DELTYBA(delamanid tablets)迪拉马尼片
Deltyba 50 mg Filmtabletten - OP50; Filmtablette; Otsuka Novel Products GmbH
Allgemeine Angaben
Eingangsnummer : 2710005
Arzneimittelname: Deltyba 50 mg Filmtabletten - OP50
Darreichungsform : Filmtablette
Administrative Daten
Antragsteller:    Otsuka Novel Products GmbH
Verkehrsfähig : ja
Zulassungs-/Reg-Nr.(AMG76) : EU/1/13/875/002
Zusammensetzung
Arzneilich wirksame Bestandteile
 

Brand name : DELTYBA Tablets 50mg
　Active ingredient: Delamanid
　Dosage form: brownish-yellow tablet, diameter: 11.7 mm, thickness: 5.3 mm
　Print on wrapping: Front: デルティバ錠50mg, Otsuka; Back: デルティバ錠50mg, DELTYBA tab 50mg, 吸湿注意, Otsuka
Effects of this medicine
This medicine exerts its antibacterial activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids in M. tuberculosis.
It is usually used to treat pulmonary multidrug-resistant tuberculosis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
•If you are pregnant, possibly pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<        to be written by a healthcare professional>>
•In general, for adults, take 2 tablets (100 mg of active ingredient) at a time, twice daily after breakfast and dinner. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•As periodic electrocardiographic monitoring and serum albumin concentration measurements are necessary while on this medicine, follow the instructions of your doctor.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include insomnia, headache, and somnolence. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•palpitations, chest discomfort, chest pain[QT prolongation]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•As this medicine is hygroscopic, tablets should be kept in the package sheet and not be removed until immediately before use.
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•If there is a remainder, this is to be discarded. Do not store it. Ask your pharmacist or medical institution about how to discard it.
Otsuka Pharmaceutical Co., Ltd.Internal
Published: 9/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
大塚制药株式会社研发的Deltyba是40年以来第一个在日本获得上市许可的抗结核药, 也是唯一获批的用于治疗耐多药结核病的药物。  继今年4月份欧洲药品监管部门批准上市后，又获得日本药品监管部门的批准。
日本的结核病患病人数在逐年下降；然而，据估算仍有2万例结核病现患病人，使得日本在发达国家中成为结核病患病非常高的国家之一。  在过去10年间，耐多药结核病患者的治愈率毫无改善，这也使得日本消除结核病的进程复杂化。现有抗结核药物对耐多药结核病患者的有效性降低，导致患者的住院时间延长，治愈率仅为40-70%。因此，强烈渴求抗结核新药的问世，以提高耐多药结核病患者治愈率，并缩短患者住院时间。   
在临床实验中，将Deltyba与世界卫生组织推荐的背景治疗方案联合使用，证实了Deltyba的有效性，并改善了患者的长期治疗转归。
全球45万例耐多药结核病患者中，仅20%的患者接受了治疗，而接受治疗患者的治疗成功率不足一半。由于治疗成功率低，每年约17万例耐多药结核病患者死亡。
日本东京（7月4日）–  大塚制药株式会社（大塚）今天接到日本卫生、劳动与福利部的正式批准，可以将Deltyba（迪拉马尼片）作为成人耐多药肺结核病患者适当联合治疗方案的一部分来使用。
Deltyba是一种新型杀菌剂，是通过干扰结核分枝杆菌细胞壁中的分枝菌酸生物合成而发挥作用。在体外实验中，它表现出对各类结核分枝杆菌，包括对异烟肼和利福平等一线抗结核药已耐药的结核分枝杆菌的高度杀灭活性。  Deltyba已被日本卫生、劳动与福利部认定为孤儿药，这意味着该药是一种用于治疗罕见疾病的药物。
在日本，结核病发病率为17/10万，与其他发达国家相比仍处在较高水平。  许多原因可导致抗结核药物产生耐药性，包括药物的不合理使用或对患者管理不佳。例如，患者因药物不良反应而未完成疗程。 耐多药结核病已成为一个主要的全球关注的问题，因其治疗疗程长达至少20个月，加重了患者的治疗负担。
在日本，鉴于使用现有抗结核药物对耐多药结核病患者的治疗成功率仅为40-70%，长期形成了一个紧迫的尚未满足的医疗需求。3由于缺乏可供选择的有效治疗，耐多药结核病患者5年内和10年内的死亡率分别高达21.6%和36.7%。  由于对现有治疗的耐受性差和产生耐药，日本耐多药结核病患者中的广泛耐药结核病患者比例较高，这与其他亚洲国家的情况类似。 ,
来自9个国家的临床试验结果显示，在接受Deltyba（100毫克，每日2次）联合一个最优背景治疗方案（OBR）治疗2个月的受试患者中（包含广泛耐药结核病患者），45.4%的患者实现了痰培养转阴（SCC，该指标表明患者不再有传染性）；相比之下，在接受安慰剂联合一个OBR治疗的患者中，仅有29.6%的患者实现了SCC，两者间差异有统计学意义。  重要的是，将Deltyba与OBR一起治疗6个月，还可降低耐多药和广泛耐药结核病患者的死亡率，改善其长期治疗转归。  临床试验结果显示，除QT间期延长以外，Deltyba组的不良事件与安慰剂组接近。心电图显示的QT间期延长在Deltyba（100毫克，每日2次）联合OBR组患者中的发生率为9.9%，而在安慰剂联合OBR组患者中的发生率为3.8%。该不良事件未伴有任何临床症状（例如晕厥或心律不齐）