Folotyn（pralatrexate注射液）作为单药应用于复发性或难治性外周T细胞淋巴瘤（PTCL）的治疗。现今，Folotyn是惟一经FDA批准应用于此病的药物。
中文名：普拉曲沙
英文名：pralatrexate
英文化学名：N-(4-(1-((2,4-Diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-L-glutamic acid;10-Propargyl-10-deazaaminopterin
中文化学名：10-炔丙基-10-去氮杂氨基蝶呤
分子式：C23H23N7O5
分子量：477.47
CAS号：146464-95-1
分子结构式：

适应症：复发性外周T细胞淋巴瘤
生产商：Allos Therapeutics
批准日期：2009年9月24日
Folotyn(pralatrexate)为首个获批上市的治疗外周T细胞淋巴瘤（PTCL）药物。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。用于治疗复发性或其它化学疗法疗效不佳的PTCL患者。
基于Folotyn能够有效缩小肿瘤体积，FDA批准其上市，通常肿瘤缩小被作为延长癌症患者生存期的替代指标。对109名PTCL患者试验研究，成像扫描结果27%患者被确定肿瘤体积缩小。
Folotyn的最常见不良反应为激越或粘膜溃疡，如嘴唇、口腔、消化道溃疡，和血小板计减少、白细胞减少、发热、恶心和疲惫。Folotyn对胎儿有危害。
Folotyn由美国柯罗拉多州威斯敏斯特的Allos Therapeutics Inc公司制造。由于Folotyn为有条件批准，Allos公司将继续进行研究，以证明肿瘤缩小与延长患者生存期的正效应。
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 SeptraDS,SulfatrimPediatric,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.