部份中文依维莫司处方资料（仅供参考）
依维莫司(Everolimus)由瑞士诺华公司(Novartis)首先研制开发成功，于2009年3月美国FDA批准其在美国上市销售，用于舒尼替尼或索拉非尼治疗无效的晚期肾癌患者(商品名：Afinitor)。2010年4月FDA 批准其用于预防有轻中度免疫排斥风险的肾脏移植患者出现的肾脏移植的排异反应(商品名：Zortress)。2011年，FDA批准依维莫司扩大其适应证，用于治疗不宜手术的罕见遗传性疾病脑部良性肿瘤室管膜下巨细胞星形细胞瘤(SEGA)。
依维莫司(Everolimus)是一种大环内酯类药物，结构上属于雷帕霉素(rapamycin)的衍生物，故又称为40-O-(2-羟乙基)-雷帕霉素，功能上其属于mTOR激酶抑制剂，作用机制主要是与细胞内蛋白FKBP-12结合形成抑制复合物，从而抑制mTOR激酶的活性，降低mTOR的下游效应物S6核糖体蛋白激酶(S6K1)和真核延伸因子4E结合蛋白(4E-BP)的活性，干扰癌细胞的生长、分化和代谢，发挥抗肿瘤效应。
研究显示，依维莫司具有免疫抑制作用、抗肿瘤作用、抗病毒作用、血管保护作用等。目前，临床上依维莫司主要用来预防预防有轻中度免疫排斥风险的肾脏移植患者出现的肾脏移植的排异反应，以及用于舒尼替尼或索拉非尼治疗无效的晚期肾癌患者。此外，除了肾细胞癌，依维莫司也正在进行对神经内分泌肿瘤、淋巴瘤、其他癌症以及结节性硬化症的研究，可作为单一制剂或者与现有的癌症治疗方法合用。
依维莫司相对于目前已上市药物具有以下几个特点：
(1)高效作用：临床研究显示，依维莫司比常规的酪氨酸激酶抑制剂具有更加高效的抗肿瘤作用，可用于治疗舒尼替尼或索拉非尼无效的晚期肾癌患者。
(2)毒副作用轻微: 与酪氨酸激酶抑制剂舒尼替尼或索拉非尼用于抗肿瘤治疗相比，依维莫司具有更加轻微的毒副作用。临床研究显示，本品可预防器官排异，保护肾功能，同时与钙调素抑制剂麦考酚酸酯相比，其可使环孢菌素的用量降低60%，提示联用本品可在保持同等疗效的情况下降低钙调素抑制剂的不良反应。
(3)优越的药物动力学性质：与雷帕霉素相比，其具有更加优越的药物动力学性质。

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通用名称：
依维莫司（依维莫司）
疗效或效果：
排斥反应抑制在以下器官移植
心脏移植，肾移植
用法与用量：
<在心脏移植手术的情况下>
为1.5mg如依维莫司对于成年人，口服给药每天两次分割。此外，起始剂量可高达为3mg作为每日剂量。可以根据患者的状态和谷浓度进行调整。
<肾移植的情况下>
为1.5mg如依维莫司对于成年人，口服给药每天两次分割。可以根据患者的状态和谷浓度进行调整。
包装规格：
CERTICAN®为0.25mg片：60片（双面铝PTP）
CERTICAN®片0.5毫克60片（双面铝PTP）
CERTICAN®片为0.75mg：60片（双面铝PTP

完整资料附件：http://www.info.pmda.go.jp/go/pack/3999022F1028_1_09/
Certican®（everolimus）
INDICATION
Certican is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving allogeneic kidney or heart . Certican should be administered in combination with ciclosporin microemulsion and corticosteroids.
Dosage and administration :
Certican therapy should begin and be carried out only by physicians experienced in immunosuppressive therapy after organ transplantation , able to trace levels of everolimus in whole blood.
adults:
The initial dose of 0.75 mg twice daily is recommended for the general population of patients with transplanted kidney or heart , as applicable in the shortest possible time after transplantation. Always Certican daily dose should be administered orally in two divided doses , with or without food and at the same ciclosporin microemulsion .
Certican is for oral use .
Certican tablets should be swallowed whole with a glass of water and must be crushed before use. For patients who can not swallow tablets whole , are created dispersible tablets Certican.
Host Certican patients may need a dosage adjustment according to blood levels achieved , tolerability , individual response , change in concomitant medications and clinical status . Dosage adjustment may be made at intervals of 4-5 days.
Black patients :
The incidence of biopsy-proven acute rejection of organs in Black patients was significantly higher than patients of other races . There is a limited amount of data , which indicate that Black patients may require larger doses Certican, in order to achieve efficacy comparable to that of patients with other races . Currently, the efficacy and safety are too small to be able to make specific recommendations on the use of everolimus in Black patients .
Use in children and adolescents:
Not enough experience to make recommendations for the use of Certican in children. There is only limited information on pediatric renal transplant patients.
Elderly :
Clinical experience in patients under 65 years is limited.
Patients with impaired renal function:
It is not necessary to adjust the dosage.
Patients with impaired hepatic function:
Concentrations of everolimus blood levels should be monitored carefully. In patients with mild to moderate hepatic impairment , dosage should be reduced to half the normal
CONTRAINDICATIONS :
Certican is contraindicated in patients with known hypersensitivity to everolimus, sirolimus or any of the excipients .
Pregnancy and lactation
There are no adequate data from the use of everolimus, in pregnant women. Studies in animals have shown reproductive toxicity effects including embryo / fetal toxicity . The potential risk for humans is unknown. Certican should not be taken by pregnant women unless the potential benefit outweighs the potential risk to the fetus . Women of childbearing potential must not exceed the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception while taking Certican and 8 weeks after cessation of treatment.
It is not known whether everolimus, is excreted in human milk . In animal studies, everolimus and / or its metabolites are rapidly and easily pass into the milk of lactating rats. Therefore host Certican women should not breastfeed.
SIDE EFFECTS :
Infections and infestations:
Common - viral, bacterial and fungal infections , sepsis
Uncommon - wound infections
Blood and lymphatic system disorders:
Common - thrombocytopenia , anemia, coagulopathy , thrombotic trombotsitopichna purpura / hemolytic uremic syndrome
Uncommon - hemolysis
Endocrine disorders:
Uncommon - male hypogonadism / low testosterone , elevated LH
Metabolism and nutrition disorders :
Very common - hypercholesterolemia , hyperlipidemia
Common - hypertriglyceridemia
Vascular disorders:
Common - hypertension, lymphocele , venous thromboembolism
Respiratory, thoracic and mediastinal disorders:
Common - pneumonia
Uncommon - pneumonitis
Gastrointestinal Disorders:
Common - abdominal pain, diarrhea , nausea, vomiting
Hepatobiliary disorders:
Uncommon - Hepatitis, liver disorders , jaundice, liver function tests
Skin and subcutaneous tissue disorders:
Uncommon - rash
Violation of the musculoskeletal system :
Uncommon - myalgia
Renal and urinary disorders:
Common - UTI
Uncommon - tubular necrosis of the kidney
General disorders and administration site conditions :
Common - swelling , pain

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产地国家：日本 
原产地英文商品名:
Certican Tablets（サーティカン®錠）0.25mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片（サーティカン®錠）0.25毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis
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产地国家：日本 
原产地英文商品名:
Certican Tablets（サーティカン®錠）0.5mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片（サーティカン®錠）0.5毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis
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产地国家：日本 
原产地英文商品名:
Certican Tablets（サーティカン®錠）0.75mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片（サーティカン®錠）0.75毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis
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产地国家：德国 
原产地英文商品名:
Certican Tablets 0.25mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片 0.25毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis
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产地国家：德国
原产地英文商品名:
Certican Tablets 0.5mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片 0.5毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis
---------------------------------------------
产地国家：德国 
原产地英文商品名:
Certican Tablets 0.75mg/TAB 60TABS/BOX
原产地英文药品名:
Everolimus
中文参考商品译名:
Certican片 0.75毫克/片 60片/盒
中文参考药品译名:
依维莫司
生产厂家中文参考译名:
诺华制药
生产厂家英文名:
Novartis