爱克兰注射剂ALKERAN injection(MELPHALAN)

药店国别:

产地国家:美国

处方药:是

所属类别: 50毫克/瓶

包装规格: 50毫克/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:GLAXOSMITHKLINE

原产地英文商品名:ALKERAN injection 50mg vial

原产地英文药品名:MELPHALAN

中文参考商品译名:爱克兰 注射剂 50mg vial

中文参考药品译名:美法仑

曾用名:

简介:马法兰的部分中文处方资料(仅供参考)马法兰、爱克兰、Alkeran

【别名】

左旋苯丙氨酸氮芥、米尔法兰、马尔法兰、美法仑。

【厂家】

英国葛兰素史克

【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30oC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 。

爱克兰注射剂英文版说明书

MelphalanOther names: L-PAM, L-Sarcolysin, Phenylalanine MustardChemocare.com uses generic names in all descriptions of drugs.Alkeran is the trade name for Melphalan. L-PAM, L-Sarcolysin, and Phenylalanine Mustard are other names for Melphalan. In some cases, health care professionals may use the trade name Alkeran or other names L-PAM, L-Sarcolysin, and Phenylalanine Mustard when referring to the generic drug name Melphalan.Drug type: Alkeran is an anti-cancer (“antineoplastic” or “cytotoxic”) chemotherapy drug. Alkeran is classified as an “alkylating agent.” (For more detail, see “How this drug works”section below).—————————————————————————-What this drug is used for:Multiple myelomaOvarian cancerNeuroblastomaRhabdomyosarcomaBreast cancerUsed in some conditioning regimens prior to bone marrow transplantNote: If a drug has been approved for one use, physicians may electto use this same drug for other problems if they believe it may be helpful.—————————————————————————How this drug is given:As a pill by mouth. Tablets come in a 2mg size.Take medication on an empty stomach (1 hour before to 2 hours after meals).As an injection or infusion into the vein (intravenous, IV).The amount of melphalan that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.—————————————————————————-Side effects:Important things to remember about the side effects of melphalan:Most people do not experience all of the side effects listed.Side effects are often predictable in terms of their onset and duration.Side effects are almost always reversible and will go away after treatment is complete.There are many options to help minimize or prevent side effects.There is no relationship between the presence or severity of side effects and the effectiveness of the medication.The side effects of melphalan and their severity depend on how much of the drug is given. In other words, high doses may produce more severe side effects).The following side effects are common (occurring in greater than 30%) for patients taking melphalan:Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding.This effect may be prolonged and cumulative.Nausea and vomiting. (mild with regular dosing, can be severe with high-dose therapy)These side effects are less common side effects (occurring in about 10-29%) of patients receiving melphalan:Allergic reaction. (rare with pill form, happen in about 10% of patients treated with IV form).Mouth sores. (mild with regular dosing, can be severe with high-dose therapy).Diarrhea. (mild with regular dosing, can be severe with high-dose therapy).Loss of fertility. Meaning, your ability to conceive or father a child may be affected by melphalan.Discuss this issue with your health care provider.Hair loss. (rare with regular dosing, common with high-dose used for bone marrow transplant).Nephrotoxicity (see kidney problems): Uncommon with regular doses, seen when melphalan is given in high-doses used for bone marrow transplant.Arrythmias (see heart problems): Uncommon with regular doses, seen when melphalan is given in high-doses used for bone marrow transplant.—————————————————————————-Delayed effects:There is a slight risk of developing a blood cancer such as leukemia or myelodysplasia after taking melphalan.Talk to your doctor about this risk.Nadir: Meaning low point, nadir is the point in time between chemotherapy cycles in which you experience low blood counts.Onset: 7 daysNadir: 8-10 days (white blood cells), 27-32 days (platelets).Recovery: 42-50 daysNot all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.—————————————————————————-When to contact your doctor or health care provider:Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:Fever of 100.5o F (38o C) or higher, chills (possible signs of infection)The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:Nausea (interferes with ability to eat and unrelieved with prescribed medication)Vomiting (vomiting more than 4-5 times in a 24 hour period)Diarrhea (4-6 episodes in a 24-hour period)Unusual bleeding or bruisingBlack or tarry stools, or blood in your stools or urineExtreme fatigue (unable to carry on self-care activities)Mouth sores (painful redness, swelling or ulcers)Yellowing of the skin or eyes.Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.Always inform your health care provider if you experience any unusual symptoms.—————————————————————————-Precautions:Before starting melphalan treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).Do not receive any kind of immunization or vaccination without your doctor’s approval while taking melphalan.Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (melphalan may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to thefetus).For both men and women: Do not conceive a child (get pregnant) while taking melphalan. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.Do not breast feed while taking this medication.—————————————————————————-Self-care tips:If taking melphalan pills take on an empty stomach 1 hour before or 2 hours after meals.Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.You may be at risk of infection so try to avoid crowds or people with colds and those not feeling well, and report fever or any other signs of infection immediately to your health care provider.Wash your hands often.To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.Use an electric razor and a soft toothbrush to minimize bleeding.Avoid contact sports or activities that could cause injury.This medication when taken as pills causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals.Sucking on lozenges and chewing gum may also help.Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.Get plenty of rest.Maintain good nutrition.If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.—————————————————————————-Monitoring and testing:You will be checked regularly by your health care professional while you are taking melphalan, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such asyour kidneys and liver) will also be ordered by your doctor.—————————————————————————-How this drug works:Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. “Normal” cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability.Cancer cells no longer have the normal checks and balances in place that control and limit cell division.The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division.Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division.If the cells are unable to divide, they die.The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink.They also induce cell suicide(self-death or apoptosis).Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific.Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific.The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective.This is why chemotherapy is typically given in cycles.Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The “normal” cells will grow back and be healthy but in the meantime, side effects occur. The “normal” cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss.Different drugs may affect different parts of the body.Melphalan is classified as an alkylating agent.Alkylating agents are most active in the resting phase of the cell.These drugs are cell cycle non-specific. There are several types of alkylating agents:Mustard gas derivatives: Mechlorethamine, Cyclophosphamide, Chlorambucil, Melphalan, and Ifosfamide.Ethylenimines: Thiotepa and Hexamethylmelamine.Alkylsulfonates: Busulfan.Hydrazines and Triazines: Altretamine, Procarbazine, Dacarbazine and Temozolomide.Nitrosureas: Carmustine, Lomustine and Streptozocin.Nitrosureas are unique because, unlike most chemotherapy, they can cross the blood-brain barrier.They can be useful in treating brain tumors.Metal salts: Carboplatin, Cisplatin, and Oxaliplatin.—————————————————————————-Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments.The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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