部份中文莫格利珠单抗处方资料（仅供参考）
英文名：Mogamulizumab
商品名：Poteligeo
中文名：莫格利珠单抗重组点滴静注
生产商：协和发酵麒麟
药品简介 
新型抗体单抗mogamalizumab(商品名：Poteligeo，ポテリジオ点滴静注)注射溶液,是由日本协和发酵麒麟研发的新型抗癌药，用于治疗CCR4阳性成人T细胞白血病淋巴瘤、复发性或难治性CCR4阳性外周T细胞淋巴瘤、复发性或难治性皮肤T细胞淋巴瘤。每瓶共5mL含20mg。推荐剂量为每次1mg/kg，每周一次，共8次。
ポテリジオ点滴静注20mg
药物分类名称
抗肿瘤药
人源化抗CCR4Note）单克隆抗体
注）CCR 4：CC趋化因子受体4（CC趋化因子受体4）
批准日期：2012年5月
欧文商標名
POTELIGEO Injection
一般名
モガムリズマブ（遺伝子組換え）
Mogamulizumab（GeneticalRecombination）
分子量
約149,000
本質
ヒトCCケモカイン受容体4に対する遺伝子組換えヒト化モノクローナル抗体である。チャイニーズハムスター卵巣細胞により産生される449個のアミノ酸残基からなる重鎖2分子及び219個のアミノ酸残基からなる軽鎖2分子
批准条件
制定药品风险管理计划并适当实施。
○复发性或难治性CCR4阳性成人T细胞白血病淋巴瘤
由于日本的临床试验数量非常有限，通过对所有病例进行使用结果调查，直到制造和销售后累积一定数量的病例数据为止， 除了掌握所用患者的背景信息外，尽快收集该药的安全性和有效性数据，并采取必要措施正确使用该药。
药用药理学
作用机制
Mogam llizumab被认为主要通过抗体依赖性细胞毒性（ADCC）活性损伤CCR4阳性细胞。
抗肿瘤作用
体外试验
莫加木珠单抗是，CCR4阳性人ATL来源的细胞系（TL-OM1，ATN-1和ATL102）和CTCL来源的细胞系（HH和的Hut-78）相对于（靶细胞），人外周血单核细胞（效应细胞）它在存在时显示出ADCC活性。
莫加木珠单抗，从ATL患者※（靶细胞）来源的CD3阳性细胞，在来自同一患者的存在表明在CD3阴性细胞的ADCC活性（自体效应细胞）。此外，莫加木珠单抗，到PTCL-NOS患者来源的CD3阳性※（靶细胞），在从健康成人的存在表明在CD3阴性细胞的ADCC活性（同种异体效应细胞）。
*包括CCR4阳性细胞。
体内试验
莫加木珠单抗是，CCR4阳性人ATL来源的细胞系（TL-OM1）和CTCL衍生的细胞系（HH）表明在严重联合免疫缺陷小鼠模型中皮下植入的肿瘤生长抑制。
适应症
CCR4阳性成人T细胞白血病淋巴瘤
复发性或难治性CCR4阳性外周T细胞淋巴瘤
复发性或难治性皮肤T细胞淋巴瘤
用法与用量
CCR4阳性成人T细胞白血病淋巴瘤
通常，成人每周一次静脉滴注1mg/kg，剂量为1周，为Mogum Lysmab（遗传重组）。
当与其他抗肿瘤药物联合使用时，成人通常静脉内输注1mg/kg的单剂量，每周间隔2周，间隔2周作为mogam lesumab（遗传重组）。
对于未经治疗的化疗患者，可与其他抗肿瘤药联合使用。
复发性或难治性CCR4阳性外周T细胞淋巴瘤
通常，成人每周一次静脉滴注1 mg/kg，剂量为1周，为Mogum Lysmab（遗传重组）。
复发性或难治性皮肤T细胞淋巴瘤
通常，成人每周一次静脉滴注1mg/kg，间隔一周为mogum lysumab（遗传重组），然后每隔2周静脉滴注一次。
包装
静脉输注20毫克：1小瓶
制造供应商
协和发酵麒麟
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整处方资料附件：
https://medical.kyowakirin.co.jp/site/infopdf/notice/1182.pdf
POTELIGEO Injection（Mogamulizumab(genetical recombination)）
Brand name :POTELIGEO Injection
　Active ingredient:Mogamulizumab(genetical recombination)
　Dosage form:injection
　Print on wrapping:
Effects of this medicine
This medicine acts on CCR4, a protein which appears on the surface of cancer cells, and shows antitumor effect by selectively damaging the cancer cells.
It is usually used in the treatment of CCR4-positive adult T-cell leukemia-lymphoma, relapsed or refractory CCR4-positive Peripheral T-cell lymphoma and relapsed or refractory Cutaneous T-cell lymphoma.
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: infection or serious myelosuppression.
If you have cardiac dysfunction or infections such as hepatitis virus and tuberculosis, or history of these diseases.
If you are 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))
For CCR4-positive adult T-cell leukemia-lymphoma, relapsed or refractory CCR4-positive Peripheral T-cell lymphoma : In general, for adults, administer by intravenous drip infusion repeated at 1to 2 week intervals for eight times (drip infusing time is 2 hours per one administeration).
For relapsed or refractory Cutaneous T-cell lymphoma:In general, for adults, administer by intravenous drip infusion repeated at 1 week intervals for five times, and then drip infusion repeated at 2 weeks intervals(drip infusing time is 2 hours per one administeration).
In any case, the dosage intervals depend on concomitant drugs or symptoms/conditions. Ask your doctor about your dosing schedule.
You will be administered medicines to prevent allergic reactions and anaphylactoid symptoms before drip infusion of this medicine.
Precautions while taking this medicine
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, chills, increased pulse rate, nausea, blood pressure increase, fatigue, diarrhea, anemia, alopecia, decreased appetite, weight decreased, constipation, stomatitis, vomiting, malaise, headache and edema.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.
fever, chills, palpitaion, dizziness, vomiting [infusion reaction]
red rash with dropsical swelling in the center, red spots and breakable blisters all over the body, lip and mouth sore, fever[severe skin disorders]
cold-like symptoms, general malaise, fever[infections]
general malaise, yellowing of the white of eyes and the skin, nausea, impaired mind [hepatitis fulminant caused by hepatitis B virus, hepatitis, hepatic dysfunction]
consciousness decreased, decreased urine output, breathing difficulty[tumor lysis syndrome]
fever, sore throat[severe haematotoxicity: leukopenia]
nasal bleeding, bruise, prolonged bleeding[severe haematotoxicity: thrombocytopenia]
general malaise, palpitations or shortness of breath when going upstairs or uphill[severe haematotoxicity: anemia]
dry cough, breathing difficulty, fever[interstitial lung disease]
general malaise, lassitude[hyperglycemia]
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.
Injection
Revised: 2/2020
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.