部分中文卡泊芬净处方资料（仅供参考） 药品英文名 Caspofungin 药品别名 醋酸卡泊芬净、科赛斯、Cancidas、Caspofungin Ace-tate 药物剂型 卡泊芬净注射剂：50mg/支；70mg/支。2～8℃冰箱冷藏。本品溶解原液可在25℃以下保存1h，稀释好的静脉注射液可2～8℃冰箱冷藏48h，或25℃以下存放24h。 药理作用 本品为棘白菌素类抗真菌药物，是葡聚糖合成酶抑制剂，能有效抑制β-1，3-D-葡聚糖的合成，从而干扰真菌细胞壁的合成。本品有广谱抗真菌活性，对白色念珠菌、热带念珠菌、光滑念珠菌、克柔念珠菌等有良好的抗菌活性，对烟曲霉、黄曲霉、土曲霉和黑曲霉及除曲菌以外的几种丝状真菌和二形真菌也有抗菌活性。 药动学 本品的血药浓度随着静脉应用剂量的加大(从5mg到100mg)而呈线性增加。单剂静滴卡泊芬净70mg后，平均血药浓度为12.4μg/ml，24h后为1.42μg/ml，消除半衰期9.29h。本品的血清蛋白结合率高(约96%)。在肝、肾和大肠组织的药物浓度明显比血浆高，小肠、肺和脾的浓度与血浆相似，而心、脑和大腿的浓度低于血浆浓度。消除半衰期为9～10h。本品主要在肝脏代谢，经粪便和尿液排出。其中约1.4%的剂量以原形从尿液中排出。本品进入人体后97%与白蛋白结合，经水解及N-乙酰化作用而缓慢地被代谢。 适应证 本品适用于治疗念珠菌败血症和下列念珠菌感染：腹腔脓肿、腹膜炎和腹腔感染；食管念珠菌病；难治性或不能耐受其他治疗如两性霉素B、两性霉素B脂质体制剂和/或伊曲康唑的侵袭性曲霉病的治疗。也用于发热性中性粒细胞减少症患者真菌感染的治疗。 禁忌证 1.对本品过敏者禁用。 2.尚无儿童用药安全性资料，不推荐18岁以下患者使用。 注意事项 1.妊娠期及哺乳期妇女慎用。 2.严重肝功能不全的病人，目前尚无用药的临床经验。 3.本品应单独输注，不宜与其他静脉注射剂混合。 4.本品在葡萄糖溶液中不稳定，故不能用葡萄糖注射液稀释。 5.尚无药物过量报告，已使用的最大剂量100mg耐受良好。本品不能被透析清除。 不良反应 1.一般发热、头痛、腹痛。 2.消化道 恶心、呕吐、腹泻。 3.肝脏 肝酶水平升高。 4.血液 贫血。 5.外周血管 静脉炎、血栓性静脉炎、静滴相关反应。 6.皮肤 皮疹、瘙痒症。 7.常见的实验室检查异常有血清氨基转移酶、胆红素、碱性磷酸酶、血肌酐、血尿素氮升高，血钾、血细胞比容和血红蛋白降低。 用法用量 1.念珠菌败血症及其他念珠菌感染：成人剂量为首日负荷剂量70mg，继以维持剂量每日50mg，缓慢静脉滴注1h。疗程依据患者的临床及微生物学反应而定，一般为末次血培养阴性后至少14天。粒细胞缺乏患者疗程宜长，持续至粒细胞恢复。 2.食管念珠菌病：每日50mg，缓慢静滴1h。由于HIV患者易于复发，可予以抑制治疗。 3.侵袭性曲霉病：首日负荷剂量70mg，继以维持剂量每日50mg，缓慢静滴1h。疗程依据患者基础疾病的严重程度、免疫缺陷恢复情况以及临床反应而定。 4.肾功能损害及轻度肝功能损害患者不需调整剂量，中度肝功能损害患者首日负荷剂量为70mg，继以维持剂量每日35mg。 5.与依非韦仑、奈非那韦、奈非拉平、利福平、地塞米松、苯妥英钠、卡马西平合用时，首日负荷剂量70mg，维持剂量每日70mg。 6.溶液配制：将本品注射剂放至室温，加入注射用水或O.9%氯化钠注射液10.5ml溶解得溶解原液，浓度为7mg/ml(每瓶70mg包装)或5mg/ml(每瓶50mg包装)；根据患者用药剂量，取溶解原液适量加入到0.9%氯化钠注射液或乳酸林格注射液250ml中，得稀释液供静滴。 药物相应作用 1.本品可致他克莫司血药浓度升高，两者合用时应监测他克莫司的血药浓度，并调整他克莫司的剂量。 2.本品可使环孢素A的AUC增加，但血药浓度不变。两者合用时可发生血清氨基转移酶水平升高，应避免两者合用。 3.利福平、依法韦司、奈韦拉平、苯妥英、地塞米松、卡马西平可使本品血药浓度降低，与上述药物合用时，应予以本品每日70mg。 Generic name: Caspofungin - Injection Brand name(s): Cancidas Cancidas 50 mg IV Solution Cancidas 70 mg IV Solution Usual Diluents NS  Standard Dilutions   [Amount of drug] [Infusion volume] [Infusion rate] [35 to 75 mg] [250 ml] [1 hour] Additional info below. Stability / Miscellaneous Label: Refrigerate. Indications: * Empirical therapy for presumed fungal infections in febrile, neutropenic patients. * Treatment of Candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida. * Treatment of Esophageal Candidiasis. * Treatment of Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis. DOSAGE AND ADMINISTRATION Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (a-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose. CANCIDAS should be administered by slow IV infusion over approximately 1 hour. Empirical Therapy A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. Empirical therapy should be continued until resolution of neutropenia. Patients found to have a fungal infection should be treated for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved. If the 50-mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg. Although an increase in efficacy with 70 mg daily has not been demonstrated, limited safety data suggest that an increase in dose to 70 mg daily is well tolerated. Candidemia and other Candida infections A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be dictated by the patient’s clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia. Esophageal Candidiasis The dose should be 50 mg daily. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered. A 70-mg loading dose has not been studied with this indication. Invasive Aspergillosis A single 70-mg loading dose should be administered on Day 1, followed by 50 mg daily thereafter. Duration of treatment should be based upon the severity of the patient’s underlying disease, recovery from immunosuppression, and clinical response. The efficacy of a 70-mg dose regimen in patients who are not clinically responding to the 50-mg daily dose is not known. Limited safety data suggest that an increase in dose to 70 mg daily is well tolerated. The safety and efficacy of doses above 70 mg have not been adequately studied. Hepatic Insufficiency Patients with mild hepatic insufficiency (Child-Pugh score 5 to 6) do not need a dosage adjustment. For patients with moderate hepatic insufficiency (Child-Pugh score 7 to 9), CANCIDAS 35 mg daily is recommended. However, where recommended, a 70-mg loading dose should still be administered on Day 1. There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score >9). Preparation of CANCIDAS for use: Do not mix or co-infuse CANCIDAS with other medications, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medications. DO NOT USE DILUENTS CONTAINING DEXTROSE (a-D-GLUCOSE), as CANCIDAS is not stable in diluents containing dextrose. Preparation of the 70-mg infusion 1. Equilibrate the refrigerated vial of CANCIDAS to room temperature. 2. Aseptically add 10.8 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the vial. The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained. This reconstituted solution may be stored for up to one hour at 25°C (77°F). Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated. 3. Aseptically transfer 10 mL of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection. This infusion solution must be used within 24 hours if stored at 25°C (77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F). (If a 70-mg vial is unavailable, see below: Alternative Infusion Preparation Methods, Preparation of 70-mg dose from two 50-mg vials.) Preparation of the daily 50-mg infusion 1. Equilibrate the refrigerated vial of CANCIDAS to room temperature. 2. Aseptically add 10.8 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the vial.5 This reconstituted solution may be stored for up to one hour at 25°C (77°F).6 3. Aseptically transfer 10 mL of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 mL 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection. This infusion solution must be used within 24 hours if stored at 25°C (77°F) or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F). (If a reduced infusion volume is medically necessary, see below: Alternative Infusion Preparation Methods, Preparation of 50-mg daily doses at reduced volume.) Alternative Infusion Preparation Methods Preparation of 70-mg dose from two 50-mg vials Reconstitute two 50-mg vials with 10.8 mL of diluent each (see Preparation of the daily 50-mg infusion). Aseptically transfer a total of 14 mL of the reconstituted CANCIDAS from the two vials to 250 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection. Preparation of 50-mg daily doses at reduced volume When medically necessary, the 50-mg daily doses can be prepared by adding 10 mL of reconstituted CANCIDAS to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection (see Preparation of the daily 50-mg infusion). Preparation of a 35-mg daily dose for patients with moderate Hepatic Insufficiency Reconstitute one 50-mg vial (see above: Preparation of the daily 50-mg infusion). Aseptically transfer 7 mL of the reconstituted CANCIDAS from the vial to 250 mL or, if medically necessary, to 100 mL of 0.9%, 0.45%, or 0.225% Sodium Chloride Injection, or Lactated Ringer’s Injection. CANCIDAS Concentrations HOW SUPPLIED No. 3822 — CANCIDAS 50 mg is a white to off-white powder/cake for infusion in a vial with a red aluminum band and a plastic cap. NDC 0006-3822-10 supplied as one single-use vial. No. 3823 — CANCIDAS 70 mg is a white to off-white powder/cake for infusion in a vial with a yellow/orange aluminum band and a plastic cap. NDC 0006-3823-10 supplied as one single-use vial. Storage/Stability Vials The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F). Reconstituted Concentrate Reconstituted CANCIDAS may be stored at 25°C (77°F) for one hour prior to the preparation of the patient infusion solution. Diluted Product The final patient infusion solution in the IV bag or bottle can be stored at 25°C (77°F) for 24 hours or at 2 to 8°C (36 to 46°F) for 48 hours. https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=8976 抗真菌药物Cancidas（卡泊芬净）获美国FDA及欧洲批准新适应症 Merck公司宣布美国FDA已批准每日一次的抗真菌药物Cancidas（乙酸卡泊芬净,caspofungin acetate）用于治疗持续高烧的白细胞降低症患者的真菌感染。之前，2001年 11月美国FDA和欧洲批准其用于两性霉素B治疗无效或用于不能耐受两性霉素B的侵袭性曲霉病患者。 这项批准是根据抗真菌经典治疗（empirical therapy）临床试验的结果而作出的。试验结果显示该药和常用于治疗这类真菌感染的传统药物两性霉素 B的疗效相当。侵入性真菌感染常发生在由于癌症化疗或接受造血干细胞移植的白细胞降低症患者中，是一种威胁生命的疾病。在临床上表现为尽管使用广谱抗菌素，但往往还是持续性地高烧不退。 Cancidas是第一个称之为echinocan- dins类的抗真菌药物，通过抑制真菌细胞壁（1,3)-D-糖原 (glucan）的合成而起作用，为静脉注射给药。这项研究的受试者为曾接受过化疗或接受过造血干细胞移植（如骨髓移植），并伴有白细胞降低症(500个·mm-3达96h)和高烧（＞ 38℃），且对抗生素治疗无效。临床试验结果表明Cancidas 的总有效率为33.9％，而两性霉素B为33.7％。在安全性方面，Cancidas优于两性霉素B。Cancidas患者发生与药物静注有关的不良反应事件率为35.196，而两性霉素B患者为51.6%。Cancidas常见的与药物有关的不良反应为发烧 (17%），寒战（13.8%），皮疹（6.2%），头痛（4.3%），低钾 (3.7％），恶心和呕吐（3.5％）。 --------------------------------------------------- 注：以下产品不同规格和不同价格，采购以咨询为准！ --------------------------------------------------- 产地国家：美国 原产地英文商品名: CANCIDAS IV 70mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯 IV 70毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MSD Merck ------------------------------------------------------ 产地国家：美国 原产地英文商品名: CANCIDAS IV 50mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯 IV 50毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MSD Merck ------------------------------------------------------ 产地国家：瑞士 原产地英文商品名: CANCIDAS  Trockensub 70mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 70毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MSD Merck Sharp & Dohme AG ------------------------------------------------------ 产地国家：瑞士 原产地英文商品名: CANCIDAS Trockensub 50mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 50毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MSD Merck Sharp & Dohme AG ------------------------------------------------------ 产地国家：日本 原产地英文商品名: CANCIDAS for Intravenous Drip Infusion（カンサイダス点滴静注用）70mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: CANCIDAS（カンサイダス点滴静注用）70毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MERCK ------------------------------------------------------ 产地国家：日本 原产地英文商品名: CANCIDAS for Intravenous Drip Infusion（カンサイダス点滴静注用）50mg/vial vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: CANCIDAS（カンサイダス点滴静注用）50毫克/瓶 10瓶/盒 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: MERCK ------------------------------------------------------ 产地国家：英国 原产地英文商品名: CANCIDAS Powder infusion 70mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 70毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: Merck ------------------------------------------------------ 产地国家：英国 原产地英文商品名: CANCIDAS Powder infusion 50mg/10ml/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 50毫克/10毫升/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: Merck ------------------------------------------------------ 产地国家：德国 原产地英文商品名: CANCIDAS Powder infusion 70mg/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 70毫克/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: Merck ------------------------------------------------------ 产地国家：德国 原产地英文商品名: CANCIDAS Powder infusion 50mg/10ml/vial 原产地英文药品名: CASPOFUNGIN ACETATE 中文参考商品译名: 科赛斯注射剂 50毫克/10毫升/瓶 中文参考药品译名: 醋酸卡泊芬净 生产厂家中文参考译名: 默克 生产厂家英文名: Merck