无钙无树脂FOSRENOL的推出为日本末期肾病患者带来了新的治疗选择 2009年3月11日,FOSRENOL是日本第一款上市的无钙无树脂磷酸盐结合剂，该药被用于控制接受透析治疗的慢性肾衰竭患者的高磷酸盐血症。 Bayer Yakuhin于2003年12月从 Shire获得了独家授权，可在日本开发FOSRENOL，并在日本患者中完成二期和三期临床试验。 基于日本分布广泛的筛查项目的研究显示，该国慢性肾病(CKD)发病率极高，1.032亿的成年人口中约有20%的人患有不同形式的慢性肾病。在日本，接受透析治疗的患者估计约有27万，而且每年还在以1万人的速度递增。 肾功能下降的一个直接后果就是无法充分控制血磷水平，从而导致高磷酸盐血症。磷酸盐增多会破坏体内钙、甲状旁腺激素和维生素D水平之间微妙的相互作用。这又会导致骨代谢异常，削弱骨骼的存储功能（骨骼是磷酸盐和钙的重要储存地），最终导致血管钙化。这三重相互关联的症状被称为慢性肾病矿物质和骨代谢异常。 通过持续的磷酸盐控制来改善骨骼存储功能是防止血管钙化的重要措施。血管钙化积分有助于预测慢性肾病患者的死亡率，骨代谢的改善与钙化积分增加速度的降低相关。当前，日本最常用的磷酸盐结合剂是碳酸钙。但是，含钙的磷酸盐结合剂会增加钙负荷，进而加快血管钙化。 FOSRENOL能够持续控制磷酸盐，对CKD5D患者进行的两年的治疗表明FOSRENOL能够改善骨代谢和骨体积。FOSRENOL通常具有较好的耐受性，长达6年的治疗过程中的观察表明，FOSRENOL具有可预测的耐受性。 FOSRENOL(R)简介（碳酸镧） FOSRENOL 是一种磷酸盐结合剂，用于控制那些正在接受血液透析或连续非卧床腹膜透析的慢性肾病患者的高磷酸盐血症。 FOSRENOL通过在胃肠道内与食物中的磷酸盐相结合来发挥作用。一旦与食物中的磷酸盐结合，镧/磷酸盐化合物就无法穿过肠壁进入血液而被人体排出。因此，食物中磷酸盐的总吸收量就会显著降低。 市面上的 FOSRENOL 包括 500mg、750mg和1000mg等多种不同剂量的药片。患者只需每餐服用一片FOSRENOL，就可持续控制磷酸盐水平。 重要安全信息 肾功能不全患者有可能罹患低钙血症 (hypocalcemia)。这类患者的血钙水平因而需要定期监测，并需要适当补钙。 目前还没有 FOSRENOL 用于严重肝损伤患者的数据。所以，对于这类患者需要注意，因为所摄入的镧的排出量有可能会减少。 孕期女性禁用 FOSRENOL。 急性胃溃疡、溃疡性结肠炎、克罗恩病 (Crohns disease) 或肠梗阻患者未被列入FOSRENOL临床研究范围。 最常见的药物不良反应包括腹痛、便秘、腹泻、消化不良、肠胃气胀，恶心和呕吐等胃肠道反应。随餐服用FOSRENOL可使上述不良反应的程度降至最低，一般来说，这些症状会随着服药时间的延长而逐渐减轻。低钙血症是唯一一种其它常见的不良反应。完整的处方信息可根据您的要求予以提供。 ホスレノール顆粒分包250mg／ホスレノール顆粒分包500mg 薬効分類名 高リン血症治療剤 商標名 Fosrenol Granules 一般名 炭酸ランタン水和物（Lanthanum Carbonate Hydrate）JAN 化学名 Lanthanum carbonate hydrate 分子式 La2（CO3）3・xH2O（x＝主として4） 分子量 529.90（4水和物） 性状 本品は白色～ほとんど白色の粉末である． 本品は水又は有機溶媒にはほとんど溶けない． 取扱い上の注意 湿気により，製品の品質が影響を受けるので，アルミニウム袋の状態で保存すること． 効能又は効果／用法及び用量 ＊慢性腎臓病患者における高リン血症の改善 用法及び用量 通常，成人にはランタンとして1日750mgを開始用量とし，1日3回に分割して食直後に経口投与する．以後，症状，血清リン濃度の程度により適宜増減するが，最高用量は1日2,250mgとする 包装 顆粒剤 250mg アルミニウム袋　120包（3包×40），600包（3包×200） 500mg アルミニウム袋　120包（3包×40），600包（3包×200） http://www.info.pmda.go.jp/go/pack/2190029D1025_1_06/ Fosrenol Generic Name: lanthanum carbonate (LAN than um CAR bo nayt )Brand Names: Fosrenol ------------------------------------------------------------------- What is Fosrenol? Fosrenol is a phosphate binder used for reducing serum phosphate levels in patients with end stage kidney (renal) disease. High levels of phosphate can lead to complications with calcium absorption, resulting in serious medical problems. Fosrenol prevents the body from absorbing phosphate, allowing it to be removed the body. Fosrenol may also be used for purposes other than those listed in this medication guide. ------------------------------------------------------------------- Important information about Fosrenol Fosrenol tablets should be completely chewed before swallowing. Do not swallow the tablet whole. Take Fosrenol with meals or immediately after eating. ------------------------------------------------------------------- Before taking Fosrenol Before taking this medication, tell your doctor if you have: a stomach ulcer; ulcerative colitis; Crohn's disease; or a bowel obstruction. If you have any of the conditions listed above, you may not be able to use Fosrenol or you may require a dosage adjustment or special monitoring during treatment. Fosrenol is in the FDA pregnancy category C. This means that it is not known if it will be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment. Do not take this medication without telling your doctor if you are breast-feeding a baby. Taking this medication may affect the results of certain x-ray tests of your stomach. Tell the doctor or x-ray technician that you are using Fosrenol before having any x-rays. ------------------------------------------------------------------- How should I take Fosrenol? Fosrenol should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not take Fosrenol for longer than your doctor has prescribed. Chew the this medication tablet completely before swallowing. Do not swallow the tablet whole. Fosrenol is usually taken with meals or immediately after eating. Store this medication at room temperature away from moisture and heat. ------------------------------------------------------------------- What happens if I miss a dose? Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take extra medicine to make up the missed dose. ------------------------------------------------------------------- What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms from Fosrenol are unlikely to occur. ------------------------------------------------------------------- What should I avoid while taking Fosrenol? Avoid making any changes to your diet while you are taking this medication. ------------------------------------------------------------------- Fosrenol side effects Stop using Fosrenol and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Other, less serious side effects may be more likely to occur. Continue to take Fosrenol and tell your doctor if you have: nausea or vomiting; diarrhea or constipation; stomach pain; ordialysis graft blockage. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088. ------------------------------------------------------------------- What other drugs will affect Fosrenol? There may be other drugs that can affect Fosrenol. 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. ------------------------------------------------------------------- Where can I get more information? Your pharmacist has additional information about Fosrenol written for health professionals that you may read. ------------------------------------------------------------------- What does my medication look like? Lanthanum carbonate is available with a prescription under the brand name Fosrenol. Each chewable tablet is round with a beveled edge, and white or off-white in color. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you. 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.      附件: 201272319544814.pdf -------------------------------------------------------- 产地国家: 日本 原产地英文商品名: FOSRENOL GRANULES(ホスレノール)500mg/sachet 120sachets/box 原产地英文药品名: LANTHANUM CARBONATE HYDRATE 中文参考商品译名: FOSRENOL颗粒剂(ホスレノール)500毫克/小袋 120小袋/盒 中文参考药品译名: 碳酸镧水合物 生产厂家中文参考译名: 拜耳 生产厂家英文名: bayer ------------------------------------------------------- 产地国家: 日本 原产地英文商品名: FOSRENOL GRANULES(ホスレノール) 250mg/sachet 120sachets/box 原产地英文药品名: LANTHANUM CARBONATE HYDRATE 中文参考商品译名: FOSRENOL颗粒剂(ホスレノール) 250毫克/小袋 120小袋/盒 中文参考药品译名: 碳酸镧水合物 生产厂家中文参考译名: 拜耳 生产厂家英文名: bayer