【中文品名】莫罗单抗-CD3
【药效类别】T细胞抑制药
【通用药名】MUROMONAB-CD3
【别 名】Anti-CD3 Mab, OKT-3 antibody, Orthoclone OKT-3
【C A 名称】Muromonab CD3
【CA登记号】[140608-64-6]
【收录药典】
【开发单位】强生
【首次上市】1986年，美国
【性 状】
【用 途】
一种单克隆抗T细胞抗体，用于肾、心脏和肝移植的排异和使供体骨髓的T细胞在移植前失活。
鼠单克隆抗体-CD3，CD3-单克隆抗体，ORTHOCLONE，OKT3）
本品为鼠IgG2的免疫球蛋白，具有一重链（分子量约5万）及一轻链（分子量约2.5万），能特异地与人T细胞的抗原（CD3）结合，而阻断T细胞的再生及其功能，因而起到免疫抑制作用，但对骨髓无影响。
可用于器官移植后的急性排异反应，静脉注射，每日1次，5mg，连用10～14日。可合用皮质激素或硫唑嘌呤。对肾移植的排异反应效果较好，也试用于心、肝的移植。
不良反应主要为寒战、发热、呼吸困难、呕吐、腹泻、震颤等。禁用于对本品过敏的患者。可服用对乙酰氨基酸或抗组胺药防止早期反应。
常用的制剂为注射液，每支5mg（5ml）。不能冷冻保存，不能振摇。 
罗莫那-CD3的说明书：
[药品名]莫罗莫那—CD3
[英文名]Muromonab—CD3
[别名]鼠单克隆抗体—CD3，CD3—单克隆抗体，ORTHOCLONE，OKT
罗莫那-CD3简单介绍：莫罗莫那-CD3(OKT3)为鼠IgG2的免疫球蛋白，能特异地与人T细胞的抗原(CD3)结合，而阻断T细胞的再生及其功能，起到免疫抑制作用，且对骨髓无影响。经FDA批准用于治疗肾移植排斥和心脏移植排斥反应，在临床用药过程中还发现了该药在其它疾病方面的一些治疗作用。用于治疗器官移植的排斥反应
OKT3对肾移植的排斥反应效果较好，能有效逆转移植肾的急性排斥反应，其逆转率可达95%，而对于抗激素或抗胸腺细胞球蛋白(ATG)的急性排斥反应，OKT3也有较好的效果，其逆转率可达93%。
[作用与用途]:本品为鼠IgG2的免疫球蛋白，具有一重链(分子量约5万)及一轻链(分子量约2。5万)，能特异地与人了细胞的抗原(CD3)结合，而阻断T细胞的再生及其功能，因而起到免疫抑制作用，但对骨髓元影响。可用于器官移植后的急性排异反应。
[用法与用量]:静脉注射，每日1次，5mg，连用10—14日，可合用皮质激素或硫唑嘌呤。对肾移植的排异反应效果较好，也试用于心、肝的移植。
[注意事项]:不良反应主要为寒战、发热、呼吸困难、呕吐、腹泻、震颤等。禁用于对本品过敏的患者。可服用对乙酰氨基酸或抗组胺药早期反应。
[制剂]常用的制剂为注射液，每支5mg(5ml)。不能冷冻保存，不能振摇。
Muromonab-CD3
(myoo roe MOE nab see dee three)
The following medications contain Muromonab-CD3:
Click for U.S. Brand Names
Orthoclone OKT® 3 [DSC]
Click for Mexican Brand Names
Orthoclone OKT3
Dosage Forms
•This medicine is available as an injection.
Pharmacologic Category
•Immunosuppressant Agent
•Monoclonal Antibody
What key warnings should I know about before giving this medicine to my child?
•Some patients experience severe reactions during the infusion.
•This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with child's healthcare provider.
•Your child will be closely monitored while taking this medicine.
Is it safe for my child to take this medicine?
•Not if your child has an allergy to muromonab-CD3 or any other part of this medicine.
•Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.
•If your child is allergic to mouse proteins, talk with healthcare provider.
•Not if your child has any of the following conditions: seizures, uncontrolled high blood pressure or lungs filled with fluid.
Why does my child need this medicine?
•This medicine is used to prevent rejection after organ transplant.
How does this medicine work?
•Muromonab-CD3 helps the body accept a transplanted organ.
How is this medicine given?
•This medicine is given as a shot.
How long does this medicine take to work?
•It may take a few days to see the full effect.
What do I do if my child misses a dose? (does not apply to patients in the hospital)
•Give a missed dose as soon as possible.
•If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.
•Do not change dose or stop your child's medicine. Talk with healthcare provider.
What safety measures should I take while my child is using this medicine?
•Serious infections have been reported with use of this medicine. If your child has any infection, has many infections, or is taking antibiotics, talk with healthcare provider.
•Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.
•Your child's other medicines may be decreased while taking this medication.
•The risk of cancer is higher after using this medicine.
•Talk with healthcare provider before your child receives any vaccinations. Use with this medicine may either increase the risk of serious infection or make the vaccination less effective.
What are some possible side effects of this medicine?
•Flu-like symptoms. These include headache, weakness, fever, shakes, aches, pains, and sweating. Your child may be given medicine before this shot to prevent these symptoms.
•Diarrhea.
•Dizziness.
•Nausea or vomiting. Small frequent meals and frequent mouth care may help. Older children may suck hard, sugar-free candy.
•Change in blood pressure.
What should I monitor?
•Change in condition being treated. Is it better, worse, or about the same?
•Check weight weekly. Report a weight change to healthcare provider.
•Check blood work regularly. Talk with healthcare provider.
•For the occurrence of side effects.
When should I call my child's healthcare provider?
•If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.
•If you suspect an overdose, call your local poison control center or emergency department immediately.
•If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.
•If your child has severe nausea or vomiting.
•If your child has severe diarrhea.
•If your child has difficulty breathing.
•If your child develops a fast heartbeat.
•If your child has swelling.
•If your child has significant change in thinking clearly and logically.
•If your child has a severe headache.
•If your child has a seizure.
•If your child has difficulty passing urine.
•If your child develops a rash.
•No improvement in condition or if you believe your child's condition is worse.
How should I store and/or dispose of this medicine?
•This medicine will be given to you in a healthcare setting. You will not store it at home.
General statements
•If your child has a life-threatening allergy, he/she should wear allergy identification at all times.
•This medicine is available by prescription only.
•This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.
•Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.
•Do not share your child's medicine with others and do not give anyone else's medicine to your child.
•Keep all medicine out of the reach of children and pets.
•Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).
•Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.
•Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.
•Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.
オルソクローンOKT3注
製造販売元／ヤンセンファーマ株式会社
商品名 オルソクローンＯＫＴ３注
薬効 6399 他に分類されない生物学的製剤
一般名 ムロモナブ－ＣＤ３注射液 英名 Orthoclone OKT 3
剤形 注射液
規格 ５ｍｇ５ｍＬ１管 メーカー ヤンセンファーマ
毒劇区分 (劇)
効能・効果 腎移植後の急性拒絶反応の治療
禁忌病名
1. 類薬で過敏症の既往歴、本剤成分又は含有成分で過敏症の既往歴、血清病の既往、過敏症の既往、皮疹の既往 記載場所： 使用上の注意
注意レベル： 禁止
2. 体液貯留、白血球減少症＜３０００／ｍｍ３以下＞ 記載場所： 使用上の注意
注意レベル： 慎重投与
3. 体温が３７．８℃以上、高血圧症、糖尿病 記載場所： 使用上の注意
注意レベル： 注意
副作用等
1. 重篤な感染症、肺炎、敗血症、髄膜炎、帯状疱疹 記載場所： 重大な副作用
頻度： ５％以上
2. 進行性多巣性白質脳症、ＰＭＬ、意識障害、認知障害、麻痺症状、片麻痺、四肢麻痺、言語障害 記載場所： 重大な副作用
頻度： 頻度不明
3. アナフィラキシー反応、チアノーゼ、冷汗、血圧低下、呼吸困難、胸内苦悶、脳浮腫、脳ヘルニア、ＢＫウイルス腎症 記載場所： 重大な副作用
頻度： 頻度不明
4. 無菌性髄膜炎、発熱、頭痛、髄膜症、項部硬直、羞明、錯乱、全身痙攣、幻覚、眩暈、肺水腫 記載場所： 重大な副作用
頻度： ５％未満
5. インフルエンザ様症状、発熱、悪寒、振戦、頭痛、全身倦怠感、白血球減少、白血球増多、血小板減少、貧血、ＡＬＴ上昇、ＧＰＴ上昇、ＡＳＴ上昇、ＧＯＴ上昇、下痢、嘔吐、悪心、呼吸困難、咳嗽 記載場所： その他の副作用
頻度： ５％以上
6. 縮瞳 記載場所： その他の副作用
頻度： 頻度不明
7. 胸痛、関節痛、顔面潮紅、筋肉痛、ＬＤＨ上昇、食欲不振、腹痛、腹部膨満感、アミラーゼ上昇、消化管出血、下血、発疹、皮膚そう痒感、紅斑、全身発赤、動悸、血圧低下、しびれ感、もうろう状態、鼻閉、鼻汁、咽頭不快感、喀痰、鼻出血、眼球充血、眼痛、結膜充血、上強膜炎、ＣＲＰ上昇、Ｐｏ２低下、尿酸値上昇、耳閉感、耳鳴、移植腎痛 記載場所： その他の副作用
頻度： ５％未満
8. 過敏症、重篤な肺水腫、抗体が産生、高体温、激しい悪寒、筋肉痛、嘔吐、下痢、浮腫、乏尿、悪性腫瘍、リンパ腫、皮膚癌、移植臓器内血栓、血管床血栓、視力消失、視力低下