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碳酸司维拉姆片/粉剂RENVELA(sevelamer carbonate tablet)

2011-07-15 18:20:18  作者:新特药房  来源:中国新特药网天津分站  浏览次数:761  文字大小:【】【】【
简介: 通用名称RENVELA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RENVELAGenzyme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 ...

通用名称RENVELA
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。

[附件:/uploadfile/article/uploadfile/201012/20101226071619396.pdf]

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。

 

Important Treatment Considerations

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

Generic Name for RENVELA
Sevelamer carbonate 800mg; tabs.

Legal Classification:
Rx

Pharmacological Class for RENVELA
Phosphate binder.

Manufacturer of RENVELA
Genzyme Corporation

Indications for RENVELA
Control of serum phosphorus in patients with chronic kidney disease on dialysis.

Adult dose for RENVELA
Take with meals. Patients not taking a phosphate binder: serum phosphorus >5.5 and <7.5mg/dL: 1 tablet 3 times daily; ≥7.5mg/dL: 2 tablets 3 times daily. May switch from sevelamer HCl on a gram/gram basis. Switching from calcium acetate: sevelamer carbonate 800mg approximates calcium acetate 667mg (see literature). Titrate by 1 tablet/meal at 2-week intervals to keep serum phosphorus between 3.5–5.5mg/dL; usual max 14g/day.

Children's dosing for RENVELA
Not recommended.


Contraindications for RENVELA
Hypophosphatemia. Bowel obstruction.

Warnings/Precautions for RENVELA
Dysphagia. Swallowing disorders. Severe GI motility disorders. Major GI tract surgery. Monitor serum bicarbonate, chloride levels. Pregnancy (Cat.C). Labor & delivery.

Interactions for RENVELA
May antagonize ciprofloxacin. Separate narrow therapeutic index drugs by 1 hour before or 3 hours after sevelamer, or consider monitoring (esp. with antiarrhythmics, antiepileptics).

Adverse Reactions for RENVELA
GI upset, constipation.

How is RENVELA supplied?
Tabs—30, 270

责任编辑:admin


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