Sylvant（siltuximab 中文译名 司妥昔单抗）是获欧盟批准的首个MCD治疗药物
近日，欧盟委员会（EC）已批准单抗药物Sylvant（siltuximab）用于HIV阴性和人类疱疹病毒-8（HHV-8）阴性的多中心型巨大淋巴结增生症（multicentric Castleman'sdisease，MCD）患者的治疗。
Sylvant是一种单克隆抗体，是IL-6拮抗剂，通过静脉输注给药，每3周一次，该药已于2014年4月获FDA批准用于相同适应症，也是FDA批准的首个MCD治疗药物。
SYLVANT（司妥昔单抗 siltuximab）注射，静脉滴注
最初美国批准：[2014年]
作用机理
Siltuximab结合人IL-6和防止的IL-6与可溶性和膜结合的IL-6受体的结合。IL-6已被证明参与各种正常生理过程：如免疫球蛋白分泌的诱导。过的IL-6的生产已被链接到全身表现患者MCD。
适应症和用法
SYLVANT是指示对于患者的多中心型Castleman病（MCD）谁是人免疫缺陷病毒的治疗白细胞介素-6（IL-6）拮抗剂（HIV）阴性和人疱疹病毒8（HHV-8）阴性。
使用限制
SYLVANT什么不可以的患者MCD谁是HIV阳性患者HHV-8阳性由于SYLVANT没有结合到病毒产生的IL-6的非临床研究的研究。
用法用量
静脉滴注只。
管理作为由每3周静脉滴注1小时以上11毫克/千克的剂量。
剂型和规格
在单次使用的小瓶100毫克冻干粉末。
400毫克冻干粉末在单次使用的小瓶。
禁忌症
严重的过敏性反应，任何SYLVANT的赋形剂或siltuximab的。
警告和注意事项
并发活动严重感染
严重感染SYLVANT直至感染解析不要给予病人。
监控器接收SYLVANT密切观察患者的感染。提示研究所抗感染治疗，不给予直至感染SYLVANT解析。
接种疫苗：不要给予活疫苗由于IL-6抑制可能与新的抗原正常免疫反应产生干扰。
输液相关反应：在设置辖SYLVANT没有提供急救设备，药物，并培训提供复苏人员。
胃肠（GI）穿孔：患者慎用谁可能是在增加的风险使用。及时评估患者的症状，并可能伴有或暗示的胃肠穿孔呈现。
不良反应
与SYLVANT治疗的MCD临床试验过程中，最常见的不良反应（> 10％，与安慰剂相比）分别为瘙痒，体重增加，皮疹，高尿酸血症，和上呼吸道感染。

完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=451f535b-8b6b-4ecf-9f19-d921b72eea39
Important Safety Information for SYLVANT™ (siltuximab)
CONTRAINDICATIONS–Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT™.
Concurrent Active Severe Infections–Do not administer to patients with severe infections until the infection resolves. SYLVANT™ may mask signs and symptoms of acute inflammation including suppression of fever and of acute phase reactants such as C-reactive protein (CRP). Monitor patients closely for infections.
Institute prompt anti-infective therapy and do not administer further SYLVANT™ until the infection resolves.
Vaccinations -Do not administer live vaccines to patients receiving SYLVANT™ because interleukin-6 (IL-6) inhibition may interfere with the normal immune response to new antigens.
Infusion-Related Reactions and Hypersensitivity – Stop the infusion if the patient develops signs of anaphylaxis. Discontinue further therapy.
Stop the infusion if the patient develops mild to moderate infusion reactions.
If the reaction resolves, the infusion may be restarted at a lower infusion rate. Consider medicating with antihistamines, acetaminophen, and corticosteroids. Discontinue SYLVANT™ if the patient does not tolerate the infusion following these interventions. [see Adverse Reactions].
Administer SYLVANT™ in a setting that provides resuscitation equipment, medication, and personnel trained to provide resuscitation.
Gastrointestinal (GI) Perforation–Use with caution in patients who may be at increased risk for GI perforation. Promptly eva luate patients presenting with symptoms that may be associated or suggestive of GI perforation.
Adverse Reactions – The most common adverse reactions (>10% compared to placebo) in the MCD clinical trial were pruritus, increased weight, rash, hyperuricemia, and upper respiratory tract infection.
Drug Interactions - Cytochrome P450 (CYP450) Substrates – Upon initiation or discontinuation of SYLVANT™, in patients being treated with CYP450 substrates with narrow therapeutic index, perform therapeutic monitoring of effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) as needed and adjust dose. Exercise caution when SYLVANT™ is co-administered with CYP3A4 substrate drugs where a decrease in effectiveness would be undesirable (e.g., oral contraceptives, lovastatin, atorvastatin). 
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产地国家：德国 
原产地英文商品名:
SYLVANT Pulver Injection 100mg/Vial
原产地英文药品名:
Siltuximab
中文参考商品译名:
SYLVANT注射剂 100毫克/瓶
中文参考药品译名:
司妥昔单抗
生产厂家中文参考译名:
Janssen-Cilag 
生产厂家英文名:
Janssen-Cilag 
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产地国家：德国 
原产地英文商品名:
SYLVANT Pulver Injection 400mg/Vial
原产地英文药品名:
Siltuximab
中文参考商品译名:
SYLVANT注射剂 400毫克/瓶
中文参考药品译名:
司妥昔单抗
生产厂家中文参考译名:
Janssen-Cilag 
生产厂家英文名:
Janssen-Cilag