替莫唑胺胶囊Temodal 5mg Hartkapseln(Temozolomide)

药店国别:

产地国家:德国

处方药:

所属类别: 5毫克/胶囊 20胶囊/瓶

包装规格: 5毫克/胶囊 20胶囊/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:MSD Sharp & Dohme GmbH

原产地英文商品名:Temodal 5mg Hartkapseln in Beuteln, 20ST

原产地英文药品名:Temozolomide

中文参考商品译名:Temodal胶囊 5毫克/胶囊 20胶囊/瓶

中文参考药品译名:替莫唑胺

曾用名

简介:部份中文替莫唑胺处方资料(仅供参考)商品名:Temodal 欧洲® Temodar美国英文名:Temozolomide中文名:替莫唑胺胶囊制造商:MSD Sharp & DohmeGmbH药理类别:抗癌药物孕妇用药分级D级:在对照的人体研究试验中显示该药物对胚胎有不良影响,若此药能带来之效益远超过其它药物的使用,因此即使在其危险性的存在下,仍可接受此物用于怀孕妇女上。结构式4-甲基-N-[3-(4-甲基-1H-咪唑-1-基)-5-(三氟甲基)苯基] -3-[(4-吡啶-3-基嘧啶-2-基)氨基]苯甲酰胺UpToDateUpToDate连结

药理作用

尼洛替尼是BCR-ABL激酶的抑制剂.nilotinib会结合并稳定的Abl蛋白激酶区的无活性购型。在活体外,尼罗替尼可抑制BCR-ABL调控老鼠白血球细胞株与衍生自的Ph+CML患者之人类细胞株的增生。在检测环境下,尼罗替尼能够克服33例BCR-ABL激酶突变导致之抗药性中伊马替尼的32例。活体内,尼罗替尼可减低老鼠的Bcr-Abl的异种移植模式中的肿瘤大小.nilotinib可抑制下述激酶自我磷酸化的IC50值如下:BCR-ABL(20-60nM),血小板衍生生长因子(69nM),的c-Kit(波长210nm),CSF-1R(125-250nM)与DDR(3.7nM)。

适应症

新确诊之慢性期费城染色体阳性的慢性骨髓性白血病。

用法用量

1.建议剂量:每日2次口服300mg。

2.本品不可与食物一起服用,胶囊应整颗和水吞服。服药前至少二小时与服药后至少一小时内皆不得进食。

药动力学

吸收与分布:尼洛替尼在口服后3小时可到达最高血中浓度。代谢与分泌:经每日投药的多剂量药物动力学得知,排除此药的半衰期约为17小时。

副作用

腹痛,头痛,疲倦,皮疹,发热,关节痛,肌肉疼痛,咳嗽。

交互作用

1.尼罗替尼对药物新陈代谢酵素与药物传输系统的影响体外试验显示,尼罗替尼是CYP3A4,CYP2C8,CYP2C9,CYP2D6及UGT1A1的竞争抑制剂,因此可能会增加由这些酵素排除的药物浓度。此外,当健康受尝试服用单剂量Tasigna及咪达唑仑(一种CYP3A4基质)时,可增加30%的咪达唑仑暴露量。因此,当合并使用Tasigna与治疗指数狭窄的CYP3A代谢药品时,应非常谨慎。由于warfarin是经由CYP2C9和CYP3A4代谢,故应尽量避免使用。体外试验亦显示:nilotinib可能会诱发CYP2B6,CYP2C8与CYP2C9,且可能因此可以减低会被这些酵素清除的药物的浓度.nilotinib会抑制人类P-糖蛋白(Pgp)。若使用Tasigna与Pgp的受质药物一起使用,可能会增加此类药物浓度,因此应格外小心。

2.抑制或诱发CYP3A4酵素的药物nilotinib系透过CYP3A4进行代谢,而同时使用强效CYP3A4抑制剂或诱发剂,可能会明显增加或减低nilotinib的浓度。酮康唑:在接受酮康唑(一种CYP3A4抑制剂)每天一剂400毫克,连续6天的健康受试者中,增加约3倍的nilotinib全身暴露量(曲线下面积)。利福平:在接受CYP3A4诱发剂rifampicin每天600毫克,连续12天的健康受试者中,减少约80%的尼洛替尼全身暴露量(曲线下面积)。

3.抑制药物传输系统的药物nilotinib是排出转运体(effluxtransporter)P-glycoprotein(Pgp,ABCB1)的基质。若Tasigna与会抑制Pgp的药物一起使用,可能增加nilotinib的药物浓度,因此应格外小心禁忌切勿使用于罹患低血钾症,低血镁症或QT延长症候群的患者。给药规定9.32.2.Nilotinib150mg(如Tasigna 150mg):限用于新确诊之慢性期费城染色体阳性的慢性骨髓性白血病。

注意事项

(1)骨髓抑制:可能引起三/四级血小板减少症,嗜中性白血球减少症及贫血,故患者在治疗开始后的前两个月,应每2周进行一次完整的血球计数评估,之后,每个月评估一次,或视临床需要实施。

(2)QT延长:因本药可延长心室再极化,可能导致一种称为Torsade
pointes的心室性心搏过速,而导致昏厥,癫痫,死亡。故不应使用于患有低血症症状,低血镁症或QT延长症候群的患者。

(3)血清脂肪酶升高:会导致血清脂肪酶增加,建议过去有胰脏炎病史的患者应小心使用应规律检查血清脂肪酶。

(4)肝脏毒性:可能会导致胆红素,天门冬胺酸转胺酶/丙胺酸转胺酶与碱性磷酸酶浓度增加应定期检查肝功能测试。

(5)电解质异常:会引起低血磷症,低血钾症,高血钾症,低血钙症与低血钠症,故使用本药前应先改善电解质异常,并应于治疗期间定期监测。

(6)药物交互作用:应避免与强效的CYP3A4抑制剂或会延长QT间隔的药物并用,如必须使用上述药物治疗,建议先中止尼洛替尼的治疗。饮食提示服药期间避免饮用葡萄柚汁。警语胶囊应整颗配水吞服,不可咬碎或磨粉。过量处理在剂量超过的情况下,应观察患者并给予适当的支持性疗法。药品保存方式请储存于30℃以下。

替莫唑胺胶囊英文版说明书

TEMODAL 5 mg/20mg/100mg/140mg/180mg/250mg CapsulesTemozolomide (Temodal)This page tells you about a chemotherapy drug called temozolomide and its possible side effects. There is information aboutWhat temozolomide isTemozolomide is a chemotherapy drug used to treat certain types of brain tumours called glioblastoma multiforme or anaplastic astrocytoma.For newly diagnosed glioblastoma multiforme temozolomide is first used together with radiotherapy and then as a treatment on its own.It is used as a treatment on its own for glioblastoma multiforme or anaplastic astrocytoma that has come back or where previous treatment did not work.How temozolomide worksTemozolomide is a type of drug known as an alkylating agent and works by stopping cancer cells from making new DNA. DNA stands for DeoxyriboNucleic Acid. It is the genetic material of a cell. If cancer cells can’t make DNA, they can’t split into 2 new cells, so the cancer can’t grow.How you have temozolomideYou take temozolomide as capsules that you swallow whole with a glass of water. Take them on an empty stomach – for example, 1 hour before or after meals. Store the capsules in a safe place away from children.If you are having temozolomide alongside radiotherapy, you have radiotherapy for 6 to 7 weeks. You take the temozolomide capsules each day during this time. It is best to take them at the same time each day. If you have temozolomide together with radiotherapy you are at higher risk of getting a type of lung infection called pneumocystis carinii pneumonia, so your doctor will prescribe medicines to help protect you against this.After the radiotherapy, or if you have a brain tumour that has come back, you may have temozolomide as a course of cycles of treatment. You take the temozolomide capsules for 5 days every 4 weeks. You may repeat this treatment up to 6 times.It is very important that you take capsules according to the instructions your doctor or pharmacist gave you. You should take the right dose, not more or less. And never stop taking a cancer drug without talking to your specialist first.If you accidentally take more temozolomide capsules than you were told to, contact your doctor, pharmacist or nurse straight away.If you forget to take a dose of temozolomide take the missed dose as soon as possible during the same day. If more than a full day has gone by, check with your doctor. Don’t take a double dose to make up for a forgotten dose, unless your doctor tells you to do that.Tests during treatmentYou have blood tests before starting treatment and regularly during your treatment. The tests check your levels of blood cells and other substances in the blood. They also check how well your liver and kidneys are working.About side effectsWe’ve listed the side effects associated with temozolomide below. You can use the links to find out more about each side effect. Where there is no link, please go to our cancer drug side effects section or use the search box at the top of the page.You may have a few side effects. They may be mild or more severe. A side effect may get better or worse through your course of treatment. Or more side effects may develop as the course goes on. This depends onHow many times you’ve had the drug beforeYour general healthThe amount of the drug you have (the dose)The side effects may be different if you are having temozolomide with other drugs or alongside radiotherapy.Tell your doctor or nurse straight away if any of the side effects get severe.Common side effectsMore than 10 in every 100 people have one or more of the side effects listed below.Tiredness and weakness (fatigue) during and after treatment – most people find their energy levels are back to normal within 6 months to a yearHair loss – you may have some thinning within a month of starting treatment. Your hair will grow back when the treatment is overFeeling or being sick can start within a couple of hours of having the capsules and may last until the next day – take anti sickness medicines regularly and tell your doctor or nurse if they aren’t workingLoss of appetiteAn itchy rash and dry skinHeadachesConstipation – drink plenty of fluids and tell your doctor or nurse if it doesn’t get better within a few daysWomen may stop having periods (amenorrhoea) but this may only be temporaryLoss of fertility may happen with this drug – you may not be able to get pregnant or father a child after treatment so talk to your doctor before starting treatment if you plan to have a baby in the future. It may be possible for men to store sperm beforehandOccasional side effectsBetween 1 and 10 in every 100 people have one or more of these.DizzinessAn increased risk of getting an infection from a drop in white blood cells – it is harder to fight infections and you can become very ill. You may have headaches, aching muscles, a cough, a sore throat, pain passing urine, or you may feel cold and shivery. If you have a severe infection this can be life threatening. Contact your treatment centre straight away if you have any of these effects or if your temperature goes above 38°CTiredness and breathlessness due to a drop in red blood cells (anaemia) – you may need a blood transfusionBruising more easily due to a drop in platelets – you may have nosebleeds, or bleeding gums after brushing your teeth. Or you may have lots of tiny red spots or bruises on your arms or legs (known as petechiae)Taste changesAnxietyDifficulty sleepingLiver changes – you will have regular blood tests to check how well your liver is workingA higher risk of blood clots – let your doctor or nurse know if you have any leg pain, redness or swelling that feels warm to the touchMuscle weakness or back painWeight lossDiarrhoea – drink plenty of fluids and tell your doctor or nurse if it doesn’t get better within a few daysTummy (abdominal) pain and an upset stomachHigher levels of sugar in the blood – tell your nurse or doctor if you feel very thirsty and pass a lot of urineConfusion or drowsiness – let your doctor or nurse know if you have thisFeeling sad or depressed – let your doctor or nurse know if you have thisDifficulty speakingDifficulty balancingFits (seizures)Forgetfulness and difficulty concentratingTingling sensations in the skinShaking (tremor)Blurred vision or other eyesight changesLoss of hearingLung changes causing breathlessness or a coughFluid build up causing swollen legs or handsHeartburnDifficulty swallowingA dry mouthSwollen, painful jointsNeeding to pass urine often and discomfort when passing urine – let your nurse or doctor know if you have thisAn allergic reaction – let your nurse or doctor know straight away if you have a sudden skin rash, itching, breathlessness or swelling of the lips, face or throatRare side effectsFewer than 1 in 100 people have these effects.A second cancer or leukaemia some years after treatment.A high temperature (fever) and chills – this does not usually last for longRed spots under the skinWeight gainMood swingsHallucinations (seeing or hearing things that are not there)Dry or sore eyesRinging in the ears (tinnitus)A feeling of your heart beating fast (palpitations)Blood clots in the lung – let your nurse of doctor know straight away if you have a sudden cough, breathlessness or chest painSensitivity of the skin to sunlight – cover up with clothing and use sunscreen if you need to go out into the sunHigher blood pressure – your nurse will check your blood pressure regularlyA blocked nose due to inflamed sinusesDifficulty in controlling bowel movementsDifficulty passing urinePiles (haemorrhoids) – let your doctor or nurse know if you have thisIncreased sweatingChanged sense of smellImportant points to rememberTalk to your doctor, pharmacist or nurse about all your side effects so they can help you manage them. They can give you advice or reassure you. Your nurse will give you a contact number to ring if you have any questions or problems. If in doubt, call them.Other medicinesTell your doctor about any other medicines you are taking, including vitamins, herbal supplements and over the counter remedies. Some drugs can react together.Pregnancy and contraceptionThis drug may harm a baby developing in the womb. It is important not to become pregnant or father a child while you are having treatment and for at least 6 months afterwards. Talk to your doctor or nurse about effective contraception before starting treatment.BreastfeedingDo not breastfeed during this treatment because the drug may come through in the breast milk.Immunisations and chemotherapyYou should not have immunisations with live vaccines while you are having chemotherapy or for at least 6 months afterwards. In the UK, these include rubella, mumps, measles (usually given together as MMR), BCG, yellow fever and Zostavax (shingles vaccine).You can have other vaccines, but they may not give you as much protection as usual until your immune system has fully recovered from your chemotherapy. It is safe to have the flu vaccine.It is safe for you to be in contact with other people who’ve had live vaccines as injections. There can be problems with vaccines you take by mouth (oral vaccines), but not many people in the UK have these now. So there is usually no problem in being with any baby or child who has recently had any vaccination in the UK. You might need to make sure that you aren’t in contact with anyone who has had oral polio, cholera or typhoid vaccination recently, particularly if you live abroad.https

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