喷司他丁, 喷司他丁注射剂NIPENT VIAL 10mg/5ml(pentostatin)

药店国别:

产地国家:美国

处方药:

所属类别: 10毫克/5毫升/瓶

包装规格: 10毫克/5毫升/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:HOSPIRA WORLDWIDE INC

原产地英文商品名:Nipent infusion 10mg/5ml/VIA

原产地英文药品名:PENTOSTATIN

中文参考商品译名:NIPENT注射剂 10毫克/5毫升/瓶

中文参考药品译名:喷司他丁

曾用名:

简介

英文药名: Nipent(Pentostatin for Injection)

中文药名: 喷司他丁冻干粉注射剂

生产厂家:Hospira UK Ltd

药品说明

英文药名: Pentostatin

中文药名: 注射用喷司他丁

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:

本品是从链霉素菌中分离得的抗生素,从结构上是次黄嘌呤增加一个碳成7元环与咪唑骈合。DCF是嘌呤衍生物强力的腺苷脱氨酶(ADA)的抑制剂,是一种较新的抗代谢类药物。急性淋巴细胞白血病与髓细胞性白血病患者的淋巴母细胞和髓母细胞中ADA的活性增高。

本品在体外与ADA有较高的亲和力,并能抑制动物和人慢性髓细胞白血病患者髓细胞中此酶的活性,随着ADA的活性被抑制,细胞的脱氧腺苷三磷酸(dATP)水平增高,dATP通过抑制核糖核苷酸还原酶而阻断DNA的生物合成,抑制细胞繁殖,淋巴样细胞最为敏感。还能抑制RNA合成和增强有对DNA的损伤。

本品且能增强其他受腺苷脱氨酶代谢的抗肿瘤药物的作用,同时本品还具有免疫抑制作用。

体内过程:

静脉注射本品0.25-1mg/kg,约14小时后血药平均浓度为2-6umol/L;本品能通过血脑屏障,静脉注射后2~4小时脑脊液中药物浓度为血药浓度的10%~12%。其血浆消除半衰期为3-9.6小时,静脉注射本品5-30mg/m2后,第1日尿中可回收剂量的50%~82%。

临床应用:

对急性及慢性淋巴细胞白血病、非霍奇金淋巴瘤、皮肤T细胞淋巴瘤及毛细胞白血病有效;对抗干扰素的病人使用本品仍非常有效。

(1)行细胞白血病患者无论有无脾切除或以往是否接受a-干扰素治疗,使用本品后完全缓解率(CR)达33%~92%。几首所有患者经本品治疗2个疗程后,可见外周血细胞计数改善,最明显的改善平均在治疗4个月左右。所有CR的患者平均6年保持稳定,不需再治疗。

(2)对B细胞性慢性淋巴细胞白细胞病地完全缓解率仅为4%,部分缓解率为15%~27%。

(3)对幼淋巴细胞白细胞病的完全缓解率为10%,部分缓解率为58%。

(4)对复发性急性淋巴母细胞白血病儿童患者的完全缓解率可达10%。

(5)对皮肤T细胞淋巴瘤(CTCL)的总缓解率(CR+PR)为17%~40%;对其他非霍奇鑫淋巴瘤的CR为0%~20%,PR为10%~30%。

用法用量:静脉注射:每日5mg/m2,连用3日,每4周重复;或每次4mg/m2,每2周1次。

不良反应:

(1)骨髓抑制:为剂量限制性毒性,主要为白细胞与淋巴细胞减少,16%~25%是严重缺乏。

(2)胃肠道反应:恶心,呕吐(36%~87%)。

(3)肾脏毒性:可出现高尿酸血症。

(4)中枢神经毒性:疲倦、头痛,不适,抑郁,甚至昏睡、昏迷。

(5)其他反应:发生机会20%~58%,结膜炎,肺毒性,肝功能损害,关节痛,肌痛,皮疹,带状疱疹等。

禁忌证:哺乳妇女须慎用。

注意事项:

(1)本品与干扰素无交叉耐药性,但两者同用是否能提高疗效尚无定论。

(2)使用本品期间应定期检查血像,若发生严重毒副作用,则应停药并对症处理。

(3)本品避免与氟达拉滨同用,剂量应在推荐的范围内。

制剂规格:注射剂:10mg/支

贮藏:室温凉暗处保存。

包装供应[注:本品美国产品,采购者在线咨询]

英文版说明

NIPENT 10MG SDV PWD 1/EA PENTOSTATIN 00409-0801-01 Manufacture: "HOSPIRA, INC"NIPENT VIAL 10MG 5ML PENTOSTATIN 00409-0801-01 Manufacture: HOSPIRA WORLDWIDE INCGENERIC 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 been so 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 drugbecause he or she has judged that the benefit to you is greater than the risk of side effects.Careful monitoring by your doctor may decrease 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, andplatelets). 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 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: 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,

用药温馨提示:当您服用此药物时,需定期接受医疗专业人士的检查,以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助,不能代替医学建议和治疗。
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