英文药名: Sensipar (Cinacalcet Tablets) 中文参考药名: 盐酸西那卡塞片 原发性甲状旁腺机能亢进症(甲旁亢)是由于甲状旁腺腺瘤(单个腺瘤占绝大多数，约75%)、增生或腺癌(罕见)导致甲状旁腺素(PTH)分泌过多，引起骨、肾、消化、神经系统等病变及钙磷代谢紊乱疾病。 本病好发于女性，男女之比约1：2￣4，妇女绝经期发病率最高，在一组选择性病例调查中，〉40岁者甲旁亢的发生率高达1/1000￣1/200。本病一经确诊，即行手术切除可获治愈 研究人员昨天说，阿目金生技公司的Sensipar (cinacalcet)是原发性甲状旁腺功能亢进症的一种有效治疗，它提供了手术之外的另一种选择。 据在美国骨和矿物质研究学会西雅图会议上提交的一项多中心试验资料说，在一项对22名原发性甲状旁腺功能亢进症病人的试验中，80%使用了Sensipar的病人血浆钙水平正常化，18人治疗3年仍保持了血浆钙的降低。 阿目金公司称，目前本病在美国有50万病人，唯一确定有效的治疗是手术切除一个或以上甲状旁腺。 Sensipar，是一种拟钙剂，3月ＦＤＡ批准它来治疗透析的慢性肾病患者的继发性甲状旁腺功能亢进症，及降低甲状旁腺癌症病人血液中增高的血钙水平。 SENSIPAR TAB 90MG 30 Generic Name: CINACALCET HCL Class: R Manufacture: AMGEN USA INC Strength: 90 MG Size: 30 DosageForm: TABLET 商品名：Ｓｅｎｓｉｐａｒ 盐酸西那卡塞（Ｃｉｎａｃａｌｃｅｔ Ｈｙｄｒｏｃｈｌｏｒｉｄｅ）是一种拟钙剂，当它与维生素Ｄ类似物和磷酸盐结合剂合用时，可降低体内甲状旁腺素（ＰＴＨ）和血清钙水平。该药于２００４年３月８日获得美国食品药品管理局（ＦＤＡ）批准。 【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Ｐ４５０ ３Ａ４、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（ａｃｃｅｓｓ ｉｎｆｅｃｔｉｏｎ）。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。 Sensipar Chemical: Cinacalcet Contact your doctor immediately if you experience muscle pain, cramping, twitching, or spasms; numbness or tingling; or seizures. These may be early signs of not enough calcium in the body. Take Sensipar (cinacalcet) with food or immediately following a meal. Do not crush, chew, or break the tablets. Swallow them whole. Do not take Sansipar (cinacalcet) if you have low levels of calcium in your body. This may be determined by blood tests. Before taking cinacalcet talk to your doctor if you have * liver disease; or * a history of seizures. You may not be able to take cinacalcet, or you may require a dosage adjustment or special monitoring during treatment. Sensipar (Cinacalcet) is in the FDA pregnancy category C. This means that it is not known whether cinacalcet will be harmful to an unborn baby. Do not take cinacalcet without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether cinacalcet passes into breast milk. It is recommended that breast-feeding be discontinued during treatment with cinacalcet. Do not take cinacalcet without first talking to your doctor if you are breast-feeding a baby. What is Sensipar? Sensipar (cinacalcet) is an agent that increases the sensitivity of the parathyroid gland to calcium in the body. This causes a decrease in levels of parathyroid hormone (PTH), calcium, and phosphorous in the body. Sensipar is used to treat hyperparathyroidism (overactivity of the parathyroid glands) in people who are on long-term dialysis for kidney disease. Sensipar is also used to lower calcium levels in people with cancer of the parathyroid gland. Sensipar may also be used for other purposes not listed in this medication guide. Important information about Sensipar You should not take Sensipar if you are allergic to cinacalcet. Before you take Sensipar, tell your doctor if you have high blood pressure, heart disease, heart failure, a heart rhythm disorder, liver disease, or a history of seizures. There are many other medicines that can interact with cinacalcet. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. Sensipar works best if you take it with food or shortly after eating a meal. Do not crush or break a Sensipar tablet. Swallow the pill whole. To be sure Sensipar is helping your condition, your blood may need to be tested often. Visit your doctor regularly. Call your doctor at once if you have a serious side effect such as numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes, seizure, feeling short of breath, swelling, rapid weight gain, or feeling like you might pass out. Before taking Sensipar You should not take Sensipar if you are allergic to cinacalcet. To make sure you can safely take Sensipar, tell your doctor if you have any of these other conditions: high blood pressure; heart disease, heart failure, heart rhythm disorder; a history or seizures; or liver disease. FDA pregnancy category C. It is not known whether Sensipar will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether cinacalcet passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Sensipar. Do not give Sensipar to a child without a doctor's advice. How should I take Sensipar? Take Sensipar exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Sensipar works best if you take it with food or shortly after eating a meal. Do not crush or break a Sensipar tablet. Swallow the pill whole. To be sure your calcium and phosphorous levels do not get too low, your blood will need to be tested 1 week after you start taking Sensipar or whenever your dose is changed. You may also need blood tests on a regular basis during treatment. Do not miss any follow-up visits to your doctor. Store Sensipar at room temperature away from moisture, light, and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Symptoms of a cinacalcet overdose are not known. What should I avoid while taking Sensipar? Follow your doctor' instructions about any restrictions on food, beverages, or activity while taking Sensipar. Sensipar side effects Get emergency medical help if you have any of these signs of an allergic reaction to Sensipar: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; seizure (convulsions); feeling short of breath, even with mild exertion; swelling, rapid weight gain; or feeling like you might pass out. Less serious Sensipar side effects may include: nausea, vomiting, diarrhea; loss of appetite; muscle pain, mild chest pain; dizziness; or weakness; This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. What other drugs will affect Sensipar? Many drugs can interact with Sensipar. Below is just a partial list. Tell your doctor if you are using: chloroquine (Arelan); conivaptan (Vaprisol); diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze); imatinib (Gleevec); isoniazid (for treating tuberculosis); bladder medication such as tamsulosin (Flomax) or tolterodine (Detrol); an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek); an antidepressant such as amitriptyline (Elavil, Vanatrip), desipramine (Norpramin), duloxetine (Cymbalta), fluoxetine (Prozac), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), sertraline (Zoloft), and others antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal); ADHD medication such as atomoxetine (Strattera), dextroamphetamine (Adderall), or methylphenidate (Ritalin, Daytrana, Metadate, Concerta); cancer medicine such as doxorubicin (Adriamycin, Doxil), lomustine (CeeNU), tamoxifen (Soltamox); cough medicine (narcotic or over-the-counter); heart or blood pressure medication such as carvedilol (Coreg), diltiazem (Cartia, Cardizem), felodipine (Plendil), flecainide (Tambocor), labetalol (Normodyne), metoprolol (Lopressor), nifedipine (Nifedical, Procardia), procainamide (Procan, Pronestyl), propafenone (Rythmol), propranolol (Inderal), verapamil (Calan, Covera, Isoptin, Verelan), and others; HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), promethazine (Phenergan), or thioridazine (Mellaril); or pain medication such as codeine (Tylenol #3),, hydrocodone (Lortab, Vicodin, Vicoprofen), oxycodone (OxyContin, Percocet), or tramadol (Ultram, Ultracet). There are many other medicines that can interact with Sensipar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. Where can I get more information? Your pharmacist can provide more information about Sensipar. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2010 Cerner Multum, Inc. Version: 4.01. Revision Date: 07/28/2010 12:14:03 PM.