英文药名: Leukine (Sargramostim Injection Vials).   中文药名: 莫拉司亭注射剂,   生产商：美国先灵葆雅药厂 药品介词 中文别名：  沙格司亭、粒细胞-巨嗜细胞集落刺激因子、人粒细胞巨噬细胞集落刺激因子、重组人粒细胞巨嗜细胞集落刺激因子 英文别名：Gm-Csf、Granulocyte Macrophage Colony Stim、Granulocyte-Macrophage Colony Stimu、Levcomax、Recombinat Human Granulocyte-Macrop、Rhgm-Csf    药品类别：  其它调节免疫功能药 【药理药动】 本品是应用基因重组工程技术制成的蛋白质无菌粉剂。能刺激粒细胞及巨噬细胞等白细胞的增殖、分化及活化作用，从而增强造血功能，并能增强中粒白细胞、嗜酸粒细胞及单核细胞的多种功能，还可提高效应细胞的吞噬细菌及消灭癌细胞等免疫活动的能力。 【药动学】 皮下注射本品，在3～4h血药浓度达峰值。血药浓度峰值和曲线下面积随剂量的增大而增高。静注本品的清除半减期为1～2h，皮下注射则为2～3h。给药后在体内广泛分布，很快被代谢排泄，主要从尿中排出。 【适 应 症】 本品适用于癌症化疗和在用骨髓抑制疗法时所引起的白细胞减少症，亦适用于治疗骨髓衰竭患者的白细胞低下，也可预防白细胞减少时可能潜在的感染并发症，还能使感染引起的中性粒细胞减少的恢复加快。 【用法用量】 本品为无菌冻干粉剂，用稀释液溶解后，静注或皮下注射。剂量视具体病情而定，应调节剂量使白细胞计数维持在所期望的水平，通常为低于10×109/L。对骨髓增生异常综合征、再生障碍性贫血伴白细胞减少，使用剂量为3μg/kg，皮下注射，每日1次。癌症化疗所引起的白细胞减少症为5～10μg/kg，皮下注射，每日1次，在化疗停止1日后方可使用，持续7～10日。骨髓移植：每日5～10μg/kg，静滴4～6h，每日1次。艾滋病：1μg/kg，皮下注射，每日1次。 本品应避光贮于2～8℃，可稳定保存24个月；如用无菌溶媒溶解后，置于冰箱内(2～8℃)，可保存1周。 [剂型与规格]冻干粉针剂：150μg(1.67×106u)／瓶，300μg(3.33×106u)／瓶，700μg(7.77×106u)／瓶。 【用法】 静滴，推荐剂量为每日 250μg／平方米，连续给药 21日，在自体骨髓移植后 2—4小时即可给药，约 2小时滴完。亦可每日静滴 5—10μg／kg，在 4—6小时内滴完。 皮下注射， ①骨髓增生异常综合征、再生障碍性贫血：每日 3μg/kg，一般 2—4日白细胞开始升高，以后调节剂量，使白细胞升至所希望水平； ②肿瘤化疗：每日 5—10μg／kg，在化疗停止 1日后用本品，持续 7—10日，停药后至少间隔 48小时，方可进行下一疗程的化疗； ③艾滋病：单独用药时，每日 1μg/kg。与叠氮脱氧胸苷(AZT)或 AZT/α-干扰素合用时，每日 3—5μg／kg。与更昔洛韦合用时，每日 3—5μg／kg，一般2—4日后开始白细胞增多。 【不良反应】 常见的不良反应是发热、皮疹。较少见的反应依次为低血压、恶心、水肿、胸痛、骨痛和腹泻。罕见的反应有变态反应、支气管痉挛、心力衰竭、室上性心律失常、脑血管疾病、精神错乱、惊厥、呼吸困难、肺水肿和晕厥等。偶见血清白蛋白水平降低。 【禁忌症】 禁用于对本品有过敏史的患者和自身免疫性血小板减少性紫癜的患者。 孕妇不宜使用，哺乳妇女使用本品前应停止哺乳。 孕妇、哺乳妇、未成年人及恶性骨髓肿瘤病人慎用。骨髓及外周血中存在过多白血病的未成熟细胞(≥10％)者禁用，对本品中任何成分过敏或自身免疫性血小板减少性紫癜者忌用。 【药物相互作用】 本品不能与肿瘤化疗药同时使用，以免发生药物相互作用。 【贮藏】于 2—8℃避光保存。 【制剂】注射用冻干粉：每支 50μg； 100μg；150μg； 250μg；300μg；400μg；700μg。用无菌溶媒溶解后，于 2—8℃可保存 1周。静注稀释液于 2—8℃可保存 24小时。用溶媒溶解后可冻存 28日，冻融 2次。 【生产商】美国先灵葆雅药厂 Drug Overview Leukine belongs to the family of drugs known as an antineutropenic drug which is also known as hematopoietic stimulant group of medicines and commonly used for the treatment of those people who suffered to the problems of neutropenia. Neutropenia is a condition which is also known as low count of white blood cell. Leukine is used in cancer patients with non-Hodgkins lymphoma, acute lymphoblastic leukemia and Hodgkins lymphoma who have received a bone marrow transplant to rapidly increase the white blood cell count. It also is used to manage patients with acute myelogenous leukemia over the age of 55 years who develop neutropenia because of chemotherapy. Leukine is used in failure or delay of myeloid engraftment after hemapoietic stem cell transplantation or Myelodysplastic syndromes. Leukine always takes under doctor’s guidance. Do not take more of it and do not take it for a longer time than your doctor ordered. The recommended doses of Leukine will be depends on type of disease or different for different patients, according to the requirements of each patient; you continue to take it for as long as your doctor prescribes, even if you do not feel an immediate benefit. Your doctor will start you on a low dose of Leukine and gradually increase your dose. If you can not tolerate the recommended dosage, your doctor can prescribe a dose that sufficient for you. The generic name of Leukine is Sargramostim. Leukine is being manufactured by Berlex Laboratories and available as a powder or liquid in vials containing 250 or 500 micrograms of drug. Leukine may also be used for relieve other conditions that determined by your doctor or consultant. Effects - How it works in the body Leukine belongs to the family of drugs known as an antineutropenic drug which is also known as hematopoietic stimulant group of medicines and commonly used for the treatment of those people who suffered to the problems of neutropenia. Neutropenia is a condition which is also known as low count of white blood cells. Leukine contains active ingredient of sargramostim. Sargramostim are synthetic form of substances naturally produced in your body. These substances, also known as colony stimulating factors, help the bone marrow to make new white blood cells. When certain cancer medicines fight cancer cells, they also affect those white blood cells that fight infection. To help prevent infections when these cancer medicines are used, colony stimulating factors may be given. Colony stimulating factors also may be used to help the bone marrow recover after bone marrow transplantation and stem cell transplantation. Side effects Possible side effects during the uses of Leukine: Allergic reaction Headache Pain in arms or legs Pain in joints or muscles Pain in lower back or pelvis Skin rash or itching Dizziness or faintness Flushing of face Fever Redness or pain at the site of subcutaneous injection Shortness of breath Swelling of feet or lower legs Chest pain Rapid or irregular heartbeat Sores on skin Wheezing Weight gain Unusual tiredness or weakness Yellowing of the eyes or skin Interactions Although certain medicines should not be used together at all, so its your responsibilities that tell your doctor or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also you tell your doctor or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or addicted to illegal drugs. These may affect the working mechanism of Leukine. In these cases, your doctor may change the dose or teach precautions may be necessary. Therefore when you are taking Leukine, it is most important that your doctor or health care professional know if you are taking any of the following or other drugs: Medicines that used for cancer chemotherapy Counterindications You shouldn’t use this medicine without consultation of doctor if you have an allergy to Leukine or any other ingredients of this medicine. You shouldn’t use Leukine without consultation of doctor if you are suffering to the problem of heart failure or heart disease. You shouldn’t use Leukine without consultation of doctor if you are suffering to the problem of liver disease. You shouldn’t use Leukine without consultation of doctor if you are suffering to the kidney disease. You shouldn’t use Leukine without consultation of doctor if you are suffering to the problems of lung disease. You shouldn’t use Leukine without consultation of doctor if you are suffering to the problems of myeloid (bone marrow) cancer. You shouldn’t use Leukine without consultation of doctor if you are suffering to the problems of Sickle cell disease. You shouldn’t use Leukine without consultation of doctor if you are pregnant or plan to be pregnant. You shouldn’t use Leukine without consultation of doctor if you are suffering to breastfeeding. Similar drugs of Leukine Sargramostim Prokine Neupogen Filgrastim G-CSF (Granulocyte colony stimulating factor) GM-CSF (Granulocyte-macrophage colony stimulating factor) Major drug Manufacturers Berlex Laboratories, Inc., Richmond Merck and Company Alpharma Schering AG Germany Hoffman-LaRoche, Inc. Immunex Corporation Bristol Myers Squibb Amgen Pharmaceuticals