其余5 个疗程中剂量分别调整至 500或1000 mg。结果, 500 mg剂量组的总有效率 (ORR)达90% , 其中完全缓解率(CR)为24%; 1 000 mg剂量组的ORR则达100%, CR 为38%;试验中及试验结束后30天内均未见意外安全性问题。常见不良反应包括白细胞和中性粒细胞减少。 Genmab公司总裁L isa Drakeman 博士称:"我们对该项研究的结果感到满意,这预示了Arzerra治疗滤泡性NHL的潜力。"
    Genmab公司目前正计划开展另两项研究,进一步考察Arzerra对NHL的疗效,其可能采用的剂量为 1 000 mg。此外,一项关于Arzerra治疗风湿性关节炎的Ⅲ期临床研究也在进行中,且初步研究结果显示, 其疗效与基因泰克(Genentech)开发的Rituxan相当。

ARZERRA®
(ofatumumab) Injection, for intravenous infusion

ARZERRA (ofatumumab) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The effectiveness of ARZERRA is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA.

Important Safety Information
Highlights of Warnings and Precautions
•Infusion Reactions: Premedicate with an intravenous corticosteroid (as appropriate), an oral analgesic, and an oral or intravenous antihistamine. Monitor patients closely during infusions. Interrupt infusion if infusion reactions occur.
•Cytopenias: Monitor blood counts at regular intervals for neutropenia and thrombocytopenia.
•Progressive Multifocal Leukoencephalopathy (PML): Monitor neurologic function and discontinue ARZERRA if PML is suspected.
•Hepatitis B Infection and Reactivation: Screen high-risk patients. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis.

Infusion Reactions
ARZERRA can cause serious infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac ischemia/infarction, back pain, abdominal pain, pyrexia, rash, urticaria, and angioedema. Infusion reactions occur more frequently with the first 2 infusions. Premedicate with acetaminophen, an antihistamine, and a corticosteroid. Interrupt infusion for infusion reactions of any severity. Institute medical management for severe infusion reactions including angina, or other signs and symptoms of myocardial ischemia. In a study of patients with moderate to severe chronic obstructive pulmonary disease, an indication for which ARZERRA is not approved, 2 of 5 patients developed Grade 3 bronchospasm during infusion. Infusion reactions occurred in 44% of patients on the day of the first infusion (300 mg), 29% on the day of the second infusion (2,000 mg), and less frequently during subsequent infusions.

Cytopenias
Prolonged (>1 week) severe neutropenia and thrombocytopenia can occur with ARZERRA. Monitor complete blood counts (CBC) and platelet counts at regular intervals during therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Of 108 patients with normal neutrophil counts at baseline, 45 (42%) developed >Grade 3 neutropenia. Nineteen (18%) developed Grade 4 neutropenia. Some patients experienced new onset Grade 4 neutropenia >2 weeks in duration.

Progressive Multifocal Leukoencephalopathy
Progressive multifocal leukoencephalopathy (PML), including fatal PML, can occur with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. Discontinue ARZERRA if PML is suspected and initiate evaluation for PML including consultation with a neurologist, brain MRI, and lumbar puncture.

Hepatitis B Infection and Reactivation
Fulminant and fatal hepatitis B virus (HBV) infection and reactivation can occur in patients following treatment with ARZERRA. Screen patients at high risk of HBV infection before initiation of ARZERRA. Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection during treatment with ARZERRA and for 6 to 12 months following the last infusion of ARZERRA. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis, and institute appropriate treatment. Insufficient data exist regarding the safety of administration of ARZERRA in patients with active hepatitis.

Intestinal Obstruction
Obstruction of the small intestine can occur in patients receiving ARZERRA. Perform a diagnostic evaluation if obstruction is suspected.

Immunizations
The safety of immunization with live viral vaccines during or following administration of ARZERRA has not been studied. Do not administer live viral vaccines to patients who have recently received ARZERRA. The ability to generate an immune response to any vaccine following administration of ARZERRA has not been studied.

Most Common Adverse Reactions
In the pivotal study (total population, n=154) the most common adverse reactions (>10%, all grades) were neutropenia, followed by pneumonia (23%), pyrexia (20%), cough (19%), diarrhea (18%), anemia (16%), fatigue (15%), dyspnea (14%), rash (14%), nausea (11%), bronchitis (11%), and upper respiratory tract infections (11%).

Most Common Serious Adverse Reactions
In the pivotal study (total population, n=154), where ARZERRA was administered at 2,000 mg beginning with the second dose for 11 doses, the most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia.

A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced >Grade 3 infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.

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 详细处方信息以本药内容附件PDF文件（2011122123255618.PDF,2011122123255124.PDF）的“原文Priscribing Information”为准
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