部份中文盐酸芬戈莫德处方资料（仅供参考）
英文名：Fingolimod Hydrochloride
商品名：Imusera Capsules
中文名：盐酸芬戈莫德
生产商：田边三菱制药
药品简介
2012年11月28日，由田边三菱制药研发的鞘氨醇1-磷酸(S1P1)受体调节剂Imusera（Fingolimod Hydrochloride）胶囊，通过作用于淋巴细胞上的S1P1受体来阻止自身反应性淋巴细胞对中枢神经系统的浸润，从而抑制多发性硬化症(MS)神经炎症。
イムセラカプセル0.5mg
药效分类名称
多发性硬化症治疗
批准日期：
商品名：Imusera
一般的名称
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
它是一种白色粉末。 它易溶于水、甲醇或乙醇，几乎不溶于乙腈。
化学構造式
分配係数
D22.26（1-オクタノール／水）
处理注意事项
避免冷冻。
药效药理
作用机制
芬戈莫德在体内代谢为磷酸化代谢物，即活性代谢物。淋巴结作为S1P1受体的功能性拮抗剂，通过与 1-磷酸鞘氨醇(S1P)受体1（S1P1受体）结合并诱导其内化和降解。抑制淋巴细胞从次级淋巴组织中的输出，例如。自身反应性T细胞，包括髓鞘抗原特异性Th17细胞，也通过类似机制抑制淋巴结迁移，从而抑制浸润到中枢神经系统组织。
另一方面，芬戈莫德对效应记忆T细胞几乎没有影响，因为在外来病原体感染中起重要作用的效应记忆T细胞没有通过次级淋巴组织循环的能力。
芬戈莫德还被证明可以迁移到人类和动物的中枢神经系统(CNS)并抑制星形胶质细胞增生、脱髓鞘和神经元损伤。
实验性自身免疫性脑脊髓炎(EAE)
在多发性硬化症动物模型小鼠的复发缓解型EAE中，口服芬戈莫德治疗时，对神经系统症状的复发显示出抑制作用。
适应症
预防多发性硬化症的复发和抑制身体疾病的进展
用法与用量
通常的成人剂量是每天一次口服 0.5 毫克芬戈莫德。
包装
胶囊剂
14粒[14粒(PTP)x1]
制造商和分销商
田边三菱制药株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3999029M1029_1_17/?view=frame&style=XML&lang=ja
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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.