インフリキシマブ（遺伝子組換え）（infliximab（genetical recombination））-类克(Remicade 通用名:英利昔单抗)
治疗类别名称
抗人TNFα单克隆抗体制剂
商品名：レミケード点滴静注用100 
英文药名：Remicade for I.V. Infusion
一般名： 
インフリキシマブ（遺伝子組換え）（infliximab（genetical recombination））
组成
成分含量（1瓶）
英夫利昔单抗（基因重组）100毫克
添加剂
纯化的蔗糖：500毫克聚山梨醇酯80：0.5mg的磷酸二氢钠单水合物：2.2mg磷酸氢二钠二水合物：含pH调节剂作为6.1mg的其它添加剂
适应病症
本品治疗效果以下疾病不足
类风湿关节炎（包括预防关节结构破坏）
顽固性葡萄膜炎视网膜由于白塞氏病
寻常型银屑病，关节病型银屑病，脓疱型银屑病，红皮病牛皮癣
强直性脊柱炎
肠型白塞氏病，神经型贝切特氏病，血管型贝切特氏病
急性期的状态之一克罗恩病的治疗和维持治疗中显示了下列川崎病（限于情况，其中常规治疗是不够有效）
例中度至重度活动期
具有外瘘病人
严重的溃疡性结肠炎治疗中度（仅限于案件中，常规治疗是不够有效）
用法用量
·风湿性关节炎
静脉输液为每剂量为3mg1次体重1公斤。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。
此外，后6周施用，当效果不足或效果减弱是可能减少剂量的增加或给药间隔。这些剂量的膨胀和给药间隔逐步做的缩短。剂量的每一个的加权的上限1公斤，如果有10毫克的8周的时间间隔，并为6mg在缩短给药间隔的情况下。此外，最短的给药间隔是四个星期。该试剂可以与甲氨蝶呤制剂组合治疗中。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药
·顽固性葡萄膜炎视网膜由于白塞氏病
静脉输液为每剂量5毫克1次体重1公斤。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
·牛皮癣
静脉输液为每剂量5毫克1次体重1公斤。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药
·强直性脊柱炎
静脉输液为每剂量5毫克1次体重1公斤。第一次剂量后，2周，给药6周，在随后的6-8周的时间间隔进行施用。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
·肠型白塞氏病，神经型贝切特氏病，血管型贝切特氏病
滴注，一次按体重重1kg一次5mg剂量。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。此外，后6周施用，当效果不足或效果衰减可以是一次每体重1公斤10毫克的剂量。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
·川崎病急性期
通常情况下，每机身重1kg的5毫克到一个单次静脉滴注。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
·克罗恩病
静脉输液为每剂量5毫克1次体重1公斤。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。
此外，在六周后的施用，当效果被衰减可以是一次每体重1公斤10毫克的剂量。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
·溃疡性结肠炎
静脉输液为每剂量5毫克1次体重1公斤。第一次剂量后，2周，给药6周，然后在8周的时间间隔进行施用。
在此药物施用的时间，它是通过使用下面的膜过滤器1.2微米的在线过滤器给药。
药效药理
1.本剤在体外试验中，选择性地结合可溶性和膜结合TNFα，它显示了以下的效果。
（1）耦合常数以TNFα的可溶形式为1.04×1010米-1。
（2）抑制IL-6产生由TNFα刺激的成纤维细胞。
（3）具有人IgG1的Fc区，用表达由补体依赖性细胞毒性（CDC）和抗体依赖性细胞介导细胞毒性（ADCC）膜结合TNFαTNFα产生细胞损伤。
（4）结合TNFα结合到TNF受体，从受体解离TNFα，并抑制粘附分子的表达（ICAM-1，VCAM-1）。
2.死亡率还原的人TNFα转基因小鼠的动作进行了观察。
包装规格
单抗用于静脉输液
100：100毫克×1瓶

制药公司：
田边三菱制药株式会社

適用区分： 
这种药的影响
- 通过抑制TNFα的功能一直是各种疾病（茶NTT F-阿尔法），和平静的炎症免疫异常的原因，并改善症状。
·使用视网膜耐火材料类风湿关节炎的葡萄膜炎，白塞氏病，牛皮癣，强直性脊柱炎，克罗恩氏病，溃疡性结肠炎。
为了确保注射前
如下面的人，在注射前，请告诉医生：
以前喝中药，或注射，瘙痒和风化出来。用了感染（败血症等）。可能是在过去或目前患有肺结核。可能是个人或家庭成为脱髓鞘疾病（如多发性硬化）。你是否曾经被诊断出患有充血性心脏衰竭。我一直在接受癌症治疗。我最近被接种。如果你已经在过去接受注射。
·注射时间：
将决定给药的间隔时间，同时看着症状。
注射方法：
一般，注射用水中溶解后，再静脉注射，输注一段时间的两小时或更长时间，并用生理盐水稀释。
和其他：
哺乳期，请报告人有可能怀孕或怀孕期间。
副作用
某些人，在某些情况下，效果以外的其他用途，不希望的影响，可能会出现药物。
◎如果您发现诸如以下症状，请立即报告药剂师或医生，护士：
突然出现高热与畏寒<opportunistic感染sepsis, pneumonia,真菌infections,这种as>，发烧，寒战，头痛，呕吐，心动过速，咳嗽，咳痰，气短，呼吸困难，肌肉疼痛，关节痛，血压降低。
感觉破败，低烧咳嗽，持久<that的(including肺外tuberculosis) Tuberculosis>
输液反应严重>，气短，呼吸断断续续，喘息（呼啸声），时间短，呼吸停止，头痛，呆滞，头晕，胸闷呼吸困难（给药后2小时或在治疗过程中的反应）脖子僵硬肿胀，心悸，乏力，眼睑，口唇，舌，（指甲嘴唇，手和脚特别）蓝 - 紫 - 暗紫色的皮肤和粘膜，发热，荨麻疹
面风化，发热，瘙痒，手肿胀，荨麻疹，头痛<（注射后时隔三天以上的过敏性）过敏延迟>
我不动自由抽搐，麻木，双腿瘫痪，四肢无力，感觉异常，眼睛，它看起来翻番（多发性硬化症，视神经炎，脊髓炎，格林 - 巴利综合征等），脱髓鞘疾病>视力模糊，视力减退，大便硬，开始排尿时有困难
<Interstitial pneumonia>发热，咳嗽，呼吸困难;
一般<Liver dysfunction>感觉不适，食欲减退，眼白皮肤变黄
与积极anti-dsDNA antibody>关节疼痛<lupus-like综合征，肌肉痛，皮疹
增加出血，呼吸急促，当你爬的萎靡<血液disorders>一般的感觉，呆滞，头痛，头晕，耳鸣，山和楼梯，心悸，流鼻血，牙龈，皮下出血，月经出血，手和脚的皮肤下出血，发烧时，喉咙痛。
◆如果您发现诸如以下症状，请咨询你的医生或药剂师，护士尽快：
的<Throat头flame>喉咙红肿，血液混合到<hematuria>尿，恶心<nausea>
◇可副作用除了上述得到以下：
尿频尿<cystitis>疼痛，残尿的感觉，下腹部疼痛，小便浑浊，粘膜在<stomatitis>口，如果我们有疼痛，是一个白色的小溃疡红，<chest pain>胸痛.
·如果你觉得身体异常，请咨询药剂师或医生，护士。
我心目中注射后
·有可能成为易受感染，以降低免疫效果，也长效药。停止在日常生活中这是不可能的，请采取坚定的睡眠。痰和咳嗽时历时感觉感冒症状，请咨询你的医生。
其他
•接种疫苗，如流感，请咨询你的医生。
该药在制造过程中使用牛源性成分。有没有报告传染性海绵状脑病（TSE）的传播通过注射这种药物，但你不能否认这种风险充分受益。
注：以上中文资料仅供参 :使用以完整处方为准：http://meds.qlifepro.com/detail/640462006/infliximab
IMPORTANT SAFETY INFORMATION FOR REMICADE® (infliximab)
SERIOUS INFECTIONS
Patients treated with REMICADE® (infliximab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue REMICADE® if a patient develops a serious infection or sepsis.
Reported infections include:
Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. All reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
CONTRAINDICATIONS
REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.
HEPATITIS B REACTIVATION
TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.
HEPATOTOXICITY
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.
HEMATOLOGIC EVENTS
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.
HYPERSENSITIVITY
REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.
NEUROLOGIC EVENTS
TNF inhibitors, including REMICADE®, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.
AUTOIMMUNITY
Treatment with REMICADE® may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
ADVERSE REACTIONS
In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
USE WITH OTHER DRUGS
Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
VACCINATIONS
Live vaccines should not be given with REMICADE®. Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. Exercise caution in the administration of live vaccines to infants born to female patients treated with REMICADE® during pregnancy.