Mylotarg【商 品 名】
Mylotarg
【通 用 名】
gemtnzumab
【中 文 名】
麦罗塔
【开发公司】
惠氏、Wyeth CellTech
【销售公司】
惠氏、Wyeth CellTech
【药物种类】
Umab人流抗体；
化疗药物卡奇霉素以gemtuzumab为载体。
【靶 点】
CD—33抗体。
【适 应 症】
急性髓性白血病，骨髓增生异常综合症。
【临床阶段】
美国FDA2002年上市。
【作用机制】
CD33 单抗与卡奇霉素（Calicheamicin）偶合，通过单抗将与CD33结合内化进入肿瘤细胞，在溶酶体中将药物释放出发挥作用。（注，肿瘤细胞产生耐药后，此药无效）
【用量用法】
【贮藏条件】
避光2℃—8℃，避免剧烈摇晃。
【规 格】
针剂。
【剂 型】
5mg×1支/盒。
日本核准GemtuzumabOzogamicin(Mylotarg)治疗CD33阳性反应的AML
7月25日，日本厚生省勞工部及健康福利單位核准gemtuzumab ozogamicin靜脈注射液(Mylotarg，由日本惠氏藥廠製造)，用於治療年齡為60歲以上、無法進行化療治療的CD33陽性反應急性脊椎白血病(AML)。 7月25日，日本厚生省劳工部及健康福利单位核准gemtuzumabozogamicin静脉注射液(Mylotarg，由日本惠氏药厂制造)，用于治疗年龄为60岁以上、无法进行化疗治疗的CD33阳性反应急性脊椎白血病(AML)。
Calichaemicin共軛人化單株抗體標的治療，是由造血細胞顯示的CD33抗原，Calichaemicin的衍生物由綜合體內在化和DNA在較小的溝槽結合所釋放，結果導致DNA雙股被破壞，進而使細胞死亡。 Calichaemicin共轭人化单株抗体标的治疗，是由造血细胞显示的CD33抗原，Calichaemicin的衍生物由综合体内在化和DNA在较小的沟槽结合所释放，结果导致DNA双股被破坏，进而使细胞死亡。
此藥的核准，基於從單一群體研究的資料顯示，用gemtuzumab治療157名60歲以上CD33陽性AML復發病人產生24%的緩解率。 此药的核准，基于从单一群体研究的资料显示，用gemtuzumab治疗157名60岁以上CD33阳性AML复发病人产生24%的缓解率。
全部的緩解率定義為，從血中白血球leukemic blasts缺乏達到12%、5%或少於5%在骨髓，血紅素9 g/Dl或以上，血小板數100,000 μL或以上，紅血球及血小板transfusion independence；其餘12%之60歲和較年輕者有產生完全(13%)和部份(14%)反應，對所有年齡層皆有的症狀緩解反應為中位數時間60天，所有中位存活時間為12.4個月。 全部的缓解率定义为，从血中白血球leukemicblasts缺乏达到12%、5%或少于5%在骨髓，血红素9g/Dl或以上，血小板数100,000μL或以上，红血球及血小板transfusionindependence；其余12%之60岁和较年轻者有产生完全(13%)和部份(14%)反应，对所有年龄层皆有的症状缓解反应为中位数时间60天，所有中位存活时间为12.4个月。
反應速率隨著其他細胞毒素的服用法而逐漸降低，服用gemtuzumab的限制是，老年患者對更具侵略性的治療無法承受。 反应速率随着其他细胞毒素的服用法而逐渐降低，服用gemtuzumab的限制是，老年患者对更具侵略性的治疗无法承受。
GEMTUZUMAB OZOGAMICIN (Systemic)
Some commonly used brand names are:
In the U.S.—
Mylotarg
Category
Monoclonal antibody
antineoplastic
Description
Gemtuzumab ozogamicin (gem-TOO-ze-mab oh-zoh-GAM-ih-sin)is a monoclonal antibody. It is used to treat a certain type of leukemia which has recurred in patients who are 60 years of age or older. Gemtuzumab ozogamicin is an alternative to chemotherapy for these patients.
This medicine is to be administered only by or under the immediate supervision of your doctor. It is available in the following dosage form:
Parenteral
Injection (U.S.)
Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gemtuzumab ozogamicin, the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gemtuzumab ozogamicin, anti-CD33 antibody, or calicheamicin derivatives. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.
Pregnancy—Gemtuzumab ozogamicin may cause harm to the fetus when administered during pregnancy. There are no adequate, well-controlled studies in pregnant women. You should avoid becoming pregnant while receiving gemtuzumab ozogamicin. However, this medicine may be needed in serious diseases or other situations that threaten the mother\'s life. Be sure you have discussed this with your doctor.
Breast-feeding—It is not known if gemtuzumab ozogamicin passes into the breast milk. However, due to potential serious side effects in nursing babies from gemtuzumab ozogamicin, a decision should be made whether to stop nursing or to stop the drug.
Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of gemtuzumab ozogamicin in children with use in other age groups.
Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of gemtuzumab ozogamicin in the elderly with use in other age groups. However, laboratory values associated with liver problems were observed more often in patients 60 years old or older.
Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking gemtuzumab ozogamicin, it is especially important that your doctor or pharmacist know if you are taking any of the following:
Alpha interferons (e.g., Intron A, Roferon-A) or
Amphotericin B by injection (e.g., Fungizone) or
Antineoplastics, other (cancer medicine) or
Antithyroid agents (medicine for overactive thyroid) or
Azathioprine (e.g., Imuran) or
Chloramphenicol (e.g., Chloromycetin) or
Colchicine or
Cyclophosphamide (e.g., Cytoxan) or
Flucytosine (e.g., Ancoban) or
Ganciclovir (e.g., Cytovene) or
Mercaptopurine (e.g., Purinethol)
Methotrexate (e.g., Rheumatrex)
Plicamycin (e.g., Mithracin)
Zidovudine (e.g., AZT, Retrovir)—Concurrent use of these agents with gemtuzumab ozogamicin increases the risk of infection
Other medical problems—The presence of other medical problems may affect the use of gemtuzumab ozogamicin. Make sure you tell your doctor if you have any other medical problems, especially:
Chickenpox (including recent exposure) or
Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body
High blood cell counts (peripheral blasts)—Risk of side effects increased by gemtuzumab ozogamicin
Infection—Risk increased by gemtuzumab ozogamicin
Liver disease—May be worsened by gemtuzumab ozogamicin
Stem-cell transplant—Risk of side effects increased by gemtuzumab ozogamicin
Proper Use of This Medicine
Dosing—The dose of gemtuzumab ozogamicin will be different for different patients. The dose that is used may depend on a number of things, including your size. Gemtuzumab ozogamicin is usually given by a doctor or nurse in the hospital or outpatient clinic. If you have any questions about the proper dose of gemtuzumab ozogamicin, ask your doctor.
Precautions While Using This Medicine
It is very important that your doctor check you at regular visits to make sure this medication is working properly and to check for any unwanted effects.
While you are being treated with gemtuzumab ozogamicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor\'s approval. Gemtuzumab ozogamicin may lower your body\'s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.
Gemtuzumab ozogamicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
If you can, avoid people with infections.Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
Avoid contact sports or other situations where bruising or injury could occur.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
More common
Black, tarry stools; bloating or swelling of face, arms, hands, lower legs, or feet; blood in stools or urine; bluish color of fingernails, lips, skin, palms, or nail beds; blurred vision; burning or stinging of skin; chest pain; chills; confusion; convulsions (seizures); cough or hoarseness; cracked lips; decrease or increase in urine; diarrhea; difficulty in swallowing; dizziness; dry mouth; excessive sweating; fainting; fast or slow heartbeat; fatigue; fever; flushed, dry skin; fruit-like breath odor; headache, sudden and severe; heavy, nonmenstrual vaginal bleeding; inability to speak; increased thirst or hunger; irregular heartbeat; large, flat , blue or purplish patches in the skin; light-headedness; lower back, joint, or side pain; loss of appetite; mood changes; muscle pain or cramps; muscle trembling or twitching; nausea or vomiting; numbness or tingling in hands, feet, or lips; pain, difficulty, or burning while urinating; painful cold sores or blisters on lips, nose, eyes, or genitals; pale skin; persistent bleeding or oozing from puncture sites, mouth, or nose; palpitations; pinpoint red spots on skin; pounding in the ears; red or purplish patches or spots on skin; rapid, shallow breathing; rapid weight gain; severe or continuing dull nervousness; shortness of breath; slurred speech; small red or purple spots on skin; sneezing; sore throat; sores, ulcers, or white spots on lips, tongue, or inside mouth; stomachache; sweating; swelling or inflammation of the mouth, face, fingers, feet, or lower legs; swollen glands; temporary blindness; tightness in chest; tingling of hands or feet; troubled breathing, exertional; unexplained nosebleeds; unusual bleeding or bruising; unusual tiredness or weakness; unusual weight gain or loss; weakness in arm and/or leg on one side of the body, sudden and severe; wheezing; yellow eyes or skin
Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.
More common
Acid or sour stomach; belching; difficulty in moving; dry, red, hot, or irritated skin; full or bloated feeling or pressure in the stomach; heartburn; indigestion; lack or loss of strength; muscle pain or stiffness; pain, swelling, or redness in joints; runny, stuffy nose; stomach discomfort upset; swelling of abdominal or stomach area; trouble in sleeping
Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.
发布时间：2007年07月04日