尼喷提仿制药]注射剂pentostatin 10mg(Nipent generic)

药店国别： 产地国家：美国 处方药：是 所属类别： 10毫克/瓶 包装规格： 10毫克/瓶 计价单位：瓶 生产厂家中文参考译名： 生产厂家英文名：BEDFORD 原产地英文商品名：PENTOSTATIN(NIPENT GENERIC) 10MG/VIAL 原产地英文药品名：PENTOSTATIN 中文参考商品译名：喷司他丁(尼喷提仿制药) 10毫克/瓶 中文参考药品译名：喷司他丁 曾用名： 简介： 部份中文尼喷提仿制药处方资料(仅供参考)英文药名: PENTOSTATIN(NIPENT GENERIC)中文药名: 喷司他丁(尼喷提仿制药)中文别名：脱氧肋间型霉素，脱氧考福霉素，2-脱氧咖啡霉素，喷妥司汀外文名：Pentostatin,Nipent,Deoxyco-formycin,2-Deoxycoformycin.外文缩写：2’-dcF,DCF。 药理作用 喷司他丁是拟嘌呤类的抗代谢药，其抗肿瘤作用是通过抑制体内的腺苷脱氨酶(ADA)来实现的。ADA催化细胞内的腺苷和脱氧腺苷进行不可逆的脱氨基，从而控制细胞内的腺苷水平。喷司他丁抑制了ADA的活性，结果使细胞内脱氧腺苷和5′-三磷酸脱氧腺苷(dATP)大量积累，而dATP的积累将最终导致细胞的死亡，这一过程可能与DNA或RNA的合成受到抑制有关。据报道，单一剂量的喷司他丁对ADA具有1周以上的抑制作用。 药代动力学 特性静脉注射后，喷司他丁迅速分布于机体组织，平均稳态分布容积为20.1L.m-2，分布相(α相)大约为30～85min。喷司他丁主要由肾脏排泄，24h内约有50%～96%的药物以原型由尿中排出。原型药物的终末相半衰期为3～15h，静注喷司他丁250μg.kg-1，连续4～5d后，血浆浓度范围为12～36nmol.L-1。临床用途干细胞白血病(hairycell leukemia，HCL)　这是FDA指定的适应症。HCL是一种不常见的慢性淋巴组织增生症，多见于40～60岁的男性，曾用α干扰素或脾切除术予以治疗。喷司他丁对HCL有良好的疗效，其中完全有效率为60%，部分有效率为84%～90%。同时喷司他丁还成功地应用于那些α干扰素非应答的患者，补救率为74%～86%[3]。慢性淋巴细胞白血病(chromic lymphocyticleukemia，CLL)　尽管喷司他丁对CLL有一定的疗效，但一般被用作二线药物，主要用于复发的Ⅲ，Ⅳ期的CLL患者[2]。蕈样霉菌病(mycosis fungoides)　一项二期临床实验表明，喷司他丁合用α2a干扰素对重度顽固蕈样霉菌病/红皮病有效。全部41名患者第1～3天静注喷司他丁4mg.m-2.d-1，同时肌注干扰素1×107u.m-2连续22d，第23～26天肌注干扰素5×107u.m-2，结果总有效率为41%。 用法与用量 喷司他丁可以用0.9%氯化钠注射液或5%葡萄糖注射液配制，溶液浓度应≥0.05mg.ml-1，最大为2mg.ml-1。建议HCL患者用量为4mg.m-2，隔周1次。肾衰患者的剂量应根据肌酐清除率调整，如出现严重的皮疹、感染、神经中毒的迹象应减少剂量或停药。静注喷司他丁之前，建议先给予患者5%的葡萄糖溶液500～1000ml进行水化。化疗之后，再给予患者5%的葡萄糖溶液或等量其它液体500ml。 不良反应 像其它一些抗肿瘤药物一样喷司他丁有许多不良反应，对血液、心血管、中枢神经系统、泌尿生殖系统等有着不良的影响。可引起骨髓抑制、心率失常、恶心、呕吐、腹泻、肝功能异常以及角结膜炎、皮疹等不良反应。剂量大于4mg.m-2时，还可能会出现嗜睡、昏迷、癫痫发作、血尿、BUN升高、血肌酐升高等症，甚至出现急性肾功能衰竭。 药物相互作用 喷司他丁与其它抗肿瘤药物联合应用时可能会产生严重的毒副作用。与两性霉素B联用可产生肾毒性、低血压、支气管痉挛，与环磷酰胺合用产生心脏毒性，而与氟达拉滨合用可能会产生肺毒性。当喷司他丁与阿糖腺苷联用时将同时增强两药的不良反应。 规格与贮存 本品为注射用粉针，每安瓿含喷司他丁10mg，供静脉注射，其中主要非活性成分是甘露醇。本品应贮存于2℃～8℃，由于不含防腐剂，本品一经配制后应于8h内用完 英文版说明书 GENERIC NAME: PENTOSTATIN - INJECTION (pen-toh-STAT-in)BRAND NAME(S): NipentUSES: Pentostatin is used to treat a certain type of cancer (hairy cell leukemia). It works by slowing or stopping the growth of cancer cells.OTHER 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 beenso prescribed by your health care professional.This drug may also be used to treat other types of cancer (e.g., chronic lymphocytic leukemia).HOW TO USE: This medication is given by injection into a vein by a health care professional, usually every other week or as directed by your doctor.Dosage is based on your medical condition, body size, and response to treatment.To help reduce side effects to the kidneys, your doctor may prescribe IV fluids before and after you receive pentostatin.SIDE EFFECTS: Mild rash/itching may occur. Tell your doctor or pharmacist promptly if any of these effects occur. Nausea, vomiting, diarrhea, loss of appetite, increased sweating, or mouth sores may also occur.If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor maydecrease your risk.Tell your doctor right away if you have any serious side effects, including: change in the amount of urine, dark urine, yellowing eyes/skin, severe stomach/abdominal pain, dizziness, drowsiness, headache, trouble sleeping, shortness of breath, cough, unusual weakness/tiredness, swelling ankles/feet, muscle/joint pain, muscle spasm, mental/mood changes (e.g., depression, anxiety), numbness/tingling of the skin, decreased sexual ability/interest, fainting, fast/slow/irregular heartbeat, vision/hearing changes, pain/redness/swelling of arms or legs.Get medical help right away if any of these rare but very serious side effects occur: seizures, chest pain.This medication may cause very serious blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause your body to bruise or bleed more easily.Tell your doctor immediately if you develop any of the following symptoms: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, unusual tiredness, fast/pounding heartbeat.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.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.PRECAUTIONS: Before using pentostatin, 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.Before using this medication, tell your doctor orpharmacist your medical history, especially of: kidney disease, liver disease, recent/current infections, blood/bone marrow disorder.Before having surgery, tell your doctor or dentist that you are using this medication.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 inhaledthrough the nose.Wash your hands well to prevent the spread of infections.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.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 allthe 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: allopurinol, carmustine, cyclophosphamide, drugs that may decrease bone marrow function (e.g., azathioprine), drugs that may weaken the immune system (e.g., cyclosporine), etoposide, fludarabine, vidarabine.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: trouble breathing, seizures, fainting, change in the amount of urine, severe stomach/abdominal pain.NOTES: Laboratory and/or medical tests (e.g., blood count, kidney/liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.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 immediately to establish a new dosing schedule.STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.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).