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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->外周T细胞淋巴瘤
处方药:处方药
包装规格: 20毫克/毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
Allos
生产厂家英文名:
Allos
该药品相关信息网址1:
http://www.folotyn.com/
该药品相关信息网址2:
http://www.drugs.com/folotyn.html
该药品相关信息网址3:
http://www.rxlist.com/folotyn-drug.htm
原产地英文商品名:
FOLOTYN 20mg/ml/vial
原产地英文药品名:
PRALATREXATE
中文参考商品译名:
FOLOTYN 20毫克/毫升/瓶
中文参考药品译名:
普拉曲沙
原产地国家批准上市年份:
2009/09/24
英文适应病症1:
relapsed or refractory peripheral T-cell lymphoma
临床试验期:
完成
中文适应病症参考翻译1:
外周T细胞淋巴瘤
药品信息:

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 详细处方信息以本药内容附件PDF文件(201181518180225.pdf)的“原文Priscribing Information”为准
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部分中文Folotyn处方资料(仅供参考)

美专家支持批准Folotyn(pralatrexate)用于外周T细胞淋巴瘤
    总部设在科罗拉多州威斯敏斯特的制药商Allos Therapeutics Inc。(ALTH)周五宣布,美国食品与药物管理局(FDA)经由快速审核程序,批准该公司的实验性药物Folotyn用于治疗致死率最高的侵入性白血球癌症的药物。受到这条利好消息推动,周五盘前交易中Allos Therapeutics股价一度上涨了8%。

  在Allos公司的上述药物获得批准之前,FDA旗下顾问小组在本月初报告称,Allos Therapeutics公司的临床试验数据非常有说服力,清楚的表明Folotyn (pralatrexate)药物对于复发性或者症状难以控制的外周T细胞淋巴瘤(peripheral T-cell lymphoma,PTCL)患者有帮助。

  Allos表示,Folotyn是FDA批准的第一种、而且是唯一得到该机构批准的一种外周T细胞淋巴瘤药物。Allos预计将从10月开始向美国患者提供这种药物。

  这家公司表示,FDA批准Folotyn药物是基于该药物的总体有效比例数据,并未考虑这种药物的临床有效性——例如患者继续生存并且症状不再恶化、整体生存率提高等等。

  Allos公司表示,在Folotyn药物按照快速审批程序获得批准之后,该公司已经同意继续进行临床试验,以进一步验证和描述该药物的临床效果。

FOLOTYN® is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

The indication for FOLOTYN® is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.

IMPORTANT SAFETY INFORMATION ABOUT FOLOTYN
•Low Blood Cell Counts: Patients may experience low blood cell counts. Your doctor will do weekly blood tests to check your blood counts.
•Low Platelet Count: Lower platelets may cause unusual bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away if this happens.
•Low White Blood Cell Count: Lower white blood cell counts can reduce the body's defenses against infection. If you have any of the following signs or symptoms of infection (fever, chills, cough, shortness of breath, pain or burning on urination), tell your doctor right away. Serious illness or death could result if such infections are not treated when white blood cell counts are very low.
•Low Red Blood Cell Count: Lower red blood cell counts may make you feel weak, feel tired, and get tired easily. You may appear pale and be short of breath. Contact your doctor if you experience any of these symptoms following treatment with FOLOTYN.
•Mucositis: Patients may develop mucositis, which is redness and/or sores in the mucous membranes including the mouth, lips, throat, and other areas along the digestive tract and genitals. Discomfort or pain due to mucositis may occur as early as a few days after treatment with FOLOTYN. Talk with your doctor about ways to reduce your risk of developing mucositis, and/or ways to maintain nutrition and control the discomfort if you develop it. It is important to take folic acid and vitamin B12 during your treatment with FOLOTYN. Your doctor will give you specific instructions for vitamin supplementation.
•Severe Skin reactions: Severe skin reactions may happen after treatment with FOLOTYN, which can be fatal. Tell your doctor right away if you have of any of the following skin reactions: rash, peeling and loss of skin, sores, or blisters.
•Tumor Lysis Syndrome (TLS): FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
•Pregnancy and Nursing: Tell your doctor if you are pregnant or plan to become pregnant. FOLOTYN can harm your unborn baby. FOLOTYN has not been studied in pregnant women. Tell your doctor if you are breastfeeding or plan to breast-feed. It is not known if FOLOTYN will pass into your breast milk. Talk to your doctor about whether you should discontinue breast-feeding.
•Fever: Fever is often one of the most common and earliest signs of infection. Follow your doctor's instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. If you have a fever, tell your doctor or nurse right away.
•Loss of too much fluid from the body (dehydration): If you feel tired and weak this could be a sign of dehydration. Follow your doctor's instructions for what to do to help prevent or treat dehydration.
•Shortness of breath: Tell your doctor if this is a problem for you.
•Nausea, Vomiting, Diarrhea and Constipation Patients may experience nausea, vomiting, abdominal pain, diarrhea, and/or constipation. Medicines can be given that may help reduce these symptoms. If you experience any of these symptoms, tell your doctor.
•Other side effects may include:
◦Dizziness, lightheadedness, and fainting spells
◦Fatigue, weakness, and lethargy
◦Rash, itching or swelling
◦Loss of appetite and weight loss
◦Joint and muscle pain

These are not all of the potential side effects of FOLOTYN. If you have any side effect that bothers you or that doesn't go away, be sure to talk with your healthcare professional.

Tell your doctor about you medical conditions,including liver and kidney problems.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how FOLOTYN works, and FOLOTYN may affect how other medicines work. Especially tell your doctor if you take: sulfamethoxazole trimethoprim (Bactrim®, Septra®, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS), non-steroidal anti-inflammatory drugs (NSAIDs), probenecid (Probalan, Col-Probenecid). Ask your doctor or pharmacist if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.

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 详细处方信息以本药内容附件PDF文件(201181518180225.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-09-18
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