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当前位置:药商新药自助发布 >> 马法兰片(爱克兰、美法仑、Melphalan、Alkeran)

马法兰片(爱克兰、美法仑、Melphalan、Alkeran)

ID号:653  发布日期: 2013-05-10    截止日期: 不限  地区:全国 浏览次数:15

马法兰、爱克兰、Alkeran
【别名】
左旋苯丙氨酸氮芥、马尔法兰、美法仑。
【英文名】
Alkeran,Melphalan,L-Sarcolysin,L-PAM.
【作用特点】
本品为溶肉瘤素的左旋体,较消旋体溶内瘤素作用强。口服吸收良好,均匀分布体内各脏器,但不能透过血——脑脊液屏障。
【功能主治】
本品可用与多种肿瘤,在单一化疗及联合化疗中,为多发性骨髓瘤的首选药。对精原细胞瘤、乳腺癌、卵巢癌、慢性白血病、真性红细胞增多症,恶性淋巴瘤、儿童晚期神经母细胞瘤、甲状腺癌有效。动脉灌注治疗肢体恶性肿瘤如:恶性黑色素瘤、软组织肉瘤和骨肉瘤有较好疗效,偶用于治疗某些自身免疫性疾病以及防止器官移植时的排异反应。
【用法与用量】
因为美法仑具有骨髓抑制作用,故在治疗期间内,必需频繁监测血象(血细胞计数),必要时暂缓用药或调整剂量。或遵医嘱。
成年口服用药:
口服美法仑的吸收是易变的,为了确保达到可能的治疗水平。应谨慎增加剂量,直到出现出现骨髓抑制作用为止。
多发性骨髓瘤:
有多种治疗方案,应详细查阅文献,美法仑与强的松合用,可能比单用美法仑更有效,通常联合用药间歇进行。虽然延长连续用药的优越性仍未证实,但典型的剂量是每日每公斤体重0.15毫克分次服用共四天,六周后重复疗程。对治疗有反应者延长疗程超过一年不会改进疗效。
卵巢腺癌:
典型的治疗方案是每日每公斤体重0.2毫克共五天,每4~8周或当外周血象恢复时重复疗程;当出现骨髓毒性时应减低剂量。
晚期乳腺癌:
口服美法仑每日每公斤体重0.15毫克或每平方米体表面积6毫克,共5日,每六周重复疗程,也可使用美法仑静脉注射治疗。
真性红血球增多症:
诱导缓解期,每日用6~10毫克共5~7天,之后可每日2~4毫克直至能满意地控制症状,维持剂量可每周一次用2~6毫克,其间必须对患者仔细谨慎地进行血液学控制,以血细胞计数结果为依据,适当调整剂量。
肾功能不全患者:
依据目前建立的药动学数据,对中度至重度肾功能不全患者口服美法仑,并非绝对推荐降低剂量,但起始剂量需谨慎地降低。
【不良反应】
美法仑最常见的不良反应是骨髓抑制,可导致白细胞和血小板减少。高达30%的病人在口服常规剂量美法仑后,出现胃肠道不适,包括恶心和呕吐,使用常规剂量美法仑罕见胃炎发生,而接受高剂量静注美法仑有增加腹泻、呕吐和胃炎发生的可能。有报道称使用环磷酰胺前驱治疗可降低美法仑诱导的胃肠道损伤。偶有患者接受数月以上治疗,出现美法仑过敏反应,例如:荨麻疹、水肿、皮疹和过敏性休克,另有二例出现心脏停顿,但此副作用是否因美法仑引起仍未证实,斑丘疹和搔痒也偶有报道,曾有病例显示,在使用美法仑后,出现肺纤维化和出血性贫血,有脱发的报道,但不普遍。
【禁忌证】
对本品有过敏史及妊娠和哺乳期妇女禁用,近期内做过化疗、放疗而有白细胞减少者不宜用药。
【注意事项】
1. 肾功能不良着慎用。
2. 因本品可使血中尿素氮升高,故使用时应监测血象和血中尿素氮水平,当中性粒细胞低于2×109 /L时应停药。
【相互作用】
萘啶酸并用静脉滴注本品高剂量,会令儿童因出血性肠炎而导致死。骨髓移植者,由于术前用高剂量静脉注射本品来控制病情,术后再接受环磷酰胺防止受移植者的身体排斥新骨髓,可引起肾功能缺损。
【制剂规格】
片剂:2mg、5mg
粉针剂:50mg
【储藏】
片剂:2-8 oC一下保持干燥。
针剂:避光贮存于30 oC一下。马法兰应用于多发性骨髓癌病的各种化疗方案参考,各方案的使用因病人的病情的不同需在医生的指导下使用,成人体表面积一般约1.5m2 且MP方案是马法兰方案中唯一可以口服的方案,其优点是便于在家治疗 。
【厂家】
英国葛兰素史克

Product Description
Alkeran is used for:
Treating certain types of cancer.
Alkeran is an alkylating agent. It works by destroying resting and rapidly dividing tumor cells in certain types of cancer.
Do NOT use Alkeran if:
• you are allergic to any ingredient in Alkeran
• you have used Alkeran before and it did not work
• you are taking nalidixic acid
Contact your doctor or health care provider right away if any of these apply to you.
Before using Alkeran :
Some medical conditions may interact with Alkeran . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are a female of childbearing age
• if you have bone marrow depression, an infection, low white blood cell count, kidney problems, shingles, or chickenpox, or are undergoing radiation therapy
Some MEDICINES MAY INTERACT with Alkeran . Tell your health care provider if you are taking any other medicines, especially any of the following:
• Cisplatin because the actions and side effects of Alkeran may be increased
• Carmustine (BCNU), cyclosporine, or nalidixic acid because serious lung, kidney, or intestinal problems may occur
This may not be a complete list of all interactions that may occur. Ask your health care provider if Alkeran may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Alkeran :
Use Alkeran as directed by your doctor. Check the label on the medicine for exact dosing instructions.
• Alkeran is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Alkeran at home, carefully follow the injection procedures taught to you by your health care provider.
• If Alkeran contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Use Alkeran as soon as it is mixed. Do not keep Alkeran after it has been mixed. Any leftover medicine or supplies used with Alkeran should be placed in a plastic bag and disposed of as instructed by your doctor, nurse, or pharmacist.
• If Alkeran accidentally spills on your skin, wash it off immediately with soap and water. Clean any areas (tables, counters) where Alkeran may have spilled or sprayed.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Alkeran , contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Alkeran.
Important safety information:
• If nausea, vomiting, or loss of appetite occurs, ask you doctor or pharmacist for ways to lessen these effects.
• Alkeran may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection including fever, sore throat, rash, or chills.
• Check with your doctor before having vaccinations while you are using Alkeran .
• Alkeran may reduce the number of blood cells that are needed for clotting. To prevent bleeding, avoid situations where bruising or injury may occur.
• LAB TESTS, including complete blood cell counts, may be necessary to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Alkeran with extreme caution in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Alkeran has been shown to cause harm to the fetus. Avoid becoming pregnant while taking Alkeran . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Alkeran during pregnancy. It is unknown if Alkeran is excreted in breast milk. Do not breast-feed while taking Alkeran.
Possible side effects of Alkeran :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; hair loss; nausea; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine or stools; chest pain; dark urine; diarrhea; fainting; fatigue; fever or chills; irregular or absent menstrual periods; joint pain; lower back or side pain; numbness of an arm or leg; pain, swelling, or redness at the injection site; persistent cough; persistent nausea or vomiting; shortness of breath; sore throat; sores on the mouth or lips; stomach pain; sudden severe headache; swollen feet or lower legs; unusual bruising or bleeding; unusual lumps or growths; unusual tiredness; weight loss; yellowing eyes and skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include diarrhea; drowsiness; intestinal bleeding; paralysis; seizures; severe nausea and vomiting.
Proper storage of Alkeran :
Store Alkeran at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alkeran out of the reach of children and away from pets.
General information:
• If you have any questions about Alkeran , please talk with your doctor, pharmacist, or other health care provider. • Alkeran is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Alkeran . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
2mg 25 tablets
Ürün Grubu
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