部分中文Mimpara处方资料（仅供参考）
【中文药名】盐酸西那卡塞片
【英文药名】Sensipar(欧洲叫Mimpara)
【药理作用】
慢性肾病(CKD)患者的继发性甲状旁腺功能亢进，是一种由甲状旁腺激素(PTH)水平升高引起钙、磷代谢失调的进行性疾病。升高的PTH刺激破骨活性，引起骨质再吸收。继发性甲状旁腺功能亢进的治疗目的在于降低PTH和血钙、血磷，防止由于矿物质代谢失调引起的骨病及全身影响。位于甲状旁腺主细胞上的钙敏感受体是PTH分泌的主要调节剂，本品能提高钙敏感受体对细胞外钙的敏感性，降低PTH水平，从而使血浆钙浓度降低。
【药动学】
本品口服后2～6h血药浓度达峰值(Cmax)，与高脂肪食物同服，本品的Cmax和药时曲线下面积(AUC)分别增加82%和68%；与低脂肪食物同服，本品的峰浓度Cmax和AUC分别增加65%和50%。本品吸收后血药浓度呈双相消除，消除半衰期为30～40h。连续给药7天血药浓度达稳态，Cmax和AUC随给药剂量的增大而成比例地增加。表观分布容积为1000L，表明本品分布广泛。本品93%～97%与血浆蛋白结合。本品经多种酶代谢，主要有CYP3A4、CYP2D6、CYPlA2。主要经肾脏排出，占给药剂量的80%，约15%经粪便排出。中度及重度肝功能不全患者的AUC分别升高2.4倍和4.2倍，半衰期延长33%和70%。
【适应】
本品用于治疗进行透析的慢性肾病(CKD)患者的继发性甲状旁腺功能亢进症，也用于治疗甲状旁腺癌患者的高钙血症。
【禁忌】
1．对本品及其中成分过敏者禁用。
2．尚不知本品是否经人乳汁分泌，由于本品的严重不良反应，哺乳期妇女不推荐使用，如果使用，用药期间应停止哺乳。
【注意事项】
1．本品生殖毒性分级为C，只有当对母体的益处高于对胎儿的危险时方可用于孕妇。
2．本品可引起癫痫发作，用药期间应严密监测血浆钙浓度，尤其是有癫痫病史的患者。
3．本品可引起低钙血症，治疗开始时应每周监测血钙水平，治疗剂量确定后每月监测一次。
4．中度至重度肝功能不全患者治疗期间应进行监护。
5．儿童用药安全性尚未评价。
6．本品过量可引起低钙血症，应严密观察低钙血症的临床症状并采取对症治疗。由于本品血浆蛋白结合率高，透析治疗无效。
7．15～30℃保存。
【不良反应】
本品最常见的不良反应为恶心和呕吐，其他不良反应还有：腹泻、肌痛、眩晕、高血压、无力、食欲减退、胸痛。本品过量可引起低钙血症，表现为感觉异常、肌痛、抽筋、手足抽搐和抽风。
【用法用量】
口服给药，应整片吞服，不能掰开，与食物同服或餐后短时间内服用，剂量应个体化。用于透析CKD患者的继发性甲状旁腺功能亢进：推荐开始剂量为每日1次，每次30mg，1周内检测血钙和血磷水平，1～4周检测PTH水平。每日剂量调整为60mg、90mg、120mg、180mg的时间均不得少于2～4周。患者PTH浓度应控制在150～300pg/ml。用于治疗甲状旁腺癌患者的高钙血：推荐开始剂量为每日2次，每次30mg。剂量调整每2～4周一次，根据血钙浓度，剂量可调整为每次60mg，每日2次；每次90mg，每日2次；每次90mg，每日3～4次。
【药物剂型】
片剂：30mg；60mg；90mg。
【生产厂家】
美国安进公司 Amgen Inc
【国外上市情况】盐酸西那卡塞由美国NPS Pharmaceuticals 公司研发的拟钙剂，2004年3月8日FDA批准Amgen公司（NPS制药公司该产品的许可权受让人）生产的盐酸西那卡塞上市，商品名为Sensipar；2008年1月，协和麒麟公司生产的盐酸西那卡塞在日本上市，商品名为REGPARA，规格为25mg、75mg（以西那卡塞计）。

Mimpara (active ingredient's chemical name is cinacalcet) 30mg 28 film tablet, is a new generation medication which is used for the treatment of increased amounts of a certain hormone (parathyroid) in people with long-term kidney disease who are on dialysis. It is also used to treat increased amounts of calcium in people with an overactive parathyroid gland or in people with cancer of the parathyroid gland. Mimpara (cinacalcet) 30mg works by decreasing the amount of parathyroid hormone, calcium, and phosphorus in your body. Having the right amount of these substances in your body helps to prevent bone disease.
What is Mimpara?
Mimpara is a medicine that contains the active substance cinacalcet. It is available as light green, oval tablets (30, 60 and 90 mg).
What is Mimpara used for?
Mimpara is used in adults and elderly patients in the following ways:
to treat secondary hyperparathyroidism in patients with serious kidney disease who need dialysis to clear their blood of waste products. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to bone and joint pain and deformities of the arms and legs.
‘Secondary’ means that it is caused by another condition.
Mimpara can be used as part of treatment including phosphate binders or vitamin D sterols;to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands) or with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate.
‘Primary’ means that the hyperparathyroidism is not caused by any other condition.
The medicine can only be obtained with a prescription.
How is Mimpara used?
In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
The dose is adjusted every two to four weeks, according to the patient’s PTH levels, up to a maximum of 180 mg once a day. PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Mimpara.
Blood calcium levels should be measured frequently, and within one week of each dose adjustment of Mimpara. Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Mimpara for adults is 30 mg twice a day. The dose of Mimpara should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Mimpara is taken with food or shortly after a meal.
How does Mimpara work?
The active substance in Mimpara, cinacalcet, is a calcimimetic agent. This means that it mimics the action of calcium in the body. Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion. By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands. The reduction in PTH levels also leads to a decrease in blood calcium levels.
How has Mimpara been studied?
Mimpara has been compared with placebo (a dummy treatment) in three main studies involving 1,136 dialysis patients with serious kidney disease.
The studies lasted for six months. The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.
Mimpara has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma, and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
The study continued for over three years. A further three studies compared Mimpara with placebo in a total of 136 patients with primary hyperparathyroidism over up to a year. Of these, 45 went on to a fourth, long-term study looking at the effectiveness of Mimpara over a total of almost six years.
What benefit has Mimpara shown during the studies?
In dialysis patients with serious kidney disease, about 40% of the patients taking Mimpara had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo. Mimpara brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Mimpara produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism (15 out of17). The results of the additional studies supported the use of Mimpara for hypercalcaemia in patientswithprimaryhyperparathyroidism.
What is the risk associated with Mimpara?
The most common side effects with Mimpara in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting. In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting. For the full list of all side effects reported with Mimpara, see the Package Leaflet.
Mimpara should not be used in people who may be hypersensitive (allergic) to cinacalcet or any of the other ingredients.
Why has Mimpara been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Mimpara’s benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whomparathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated. The Committee recommended that Mimpara be given marketing authorisation.
Other information about Mimpara:
The European Commission granted a marketing authorisation valid throughout the European Union for Mimpara to Amgen Europe B.V. on 22 October 2004. The marketing authorisation was renewed on 22 October 2009.

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产地国家: 欧洲共同体国家
原产地英文商品名:
MIMPARA FILM COATED TAB 90mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA薄膜衣片 90毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 欧洲共同体国家
原产地英文商品名:
MIMPARA FILM COATED TAB 60mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA薄膜衣片 60毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 欧洲共同体国家
原产地英文商品名:
MIMPARA FILM COATED TAB 30mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA薄膜衣片 30毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 英国
原产地英文商品名:
MIMPARA 30mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA 30毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 英国
原产地英文商品名:
MIMPARA 60mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA 60毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 英国
原产地英文商品名:
MIMPARA 90mg/tablet 28tablets/bottle
原产地英文药品名:
CINACALCET
中文参考商品译名:
MIMPARA 90毫克/片 28片/瓶
中文参考药品译名:
西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
AMGEN
---------------------------------------------
产地国家: 德国
原产地英文商品名:
MIMPARA 30mg/tablet 28tablets/bottle
原产地英文药品名:
Cinacalcet Hydrochloride
中文参考商品译名:
MIMPARA 30毫克/片 28片/瓶
中文参考药品译名:
盐酸西那卡塞
生产厂家中文参考译名:
安进公司
生产厂家英文名:
Amgen GmbH