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部份中文MabCampath处方资料（仅供参考）
Campath(MabCampath)—人源化单克隆抗体 外周T细胞淋巴瘤
目前，已有越来越多的肿瘤专家在早期治疗中选择Campath
▲MabCampath为第一及现时唯一一种被美国药物及食物管理局准许使用在B细胞型 CLL 的新的药物。
▲MabCampath是一种单克隆抗体，能有效对化疗没有效用的病人产生疗效。
▲MabCampath 的原理是针对CD52抗原，这种抗原主要分布在B及T细胞的表面。
▲MabCampath由于是一种抗体，会在淋巴细胞表面与CD 52抗原结合，并会引导身体的免疫系统破坏及吞噬在血液及骨髓结合后的细胞。
Campath(alemtuzumab,欧洲商品名：MabCampath）
其它名称：
Campath、Mabcampath,坎帕斯
来源：
利用基因重组及单克隆抗体技术生产的人源性抗CD52单克隆抗体。
药物机制：
本品是CD52单抗，与表达CD52的细胞结合后，可以通过抗体领带的溶解作用破坏白血病细胞。CD52表达于所有B细胞、T细胞、NK细胞、多数单核巨噬细胞、部分粒细胞表面，而红细胞和造血干细胞不表达。皮肤细胞和男性生殖器（附睾、精子、精襄）细胞也表达CD52。成熟精子表达CD52，但是精原细胞和不成熟精子不表达。
药代动力学：
慢性淋巴细胞白血病（CLL）患者每周静脉输液3次，每次30mg,治疗6周后，达到稳态血药浓度。最大血药浓度（Cmax）和曲线下面积（AUC）与用药剂量有关。平均半衰期（T1/2）为12天。本品存在较大的个体差异。随着治疗中恶性淋巴细胞数降低，本品血药浓度会有调高。
药物相互作用：
尚无正式有关本品与其它药物间相互作用的研究报道。
适应证：
本品为抗细胞表面CD52抗原的单克隆抗体，FDA批准此药用于治疗对烷化剂和氟达拉滨耐药的进展期CLL。此外，已进行的临床研究还包括非霍奇金淋巴瘤（NHL）、多发性硬化症及其它自身免疫性疾病、实体器官移植及骨髓移植后移植抗宿主病（GVHD）等。
单药有效率：
治疗烷化剂和氟达拉滨耐药的进展期CLL单药有效率为21%-33%。
剂型：
每支（3ml）Campath含有30mg
Alemtuzumab,24.0mg氯化钠，3.5mg磷酸氢二钠，0.6mg氯化钾，0.6mg磷酸二氢钾，0.3mg polysorbate 80,0.056mg依地酸二钠。不含防腐剂。
剂量：
起始剂量：3mg/d，静脉输液持续2小时。如患者可以耐受，剂量可增加至10mg/d，如还可以耐受，加量至30mg,隔日用药，每周3次，持续12周。（建议每次剂量不超过30mg,或者每周累积剂量不超过90mg).
给药途径：
本品只能静脉点滴，不能静脉注射或者静脉冲击给药。
配伍：
尚无相关资料。
禁忌证：
全身活动性感染、免疫缺陷症（如HIV血清学检查阳性）、已知对本品中Campath和其它添加成分有I型超每反应和过敏史的患者。
不良反应：
1.输液相关副作用：
寒战、发热、恶心、呕吐、低血压、皮疹、乏力、荨麻疹、呼吸困难、瘙痒、头痛、腹泻。
2.全身副作用：
发热、乏力、疼痛、衰弱、水肿、脓血症、单纯疱疹、念珠菌病、病毒感染和其它病原菌感染。
3.血液系统：
全血减少、骨髓增生低下、贫血、中性粒细胞减少、血小板减少、淋巴细胞减少、紫癜。
4.循环系统：
低血压、高血压、心律失常（心动过速）。
5.中枢和外周神经系统痢疾：头痛眩晕、颤抖。
6.消化系统：
食欲不振、呕吐、腹泻、胃炎、溃疡性口炎、粘膜炎、腹痛、消化不良、便秘。
7.肌肉骨骼：
肌痛、骨痛、背痛、胸痛。
8.精神病变：
失眠、抑郁、嗜睡。
9.呼吸系统：
呼吸困难、咳嗽、支气管炎、肺炎、咽炎、鼻炎、支气管痉挛。
10.皮肤病变：
皮疹、斑丘疹、红斑疹、多汗。
临床应用规程：
1.用药前检测血常规、肝肾功能、血压、心电图、免疫功能。
2.静脉输液30分钟前予以苯海拉明50mg和对乙酰氨基酚650mg预防和减轻输液反应。如果出现严重输液反应，予以氢化可的松200mg.
3.用药前予以磺胺类药物和法昔洛韦及类似药物预防感染，直至停药后2个月或者CD4+细胞达到200000000/l以上。
4.每周检查外周血全血细胞计数，如果出现中性粒细胞减少、血小板减少则需增加检查频次。定基检测CD4+细胞直至达到200000000/l以上。
5.首次出现ANC<250000000/l以上，和/或血小板≤25000000000/L.则需要停药，直至ANC≥500000000/L.和血小板≥50000000000/L。重新用药时，停药时间在7天之内者，剂量同停药前；如停药时间超过7天，则从3mg起用，渐渐加量至10mg,30mg。
6.如果第二次出现ANC<250000000/L,和/或血小板≤25000000000/L，则需要停药，直至ANC≥500000000/L.和血小板≥50000000000/L。重新用药时，停药时间在7天之内者，剂量为10mg/d；如停药时间超过7天，则从3mg/d起用，并只能加量至10mg/d.
7.如果第三次出现ANC<250000000/L,和/或血小板≤25000000000/L，则永久停药。
8.如果患者用药前ANC<500000000/L，和/或血小板≤25000000000/L，则于ANC和/或血小板减少至用药前50%以下时停药。在ANC和/或血小板调高至用药前水平时，重新开始用药。如果停药时间超过7天，则从3mg起用，渐渐加量至10mg/30mg.
9.使用时100ml0.9%无菌生理盐水或者5%葡萄糖稀释，轻轻颠倒混匀。丢掉用过的注射器和剩余药品。每次输液持续时间2小时以上。
贮存：
原药2-8℃(36-46℃)避光保存，严禁冻存。稀释后室温（15-30℃）避光保存，8小时内使用。
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产地国家： 德国
原产地英文商品名:
MabCampath 30MG/ML/VIAL 3VIALS/BOX
原产地英文药品名:
ALEMTUZUMAB
中文参考商品译名:
坎帕斯 30毫克/毫升/瓶 3瓶/盒
中文参考药品译名:
阿仑单抗
生产厂家中文参考译名:
Genzyme GmbH
生产厂家英文名:
Genzyme GmbH
MabCampath 30 mg/ml concentrate for solution for infusion
What is it and how is it used?
MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell). It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
The active substance in MabCampath, alemtuzumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body. In CLL, too many lymphocytes are produced. Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes. As a result of this binding, the lymphocytes die, and this helps to control the CLL.
What do you have to consider before using it?
Do not use MabCampath if you:
are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath see section 6 Further Information. Your doctor will inform you accordingly have an infection have HIV have an active second malignancy are pregnant see also Pregnancy.
Take special care with MabCampath:
When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 Possible side effects?). These effects will gradually reduce as treatment is continued.
You may also be given
steroids, antihistamines or analgesics treatment for fever to help reduce some of the side effects.
The dosage of MabCampath will not be increased until the effects are reduced.
MabCampath treatment may reduce your natural resistance to infections
antibiotics and antivirals may be given to provide you with extra protection.
You will be examined for symptoms of a certain type of viral infection called CMV (cytomegalovirus) during your MabCampath therapy and for at least 2 months afterwards.
Your doctor will monitor you carefully if you
have heart disease or chest pains andor you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse. Patients with these conditions may be at higher risk of a heart attack.
have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function ECG, heart rate, body weight while receiving MabCampath.
have other side effects, most often blood disorders from taking MabCampath. Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.
are over 65 years of age as you may be more intolerant to the medicine than other patients.
You may experience an allergic or hypersensitivity reaction to MabCampath solution, especially against the protein contained in it, while the infusion is given to you. Your doctor will treat you for this, if this happens.
Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommended that you speak to your doctor regarding the irradiation of blood products prior to receiving the transfusion. You should inform your doctor if you experience any unusual symptoms after a transfusion.
MabCampath is not recommended in children below 17 years of age or in patients who have kidney or liver disorders.
Taking other medicines
You should inform your doctor if you are taking or have recently taken any other medicines, even those not prescribed.
In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer agents.
Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment. Speak to your doctor before receiving any vaccinations.
Pregnancy
MabCampath must not be administered to patients who are pregnant, therefore if you:
are pregnant or you think you may be pregnant, you should tell your doctor immediately.
are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.
Breast-feeding
You should stop breast-feeding when you start your treatment and you should not begin breast-feeding again until at least 4 weeks after you have finished your treatment and you have consulted your doctor on the matter.
Driving or using machines
No studies of the effects of MabCampath on the ability to drive and use machines have been performed. However you should be cautious as confusion and sleepiness have been seen. You should ask your doctor for advice.
How is it used?
MabCampath is administered into one of your veins via a drip (see also ?information intended for medical or healthcare professionals).
Each time you are given MabCampath, it will take about 2 hours for all the solution to enter your blood.
MabCampath treatment may continue for up to 12 weeks depending on your progress.
During the first week, your doctor will increase the dose of MabCampath slowly to reduce the possibility of you having side effects and to allow your body to tolerate MabCampath better.
If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce. The doctor will carefully monitor you and decide what are the appropriate amounts of MabCampath to give you during your whole treatment period.
If more MabCampath is given than recommended
Your doctor will treat you, as appropriate, if you have any side effects.
What are possible side effects?
Like all medicines, MabCampath can cause side effects, although not everybody gets them.
Your doctor may give you other medicines or change your dose to help reduce any side effects (see section 2 Take Special care).
Serious side effects, including difficulty in breathing, inflammation of the lungs, extreme shortness of breath, fainting, heart attack, low red blood cell and low blood platelet levels, infections, bleeding in the brain (intracranial haemorrhage) have occurred with fatal outcome. Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal. Tell your doctor immediately if you experience any of these side effects.
In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.
Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):
Usually one or more of these effects happen during the first week after the start of treatment:
fever, shiveringchills, sweating, nausea feeling sick, vomiting, low blood pressure, low whitered blood cell levels, infections including pneumonia and blood poisoning, irritation andor blistering of the mouth region, low blood platelet levels, tiredness, rash, itching, red raised lesions on the skin, shortness of breath, headache, diarrhoea and loss of appetite.
They are usually only mild or moderate problems and they gradually diminish during the course of treatment.
Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):
high blood pressure, fast or slow heart rate, feeling your heart racing, blood vessel spasm becoming red in the face, bruising of the skin taste changes decreased sense of touch dizziness, sensation of spinning, fainting, shaking or trembling movements, feeling restless eye inflammation e.g. conjunctivitis pins and needles or burning sensation of the skin abnormal liver function, constipation, indigestion, passing abdominal gas inflammation, irritation andor tightness of the lungs, throat andor sinuses, too little oxygen reaching the body organs, coughing, coughing up of blood abdominal bleeding e.g. in the stomach and intestine injection site reactions including redness, swelling, pain, bruising, inflammation generally feeling unwell, weakness, pain in various parts of the body muscle, back, chest, bones, joints, stomach and intestine weight loss, dehydration, thirst, swelling of the lower legs, temperature change sensation, low calcium or sodium blood levels flu-like symptoms abscess, skin redness or allergic skin reaction, blistering of the skin confusion, anxiety, depression, sleeplessness
Uncommon side effects (affects 1 to 10 in every patients in 1,000 patients treated in clinical trials):
bone marrow disorders heart disorders heart stopping, heart attack, heart congestion, irregular heart rate blood disorders abnormal clotting, decreased protein, low potassium levels high blood sugar, worsening diabetes bleeding and inflammation of the gums, blisters on the tongue, nosebleeds fluid in the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal findings in the lungs, lymph gland disorders nervousness, abnormal thinking swelling around the eye ringing sound in the ears, deafness hiccups, burping hoarseness abnormal kidney function paralysis of the small bowel impotence unsteadiness, increased muscle tone unusual increased or altered sensitivity to touch abnormal sensationfeeling or movement pain when urinating, decreases in urine flow, increased frequency in urination, blood in urine, incontinence 58
tumour lysis syndrome a metabolic disorder, which may begin with pains in the side and blood in the urine
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use MabCampath after the expiry date (EXP) which is stated on the outer carton and the vial label. The expiry date refers to the last day of that month.
Store in a refrigerator (2-C-8-C).
Do not freeze.
Store in the original packaging in order to protect from light.
MabCampath should be used within 8 hours after dilution. During that time the solution may be stored at 15°C-30°C or refrigerated.
Do not use MabCampath if you notice any signs of particulate matter or discolouration prior to administration.
Medicines should not be disposed of via wastewater or household waste. Your healthcare professional will dispose of medicines no longer required. These measures will help protect the environment.
Further information
What MabCampath contains
The active substance is alemtuzumab.
One ml contains 30 mg of alemtuzumab. Each vial contains 30 mg of alemtuzumab.
The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
What MabCampath looks like and contents of the pack
MabCampath is a concentrate for solution for infusion that comes in a glass vial.
Each pack of MabCampath contains 3 vials.
Marketing Authorisation Holder
Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Manufacturer
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom
Genzyme Ireland Limited., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
ItaliaMalta Genzyme Srl ItaliaItalja, Tel 39 059 349 811 BelgiëBelgiqueBelgien Luxemburg Luxembourg Genzyme Belgium N.V., TélTel 32 2 714 17 11
. 359 2 971 1001 Magyarország Genzyme Europe B.V. Képviselet Tel 36 1 310 7440
Nederland Genzyme Europe B.V., Tel 31 35 699 1200 eská RepublikaSlovenská Republika Slovenija Genzyme Czech s.r.o. Tel 420 221 722 511
Österreich Genzyme Austria GmbH, Tel 43 1 774 65 38 DanmarkNorgeSverigeSuomiFinland Ísland Genzyme AS, DanmarkTanskaDanmörk, TlfPuh.Sími 45 32712600
Deutschland Genzyme GmbH, Tel 49 610236740 PolskaEestiLatvijaLietuva Genzyme Polska Sp. z o.o. PoolaPolijaLenkija, Tel 48 22 246 0900
Genzyme Hellas Ltd. 30 210 99 49 270 Portugal Genzyme Portugal S.A. Tel 351 21 422 0100
España Genzyme, S.L.U., Tel 34 91 6591670 România Genzyme Biopharma SRL Tel 40 212 43 42 28
France Genzyme S.A.S, Tél 33 0 825 825 863 United KingdomIreland Genzyme Therapeutics Ltd. United Kingdom, Tel 44 1865 405200
This leaflet was last approved in
The following information is intended for medical or healthcare professionals only:
During the first week, 3 mg of MabCampath is given on Day 1, then 10 mg on Day 2 and then 30 mg on Day 3, depending on tolerability. MabCampath will be given at 30 mg three times per calendar week on alternate days, for up to 12 weeks.
The vial contents should be inspected for particulate matter and discolouration prior to administration. If particulate matter is present or the solution is coloured, then the vial should not be used.
MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampathshould be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light. The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion. The bag should be inverted gently to mix the solution. Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Other medicinal products should not be added to the MabCampath infusion solution or simultaneously infused though the same intravenous line.
Caution should be exercised in the handling and preparation of the MabCampath solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. Women who are pregnant or trying to become pregnant should not handle MabCampath.
Procedures for proper handling and disposal should be observed. Any spillage or waste material should be disposed of by incineration. |
