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他米巴罗汀（Tamibarotene）系由日本新药株式会社研制开发，于2005年6月13日在日本首次上市（商品名：Amnolake Tablets 2mg）。
急性前骨髓细胞性白血病(APL)约占同期白血病的3.3％～17.4％。尽管1986年国内首创的全反式维甲酸(all trans retinoic acid,ATRA)诱导分化疗法可使其完全缓解(CR)率达85％以上，但快速发展的耐药与高复发率仍是影响长期疗效的两大障碍，随着临床进一步应用，发现其可形成耐药性并使复发患者难以再次获得缓解。全反式维甲酸（ATRA）与化疗药物联合应用是当前APL的一线及标准治疗方法。ATRA可并发视黄酸综合征，这种并发症是严重的且有时可致命，在患者中出现的比例已达25％。不幸的是，ATRA单独治疗诱导的缓解持续时间比较短暂。另外，患者经常对ATRA的二次治疗应答失败。如今，ATRA基础治疗失败的患者采用三氧化二砷治疗，此化合物由静脉内给药且具有明显的毒性（包括心搏不齐）。
他米巴罗汀针对ATRA的耐药性而开发，是一个新的RARα促进剂，对急性前骨髓细胞性白血病复发患者具有显著分化诱导能力的药品。本品显示对ATRA缓解后复发的APL 具有显著有效性，对ATRA应答困难患者的有效性也可期待。
Nippon Shinyaku Co., Ltd.
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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.
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Brand name :
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Amnolake Tablets 2mg
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Dosage form:
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white tablet, diameter 7mm, thickness 3mm
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Print on wrapping:
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(face) 402, (back) アムノレイク錠 2mg
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Effects of this medicine
This medicine has therapeutic action to differentiate myeloid cell.
It is used to treat relapsed or refractory acute promyelocytic leukemia.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you ever experienced any allergic reaction (itch, rash, etc.) to any medicines.
Woman who has a possibility of being pregnant, or getting pregnant.
If you are patient with hypervitaminosis A, hyperlipemia, disorders in liver/kidney, or reduced gastric acid secretion.
If you are elderly patient, or 25 years or under.
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If you are pregnant or breastfeeding.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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General dosage regimen: Take 6mg/m2 in 2 divided doses a day after breakfast and dinner. This tablet contains 2mg of the active ingredient. Strictly follow the instructions of dosage regimen.
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Swallow the medicine without breaking this tablet into small pieces or chewing.
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If you missed a dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.
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If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
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Do not stop taking this medicine without the instructions of your doctor.
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Precautions while taking this medicine
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Woman make sure to avoid pregnancy for at least 1 month before starting this medication, during taking this medicine and for at least 2 years after discontinuing it.
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Man make sure to avoid pregnancy during taking this medicine, and for at least 6 month after discontinuing it.
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Note that the grapefruit juice might strengthen the action of this medicine.
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Note that St. John's wort-containing food might weaken the action of this medicine.
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If you are taking vitamin A product (Chocola A etc.) or fibrate drug, tell your doctor/pharmacist before using this medicine.
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Possible adverse reactions to this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
rash, bone pain, fever, dry skin, etc.
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.
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high fever of over 38℃, chest pain, breathlessness [retinoic acid syndrome]
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cold-like symptoms, lassitude, vomiting [infection]
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fever, dry cough, breathlessness [interstitial lung disease]
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fever, chest pain, swallowing difficulty [mediastinitis]
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muscle pain of the hands and feet, stiffness, numbness, lassitude, red/brown urine [rhabdomyolysis]
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.
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Storage conditions and other information
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Keep out of the reach of baby and children. Store away from direct sunlight, high temperature and humidity.
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Pay close attention to storage, not to lose this medicine.
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Do not share this medicine with any other person, and make sure that any other person do not take it by mistake.
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Discard the remainder. Do not store them. Ask the pharmacist how to discard.
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