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2012年9月28日美国食品药品监督管理局(FDA)扩展批准使用Humira(adalimumab)包括治疗成人中度至严重溃疡性结肠炎。
Humira被批准当免疫抑制药物像皮质激素类，硫唑嘌呤[azathioprine]，和6-巯基嘌呤[6-mercaptopurine]不起作用时控制溃疡性结肠炎。药物是一种抗肿瘤坏死因子(TNF)，阻断在异常炎症和免疫反应起重要作用的蛋白。
溃疡性结肠炎是一种慢性疾病，在大肠内壁衬里引起炎症和溃疡。它是两种主要形式慢性炎症性常见疾病之一和按照美国国立卫生研究院影响约620,000美国人。
FDA的药物评价和研究中心的胃肠病学和先天缺陷产品部主任Donna Griebel，M.D.说“每例溃疡性结肠炎患者经历不同疾病，和治疗必须调整以调整符合个体需要，”“今天的批准对常规治疗反应不佳的患者提供一种重要新治疗选择。”
FDA既往批准Humira治疗类风湿性关节炎(2002)，银屑病关节炎(2005)，强直性脊柱炎(2006)，克罗恩病(2007)，斑块型银屑病(2008)和幼年特发性关节炎(2008)。
有溃疡性结肠炎患者正常地被对大便次数，直肠出血，内窥镜发现和医生评估评价，这些组合提供一个计分范围从0至12有助于评估溃疡性结肠炎的活动性。这个计分系统常被称为Mayo计分。
在两项临床研究中确定对溃疡性结肠炎Humira的安全性和有效性。总共908例从未曾用TNF-阻断剂治疗过的患者，或对TNF-阻断剂丧失反应或不能耐受，参加研究。所有被纳入研究患者有Mayo计分6至12和内窥镜子计分 2至3。患者被随机赋予用 Humira或某种安慰剂。
研究被设计成测量Mayo计分减低2或更小，在治疗8周后个人子计分没有大于1的患者的百分数。Mayo计分测定达到如此减低的患者已达到临床缓解。
来自两项研究的结果显示16.5 %至18.5 %用Humira治疗患者达到临床缓解与之比较接受安慰剂治疗患者为9.2 %至9.3 %。此外，在第二项研究，用Humira治疗患者8.5 %持续缓解相比较用安慰剂治疗患者为4.1 %。尚未确定对TNF阻断剂丧失反应或不能耐受的溃疡性结肠炎患者中Humira的有效性。
FDA-批准Humira 对溃疡性结肠炎的给药方案用初始剂量160 mg开始，2周后80 mg第二剂量，和其后每隔周维持剂量。只应在治疗8周显示临床缓解证据患者中继续使用药物。
临床研究期间未鉴定新副作用。Humira 的常见副作用 包括感染注射部位反应，头痛和皮疹。
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Humira由位于北伊利诺伊州芝加哥的Abbott Laboratories制造。.
HUMIRA(阿达木单抗[adalimumab])注射剂，皮下使用溶液。
美国初次批准：2002
适应症和用途
HUMIRA是一种肿瘤坏死因子(TNF)阻断剂适用于治疗：
类风湿样关节炎(RA) (1.1)
在有中度至严重活动性RA成年患者中减轻征象和症状，诱导主要临床反应，抑制结构损伤进展，和改善机体功能。
幼年特发性关节炎(JIA) (1.2)
在4岁和以上儿童患者中减轻中度至严重活动性多关节JIA的征象和症状。
银屑病关节炎(PsA) (1.3)
在活动性PsA成年患者中减轻征象和症状, 抑制结构损伤进展，和改善机体功能。
强直性脊柱炎(AS) (1.4)
活动性AS成年患者中减轻征象和症状。
克罗恩氏病(CD) (1.5)
在有中度至严重活动性克罗恩氏病对常规治疗反应不充分的成年患者中减轻征象和症状和诱导和维持临床缓解。如这些患者还对英夫利昔单抗[infliximab]丧失反应或不能耐受减轻征象和症状和诱导临床缓解。
溃疡性结肠炎 (UC) (1.6):
在对免疫抑制剂如免疫抑制剂如皮质激素类, 硫唑嘌呤或6-巯基嘌呤(6-MP)已反应不佳的中度至严重活动性性结肠炎成年患者诱导和持续临床缓解。尚未确定对TNF阻断剂丧失反应或不能耐受患者中 HUMIRA的有效性。.
斑块性银屑病(Ps) (1.6)
中度至严重慢性斑块性银屑病成年患者的治疗，全身治疗或光疗，和其它全身治疗医学上不适宜的备选者。
剂量和给药方法
HUMIRA是通过皮下注射给药。(2)
类风湿样关节炎，银屑病关节炎，强直性脊柱炎(2.1)
每隔周40 mg。
某些有RA不接受氨甲喋呤患者[methotrexate]可能从增加频数至每周40 mg获益。
幼年特发性关节炎(2.2)
15 kg (33 磅)至<30 kg(66 磅)：20 mg每隔周
≥30 kg(66 磅)：40 mg每隔周。
克罗恩氏病和溃疡性结肠炎 (2.3, 2.4)：
初始剂量第一天)：160 mg(4次40 mg注射在一天或2次40 mg注射每天连续2天)。
两周以后(第15天)第二次剂量接着80 mg。
两星期以后(第29天)开始每隔周维持剂量40 mg。
只对溃疡性结肠炎患者：只有在治疗第8周(第57天)已显示临床缓解证据的患者继续用HUMIRA。
斑块性银屑病(2.5)
80 mg初始剂量，接着40 mg每隔周初始剂量开始一周后。
剂型和规格
（1）40 mg/0.8 mL在一支单次使用预装笔(HUMIRA笔)中(3)
（2）40 mg/0.8 mL在一支单次使用预装玻璃注射器中(3)
（3）20 mg/0.4 mL在一支单次使用预装玻璃注射器中(3)
禁忌证
无(4)
警告和注意事项
（1）严重感染 – 活动性感染期间不开始用HUMIRA。如发生感染，仔细监视，和如感染变得严重停止HUMIRA(5.1)
（2）侵袭性真菌感染 – 对用HUMIRA发生全身性疾患的患者，对居住或在霉菌病流行区域患者考虑经验性抗真菌治疗(5.1)
（3）恶性病 – HUMIRA-治疗患者比对照恶性病发生率更高(5.2)
（4）过敏反应或严重性过敏反应：可能发生(5.3)
（5）乙型肝炎病毒再激活 – 治疗期间和其后几个月监视HBV携带者。如发生再激活, 停止HUMIRA和开始抗-病毒治疗(5.4)
（6）脱鞘性疾病：可能加重或新发生(5.5)
（6）血细胞减少，全血细胞减少 – 建议如发生症状患者立即求医，和考虑停止HUMIRA (5.6)
（7）可能发生心衰，恶化或新发生 (5.8)
（8）狼疮样综合征 – 如发生症状停止HUMIRA (5.9)
不良反应
最常见不良反应(发生率 >10%)：感染(如上呼吸，窦炎)，注射部位反应，头痛和皮疹(6.1)
药物相互作用
（1）阿巴西普[Abatacept] – 增加严重感染风险(5.1, 5.11, 7.2)
（2）阿那白滞素[Anakinra] – 增加严重感染风险(5.1, 5.7, 7.2)
（3）活疫苗 – 不应与HUMIRA同时给予(5.10, 7.3)
特殊人群中使用
妊娠：鼓励医生纳入妊娠患者HUMIRA妊娠注册中通过电话1-877-311-8972 (8.1)
Important Safety Information You Should Know About HUMIRA(adalimumab) Serious infections have happened in patients taking HUMIRA.
These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body.
Some patients have died from these infections. Your doctor should test you for TB before starting HUMIRA, and monitor you closely for signs and symptoms of TB during treatment with HUMIRA.
Before starting HUMIRA:
You should not start taking HUMIRA if you have any kind of infection. Tell your doctor if you think you have an infection, are being treated for an infection, have signs of an infection (such as a fever, cough, or flu-like symptoms), have any open cuts or sores on your body, or get a lot of infections or have infections that keep coming back. Tell your doctor if you have diabetes, have TB or have been in close contact with someone with TB, were born in, lived in, or traveled to countries where there is more risk for getting TB,
live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis), have or have had hepatitis B, use the medicine Kineret (anakinra), or are scheduled to have major surgery.
Tell your doctor if you have any numbness or tingling, or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome, have heart failure or other heart conditions, are pregnant, become pregnant, plan to become pregnant or are breastfeeding. Tell your doctor if you are allergic to HUMIRA or any of its ingredients or are allergic to rubber or latex. The needle cover of the prefilled syringe and the pen contain dry natural rubber.
Also, tell your doctor if you have recently received or are scheduled for any vaccines. Except for live vaccines, patients may still receive vaccines while on HUMIRA. It is recommended that children with juvenile idiopathic arthritis be brought up to date with all immunizations prior to starting HUMIRA.
After starting HUMIRA:
Call your doctor right away if you have an infection, or any sign of an infection, including a fever, feeling very tired, cough, flu-like symptoms, warm, red or painful skin, or if you have any open cuts or sores on your body. HUMIRA can make you more likely to get infections or make any infection that you may have worse.
Possible side effects of HUMIRA:
Serious side effects, which sometimes lead to death, have happened in patients taking HUMIRA.
Serious infections. These infections include TB and infections caused by viruses, fungi, or bacteria. Your doctor will examine you for TB and perform a test to see if you have TB.
If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with HUMIRA and during treatment with HUMIRA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking HUMIRA.
Patients who had a negative TB skin test before receiving HUMIRA have eveloped active TB. Tell your doctor if you have any of the following symptoms while taking or after taking HUMIRA: cough, low-grade fever, weight loss, or loss of body fat and muscle.
Certain types of cancer. There have been cases of certain kinds of cancer, in patients taking HUMIRA or other TNF blockers. Patients with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.
Allergic reactions. Signs of a serious allergic reaction include skin rash, a swollen face, or trouble breathing.
Hepatitis B virus reactivation in patients that carry the virus in their blood. Tell your doctor if you have any of the following symptoms: feel unwell, poor appetite, fatigue, fever, rash or joint pain.
Nervous system problems. Signs and symptoms include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
New heart failure or worsening heart failure you already have.
Symptoms include shortness of breath or swelling of your ankles or feet, or sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or rms that gets worse in the sun.
Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with HUMIRA may be stopped.
Common side effects of HUMIRA are: injection site reactions (redness, rash, swelling, itching or bruising), upper respiratory infections (sinus infections), headaches, rash and nausea.
These are not all the side effects with HUMIRA. Ask your doctor or pharmacist for more information.
Information You Should Know About HUMIRA® (adalimumab)HUMIRA is a medicine called a tumor necrosis factor (TNF) blocker.
HUMIRA is taken by injection and is available by prescription only.
HUMIRA is used to:
Reduce the signs and symptoms of:moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone or with methotrexate or with certain other medicines. HUMIRA may preventfurther damage to your bones and joints and may help your ability to perform daily activities.
moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone or with methotrexate or with certain other medicines.
psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
ankylosing spondylitis (AS) in adults. moderate to severe Crohn's disease (CD) in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab.
Treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who are under the ongoing care of a physician, have the condition in many areas of their body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
When considering HUMIRA, your physician will determine if other systemic therapies are medically less appropriate.
附件:
200941522475131.pdf
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注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
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产地国家: 美国
原产地英文商品名:
HUMIRA PSORIASIS STARTER PACK 4PENS/KIT
原产地英文药品名:
ADALIMUMAB
中文参考商品译名:
HUMIRA银屑病起始装 4支笔/套
中文参考药品译名:
阿达木单抗
生产厂家中文参考译名:
雅培公司
生产厂家英文名:
Abbott
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产地国家: 美国
原产地英文商品名:
HUMIRA 20MG/0.4ML/SYRINGE 2SYRINGES/KIT
原产地英文药品名:
ADALIMUMAB
中文参考商品译名:
HUMIRA 20毫克/0.4毫升/注射器 2支注射器/套
中文参考药品译名:
阿达木单抗
生产厂家中文参考译名:
雅培公司
生产厂家英文名:
Abbott
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