皮肤T细胞淋巴瘤是一种名为T-淋巴细胞的抗感染白细胞缓慢生长的癌症。大多数病例在开始时伴有皮肤干燥、红疹和瘙痒，并可能加重。可能发生肿瘤的皮肤会出现溃疡并引发感染。在一些病例中，CTCL可扩散至血液、淋巴结或内部器官。在美国，每年约有1500个新的CTCL病例。伴有皮肤局部CTCL的患者可接受局部药物或光疗治疗，一旦病情恶化，则可能需要进行化疗。Istodax可干扰细胞复制程序。该药被计划用于在已使用至少一种其他类型的化疗后病情仍趋于恶化或复发的CTCL患者。
常见副作用包括恶心、疲劳、感染、呕吐、食欲减退、血红细胞计数降低、血小板计数减少以及白细胞组成减少。Istodax可能引起心电图（ECG）改变。在伴有某些心律异常风险的患者中应考虑做定期的血液检验以监测电解质，以及定期的ECG监测。

商品名：Istodax

通用名：Romidepsin

生产公司：Gloucester Pharmaceutical

最初美国批准：2009年

适应症
FOLOTYN是叶酸模拟的代谢抑制剂，用于治疗复发或难治性外周T细胞淋巴瘤（PTCL）患者表示。这个指示是基于对整体回应率。尚未得到证实，如无进展生存期或总生存改善的临床受益。
 
剂量和用法
FOLOTYN的推荐剂量为30 mg/m2的管理，为6周，每周一次在7个星期的周期超过3至5分钟静脉推。
补充维生素B12 1 mg肌注每8-10个星期，每天口服1.0〜1.25毫克叶酸的患者。
可能需要中断治疗或降低剂量为20 mg/m2的管理药物不良反应。
 
剂型和优势
无菌，一次性使用的小瓶含有浓度20毫克/毫升以下介绍针对pralatrexate：
 
- 针对pralatrexate一小瓶在1 mL溶液（20毫克/ 1毫升20毫克）
 
- 40毫克针对pralatrexate溶液2毫升一小瓶（40毫克/ 2毫升）
 
禁忌
没有。
 
注意事项：
可能会出现血小板减少，中性粒细胞减少，贫血。监测血细胞计数和省略或修改血液学毒性的剂量。
黏膜炎可能发生。如果≥2级黏膜炎是观察，省略或修改剂量。
致命的皮肤反应，可能会出现。皮肤反应可能是渐进的和严重程度增加，与进一步治疗。皮肤反应的患者应密切监测，并FOLOTYN如果严重，应暂缓或中止。
可能发生肿瘤溶解综合征。监测病人和治疗如果需要的话。
FOLOTYN可对胎儿造成伤害。妇女应避免怀孕FOLOTYN治疗，孕妇应告知对胎儿的潜在危害。
使用在中度至重度肾功能不全患者慎用。
可能会出现肝功能试验异常。如果肝功能试验异常≥3级，省略或修改剂量。
 
不良反应
最常见的不良反应，粘膜炎，血小板减少，恶心，疲劳。最常见的严重不良反应是发热，口腔粘膜炎，败血症，发热性中性粒细胞，脱水，呼吸困难和血小板减少。

报告疑似不良反应，接触Allos Therapeutics公司（1-888-255-6788）或1-888-ALLOS88 www.FOLOTYN.com或FDA在1-800-FDA-1088或www.fda.gov / medwatch
 
药物相互作用
与丙磺舒或其他药物，可能会影响有关的转运系统（如非甾体抗炎药）联合用药，需要密切监测全身毒性的迹象。
 
在特殊人群中使用
应建议妇女对母乳喂养的同时FOLOTYN治疗。

看到病人咨询信息和FDA批准的病人标签17

更新日期：02/2012

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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产地国家：美国
所属类别：抗癌药物 ->外周T细胞淋巴瘤
原产地英文药品名：
PRALATREXATE
中文参考药品译名：
普拉曲沙
原产地英文商品名：
FOLOTYN 40mg/2ml/vial
中文参考商品译名：
FOLOTYN 40毫克/2毫升/瓶
生产厂家英文名：
Allos
生产厂家中文参考译名：
Allos
该药品相关信息网址1：
http://www.folotyn.com/
曾用名：
未知
该药品相关信息网址2：
http://www.drugs.com/folotyn.html