简介：

【药品名称】
商品名：卫萌
药物别名： 替尼泊甙，足叶噻吩甙，鬼臼甲叉甙，替尼泊苷,VM-26.
英文名： Teniposide或Vumon
英文缩写： VM-26或EPT或PGT或NSC-122891
【成分】
替尼泊苷 Teniposide
【药物分类】
抗肿瘤药
【制造商】
百时美施贵宝
【性状】
本药为中性亲脂性物质，几乎不溶于水，而溶于有机溶媒。本药含下列成分 ：N,N二甲基乙酰胺300 mg，苯甲醇150mg，聚氧乙基蓖麻油2.5 g，无水乙醇42.7%，并用马来酸调节pH值在5左右。
【药理作用】
本药为鬼臼毒素的半合成衍生物，是周期特异性细胞毒药物，作用于细胞周期S2后期和G2期，通过阻止细胞的有丝分裂而起作用。本药也可引起DNA键的单股性和双股性断裂，其作用机理可能是抑制II型拓扑异构酶所致。
【药代动力学】
在一定的剂量范围内，本药的药代动力学参数呈线性，每日注射1次，连续用3日后，药物在体内不发生蓄积。成人和儿童对本药的代谢没有显著差异。静脉输注后，药物从中央室I相清除，即分布相半衰期约为1小时。本药在体内的高蛋白结合率(>99%)可能限制其在体内的分布。本药在脑脊液的浓度低于同时测定的血浆药物浓度。经肾脏的清除率仅占总清除率的10%左右。本药的清除半衰期为6-20小时。
【毒理研究】
本药与其它抗肿瘤药物合用，可引起急性非淋巴细胞性白血病。用药时应考虑到本药对人类是一个潜在的致癌因素。在各种细菌和哺乳动物遗传毒性实验中也发现本药的诱变性。动物实验已证实本药可以引起鼠细胞系的基因变异和人类细胞的DNA损伤。此外，在几种人类和鼠组织培养物中已证实发生了染色体畸变。动物实验也显示本药可减少猴和狗的精子生成，降低狗的睾丸和卵巢的重量。
【适应症】
本药通常与其它抗癌药物联合使用治疗 ：恶性淋巴瘤 ；何杰金氏病 ；急性或淋巴细胞性白血病之高危病例；颅内恶性肿瘤如胶质母细胞癌、空管膜瘤、星型细胞瘤、膀胱癌 ；神经母细胞瘤 ；儿童的其它实体瘤。
【用法用量】
单药治疗 每个疗程总剂量为300 mg/m2，在3-5日内给予，每3周或待骨髓象恢复后可重复下一个疗程。
联合治疗
与其它骨髓抑制药联合应用时，应适当降低本药的剂量，并应定期监测外周血象计数，必要时定期进行骨髓检查。唐氏综合征的病人对骨髓抑制性化学疗法的反应特别敏感，因此，对这些病人应考虑减少用量。
【不良反应】
血液学反应：本药治疗7-14日后可发生白细胞及血小板减少，通常2-3周内骨髓抑制可完全恢复。白细胞减少常较血小板减少常见且更严重。也可见贫血和免疫性溶血性贫血。
胃肠道反应：恶心、呕吐是主要的胃肠道毒性反应，但通常用止吐药物可以控制这些症状。也可见口炎、粘膜炎、厌食、腹泻、腹痛和肝功能异常。
秃发的发生率很高，特别见于多疗程的患者。
快速输注本药后可以发生暂时性低血压，已有报道显示病人可能由于心率失常和低血压而致突然死亡。
过敏反应：主要表现为寒战、发热、心动过速、支气管痉挛、呼吸困难以及低血压。这些反应可在第1次用药时就发生，更常见于脑肿瘤或神经细胞瘤的病人。出现这一反应的危险性可能与重复给药及药物在体内的蓄积有关。此外，潮红、出汗、荨麻疹、高血压及水肿等反应也有报道。
神经病变 ：硫酸长春新碱和本药相互作用而导致病人出现严重的神经病变，使用高于推荐剂量的本药也可引起中枢神经系统抑制。
其它不良反应有感染、肾功能不全、高血压、头痛、精神混乱和肌无力等。
【禁忌症】
对本药任一成分过敏者、严重白细胞减少或血小板减少者。
【警告】
本药可能导致严重的骨髓抑制、感染或出血。如发现骨髓受抑制应停止使用。曾有报道显示，初次使用或重复使用本药后偶见致死的严重过敏反应。
【注意事项】
有肝肾功能损害或肿瘤已侵犯骨髓的病人慎用。使用本药时，应定期监测白细胞和血小板计数。如白细胞计数低于2000/mm3或血小板低于75000/mm3，且并非由肿瘤本身所引起，应推迟使用，直至骨髓完全恢复正常。在开始输注本药之前，应特别注意留置导管处于正确的位置，以保证药物进入静脉，以免引起组织坏死和血栓性静脉炎。曾有报道显示输注本药时可出现低血压，所以在开始用药后30-60分钟内应注意监测，以免发生严重的副作用。
【孕妇及哺乳期妇女用药】
孕妇使用本药可对胎儿造成损害。在动物实验中，给予妊娠大鼠本药后可出现胚胎毒性和致畸性。本药是否从人乳中排泄尚不明了，故应慎用于妊娠及哺乳妇女。
【儿童用药】
本品含有苯甲醇。曾报道，当使用含大量苯甲醇冲洗液洗低体重早产儿时，发生以喘息性呼吸、核黄疸症、代谢性酸中毒、神经退行性变、血液异常为特征表现的综合征，并可能引起死亡。
【药物相互作用】
苯巴比妥和苯妥英等对肝代谢起诱导作用的药物可增加本药的清除，导致药物在体内的作用时间缩短。因此，接受这类抗惊厥药治疗的病人应增加本药的用量。甲苯磺丁脲、水杨酸钠和磺胺甲噻二唑在体外可以置换与血浆蛋白结合的鬼臼噻吩甙。由于本药的蛋白结合率极高，少量降低与蛋白结合的药物即可导致游离药物的显著增高，进而增强药物的毒性。
【药物过量】
症状 过量用药和先前用过止吐药的病人可发生急性中枢神经抑制和低血压。治疗 尚未发现有效的解毒药，应给予对症支持治疗。
【用药须知】
为了避免本药从聚氯乙烯容器中抽提出塑化剂DEHP，应使用不含DEHP的大容量灭菌容器，如玻璃或聚烯烃容器制备本药的溶液。同样，给病人输注药液时亦应使用不含DEHP的器具。使用本药前可将一安瓿用50、125、250或500mL的5%葡萄糖或0.9%的氯化钠注射液稀释，然后将已稀释的溶液进行静脉输注，输注时间不少于30分钟。为减少发生低血压的可能性，本药不应静脉推注或快速静脉输注。浓度为1mg/mL的溶液，贮存于室温或普通日光灯下时的稳定性较差，因此需在制备后4小时以内使用以减少沉淀发生的可能性。同样，通过各种输液器具长时间输注本药时，也可发生沉淀反应。因此，在给病人输液时，需检查药液及整个输液系统。肝素溶液可引起本药产生沉淀，因此在给病人输液之前或之后，必须用5%葡萄糖或0.9%氯化钠注射液彻底冲洗注射针/管等用具。配制时应轻轻搅动溶液，剧烈搅动可引起沉淀。本药不应与其它药物混合使用。如药液溅上皮肤粘膜，应立即用肥皂和清水彻底清洗。

GENERIC NAME: TENIPOSIDE - INJECTION (ten-IP-oh-side)
BRAND NAME(S): Vumon
WARNING: This medication may cause certain severe blood and bone marrow problems (low red blood cells/white blood cells/platelets). This can affect your body's ability to stop bleeding or fight infection.
Tell your doctor immediately if you develop easy bleeding/bruising or signs of infection (e.g., fever, chills, persistent sore throat).
This medication can also cause a serious allergic reaction.
Your health care professional will monitor you closely during treatment for any signs of a reaction. (See also Side Effects section)USES: This medication is used with other anti-cancer drugs to treat leukemia and certain cancers. Teniposide works by slowing or stopping the growth of cancer cells.
HOW TO USE: Follow all instructions for proper mixing with the correct IV fluids. Before using, check the product visually for particles or discoloration.
If either is present, do not use the liquid. Particles may form while the drug is being given, especially if it is given over many hours. Read the product labeling to learn how to prevent particles from forming/entering the blood.
This medication is given by slow injection into a vein by a health care professional over at least 30 to 60 minutes, usually once or twice a week or as directed by your doctor.
This medication may cause low blood pressure. Tell your doctor or other health care professional if you feel dizzy. Your injection may need to be stopped or given more slowly.Dosage is based on your medical condition, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next dose. Be sure to keep all medical/lab appointments.If this medication accidentally leaks into surrounding tissue, the skin and/or muscle may be severely damaged.
Tell your doctor immediately if you feel pain or irritation at the
injection site.Wear gloves when handling this medication.
If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the
eyelids and flush with water, then seek immediate medicalattention.
Learn how to store and discard needles, medical supplies, and medical waste safely.
Consult your pharmacist for details.
SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, drowsiness, and pain/redness at the injection site 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, tell your doctor or pharmacist promptly.
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.Many people using this medication may have serious side effects. However, 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. To lower your risk of serious side effects,
your doctor will follow your condition closely and order lab tests.Pain or sores in the mouth and throat may occur.
Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness/fainting, bloody/black/tarry stool, unusual
weakness/tiredness, coughing up blood.Tell your doctor immediately
if any of these rare but very serious side effects occur: severe abdominal pain, slow/shallow breathing, mental/mood changes (e.g., confusion, difficulty staying awake).A very serious allergic reaction to this drug is unlikely. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: fast/irregular heartbeat, flushing of the face, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever/chills.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 teniposide, tell your doctor or pharmacist
if you are allergic to it; or to polyoxyethylated castor oil; or if
you have any other allergies.Tell your doctor your medical history,
especially of: current infections, certain virus illnesses (herpes,
chickenpox), liver problems, kidney problems, blood disorders (e.g.,
anemia, clotting problems), Down syndrome, low blood proteins (hypoalbuminemia).
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.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.Wash your hands well to prevent the spread of infections.
Avoid contact with people who have illnesses that may spread to
others (e.g., flu, chickenpox).To lower your chance of getting cut,
bruised, or injured, use caution with sharp objects like razors and
nail cutters, and avoid activities such as contact sports.
This product contains alcohol. Caution is advised if you have alcohol
dependence or liver disease. Ask your doctor or pharmacist about using this product safely.This drug is not recommended for use during pregnancy. It may harm the unborn baby.
If you become pregnant or think you may be pregnant, tell your doctor immediately.
To avoid pregnancy, both males and females using this drug should
use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS:
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.
Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: live vaccines (e.g., flu vaccine inhaled through the nose, typhoid/polio vaccine taken by mouth).
If you are currently receiving or planning any vaccinations, tell your doctor or pharmacist before starting teniposide.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin, enoxaparin), salicylates/NSAIDs (e.g., aspirin, ibuprofen, naproxen, sodium salicylate), drugs that may interact with alcohol(e.g., disulfiram, metronidazole), tolbutamide, methotrexate, sulfonamide antibiotics (e.g., sulfamethizole).Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs
(e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).Check the labels on all your medicines (e.g., cough-and-cold products) because
they may contain ingredients that cause drowsiness.
Ask your pharmacist about using those products safely.Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that can increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day). Consult your doctor or pharmacist for more details.
This document does not contain all possible interactions. Therefore,
before using this product, tell your doctor or pharmacist of all the
products you use. Keep a list of all your medications with you, and
share the list with your doctor and pharmacist.
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.
NOTES: Laboratory and/or medical tests (e.g., complete blood count,
liver tests, kidney tests) 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 to establish a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not store in the bathroom. After mixing, do not refrigerate. Discard any unused liquid/solution. Do not save for later use. Keep all medicines 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 for more details about how to safely discard your product.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).
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