新型抗癌化疗药Folotyn(pralatrexate)为首个获FDA批准上市，用于治疗外周T细胞淋巴瘤（PTCL）。PTCL为浸润性非霍奇金淋巴瘤，在美国每年有约9500名患者发病，被确定为罕见性疾病，Folotyn被指定为孤儿药。FDA通过快速审批程序批准该药。 批准日期：2009年9月24日 公司：Allos Therapeutics，Inc FOLOTYN（[pralatrexate]）注射液，用于静脉注射 美国最初批准：2009年 最近的重大变化 剂量和用量：05/2016 作用机制 Pralatrexate是一种叶酸类似物代谢抑制剂，可竞争性抑制二氢叶酸还原酶。 它也是通过酶聚谷氨酰胺合成酶进行聚谷氨酰化的竞争性抑制剂。 这种抑制导致胸苷和其他生物分子的消耗，其合成取决于单个碳转移。 适应症和用法 FOLOTYN是一种叶酸类似物代谢抑制剂，用于治疗复发或难治性外周T细胞淋巴瘤（PTCL）患者。该指示基于总体响应率。尚未证实临床益处，例如无进展存活率或总体存活率的改善。 剂量和给药 •推荐剂量的FOLOTYN为30 mg/m 2静脉推注，每周一次，每次3至5分钟，连续7周，持续6周。 •对于严重肾功能不全（eGFR 15至<30 mL/min/1.73m 2）的患者，推荐剂量的FOLOTYN为15mg/m2。 •在开始FOLOTYN之前，每8-10周肌肉注射维生素B 12 1mg，每日口服1.0-1.25 mg叶酸。 •可能需要剂量遗漏和/或剂量减少来控制药物不良反应。 剂量形式和强度 •以下介绍中含有浓度为20mg/mL的pralatrexate的无菌单剂量小瓶： - 在小瓶（20mg/1mL）中的1mL溶液中加入20mg普拉曲沙 -40mg pralatrexate在2mL小瓶中的溶液（40mg/2mL） 禁忌症 •没有。 警告和注意事项 •血小板减少，中性粒细胞减少和贫血：监测血细胞计数，省略和/或减少血液毒性剂量。 •粘膜炎：至少每周监测一次。如果观察到≥2级粘膜炎，则省略和/或减少剂量。 •皮肤病学反应：已发生反应，包括致命反应，可能是进行性反应，并且随着进一步治疗而增加严重程度。密切监测，省略和/或减少剂量或停止FOLOTYN。 •肿瘤溶解综合征：及时预测，监测和治疗。 •肝毒性：监测毒性。对于肝功能检查异常3级或更高，省略直至恢复然后减少剂量或根据需要停止治疗。 •伴有肾功能损害的毒性增加的风险：患有中度至重度肾功能损害的患者暴露和毒性增加的风险可能更高。监测患者的肾功能和全身毒性并相应地调整剂量。避免使用FOLOTYN治疗终末期肾病患者，包括接受透析治疗的患者，除非潜在的益处证明存在潜在风险。 •胚胎 - 胎儿毒性：女性在接受FOLOTYN治疗时应避免怀孕。告知孕妇对胎儿的潜在危害。 不良反应 最常见的不良反应（> 35％）是粘膜炎，血小板减少症，恶心和疲劳。最常见的严重不良反应是发热，粘膜炎，败血症，发热性中性粒细胞减少症，脱水，呼吸困难和血小板减少症。 药物相互作用 •与可能影响相关转运系统（例如NSAID）的丙磺舒或其他药物共同给药需要密切监测全身毒性的迹象。 用于特定人群 •在接受FOLOTYN治疗时，应建议女性不要母乳喂养。 •严重肾功能不全患者的剂量减少（eGFR 15至<30mL/min/1.73m 2） 包装提供/存储和处理 FOLOTYN 20MG/ML 1ML SDV 1/EA  PRALATREXATE  SPECTRUM PHARMACEUTICALS  48818-0001-01 FOLOTYN 20MG/ML 2ML SDV 1/EA  PRALATREXATE  SPECTRUM PHARMACEUTICALS  48818-0001-02 --------------------------------------------------------- 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. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e4cf15b-bf7b-4b83-863e-e9ef27741a51