部分中文CAMPTOSAR信息资料（仅供参考） 【药物功效】 适用于治疗成人转移性大肠癌，也可用于其它肿瘤(如胃癌、胰腺癌、宫颈癌、卵巢上皮细胞癌等)。 禁忌症 (1)肝肾功能不全者或血胆红素超过正常值上限1.5倍的患者。 (2)有慢性肠炎和(或)肠梗阻的患者。 (3)对本药有严重过敏史者。 (4)严重骨髓抑制者。 (5)WHO行为状态评分(BaselinePerformance)大于2的患者。 (6)孕妇。(7)哺乳期妇女。 【注意事项】: 1慎用WHO行为状态评分为2的患者。 2药物对老人的影响由于老年人各项生理功能(尤其是肝功能)可能有所减退，故老年患者用药时须谨慎。 3药物对妊娠的影响在兔和大鼠实验中，发现本药对胎仔有毒性、致畸性。因此，妇女于妊娠期间不能使用本药，育龄妇女在接受本药治疗期间应避孕(直至治疗结束后3个月)。美国药品和食品管理局(FDA)对本药的妊娠安全性分级为D级。 4药物对哺乳的影响在哺乳大鼠的乳汁中发现了☆14☆C标记的本药，但目前尚无法证实本药是否会经人乳分泌。由于本药可能对母乳喂养儿有毒性，故在使用本药治疗期间应停止母乳喂养。 5用药前后及用药时应当检查或监测在每个治疗周期前均应检查肝功能，治疗期间应每周检查全血细胞计数。 【不良反应】: 1.血液系统可见中性粒细胞减少、贫血、嗜酸粒细胞增多和血小板减少。 (1)中性粒细胞减少是本药的剂量限制性毒性，但具有可逆性和非蓄积性，中性粒细胞到最低值的中位时间为8天，通常在第22天完全恢复正常。78.7%的患者出现过中性粒细胞减少，严重者(中性粒细胞计数低于0.5×10☆9☆/L)占22.6%。6.2%的患者(按周期为1.7%)出现严重中性粒细胞减少合并发热。10.3%的患者(按周期为2.5%)出现感染；5.3%的患者(按周期为1.1%)出现严重中性粒细胞减少性感染，其中有2例患者死亡。"每周治疗方案"及"3周治疗方案"引起的3-4级中性粒细胞减少分别为14%、22%，曾接受过盆腔/腹部放疗者与未接受者3-4级中性粒细胞减少分别为48%、24%。 (2)贫血的发生率为58.7%。有报道，3-4级贫血发生率为7%，10%患者需要输血。 (3)有1/3患者可见嗜酸粒细胞增多。 (4)有7.4%的患者(按周期为1.8%)出现血小板减少(低于100×10☆9☆/L)，几乎均在第22天得到恢复，接受"3周治疗方案"者血小板减少发生率为1%-4%。 2.心血管系统曾报道有心律失常、心肌缺血、心功能异常。 3.中枢神经系统可有眩晕、失眠。报道有1例患者出现构音障碍。 4.胃肠道腹泻也是本药剂量限制性毒性，在所有听从腹泻处理措施忠告的患者中有20%发生严重腹泻。出现第一次稀便的中位时间为滴注本药后第5日。常见的还有腹部痉挛性疼痛、恶心、呕吐、畏食、粘膜炎，其中3-4级恶心及呕吐的发生率约为20%。有不到10%的患者出现便秘。据报道还可有麻痹性肠梗阻、假膜性结肠炎。 5.泌尿生殖系统有7.3%的患者出现短暂的轻至中度血清肌酸酐升高。偶有患者发生肾衰竭，可能与腹泻引起的肾脏低灌注有关。 6.肝可出现氨基转移酶、碱性磷酸酶、胆红素水平轻至中度短暂升高，其发生率分别为9.2%、8.1%和1.8%(指在无进展性肝转移的患者)。有报道，3-4级氨基转移酶升高仅发生于已有肿瘤肝转移的患者。 7.呼吸系统可有呼吸困难和咳嗽，3-4级呼吸道症状发生率为4%-10%。尚报道有肺炎。 8.皮肤较常见多汗、皮肤潮红、皮肤温暖感，少见皮疹、静脉滴注部位疼痛。脱发的发生率为12%-70%。 9.骨骼肌肉系统"每周治疗方案"者肌无力发生率为76%。接受"每周治疗方案"或"3周治疗方案"的患者3-4级肌无力发生率为12%-15%。还有全身性虚弱和疲乏的报道。 10.胆碱能综合征有9%的患者出现短暂严重的急性胆碱能综合征。主要表现为早发性腹泻以及其它征象，如腹痛、结膜炎、鼻炎、低血压、血管舒张、出汗、寒战、全身不适、头晕、视力障碍、瞳孔缩小、流泪、流涎增多，以上症状多与用药后第一个24小时内发生，使用阿托品治疗后消失。 【给药说明】: 1.本药配伍禁忌尚不清楚，但建议不要与其它药物混合。 2.本药应静脉滴注给药，不能静脉注射。静脉滴注时间一般为30-90分钟。 3.使用本药后24小时内，有可能出现头晕及视力障碍，因此用药后禁止驾车。 4.在配制本药时应戴眼镜、口罩、手套等。如皮肤接触药液，立即用肥皂和清水彻底冲洗。如粘膜接触药液，立即用清水冲洗。 5.所有用于稀释或输液的材料均需按照细胞毒性药物的标准处理程序进行处置。 6.本药溶液首次打开后在室温下可保存12小时，在2-8℃下可保存24小时，但稀释后应立即使用。 7.迟发性腹泻的处理：因腹泻治疗不当可能危及生命，患者用药后，一旦出现第一次稀便，需饮用大量含电解质的液体，并立即给予适当的抗腹泻治疗。当出现以下情况时，患者应住院治疗腹泻： (1)腹泻同时伴有发热。 (2)严重腹泻。 (3)已用大剂量洛哌丁胺治疗，但48小时后仍有腹泻。建议出院患者携带一定数量的抗腹泻药。 8.可用昂丹司琼和苯海拉明预防本药所致的胃肠道反应。为预防或减弱早期腹泻(使用本药后不久即出现的腹泻)和其它胆碱能症状，可在用药前静脉或皮下注射阿托品0.25-1mg。晚期腹泻(迟发性腹泻，通常使用本药24小时后)可给予洛哌丁胺治疗，在首次出现稀便或肠蠕动较正常频繁时给药：首次给予4mg，以后每2小时给予2mg，直至腹泻停止后至少12小时；夜间可每4小时给予4mg。不应预防性使用洛哌丁胺(即使是上一周期已出现过迟发性腹泻者)。 9.使用本药期间，应避免使用具有通便作用的药物，因为可能会加重腹泻。出现严重腹泻的患者，在下一周期用药时应减量。 10.中性粒细胞减少性发热(体温超过38℃，中性粒细胞计数低于1×10☆9☆/L)应立即住院静脉滴注广谱抗生素治疗。只有当中性粒细胞计数高于1.5×10☆9☆/L时，方可恢复本药治疗。 11.当出现急性胆碱能综合征时，如没有禁忌，可使用硫酸阿托品治疗(0.25mg皮下注射)治疗。以后使用本药时，应预防性给予硫酸阿托品。 12.如患者出现了严重中性粒细胞减少或严重胃肠道不良反应，必须推迟使用本药，直到这些症状(尤其是腹泻)完全消失为止。 13.目前尚无关于药物过量的报道。在Ⅰ期研究中，在严密观察下使用剂量曾高达750mg/m☆2☆，最显著的不良反应是严重中性粒细胞减少和腹泻。目前尚无本药的特效解毒剂。 【用法用量】: 成人 ·常规剂量 ·静脉滴注应根据中性粒细胞计数调整剂量。推荐剂量为一次350mg/m☆2☆，每3周1次，持续使用直至病情加重或出现了严重毒性。对于无症状的严重中性粒细胞减少(低于0.5×10☆9☆/L)、中性粒细胞减少伴发热或感染(体温超过38℃、中性粒细胞计数低于或等于1×10☆9☆/L)或严重腹泻(需静脉输液治疗)的患者，下周期治疗剂量应减至300mg/m☆2☆，如仍出现以上不良反应，下一周期剂量可进一步减至250mg/m☆2☆。 [国外用法用量参考] 成人 ·常规剂量 ·静脉滴注 1.胃癌、胰癌、宫颈癌：一次100-150mg/m☆2☆，每1-2周1次。 2.卵巢上皮细胞癌：一次200mg/m☆2☆，每3-4周1次。 3.结肠直肠癌： (1)单药治疗： ①"每周治疗方案"，对氟尿嘧啶治疗失败的患者，推荐本药初始剂量为一周125mg/m☆2☆，静脉滴注90分钟，使用4周后，停2周后可重复疗程，并根据毒性反应调整剂量。 ②"3周治疗方案"，推荐初始剂量为每3周给药350mg/m☆2☆，静脉滴注90分钟。如果用药有效且未出现不可耐受的毒性，可长期坚持治疗。70岁或70岁以上者和(或)曾接受了骨盆或腹部放疗的患者，初始剂量为300mg/m☆2☆。必要时根据毒性反应调整剂量。 (2)联合用药： ①甲酰四氢叶酸/氟尿嘧啶弹丸式注射方案：本药125mg/m☆2☆静脉滴注90分钟，之后立即先后静脉弹丸式注射甲酰四氢叶酸20mg/m☆2☆、氟尿嘧啶500mg/m☆2☆。以上药物均在每个疗程的第1、8、15、22日给予。下一疗程在第7周(第43日)开始。 ②甲酰四氢叶酸/氟尿嘧啶静脉滴注方案：在第1、15、29日给予本药180mg/m☆2☆，静脉滴注90分钟；在第1、2、15、16、29、30日静脉给予甲酰四氢叶酸200mg/m☆2☆，给药时间不应低于2小时；在给予甲酰四氢叶酸后立即静脉快速弹丸式注入氟尿嘧啶400mg/m☆2☆，然后静脉滴注氟尿嘧啶600mg/m☆2☆，滴注时间不应低于22小时。下一疗程在第7周(第43日)开始。 4.非小细胞肺癌：与顺铂联用(80mg/m☆2☆，在每个疗程的第1日给药)，本药初始剂量为30mg/m☆2☆，在第1、8、15日给予，每28日重复1次。以后按10mg/m☆2☆递增(直至出现严重毒性)。最大耐受剂量可达70mg/m☆2☆。 ·肝功能不全时剂量 有肿瘤肝转移但肝功能尚正常的患者不必调整剂量。对肝功能不全者，目前尚无具体推荐剂量。 【贮法】：密封，遮光保存。 【禁忌】: (1)肝肾功能不全者或血胆红素超过正常值上限1.5倍的患者。 (2)有慢性肠炎和(或)肠梗阻的患者。 (3)对本药有严重过敏史者。 (4)严重骨髓抑制者。 (5)WHO行为状态评分(BaselinePerformance)大于2的患者。 (6)孕妇。 (7)哺乳期妇女。 Medication name Generic name: Irinotecan - Injection Pronunciation: (eye-ree-no-TEE-kan) Brand name(s): Camptosar Warning You will be closely monitored (e.g., blood tests) by your doctor while using this medication. Keep all medical and laboratory appointments.Irinotecan may cause severe diarrhea, which can occur during or right after you receive this medication and/or more than 24 hours afterward. If the diarrhea starts immediately, you may also have other side effects such as runny nose, increased saliva, watery eyes, sweating, stomach cramps, or flushing. If the diarrhea starts later, it could be a different type that may be persistent and can cause serious (possibly fatal) loss of too much body water (dehydration), mineral imbalance, or serious infection (sepsis). Tell your doctor immediately if you have diarrhea and/or any of the symptoms that occur with the early form of diarrhea. Also tell your doctor if you have stomach/abdominal pain, extreme thirst, very dry mouth, muscle cramps/weakness, fast/slow/irregular heartbeat, fainting, dizziness, lightheadedness, or signs of infection (e.g., fever, persistent sore throat). Your doctor should prescribe other medications to treat the diarrhea and other symptoms.This medication may cause very serious (possibly fatal) blood disorders (decreased bone marrow function leading to low number of blood cells such as white cells, red cells, and platelets). This effect can decrease your body's ability to fight an infection, cause your body to bruise or bleed easier, or cause anemia. Tell your doctor immediately if you develop any of the following: signs of infection (fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat. Uses This medication is used to treat cancer of the colon and rectum. Other uses This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used to treat other types of cancer (such as lung, bone cancer). How to use This medication is given by injection into a vein as directed by your doctor. The dosage is based on your medical condition, body size, and response to treatment.If you are giving this medication to yourself at home, learn all usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.If this medication comes into contact with your skin, wash the skin immediately and completely with soap and water. If this medication gets into your eyes, mouth, or nose, flush completely with plenty of water. Consult your doctor for more details. Precautions Before using irinotecan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: bowel blockage (e.g., paralytic ileus), certain genetic metabolism disorder (fructose intolerance).Before using this drug, tell your doctor your medical history, including: radiation treatments, blood/bone marrow disorders (e.g., low platelet/neutrophil/red blood cell levels), diabetes, liver disease, kidney disease, lung disease.Before having surgery, tell your doctor or dentist that you are using this medication.This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.To avoid dizziness and lightheadedness when rising from a sitting or lying position, get up slowly.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Wash your hands well to prevent the spread of infections.Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially diarrhea.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. Drug interactions Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: atazanavir, drugs affecting liver enzymes that remove irinotecan from your body (such as rifamycins including rifabutin, certain anti-seizure medicines including carbamazepine/phenytoin/phenobarbital), laxatives, "water pills"/diuretics (e.g., furosemide).Avoid taking St. John's wort within 2 weeks before or during treatment with this medication, and avoid taking ketoconazole within 1 week before or during treatment with this medication.Avoid eating foods or taking products containing tumeric (curcumin) while being treated with irinotecan. It may decrease this medication's effects. Consult your doctor or pharmacist for more details. Side effects See also Warning section.Nausea, vomiting, loss of appetite, constipation, cough, drowsiness, mouth sores, weakness, or trouble sleeping may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, or if you are unable to drink/eat because of nausea/vomiting, tell your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: pain/redness/swelling at the injection site or arms/legs, numbness/tingling/burning of arms/legs, black/bloody stools, change in the amount of urine, lung problems (such as shortness of breath, cough).Get medical help right away if any of these unlikely but serious side effects occur: chest pain, weakness on one side of the body, slurred speech, confusion, trouble breathing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.Irinotecan can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Missed dose For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule. Do not double the dose to catch up. Overdose If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: signs of infection (e.g., persistent sore throat, fever), severe diarrhea. Notes Laboratory and/or medical tests (e.g., complete blood count, hemoglobin, platelets) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Medical alert Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada). Storage Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Photos by medication strength Click the "Photos" link to see sample photographs for a specific medication strength. Common strengths Camptosar 100 mg/5 mL IV Camptosar 300 mg/15 mL IV Camptosar 40 mg/2 mL IV *The photos shown are samples only. Not all photos of the drug may be displayed. Your medication may look different. If you have questions, ask your pharmacist. Important note HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Information last revised May 2012. Copyright(c) 2012 First Databank, Inc. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First DataBank, Inc., 2012. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. ------------------------------------------------------------ 产地国家：美国 所属类别：抗癌药物 ->治疗肠癌药物 原产地英文药品名： IRINOTECAN HCL 中文参考药品译名： 盐酸伊立替康 原产地英文商品名： CAMPTOSAR 300mg/15ml/Vial 中文参考商品译名： 坎普土沙 300毫克/15毫升/瓶 生产厂家英文名： PFIZER INC 生产厂家中文参考译名： 辉瑞制药 该药品相关信息网址1： http://www.drugs.com/camptosar.html 曾用名： 未知 该药品相关信息网址2： http://www.pfizer.com/products/rx/rx_product_camptosar.jsp