英文药名: IMUSERA Capsules（Fingolimod Hydrochloride）

中文药名: 盐酸芬戈莫德

生产厂家: 田边三菱制药
类别名称
多发性硬化症的治疗剂
欧文商標名
IMUSERA Capsules 0.5mg

構造式
一般名
フィンゴリモド塩酸塩（Fingolimod Hydrochloride）
化学名
2-Amino-2-［2-（4-octylphenyl）ethyl］propane-1,3-diol monohydrochloride
分子式
C19H33NO2・HCl
分子量
343.93
性　状
白色粉末。水，易溶于甲醇或乙醇中，在乙腈中几乎不溶。
分配系数
D22.26（1-辛醇/水）
条件批准
上市后，直到根据一定数量例的数据被集成，通过实施的所有情况下，使用效果的调查，以及理解本用药患者的背景资料，这种药物的它收集在对安全性和有效性的早期阶段的数据，采取必要的措施，正确地使用这种药物。
药效药理
作用机序
芬戈莫德在体内活性代谢物的磷酸化形式代谢。磷酸化，结合鞘氨醇1-磷酸（S1P）受体1（S1P 1受体），诱发分解的内化，作为受体S1P1的功能拮抗剂，淋巴结抑制从次级淋巴组织，如淋巴细胞的迁出。对自身反应性T细胞，包括髓鞘抗原特异性Th17细胞还，从类似的机制的出口：淋巴结被抑制，浸润抑制到中枢神经系统组织
另一方面，效应记忆T细胞，从而起到感染了外来病原体的一个重要的作用，因为它们不具有通过次级淋巴组织中的循环能力，芬戈莫德是效应记忆T细胞的影响不大。
此外，芬戈莫德具有人和动物的中枢神经系统（CNS），星形胶质细胞增生，抑制脱髓鞘损伤的迁移和神经元细胞已被证明
实验性自身免疫性脑脊髓炎（EAE）
在复发 - 缓解EAE小鼠，多发性硬化症，当芬戈莫德治疗口服给药表现出神经系统症状复发抑制作用的动物模型。
适应病症
抑制预防复发的多发性硬化的进展和残疾
用法用量
成人每天服用1次，每次口服0.5毫克
包装
胶囊：0.5mg
14胶囊（14胶囊×1）

制造厂商
田边三菱制药株式会社
IMUSERA Capsules（Fingolimod hydrochloride）
IMUSERA Capsules 0.5mg（イムセラカプセル0.5mg） 
Brand name : IMUSERA Capsules 0.5mg
　Active ingredient: Fingolimod hydrochloride
　Dosage form: bright yellow/white capsule, major axis: 15.9 mm, minor axis: 5.8 mm
　Print on wrapping: イムセラ 0.5mg, IMUSERA0.5mg
Effects of this medicine
This medicine acts on lymphocytes, inhibiting lymphocytes egress, including the autoreactive T-cells that attack the patient's own nervous system, from lymph nodes and other secondary lymphoid tissue, thus reduces nerve inflammation.
It is usually used to prevent recurrence of multiple sclerosis, and to suppress progression of physical disability due to this disease.
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 have: infections, second-degree or greater atrioventricular block, sick sinus syndrome, ischemic heart disease, congestive heart failure, low heart rate, macular oedema, diabetes mellitus, history of uveitis, hepatic dysfunction or its history, no history of varicella or herpes zoster who have not been vaccinated.
•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 1 capsule (0.5 mg of fingolimod) at a time, once a day. Strictly follow the instructions.
•Electrocardiography should be carried out before and 6 hours after the initial dose. In addition, the measurement of heart rate and blood pressure, and continuous electrocardiographic monitoring may be carried out for 24 hours after the initial dose. If you notice symptoms of bradyarrhythmia such as dizziness, fatigue or palpitations, consult with your doctor immediately.
•If you missed a dose, take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue 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. If you restart this medicine after stop taking it, consult with your doctor.
Precautions while taking this medicine
•Serious infections may occur after taking this medicine. If you notice symptoms of infection, such as fever or malaise, contact with your doctor immediately. The effects of this medicine continue for up to 2 months after you stop taking it, so you should be aware of the possibility of developing infectious disease during that time.
•The medicine may cause dizziness and light-headedness in the beginning of the treatment. Take care in driving a car or operating machinery requiring alertness.
•Do not receive live vaccines during the treatment because infection may occur by the vaccines. Consult with your doctor or pharmacist when you receive vaccines.
•You should avoid getting pregnant while taking this medicine, and for up to 2 months after you stop taking it.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include nasopharyngitis, bradycardia and headache. 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.
•malaise, fever [infection]
•dizziness, fatigue, palpitation [bradyarrhythmia (bradycardia, atrioventricular block, etc.)]
•blurred vision, decreased visual acuity [macular oedema]
•generalized lymph node enlargement, fever, decreased weight [malignant lymphoma]
•disturbed consciousness, convulsion, visual disturbance [posterior reversible encephalopathy]
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
•Keep out of the reach of children. Store at 25℃ or lower and away from direct sunlight, heat, moisture and freezing.
•Discard the remainder. Do not store them. Consult with your dispensing pharmacy or healthcare provider when you discard the remainder.
Mitsubishi Tanabe Pharma CorporationInternal
Revised: 7/2015
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.
http://www.kegg.jp/medicus-bin/japic_med?japic_code=00059794
http://medical.mt-pharma.co.jp/di/file/dc/imu_a.htm