英文药名：Remicade(infliximab)

中文药名：注射用英夫利西单抗  类克（Remicade）

品牌生产厂家：强生公司生物制药

药品介绍

美国FDA批准Remicade(infliximab)用于治疗6岁以上儿童对常规治疗反应不佳的中度至严重活动性溃疡性结肠炎(UC)。Remicade可以减轻这些患者的UC症状,并且诱导及延长临床缓解期。UC是一种影响大肠(结肠)和直肠内膜的炎性肠病(IBD)。UC的症状包括腹痛、腹泻、直肠出血、体重减轻和发热。在美国,有50 000～100 000名儿童患有IBD,其中40%为UC。肿瘤坏死因子(TNF)在体内可引起炎症和导致自身免疫病。

适应证和用途
REMICADE是一种肿瘤坏死因子(TNF)阻断剂适用于：
克罗恩病：
（1）在有中度至严重活动性疾病，对常规治疗曾反应不充分的成年和儿童患者中减轻体征和症状和诱导和维持临床反应。
（2）有瘘管成年患者中减少排泄肠皮和直肠阴道瘘数和保持瘘管闭合。

溃疡性结肠炎：
（1）在对常规治疗反应不充分中度至严重活动性疾病患者中减轻体征和症状，诱导和维持临床缓解和粘膜愈合，和消除皮质激素使用。

类风湿样关节炎与甲氨蝶呤[methotrexate]联用：
（1）在有中度至严重活动性疾病患者中减轻体征和症状，抑制结构损伤的进展，和改善体力功能。

强直性脊柱炎：
（1）在活动性疾病患者中减轻体征和症状。

银屑病关节炎：
（1）减轻活动性关节炎体征和症状，抑制结构损伤的进展，和改善身体功能。

斑块性银屑病：
（1）治疗有备选全身治疗和当其它全身治疗医学上不适宜的慢性严重(即，广泛和/或残疾)斑块性银屑病成年患者。
 
剂量和给药方法
REMICADE是通过静脉输注给药。
克罗恩病
在0，2和6周时5 mg/kg，然后每8周。有些开始对治疗有反应成年患者，如以后丧失反应增加剂量至10 mg/kg可能获益。
溃疡性结肠炎
在0，2和6周时，然后每8周5 mg/kg.
类风湿样关节炎
与甲氨蝶呤联用，0，2和6周时，然后每8周3 mg/kg。有些患者增加剂量至10 mg/kg或每隔4周更常治疗可能获益。
强直性脊柱炎
在0，2和6周时，然后每6周5 mg/kg.
银屑病关节炎
在0，2和6周时，然后每8周5 mg/kg.
斑块性银屑病
在0，2和6周时，然后每8周5 mg/kg.

剂型和规格 
在20 mL小瓶内100 mg冻干英夫利昔单抗将配制在10 mLf无菌注射用水内。

禁忌证

在中度至严重心衰中禁忌REMICADE剂量 >5 mg/kg。
既往对REMICADE严重性超敏性反应或已知对REMICADE无活性组分或对任何鼠类蛋白超敏性。

警告和注意事项
（1）严重感染 –在活动性感染期间不要给REMICADE。如发生感染，仔细监查和如感染变成严重停止REMICADE。
（2）恶性病 – 比对照更常见。淋巴瘤比一般人群更常见；小心评估治疗的风险和获益和在儿童和青年中监视恶性病。
（3）肝脾T细胞淋巴瘤 – 仔细评估风险/效益尤其是如患者有克罗恩病或溃疡性结肠炎，是男性，和接受硫唑嘌呤或6-巯基嘌呤治疗。
（4）乙型肝炎病毒再激活 – 监视HBV携带者治疗期间和后几个月。如发生重新激活, 停止REMICADE和开始抗病毒治疗。
（5）肝毒性 – 罕见严重肝反应, 有些致命性或需要肝移植，在黄疸和/或明显肝酶升高情况中停止REMICADE。
（6）心衰 – 如发生新或恶化症状密切监视有心衰患者和停止REMICADE。
（7）血细胞减少症 –如发生体征和症状建议患者立即求医，和考虑停止REMICADE。
（8）超敏性 –可能发生严重输注反应包括过敏反应或血清病样反应。
（9）脱髓鞘病 –如加重或发生新发作考虑停止REMICADE。
（10）狼疮样综合征 –如发生综合征停止REMICADE。

不良反应
最常见不良反应(>10%) – 感染(如上呼吸道，窦炎，和咽炎)，输注相关反应，头痛，和腹痛。

药物相互作用
（1）与阿那白滞素[anakinra]或阿巴西普[abatacept]使用 – 增加严重感染的风险。
（2）活疫苗 – 不应与REMICADE接种。Bring 儿童 克罗恩氏患者up to date with all 免疫接种开始用REMICADE前.

特殊人群中使用
（1）儿童使用 – 尽管适用于儿童克罗恩病中使用，在<6岁克罗恩病儿童中未曾研究过REMICADE。

如何供应/贮存和处置
每个REMICADE 20 mL小瓶单个地包装在盒内。REMICADE在累加盒含10小瓶供应。
NDC 57894-030-01 100 mg小瓶
各单剂量小瓶含100 mg英夫利昔单抗为最终配制体积10 mL。

贮存和稳定性
REMICADE必须放在冰箱在2ºC至8ºC(36ºF至46ºF)。不要使用超过位于盒和小瓶上失效日期(Exp) REMICADE。这个产品不含防腐剂。

REMICADE Infusion

REMICADE infusions or chemotherapy is for patients that live with rheumatoid arthritis, ulcerative colitis, plaque psoriasis, ankylosing spondylitis and Crohn's disease. Patients can endure mild to severe side effects.

REMICADE is given by IV infusion, a simple process that usually takes about two hours. A healthcare professional administers the treatment in a supervised environment, which is either a physician's office or a treatment center. You will receive your first dose followed by additional doses at two and six weeks after the first dose. You will then receive a dose every eight weeks. If you have ankylosing spondylitis, you will receive treatment every six weeks.

With REMICADE, all you have to do is come for your appointment. Your physician will carefully calculate the dosage customized to your weight so that you get the best response to the treatment. Individual results may vary.

CHEMICAL NAME
INFLIXIMAB.

INDICATIONS
This medicine is a protein that may help reduce the imflammation associated with Crohn's disease. It is also used along with methotrexate to treat the signs and symptoms of rheumatoid arthritis. This medicine is not a cure for Crohn's disease or rheumatoid arthritis. It may also be used to treat other conditions as determined by your doctor.
DIRECTIONS
Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine is usually administered as an infusion at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions you may have about this medicine. Store this medicine as directed on the prescription label. If you miss a dose of this medicine, contact your doctor immediately.
SIDE EFFECTS
SIDE EFFECTS that may occur while taking this medicine include abdominal pain, fatigue, nausea, or pain, redness, or swelling at the injection site. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience sore throat, fever, headache, chills, muscle or joint pain, trouble swallowing, chest pain, unusual weakness or fatigue, unusual bruising or bleeding, fainting, painful urination or change in the amount of urine produced, swelling of feet or ankles, unusual vaginal discharge, seizure, change in vision, weakness in the arms or legs, numbness or tingling, a lump or swelling in the neck, armpit, or groin, excessive sweating, unexplained or sudden gain or loss of weight, loss of appetite, unusual tiredness, unexplained cough or breathlessness, or a rash on the cheeks or arms that gets worse in the sun. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction inclue rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.
PRECAUTIONS
Do not use this medicine if you have had an allergic reaction to it, to murine (mouse) proteins, or to any ingredient in this product. If you experience difficulty breathing tightness of chest swelling of eyelids, face, lips, or hands or if you develop a rash or hives, tell your doctor immediately. Laboratory and/or medical tests may be performed to monitor your progress or to check for side effects. Keep all doctor and laboratory appointments while you are using this medicine. This medicine may lower your resistance to infection. Prevent infection by avoiding contact with people who have colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Infrequently, blood problems, some fatal, have developed in patients using this medicine. Contact your doctor immediately if you develop persistent sore throat or fever, unusual bruising or bleeding, or if your skin becomes very pale. Rarely, nervous system problems have developed in patients using this medicine. Contact your doctor immediately if you experience a change in vision weakness in your arms or legs or numbness or tingling in any part of your body. Use of this medicine may increase your risk for a certain type of blood cancer (lymphoma). Contact your doctor immediately if you experience a lump or swelling in the neck, armpit, or groin excessive sweating fever unexplained loss of weight or appetite unusual tiredness unexplained cough or breathlessness or persistent itching. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. Check with your doctor before having immunizations (vaccinations) while you are using this medicine. Caution is advised when using this medicine in the elderly because they may be more sensitive to the effects of this medicine, especially the risk of infection. For women: if you plan on becoming pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. It is unknown if this medicine is excreted in breast milk. Do not breast-feed while taking this medicine.

OVERDOSAGE
If overdose is suspected, contact your local poison control center or emergency room immediately.

INFORMATION
Do not share this medicine with others for whom it was not prescribed. Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for ing an appropriate container and properly disposing of the container when it is full.

NOTES
The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your
healthcare professional before taking the product.

DRUG INTERACTIONS
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other.