FDA近日批准一种治疗继发性甲状旁腺功能亢进（常因出现于慢性肾衰血透治疗患者）和高钙血症（常见于甲状旁腺癌症患者）的药物Sensipar (cinacalcet)。   Cinacalcet是第一种被FDA批准的此类药物。PTH水平升高是甲状旁腺功能亢进的标志，改变钙磷代谢，使骨质疏松，并且是冠心病的诱发因素。Cinacalcet可以降低血清PTH水平，从而调节钙磷代谢。Cinacalcet还可以治疗甲状旁腺癌引起的高钙血症。血液中钙含量过多可以引起明显的精神混乱、嗜睡、脱水、恶心呕吐、便秘和肾损伤。 经过6个月1000多个接受血透治疗的慢性肾衰患者临床试验证明，本药最主要的副作用为恶心呕吐。使用本药的患者恶心发生率31％，呕吐发生率27％，而使用安慰剂的患者其发生率分别为19%和15%。使用本药对肾衰患者的高钙血症也有明显作用。 【适应症】 该药主要用于治疗肾病透析患者的继发性甲状旁腺机能亢进，或者甲状旁腺癌所致的高钙血症。 【药理及药代动力学】 该药可与甲状旁腺中的钙敏感受体结合，减少甲状旁腺素的分泌，进而导致血清钙及磷酸钙产物水平的降低。通常而言，原发性甲状旁腺功能亢进患者会在服用该药第二剂后２小时内 观察到最初的治疗反应；在治疗开始后４～６周内观察到持续的治疗反应该药达峰时间为２～６小时。该药与高脂饮食同服时，可导致血药浓度和药时曲线下面积（ＡＵＣ）升高。该药蛋白结合率为９３％～９７％，分布容积达１０００升。细胞色素Ｐ４５０３Ａ４、２Ｄ６和１Ａ２均与该药代谢有关。代谢产物主要通过尿液（８０％）和粪便（１５％）排泄，消除半衰期为４０小时。 【注意事项】 该药可降低血清钙水平，因而可能引起低钙血症。患者应注意观察是否有感觉异常、肌痛、痉挛、手足抽搐和惊厥的发生。 【药物相互作用】 该药是细胞色素Ｐ４５０２Ｄ６（ＣＹＰ２Ｄ６）同功酶的抑制剂，因此，当该药与同样通过ＣＹＰ２Ｄ６代谢，且治疗指数较小的药物（如氟卡胺、长春碱、硫利达嗪和大多数三环类抗抑郁药）合用时，后者可能需要调整给药剂量。开始应用或停用ＣＹＰ３Ａ４强抑制剂（如酮康唑、红霉素或伊曲康唑）时，均有可能导致同时应用的该药的血药浓度发生较大幅度改变，因而需相应调整该药剂量。 【不良反应】 临床试验中该药最常见的不良事件为恶心和呕吐。其他发生率大于５％的不良事件还包括腹泻、肌痛、高血压、无力、食欲减退、非心脏性胸痛和通路感染（ａｃｃｅｓｓｉｎｆｅｃｔｉｏｎ）。此外，西那卡塞治疗组和安慰剂对照组的严重感染发生率基本相当。 【剂量及用药】 该药为口服片剂，规格为３０ｍｇ／片。该药应整片吞服，初始剂量为３０ｍｇ／天，进食时服用。随后根据患者反应情况，每２～４周调整一次剂量（按６０ｍｇ／天、９０ｍｇ／天、１２０ｍｇ／天和１８０ｍｇ／天顺序依次递增），直至患者ＰＴＨ水平达到美国肾脏基金会临床指南推荐的标准（１５０～３００ｐｇ／ｍｌ）。该药可单独应用或与维生素Ｄ醇和磷酸盐结合剂合用。 【患者咨询】 服用该药期间，患者应避免怀孕或哺乳。许多药物可能与该药产生药物相互作用，因此服用该药时应尽量停用其他药物，包括非处方药和营养补充剂。提醒患者在出现下述不良反应时，应尽快与医师联系，并采取相应治疗措施。这些不良反应包括：腹部痉挛或疼痛；面部、口唇、舌头和手足出现烧灼感、麻痹、刺痛、瘙痒或麻刺感；背部或腿部出现痛性痉挛；抑郁；意识错乱；吞咽或呼吸困难；幻觉；易怒；面肌抽搐；肌痛或癫痫发作。 【原产地英文商品名】SENSIPAR 90mg/tablet 30 tablets/bottle 【原产地英文药品名】cinacalcet HCI 【中文参考商品译名】 注：以下产品是不同的规格和不同的价格，购买时请以电话咨询为准 ·SENSIPAR 90毫克/片 30片/瓶 ·SENSIPAR 60毫克/片 30片/瓶 ·SENSIPAR 30毫克/片 30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 Sensipar (Cinacalcet Tablets) Sensipar (Cinacalcet) lowers PTH by telling your parathyroid glands to stop releasing too much PTH into your blood. It also lowers your calcium and phosphorus levels. Sensipar (Cinacalcet) is the first medicine of its kind. It works quickly and lowers PTH directly at the parathyroid glands. Sensipar (Cinacalcet) also helps improve the calcium and phosphorus balance in your body. Sensipar (Cinacalcet) can help you reach your lab value goals for PTH, calcium-phosphorus product, calcium, and phosphorus. Before starting Sensipar (Cinacalcet), tell your doctor if you have ever had a seizure. While on Sensipar (Cinacalcet) your doctor may have to do blood tests. Tell your doctor if you experience any muscle spasms, aches or cramping, tingling in your limbs, or seizures. The most common side effects of Sensipar (Cinacalcet) are mild to moderate nausea and vomiting. These side effects usually last just a short time. People rarely have to stop taking Sensipar (Cinacalcet) because of side effects. Sensipar (Cinacalcet) is a small, green pill that you take once a day with food or right after a meal. It is important to take Sensipar (Cinacalcet) every day as your doctor prescribes. Sensipar (Cinacalcet) should be taken whole. It’s best to take Sensipar (Cinacalcet) at the same time each day. Your doctor may also give you phosphate binders and vitamin D while you are on Sensipar (Cinacalcet). You should see an improvement in your key lab values (PTH, calcium-phosphorus product, calcium, and phosphorus) while taking Sensipar (Cinacalcet). It’s important to keep your lab values in your goal range. Knowing your lab values and reaching your goals for PTH, calcium-phosphorus product, calcium, and phosphorus levels is important in order to stay as healthy as possible. Secondary hyperparathyroidism means you have too much of a hormone in your body. This signal is called parathyroid hormone (PTH). PTH is made by 4 small glands in your neck called parathyroid glands. Normally, PTH makes sure you have just enough calcium and phosphorus in your blood to keep your bones, heart, muscles, nerves, and blood vessels working well. When your kidneys aren’t working, the calcium and phosphorus balance in your body is upset. These imbalances trigger a silent alarm in your parathyroid glands to send out too much PTH to your body. This condition is called secondary hyperparathyroidism. Some people call this bone disease. But it affects more than just your bones. Because it can cause serious health problems, it is important that secondary hyperparathyroidism is treated. Four small glands located behind the thyroid glands in your neck are called parathyroid glands. They make a hormone called parathyroid hormone (PTH). When your kidneys are working, PTH keeps your calcium and phosphorus levels normal by moving the right amounts of calcium and phosphorus in and out of your bones. As your kidneys fail, they can no longer do many of the things your body needs them to do. For instance, they can't filter waste from your blood, which is why you are on dialysis. Kidney disease may also cause secondary hyperparathyroidism. Secondary hyperparathyroidism can have a big impact on your health. In secondary hyperparathyroidism, your parathyroid glands make too much PTH. Over time, this can cause serious problems with your bones, heart, lungs, and blood vessels. Sensipar (Cinacalcet), phosphate binders, and vitamin D are drugs that your doctor may give you to treat secondary hyperparathyroidism. Sensipar (Cinacalcet) is a unique medicine to help treat secondary hyperparathyroidism in patients on dialysis. It lowers all 4 important lab values at the same time—PTH, calcium-phosphorus product (Ca x P), calcium, and phosphorus. Taking Vitamin D increases the Vitamin D levels in your blood. This works to lower PTH. Phosphate binders keep some of the phosphorus in the foods you eat from getting into your blood. Drug Overview Sensipar belongs to the family of Calcimimetics drugs and commonly used for the treatment and relieves in hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Sensipar works by lowers the Parathyroid hormone (PTH). Hyperparathyroidism is a problem that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). Parathyroid hormone (PTH) controls the concentrations of calcium and phosphorus in your blood. Sensipar helps lower the amount of PTH which lowers the calcium and phosphorus concentrations. Sensipar is also used to lower calcium in the blood in patients with parathyroid cancer. Sensipar is more useful medicine which used for the treatment of secondary hyperparathyroidism in people with kidney disease. Sensipar is also useful for those patients who suffered to the problems of primary hyperparathyroidism when surgical removal of the parathyroid gland is not a treatment option. Sensipar always takes under doctor’s guidance. The recommended doses of Sensipar will be different for different patients, according to the requirements of each patient; you continue to take it for as long as your doctor prescribes. If you can not tolerate the recommended dosage, your doctor can prescribe a dose that sufficient for you. Take Sensipar exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Sensipar is being manufactured by Amgen Pharmaceuticals and available in 30mg, 60mg and 90mg tablets. Sensipar comes in category of drugs called also Cinacalcet. Sensipar may also be used for relieves other conditions that determined by your doctor or consultant. Effects - How it works in the body Sensipar belongs to the family of Calcimimetics drugs and commonly used for the treatment and relieves in hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Sensipar works by lowers the Parathyroid hormone (PTH). Hyperparathyroidism is a problem that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH). Parathyroid hormone (PTH) controls the concentrations of calcium and phosphorus in your blood. Sensipar helps lower the amount of PTH which lowers the calcium and phosphorus concentrations. Sensipar is also used to lower calcium in the blood in patients with parathyroid cancer. Side effects Possible side effects that occurs during the uses of Sensipar: Allergic reactions Abdominal cramps Confusion Difficulty in breathing Irregular heartbeats Low bone turnover Mood or mental changes Muscle cramps in hands, arms, feet, legs, or face Numbness and tingling around the mouth, fingertips, or feet Shortness of breath Tremor Blurred vision Chest pain Dizziness Headache Nervousness Pounding in the ears Slow or fast heartbeat Convulsions Cough or hoarseness Fever or chills Loss of bladder control Lower back or side pain Muscle spasm or jerking of all extremities Painful or difficult urination Sudden loss of consciousness Diarrhea Difficulty in moving Joint pain Lack or loss of strength Loss of appetite Muscle aching or cramping Muscle pains or stiffness Nausea Swollen joints Vomiting Weight loss Unusual tiredness or weakness Yellowing of the eyes or skin Interactions Although certain medicines should not be used together at all, so its your responsibilities that tell your doctor or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also you tell your doctor or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or addicted to illegal drugs. These may affect the working mechanism of Sensipar. In these cases, your doctor may change the dose or teach precautions may be necessary. Therefore when you are taking Sensipar, it is most important that your doctor or health care professional know if you are taking any of the following or other drugs: Alcohol Barbiturates such as Phenobarbital Doxercalciferol Herbal or dietary supplements such as St. John's Wort Medicines which used for the treatment of fungal infections such as Fluconazole Itraconazole, Ketoconazole and Voriconazole Medicines which used for the treatment of HIV infection or AIDS Medicines which used for the treatment of seizures as Carbamazepine Phenobarbital, Phenytoin, Primidone and Zonisamide Rifampin, Rifapentine or Rifabutin Medicines which used for the treatment of pain, such as Codeine Antibiotics as Clarithromycin, Erythromycin, Telithromycin and Troleandomycin Medicines which used for the treatment of high blood pressure or chest pain Medicines which used for the treatment of heart-rhythm problems such as Amiodarone Diltiazem or Verapamil Medicines which used for the treatment of depression Medicines which used for the treatment of mental problems Counterindications You shouldn’t use this medicine without consultation of doctor if you have an allergy to Sensipar or any other ingredients of this medicine. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problem liver disease. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problem of Kidney disease. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problem of heart disease or blood disorders. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problems of asthma, lung disease or breathing difficulties. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the stomach problems low serum calcium concentrations. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problems of seizure disorder. You shouldn’t use Sensipar without consultation of doctor if you are suffering to the problems of High blood pressure. You shouldn’t use Sensipar without consultation of doctor if you are pregnant or plan to be pregnant. You shouldn’t use Sensipar without consultation of doctor if you are suffering to breastfeeding. Similar drugs Mimpara Cinacalcet HCl Major drug Manufacturers Amgen Pharmaceuticals Novartis Pharmaceuticals NPS Pharmaceuticals Inc.