美国食品和药品管理局（Food and Drug Administration，FDA）批准Genzyme Generals 和GelTex两家制药公司生产Renagel片剂，用于治疗行血液透析的晚期肾病患者的高血磷症。

FDA批准Genzyme Generals 和GelTex两家制药公司生产Renagel片剂，用于治疗行血液透析的晚期肾病患者的高血磷症。据FDA周四发表的声明称，预计在今年下半年市场上开始出售800 mg 和400 mg两种剂量的片剂。Genzyme General公司发言人指出，“为了使临床医生选择余地更大，目前的403 mg胶囊剂型仍将继续销售。”

两家公司称，“400 mg 片剂比目前的胶囊小得多，同时800 mg片剂适用于那些需要大剂量，又不愿服用太多药丸的患者。”

Renagel于1998年年底投入使用，在美国的销售额去年达到两千万美圆。Genzyme General公司期望其销售额在2000年翻一番，部分地反映出该药试图进入国际市场的愿望。该公司发言人强调，2000年第一季度，该药销售额总值为八百万美圆，主要是来自美国市场。

除了美国，Renagel胶囊正在欧洲，加拿大和以色列广泛使用。Genzyme公司于今年第一季度向欧洲申请批准生产Renagel片剂，并拟在第三季度向加拿大申请批准片剂生产。

该药品的潜在市场包括有美国每年行透析的280,000名晚期肾病患者和170,000欧洲透析患者，而且每年该数字以大约7%的幅度增长。

Renagel可在消化道和正常消化过程结合并除去饮食中的磷，血磷水平升高可能导致行血液透析的病人出现致命的并发症。

1997年，GelTex 和Genzyme General两家公司达成协议：GelTex公司负责提供药品，药品专利和相关技术；而Genzyme General公司则负责销售，患者支持，规则建议和相关活动。协议同时规定Genzyme公司付给GelTex公司合计为两千七百五十万美圆的各种费用。

根据协议，双方公司平等享有Renagel的利润以及开支。位于麻省剑桥（Cambridge, Massachusetts）的Genzyme General公司是生物技术企业Genzyme Corporation的分支机构。而GelTex公司则专门从事开发和销售非吸收性聚合体药物，其总部位于麻省的沃尔瑟姆（Waltham, Massachusetts）。

Renagel在药理分类上是全新的药物，其特色为不含铝、不含钙、亦不含任何金属成份的聚分子化合物，病人在三餐同时与药物并服，它以类似树脂交换离子方式吸附肠道中的磷酸，结合后再由粪便排出体外。由于Renagel无全身性吸收，所以安全性高，可以有效控制血磷值并且不会导致高血钙症等副作用。磷能解锭的使用禁忌，主要是对低血磷、大肠阻塞、以及对该药成份会过敏的患者。

长期洗肾的病友，还需考虑软组织钙化，尤其是动脉钙化问题，这可能与心脏血管疾病有密切关联。Braun等人在二年的长期临床试验中，研究了 114位洗肾病友，发现Renagel与其它含钙制剂的降磷效果相当。但使用含钙制剂的病人，有明显较多的高钙血症与PTH的过度抑制现象。其中高钙血症 (Ca ＞2.8 mmol/L) 在含钙制剂组与Renagel治疗组的出现比例，分别是19%与0%。另一方面，使用含钙制剂的病人，其心血管钙化程度有明显的增加 (median +34% in coronary artery)，而服用Renagel的肾友则未观察到这个问题。

1. WHAT RENAGEL® IS AND WHAT IT IS USED FOR
Renagel® tablets are off white, oval, film-coated tablets, imprinted with the code Renagel® 800 on one side. The tablets are packed in plastic bottles with child resistant closures, containing 180 tablets (800 mg) per bottle. Package sizes are for the 800 mg tablets: 1 × 100, 1 × 180, 2 × 180 and 3 × 180 tablets.
Renagel® binds phosphate from food in the digestive tract. In doing so it reduces serum phosphate levels in the blood of adult kidney failure patients on haemodialysis treatment. Renagel® does not contain calcium. So the number of episodes of high calcium levels in your blood will be reduced as compared to when you are taking calcium tablets alone to regulate the phosphate levels in the blood.
Renagel® also binds bile acids. In doing so it reduces the levels of LDL ('bad cholesterol') in your blood.
Renagel® is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis treatment. It may be necessary to use other medicines with Renagel®, which could include calcium supplements or Vitamin D supplements, to control the development of renal bone disease.

2. BEFORE YOU TAKE RENAGEL®
Do not take Renagel,
- when you have low levels of phosphate in your blood.
- when you suffer from bowel obstruction.
- if you are hypersensitive (allergic) to sevelamer or to any of the other ingredients of the product.

Take special care with Renagel®
Children: The safety and efficacy in children has not been established. Therefore if you are below the age of 18 years you should consult your physician before taking Renagel®.
Renagel® has not been tested in patients on peritoneal dialysis or in patients not yet on dialysis. It has also not been tested in patients with swallowing problems, patients with motility problems of their stomach and bowel, retention of stomach contents, active inflammation of the bowel, and patients who had major operations on their stomach or bowel.
If you are in one of the above mentioned groups please discuss this with your physician before taking Renagel®.
Due to either your kidney condition or your dialysis treatment you may develop a low or high level of calcium in your blood. Since Renagel® does not contain calcium your physician might prescribe additional calcium tablets.
Depending on the nature of your kidney condition, you may have a low amount of Vitamin D in your blood. Therefore, your physician may monitor the levels of Vitamin D in your blood and prescribe additional Vitamin D as necessary. If you do not take multivitamin supplements you may also develop low levels of vitamin A, E, K and folic acid in your blood and therefore your physician may monitor these levels and prescribe supplemental vitamins as necessary.

Pregnancy
The safety of Renagel® has not been established in pregnant women. If you are pregnant you should ask your physician or pharmacist before taking Renagel®.

Breast feeding
The safety of Renagel® has not been established in breast feeding women. If you are breastfeeding you should ask your physician or pharmacist before taking Renagel®.

Driving and using machines
Renagel® is unlikely to produce an effect on the ability to drive or to operate machines.

Taking other medicines
Always mention to your physician all medicines you are taking or have recently taken, even those not prescribed.
In human studies administering Renagel® together with digoxin (for heart failure and heart rhythm disorders), enalapril (for treatment of high blood pressure due to kidney or heart failure),metoprolol (chest pain, heart rhythm disorders) or warfarin (anti bloodclotting) no interactions between Renagel® and these substances occurred. An Interaction was observe between Renagel and ciprofloxacin (antibiotics) in a human study. Therefore, these two substances should not be taken at the same time. Please refer to your physician in such a case.
Your physician will check for interactions between Renagel® and other medicines on a regular bass.

3. HOW TO TAKE RENAGEL®
You should take Renagel® as prescribed by your physician. The physician will base the dose on your serum phosphate level. The recommended starting dose of Renagel® for adults and elderly (> 65 years) is one to two tablets of 800 mg with each meal 3 times a day.
In some cases where Renagel should be administered at the same time as another drug, your physician could advise you to take this drug one hour before or three hours after Renagel intake, or he may consider to monitor the blood levels of that specific drug.
Your physician will check the levels of phosphate in the blood periodically and your physician may adjust the dose of Renagel® when necessary between 1 and 5 tablets of 800 mg per meal, to reach an adequate phosphate level in the blood.

Instructions for use and handling
You should take Renagel® tablets with meals. However, you should adhere to your prescribed diet and liquid intake.
Do not chew. The tablets must be swallowed whole.
If you take more Renagel® than you should
There are no reported overdoses in patients.
In case of a possible overdose you should immediately contact your physician.

If you forget to take Renagel®
In case you have missed one dose, this dose should be omitted and the next dose should be taken at the usual time with a meal. Do not take two doses at the same time.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Renagel® can have side effects.
The following side effects are normally reported in kidney failure patients on haemodialysis: pain, diarrhoea, nausea, vomiting, indigestion, constipation, infection, headache, difficulty in breathing, cough, low blood pressure, dizziness, shortness of breath, formation of blood clots in the blood vessels, swelling of limbs due to fluid retention, accidental injury, chest pain, abdominal pain, fever, leg cramps, increase of blood pressure, itching, flatulence, heart and blood vessel related disorders, sore throat, rash and intestinal obstruction. These have also been reported in patients taking Renagel®.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Since constipation may be a preceding symptom in very rare cases of intestinal obstruction, please inform your doctor or pharmacist.

5. STORING RENAGEL
Keep out of the reach and sight of children.
Do not store above 25°C. Keep the container tightly closed.
Do not use Renagel after the expiry date printed on the labelling after the letters: "EXP".

通用名称：RENVELA

商用名称：磷能解

中文：盐酸司维拉姆

英文名称：Sevelamer HCL

磷能解碳酸盐800毫克;标签。

法律分类：
接收

药理班RENVELA
磷酸盐结合剂。

制造商RENVELA
Genzyme公司
 
适应症RENVELA
控制与血清透析慢性肾脏病患者磷。

成人剂量RENVELA
随身携带的饭菜。患者不要服用磷酸盐结合剂：血清磷>5.5和“<7.5mg/dL：1片，每日3次，≥7.5mg/dL：2片，每日3次。从磷能解盐酸可以切换上一克/克的基础。从醋酸钙交换：磷能解接近800毫克碳酸钙醋酸钙667mg（见文献）。 1片/餐滴定在2个星期的时间间隔保持在3.5-5.5mg/dL血清磷;平常最大14g/day。

儿童剂量为RENVELA
不推荐。

禁忌的RENVELA
低磷血症。肠梗阻。

警告/注意事项的RENVELA
吞咽困难。吞咽障碍。严重的胃肠运动障碍。主要胃肠道手术。监测血清碳酸氢盐，氯化物水平。妊娠（Cat.C）。劳动和交付。

互作RENVELA
五月对抗环丙沙星。独立缩小1小时前或药物治疗指数能解后3小时，或考虑监管（特别是与抗心律失常药，抗癫痫药物）。

不良反应为RENVELA
胃肠不适，便秘。

美国Genzyme生物制药公司药品Renvela用于慢性肾病（CKD）患者，以控制他们体内血清磷水平，这为专业医师提供了一种治疗高磷酸盐血症的全新选择。

值得指出的是，欧盟同时批准了该药的片剂和粉剂两种剂型。其中粉剂是该公司另一种磷酸盐粘结剂Renagel的下一代产品，可用于未接受过透析治疗，且体内血清磷水平≤1.78 mmol/L的患者。

导致高磷酸盐血症的原因是患者肾脏发生病变，难以将体内的磷滤除并排除体外，而血清磷含量的升高会导致身体组织钙化，从而进一步增加发生心脏病的风险。若对这种情况不加以治疗，还有可能出现骨痛、骨骼畸形和骨折等，因此，将血清磷含量维持在一个理想的水平对CKD患者来说是一种重要的治疗途径。

目前，Renvela和Renagel是唯独不含钙和任何金属成分的磷酸盐粘结剂。它们通过批准的依据均是多项临床实验的喜人结果——患者用药后体内的磷含量可以维持在正常的范围。

enzyme公司肾病药事业部负责人表示，Renvela能获准进入欧洲市场意味着在CKD治疗领域又前进了一步。该药是第一种在欧洲集中审批程序下获准，可用于治疗从未进行过透析CKD患者的产品，也为医师提供了一种可尽早治疗，控制病情的新药。

Renvela^® (sevelamer carbonate)

Important Treatment Consideration
Renvela^® (sevelamer carbonate) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

• Renvela is contraindicated in patients with bowel obstruction
• Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery
• Uncommon cases of bowel obstruction and perforation have been reported
• Serum bicarbonate and chloride levels should be monitored
• Vitamins D, E, K (coagulation parameters), and folic acid levels should be monitored
• The most frequently occurring adverse reactions in a short-term study with sevelamer carbonate tablets were nausea and vomiting
• In a short-term study of sevelamer carbonate powder dosed three times daily, adverse events were similar to those reported for sevelamer carbonate tablets
• In long-term studies with sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, the most common adverse events included: vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, and constipation
• Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported
• Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela
• Patients should be informed to take Renvela with meals and to adhere to their prescribed diets

Please see accompanying full Prescribing Information.
Renagel^® (sevelamer hydrochloride) is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

• Renagel is contraindicated in patients with hypophosphatemia or bowel obstruction
• Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation or major GI tract surgery
• Common adverse events reported with Renagel include vomiting, nausea, diarrhea, dyspepsia, abdominal pain, and constipation
• Other events reported include pruritus, rash, fecal impaction, and intestinal obstruction
• Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renagel
• Patients should be informed to take Renagel with meals and to adhere to their prescribed diets

【原产地英文商品名】renagel 800mg/tab 180tabs/bottle
【原产地英文药品名】sevelamer hydrochloride
【中文参考商品译名】磷能解 800毫克/片 180片/瓶
【中文参考药品译名】盐酸司维拉姆
【临床试验期】完成
【中文适应病症参考】肾病
【中文适应病症参考】高血磷症
【生产厂家中文参考名】健赞
【生产厂家英文名】Genzyme