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当前位置:药品说明书与价格首页 >> 肿瘤 >> 直肠癌/结肠癌 >> 药品推荐 >> 奥沙利铂注射粉剂(Oxaliplatin medac 5 mg/ml)

奥沙利铂注射粉剂(Oxaliplatin medac 5 mg/ml)

2013-06-29 11:29:01  作者:新特药房  来源:互联网  浏览次数:123  文字大小:【】【】【
简介:部份中文奥沙利铂处方资料(仅供参考)英文药名:Oxaliplatin 药品别名:Eloxatin 药物剂型 粉针剂:每瓶装本品15mg,50mg,100mg和200mg。 药理作用 本品是第三代铂类化合物。以DNA为靶作用部位,铂离子与DNA链 ...

部份中文奥沙利铂处方资料(仅供参考)
英文药名:Oxaliplatin
药品别名:Eloxatin
药物剂型
粉针剂:每瓶装本品15mg,50mg,100mg和200mg。
药理作用
本品是第三代铂类化合物。以DNA为靶作用部位,铂离子与DNA链形成交联,从而阻断其复制和转录。然而本品和顺铂(DDP)与DNA结合动力学特点有明显差别。顺铂的DNA结合动力学特点呈双相,快相结合需15分钟,慢相结合需4~8小时,而本品则15分钟内完全与DNA结合。本品可抑制多种大鼠肿瘤,如L1210和L388白血病,Lewis肿瘤,B16黑色素等效果均优于顺铂,对耐顺铂的L1210肿瘤也有效。本品与多柔比星合用有较高活性,与甲氨蝶呤、5-FU和长春碱类等药物合用有协同作用。
药动学
本品以130mg/m2的剂量连续滴注2小时,其血浆总铂峰值达(5.1±0.8)µg/mL,曲线下面积为(189±45)µg·h/mL。静脉给药2小时后,所给药物15%仍存在于循环系统中,其余85%迅速分布于组织中(肾中最多,其次为脾、膀胱、胃、胆汁、小肠),经尿液清除。重复给药未见有蓄积现象。本品经由非酶途径降解成几种不同活性代谢产物和多种无活性结合产物,大多均经尿液排泄。
适应证
对乳腺癌、卵巢癌、黑色素瘤和睾丸癌等有抑制作用,和5-氟脲嘧啶(5-FU)及亚叶酸钙合用,用于治疗转移性结肠癌、直肠癌。
禁忌证
肾功能严重受损者、中性白细胞计数小于2×109/L和(或)血小板计数小于100×109/L的骨髓抑制患者、外周感觉神经病患者、妊娠及哺乳期妇女禁用。
注意事项
每次给药前应进行神经学检查和全血细胞计数检查,发现异常时应减少用药量。肾脏或肝功能障碍者、严重骨髓抑制者等慎用。
不良反应
常见不良反应为感觉异常或肢端麻木、恶心、呕吐、腹泻、黏膜炎、血液系统毒性;血红蛋白、白细胞、中性粒细胞、血小板等均不同程度下降与减少;耳毒性较轻,发热、轻微肝功能异常、暂时性视力减退等。
用法用量
静脉滴注,20~25mg/(m2·d),与5-FU[600~700mg/(m2·d)]和亚叶酸钙(300mg/m2·d)合用治疗转移性结肠癌,每3周重复1次,在5-FU给药前2~6小时经静脉注射。
专家点评
一项在未曾治疗的转移性结肠直肠癌患者中进行的临床研究表明,使用本品85mg/m2,每2周1次,和5-FU和亚叶酸钙联用,与单用5-FU和亚叶酸钙进行比较,反应率提高2倍以上,从22%增至49%。患者无进展的存活时间从6个月延长至8.2个月。生活质量评分两组间无差异,但本品组恶心、呕吐、腹泻和黏膜炎的发生率较高,但重复给药时腹泻可减轻。本品的神经毒性呈剂量限制性。在5-FU治疗有效的患者中进行的另一项Ⅱ期临床显示,在相同的5-FU治疗的方案中加入本品,可使至少30%经原方案治疗6个月无好转的患者获得20%的反应率。
Oxaliplatin medac 5mg/ml powder and concentrate for solution for infusion
One vial with powder for solution for infusion contains 50 mg, 100mg or 150mg oxaliplatin.
One ml of reconstituted concentrate solution contains 5 mg oxaliplatin.
50 mg vial : Each vial contains 50mg oxaliplatin for reconstitution in 10 ml of solvent .
100 mg vial : Each vial contains 100mg oxaliplatin for reconstitution in 20 ml of solvent.
150 mg vial : Each vial contains 150mg oxaliplatin for reconstitution in 30 ml of solvent.
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:
1.Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumour;
2.Treatment of metastatic colorectal cancer.
Pack sizes:
50 mg N1; 100 mg N1; 150 mg N1
One ml of concentrate contains 5 mg oxaliplatin.
10 ml of concentrate for solution for infusion contains 50 mg of oxaliplatin.
20 ml of concentrate for solution for infusion contains 100 mg of oxaliplatin.
40 ml of concentrate for solution for infusion contains 200 mg of oxaliplatin.
Oxaliplatin in combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for:
1.Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumour;
2.Treatment of metastatic colorectal cancer.
Pack sizes:
10 ml N1; 20 ml N1; 40 ml N1

Oxaliplatin is an investigational chemotherapy medicine used to treat certain types of cancer by destroying cancerous cells. Oxaliplatin is also known in other countries by its brand names Eloxatin and Transplatine. Other names for oxaliplatin include Oxalatoplatin, Oxalatoplatinum, 1-OHP or L-OHP, PR-54780.
Purpose
Oxaliplatin is not yet approved by the Food and Drug Administration in the United States. It is commercially available in Europe. Oxaliplatin has been used to treat metastatic colorectal cancer, and advanced ovarian cancer and has been tested with some results in head and neck cancers, skin cancer, lung cancer, and non-Hodgkin's lymphomas.
Description
Oxaliplatin is an analog of cisplatin, the first successful platinum-containing anticancer drug. It is one of the so-called DACH (1,2-Diamincyclohexane)-containing platinum complexes that exhibited activity in Murine L1210 leukemia tumor models possessing acquired resistance to cisplatin. These platinum-containing drugs interfere with the genetic material, or DNA, inside the cancer cells and prevent them from further dividing and growing more cancer cells.
Oxaliplatin has been used to treat cancer in clinical trials in the United States. It can be used alone to treat cancer or in combination with other chemotherapy medicines. Some of the other chemotherapy medicines that Oxaliplatin is commonly combined with include the drugs fluorouracil and calcium leucovorin and used in combination with cisplatin.
Recommended Dosage
An oxaliplatin dose can be determined using a mathematical calculation that measures a person's body surface area (BSA). This number is dependent upon a patient's height and weight. The larger the person the greater the body surface area. Body surface area is measured in the units known as square meter (m2). The body surface area is calculated and then multiplied by the drug dosage in milligrams per square meter (mg/m2). This calculates the actual dose a patient is to receive.
Oxaliplatin is a clear colorless solution administered by an infusion into a vein. The infusion time period can vary. It can be given as a one-time dose every three weeks infused over 20 minutes up to six hours. There are multiple doses of oxaliplatin used in clinical trials dependent upon the type of cancer being treated. The doses have ranged from 20 mg per square meter daily for several days to 130 mg per square meter for one day every three weeks. Listed below are example dose recommendations for colorectal cancer and ovarian cancer.
To Treat Metastatic Colorectal Cancer
Oxaliplatin alone has been given at 130 mg per square meter administered into a vein for one day every three weeks. This did not have very good response rates.
Oxaliplatin is also given at a dose of 130 mg per square meter administered into a vein as a two- to six-hour infusion for one day every three weeks in combination with the chemotherapy drug fluorouracil.
To Treat Advanced Ovarian Cancer
Oxaliplatin alone has been given at 59 mg to 130 mg per square meter administered into a vein for one day as a 20-minute or two-hour infusion every three weeks.
Combination treatment of oxaliplatin at a dose of 130mg per square meter administered into a vein as a two-hour infusion every three weeks. The oxaliplatin must immediately follow a two hour-infusion of the chemotherapy drug cisplatin at a dose of 100 mg square meter every three weeks.
Precautions
When receiving the drug oxaliplatin it is important to avoid cold food and drinks.
Blood counts will be monitored regularly while on oxaliplatin therapy. During a certain time period after receiving oxaliplatin there is an increased risk of getting infections. Caution should be taken to avoid unnecessary exposure to germs.
Patients with a known previous allergic reaction to chemotherapy drugs should tell their doctors.
Patients who may be pregnant or trying to become pregnant should tell their doctors before receiving oxaliplatin.
Chemotherapy can cause men and women to be sterile or not able to have children.
Patients with existing or previous tingling or numbness in their hands and feet should tell their doctor before receiving oxaliplatin.
Patients should check with their doctors before receiving live virus vaccines while on chemotherapy.
Side Effects
One of the most common side effects from receiving oxaliplatin is nausea and vomiting. Patients will be given medicines known as antiemetics before receiving oxaliplatin to help prevent or decrease this side effect. Diarrhea and mouth sores have also been known to occur. The chance of these increase if the oxaliplatin is given along with the chemotherapy drug fluorouracil.
Oxaliplatin can commonly cause damage to nerves and nervous system tissues. Patients may feel tingling, numbness, and sometimes burning of the fingers and toes. This side effect is common, can be severe, and gets worse in the cold. The patient must inform the doctor if any of these symptoms are present. In addition, the patient may experience a tightness or spasm in their throat. The chance that this will happen increases if the patient is exposed to cold food or drinks while receiving oxaliplatin.
Low blood counts, referred to as myelosuppression, are expected due to oxaliplatin. The extent to which the blood counts fall due to oxaliplatin has been minimal. When the white blood cell count is low, this is called neutropenia and patients are at an increased risk of developing a fever and infections. There is a drug called Neupogen (filgrastim) that can be used to increase the white blood cell count.
Platelets are blood cells in the body that allow for the formation of clots. When the platelet count is low, patients are at an increased risk for bruising and bleeding. If the platelet count remains too low a platelet blood transfusion is an option. Low red blood cell counts, referred to as anemia, may also occur due to cisplatin administration. Low red counts make people feel tired and lacking energy. There is a drug called erythropoietin that can be used to increase the red blood cell count.
Oxaliplatin has caused severe allergic reactions known as anaphylaxis. The symptoms include difficulty breathing, drop in blood pressure, sweating, redness of the face, dizziness, headache, and a fast heart beat. This appears to be more common after several treatments with the drug oxaliplatin.
Less common side effects include hair loss (alopecia), fever, rash on hands and feet when given with fluorouracil, and fatigue. Oxaliplatin rarely causes kidney damage or hearing damage, unlike cisplatin chemotherapy.
All side effects a patient experiences should be reported to his or her doctor.
Interactions
Patients should avoid cold food and drinks while receiving oxaliplatin.

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