替莫唑胺胶囊(Temodar Capsules 5mg)

产地国家拿加大

处方药

所属类别 5毫克/胶囊 5胶囊/盒

包装规格 5毫克/胶囊 5胶囊/盒

计价单位

生产厂家英文名Schering

原产地英文商品名Temodal CAPSULE 5mg/cap 5caps/box

原产地英文药品名Temozolomide

中文参考商品译名TEMODAL胶囊剂 5毫克/胶囊 5胶囊/盒

中文参考药品译名替莫唑胺

简介

部分中文替莫唑胺处方资料(仅供参考)

中文药名: 替莫唑胺胶囊TEMODAR这个药通常也叫: Temodal

加拿大成份: 替莫唑胺

药品介绍

泰道是先灵葆雅公司刚刚上市的治疗脑癌的新型药物。德国先灵葆雅制药公司脑胶质瘤最新产品迅速通过血脑屏障20分钟达到血药峰浓度影响DNA复制和修复,发挥细胞毒作用起效快,中位生存期长,有效降低复发率口服方便,疗效好,不良反应轻、依从性高药理作用替莫唑胺为咪唑并四嗪类具有抗肿瘤活性的烷化剂。在体循环生理pH状态下,迅速转化为活性产物MTIC(3-甲基-(三嗪-1-)咪唑-4-甲酰胺)。MTIC的细胞毒作用主要表现为DNA分子上鸟嘌呤第6位氧原子上的烷基化以及第7位氮原子的烷基化。通过甲基化加成物的错配修复,发挥细胞毒作用。

药代动力学:临床前数据提示本品能迅速通过血脑屏障,进入脑脊液。成年患者口服本品后,被迅速吸收,最早在服药后20分钟就可达到血药峰浓度(平均时间为0.5-1.5小时)。血浆清除率、分布容积和半衰期都与剂量无关。本品的蛋白结合率低 (10-20%),因此估计不会与蛋白结合率高的药物发生相互作用。口服14C-本品后7天内粪便内排泄的14C为0.8%,表明药物是完全吸收的。口服后,24小时尿内的原形药占剂量的5%-10%左右,其余是以AIC(4-氨基-5-咪唑-盐酸羧酰胺)形式或其他极性代谢物排泄到尿中。本品药代动力学的群体分析表明本品血浆清除率与年龄、肾功能或吸烟无关。儿科患者的AUC比成人患者高,但是儿童和成人每周期的最大耐受剂量(MTD) 都是1000mg/m2。

适应症:本品用于治疗:新诊断的多形性胶质母细胞瘤,开始先与放疗联合治疗,随后作为辅助治疗 ;常规治疗后复发或进展的多形性胶质母细胞瘤或间变性星形细胞瘤。

用法用量:新诊断的多形性胶质母细胞瘤的成人患者:同步放化疗期口服本品,75mg/m2/日,共42天,同时接受放疗。随后接受6个周期的本品辅助治疗。根据患者耐受程度可暂停用药,但无需降低剂量。辅助治疗期同步放化疗期结束后4周,进行6个周期的本品单药辅助治疗。

起始剂量 :150mg/m2/日,共5天,然后停药23天。一周期为28天。从第2周期开始,根据前1周期不良反应,剂量可增至200mg/m2/日,或减至100mg/m2。常规治疗后复发或进展的多形性胶质母细胞瘤或间变性星形细胞瘤患者:成人患者以前曾接受过化疗者的起始剂量是150mg/m2/日,共5天。 成人没有接受过其他化疗者的起始剂量为200mg/m2/日,均连用5天,28天为一个周期。治疗可继续到病变出现进展,最多为2年。儿童患者在以前接受过化疗3岁或以上的患儿,每28天周期中本品口服起始剂量是 150mg/m2/日,共5天。如果没有出现毒性,下个周期的剂量增至200 mg/m2/日.治疗可继续到病变出现进展,最多为2年。全部患者应空腹(进餐前至少一小时)服用本品。服用本品前后可使用止吐药。如果服药后出现呕吐,当天不能服用第2剂。不能打开或咀嚼本品,应用一杯水整粒吞服。如果胶囊有破损,应避免皮肤或粘膜与胶囊内粉状内容物接触。FDA妊娠分级D级: 有明确证据显示,药物对人类胎儿有危害性,但尽管如此,孕妇用药后绝对有益(例如用该药物来挽救孕妇的生命,或治疗用其他较安全的药物无效的严重疾病)。

禁忌:对本药或达卡巴嗪过敏、妊娠期、严重骨髓抑制的患者禁用。

注意事项:对于接受42-49天合并治疗者需要预防卡氏肺囊虫性肺炎发生。男性患者在治疗过程及治疗结束后6个月之内应避孕,在接受该治疗之前应冰冻保存精子。严重肝功能异常或肾功能异常者慎用。本药不应用于哺乳期妇女。目前尚无3岁以下多形性胶质母细胞瘤患儿使用该药的临床经验。孕妇及哺乳期妇女用药对妊娠期妇女使用该药尚未进行研究。在用大鼠和兔所进行的临床前研究中,给药150mg/m2曾有致畸和/或胎儿毒性的报道。因此替莫唑胺不应常规用于妊娠期妇女,如果妊娠期内必须使用该药,应将可能对胎儿造成的潜在风险告知病人。对于可能怀孕的妇女,应劝阻其在接受替莫唑胺治疗或在终止替莫唑胺治疗后6个月内怀孕。替莫唑胺是否可经母乳分泌尚不可知,因此替莫唑胺胶囊不应用于哺乳期妇女。儿童用药尚无3岁以下多形性胶质母细胞瘤患儿使用该药的临床经验 ;对于3岁以上胶质瘤儿童患者,使用该药的临床经验有限。老年患者用药与年轻患者相比,老年患者(>70岁)中性粒细胞减少及血小板减少的可能性较大。

不良反应:轻中度胃肠道功能紊乱,具有自限性,或标准止吐药易于控制。骨髓抑制(一般在开始几个周期的第21-28天),通常在1-2周内迅速恢复。其他不良反应包括 :口腔念珠菌病、感染,血象异常,体重降低,焦虑、抑郁、情绪不稳定、失眠、头痛、惊厥、头晕等神经系统症状,视力障碍,听力损害、耳鸣,下肢浮肿、出血、深静脉血栓形成,咳嗽、呼吸困难,脱发、皮肤干燥,肌无力,尿失禁,疲乏、发热、疼痛、过敏反应、放射损伤、味觉异常,SGPT升高。

药物相互作用:同时服用丙戊酸,替莫唑胺清除率轻度降低。与其他可导致骨髓抑制的的药物联合应用时,骨髓抑制可能加重。药物过量在患者中已进行了剂量为500,750,1000和1250 mg/m2 (每治疗周期服药5天的总剂量)的临床评价。剂量限制性毒性为血液学毒性,在任一剂量下均有报道,但在较高剂量时较为严重。1患者5天中每天过量服用2000 mg,所报道的不良事件为全血细胞减少症、发热、多器官衰竭及死亡。在服药超过5天(最长达64天)的患者中所发生的不良事件包括骨髓抑制(伴随或不伴随感染),某些严重且持久的病例最终死亡。在药物过量事件中,应进行血液学评价。必要时应采取支持性措施。

英文版说明书

TEMODAR(temozolomide) CapsulesTEMODAR(temozolomide) for Injection Administered via Intravenous Infusion What is Temodar?Temodar (temozolomide) interferes with the development of cancer cells, slowing their growth and spread in the body.Temodar is used together with radiation therapy to treat certain types of brain tumor in adults.It works by stopping cancer cells from growing and reproducing.Temodar is sometimes given after other cancer medications have been tried without successful treatment of the tumor. Important information about TemodarDo not Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome). Before taking Temodar, tell your doctor if you have liver or kidney disease.Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby.Use an effective form of birth control, and tell your doctor if you become pregnantduring treatment.Do not open the Temodar capsule, or use a capsule that has been accidentally broken. The powder inside the capsule can be dangerous if you accidentally inhale it or if it gets in your eyes, mouth, or nose, or on your skin.If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of it. Rinse off any medicine that gets on your skin or in your eyes, nose, or mouth.Temodar is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends.There may be periods of time when you will take Temodar for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor’s instructions carefully.Your doctor may occasionally change your dose to make sure you get the best results from this medication.The size, color, and number of Temodar capsules you take may be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact your doctor or pharmacist if you have any questions.Taking Temodar may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk. Before taking TemodarYou should not take Temodar if you are allergic to temozolomide or to another cancer medication called dacarbazine (DTIC-Dome).If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:liver disease; orkidney disease.FDA pregnancy category D. Temodar can cause harm to an unborn baby.Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.It is not known whether temozolomide passes into breast milk or if it could harm a nursing baby.Do not use Temodar without telling your doctor if you are breast-feeding a baby.Taking Temodar may increase your risk of developing certain types of bone marrow cancer. Talk with your doctor about your individual risk.Women and older adults may be more likely to have bone marrow suppression (a weakened immune system) while taking Temodar. This can lead to an increased risk of infection or illness. How should I take Temodar?Take Temodar exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take Temodar on an empty stomach, at least 1 hour before or 2 hours after a meal. Swallow the capsule whole, with a full glass of water.If you vomit shortly after taking Temodar, do not take another capsule until it is time for your next regularly scheduled dose.Do not open the Temodar capsule, or use a capsule that has been accidentally broken. The powder inside the capsule can be dangerous if you accidentally inhale it or if it gets in your eyes, mouth, or nose, or on your skin.If you must handle a broken capsule, ask your doctor or pharmacist how to safely handle and dispose of it.Rinse off any medicine that gets on your skin or in your eyes, nose, or mouth.You may be given other medications to prevent infection while you are taking Temodar. Use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.Temodar can lower blood cells that help your body fight infections.This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.Temodar is often given together with radiation treatment, and then continued for several weeks or months after radiation treatment ends.There may be periods of time when you will take Temodar for only a few days in a row and then wait another 2 to 4 weeks before you start a new treatment cycle and take it again. Follow your doctor’s instructions carefully.Your doctor may occasionally change your dose to make sure you get the best results from this medication. The size, color, and number of Temodar capsules you take may be different from time to time as your doctor adjusts your dose. Be sure you know the correct number of capsules to take and on which days to take them. Contact yourdoctor or pharmacist if you have any questions.Store Temodar at room temperature away from moisture and heat. What happens if I miss a dose?Contact your doctor if you miss a dose or forget to take your medicine dose. What happens if I overdose?Seek emergency medical attention if you think you have used too much of this medicine.Taking Temodar for more than 5 days in a row can cause life-threatening overdose.Overdose symptoms may include fever, pale skin, increased thirst, dry skin, easy bruising or bleeding, confusion, weakness, and urinating less than usual or not at all. What should I avoid while taking Temodar?Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection. Temodar side effectsGet emergency medical help if you have any of these signs of an allergic reaction to Temodar: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:seizure (convulsions);numbness or tingling on one side of your body;signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, unusual weakness;dry cough, feeling short of breath, weight loss, night sweats;pain or burning when you urinate; orwhite patches or sores inside your mouth or on your lips.Less serious Temodar side effects may include:hair loss;tired feeling;diarrhea, constipation;mild skin rash;dizziness, blurred vision;sleep problems (insomnia); orunusual or unpleasant taste in your mouth.This is not a complete list of side effects and others may occur.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.  What other drugs will affect Temodar?Before taking Temodar, tell your doctor if you are using any of the following drugs:carbamazepine (Carbatrol, Tegretol);divalproex sodium (Depakote);phenytoin (Dilantin);valproic acid (Depakene, Depacon);steroids (prednisone and others); ora sulfa drug such as Bactrim, Septra, Cotrim, or SMX-TMP.This list is not complete and there may be other drugs that can interact with Temodar.Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.Do not start using a new medication without telling your doctor. Where can I get more information?Your pharmacist can provide more information about Temodar.Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drugor drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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