通用中文 | 碳酸司维拉姆片 | 通用外文 | Sevelamer Carbonate Tablets |
品牌中文 | 诺维乐 | 品牌外文 | Renvela |
其他名称 | |||
公司 | 健赞(GENZYME) | 产地 | 美国(USA) |
含量 | 800mg | 包装 | 30片/盒 |
剂型给药 | 片剂 口服 | 储存 | 室温 |
适用范围 | 慢性肾衰病人在血液透析时的血清无机磷和钙含量的控制以及继发性甲状旁腺功能亢进。 |
通用中文 | 碳酸司维拉姆片 |
通用外文 | Sevelamer Carbonate Tablets |
品牌中文 | 诺维乐 |
品牌外文 | Renvela |
其他名称 | |
公司 | 健赞(GENZYME) |
产地 | 美国(USA) |
含量 | 800mg |
包装 | 30片/盒 |
剂型给药 | 片剂 口服 |
储存 | 室温 |
适用范围 | 慢性肾衰病人在血液透析时的血清无机磷和钙含量的控制以及继发性甲状旁腺功能亢进。 |
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≤1.78mmol/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
中文名:盐酸司维拉姆片
英文名:Sevelamer hydrochloride Tablet
规格主要有400mg和800mg两种
适应症:
慢性肾衰病人在血液透析时的血清无机磷和钙含量的控制以及继发性甲状旁腺功能亢进。 Regagel(sevelamer盐酸盐)美国Genzyme生物制药公司新品碳酸司维拉姆(Renvela)已获得欧盟批准进入当地市场销售,该药用 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。
Renvela Tablets Details:US$16Brand Name: Renvela 800mg Tablets
Contents: Sevelamer Carbonate Tablets 800mg
Form: Tablets
Manufacturer :Genzyme
Packing:
Pack of 30 Tablets
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
Relative 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