英文药名：PHOTOFRIN INJECTION(Porfimer sodium) 中文药名：卟吩姆钠注射剂 生产厂家：辉瑞公司 フォトフリン静注用75mg 商標名 PHOTOFRIN INJECTION 75mg 一般名 ポルフィマーナトリウム（Porfimer sodium） 化学名 polyhematoporphyrin ether/ester 構造式 分子量 1,231.28～4,883.30 融点 250℃以上（分解） 性状 该产品是不是在一个暗红色的粉末，闻到红棕色。 此产品易溶于水，甲醇易微溶，乙醇（95），并在四氢呋喃和乙醚中几乎不溶。 药效药理 1.药理作用 培养的肿瘤细胞，在使用荷瘤动物等试验，这种疗法表示细胞抑制或细胞毒作用。 2.作用机制 卟吩姆钠是选择性地吸收到肿瘤细胞，是通过激光照射激发时，它与在肿瘤组织中的氧发生反应，产生活性氧（尤其是单线态氧）。活性氧抑制肿瘤细胞的线粒体酶系统，损害细胞内呼吸，显示了抗肿瘤作用。 适应病症 本品适用于不能手术等其它根治疗法的肺癌、子宫颈癌或需要保守治疗的患者，在内窥镜下能观察到病灶的全貌。可能进行激光照射的下列疾病：早期肺癌（O期或Ⅰ期）、浅表性食管癌、浅表性早期胃癌、宫颈癌初期及发育异常。 用法用量 本品1次2mg／kg静脉滴注。静脉滴注后48～72小时后以激光照射病灶。本品须用5％葡萄糖溶液溶解。本品不含防腐剂，溶解后须在6小时内使用。不可与其它药物混合，只供静脉注射。 包装规格 光敏剂 静脉注射：75毫克*1瓶 制造和销售 辉瑞公司日本 本品特点 本品为血叶琳衍生物的纯化产品，通过酯和醚连接的光敏聚叶琳低聚物，结合在一起的聚合体。是对肿瘤有亲合性的光敏物质。与特定波长的激光并用，可作为抗肿瘤的新疗法。 作用机制 可能由于静脉给予本品后，肿瘤细胞比正常细胞摄取本品更多，而且滞留性也好。对本品滞留的肿瘤部位光照，由于本品吸收光能成为激活状态。这种光能在组织中可使氧转变成活性氧。这种活性氧抑制线粒体的酶系统而损害细胞内呼吸，引起肿瘤细胞变性、坏死。 注：以上中文资料仅供参考，使用以原处方资料为准；http://www.info.pmda.go.jp/go/pack/4299403D1031_2_03/ IMPORTANT SAFETY INFORMATION PERTAINING TO PHOTOFRIN® WHAT DOES PHOTOFRIN® TREAT? PHOTOFRIN® is approved for: relieving symptoms of esophageal cancer when the cancer blocks the esophagus or when the cancer cannot be treated with laser alone relieving symptoms and reducing obstruction of non-small-cell lung cancer in patients in whom the cancer obstructs (or blocks) the airway treating non-small-cell lung cancer that slightly invades surrounding tissues in patients for whom usual treatments are not appropriate removal of abnormal, precancerous cells (high-grade dysplasia) in Barrett’s esophagus patients who do not undergo surgical removal of the esophagus WHO SHOULD NOT TAKE PHOTOFRIN®? PHOTOFRIN® is not for everyone. PHOTOFRIN® should not be used in patients with*: certain rare blood disorders such as porphyria an abnormal connection (fistula) between the esophagus and airways leading to the lungs tumors extending into a major blood vessel life-threatening breathing failure that requires emergency treatment enlarged veins in the stomach or esophagus or ulcers in the esophagus *Ask your doctor if PHOTOFRIN® is right for you WHAT SHOULD I BE AWARE OF WHILE TAKING PHOTOFRIN®? Fistula (an abnormal connection) can occur if esophageal tumor is eroding into the main airway leading to the lungs or one of its branches Bleeding can occur if you have enlarged veins in your esophagus Some patients that receive PHOTOFRIN® treatment are at high risk for coughing up large amounts of blood that is life-threatening If you are being treated for high-grade dysplasia in Barrett's esophagus, biopsy of your esophagus will be performed every three months and checked by your doctor until four consecutive biopsies are negative for high-grade dysplasia Extreme caution should be taken when used for tumors in locations where treatment-induced inflammation could block the main airway leading to difficulty breathing that is life-threatening You will be photosensitive for at least 30 days following injection of PHOTOFRIN®. This means that your skin and eyes will be sensitive to sunlight and bright indoor light. Protective clothing and dark sunglasses with a light transmittance of less than 4% should be worn when outdoors. Exposure to some indoor light is recommended to help break down the PHOTOFRIN® in your skin If you require radiotherapy after treatment with PHOTOFRIN®, the radiotherapy should not be started until 2-4 weeks after your PHOTOFRIN® treatment Notify your doctor if you experience chest pain after treatment with PHOTOFRIN®. Your doctor may prescribe medication to help alleviate the pain Narrowing of the esophagus occurs frequently after treatment of high-grade dysplasia in Barrett's esophagus If you have liver or kidney problems you may be photosensitive for longer. Precautionary measures to protect skin and eyes from sunlight and bright indoor light should be followed for more than 90 days WHAT ARE THE POSSIBLE SIDE EFFECTS OF PHOTOFRIN®? The most common side effects of PHOTOFRIN®, occurring in 5% or more of patients include the following: Treatment of the esophagus: Lower number of red blood cells in your blood, abnormal heart rhythm, your heart being unable to pump the blood properly, faster than normal heart rate, constipation, nausea, abdominal pain, vomiting, difficulty swallowing, watery /fluid retention producing swollen hands or feet, vomiting blood, indigestion, esophageal narrowing, diarrhea, inflammation of the esophagus, belching, blood in stool, fever, chest pain, pain (general), swelling of tissue in the lower limbs due to large fluid volume, chest pain below the breastbone, watery /fluid retention producing a swollen body, infection including thrush, urinary tract infection, post procedural complication, weight loss, loss of appetite, dehydration, back pain, bleeding tumor, difficulty sleeping, confusion, feeling nervous, fluid in your chest, shortness of breath, infection in your lung, inflammation of the throat, difficulty breathing, cough, abnormal opening between the esophagus and windpipe, sensitivity to direct sun light and bright light, low blood pressure, high blood pressure. Treatment of the lung: When cancer obstructs (or blocks) the airway: Constipation, fever, pain in the chest, pain (general), watery /fluid retention producing swollen hands or feet, difficulty sleeping, feeling nervous, shortness of breath, cough, coughing up small amounts of blood, infection in your lung, inflammation of the airways, coughing up more phlegm, difficulty breathing, fluid in your chest, sensitivity to direct sun light and bright light. When cancer slightly invades surrounding tissues: Fluid leaking out of blood vessels into nearby tissue, obstruction or mucus plug, swelling of tissues due to large fluid volume (general), stricture (narrowing) of the main airway leading to lungs, ulcers in the main airway leading to lungs, cough, shortness of breath, sensitivity to direct sun light and bright light. Other possible side effects of PHOTOFRIN®, occurring in less than 5% of patients include the following: Treatment of the esophagus: Hole in the esophagus, stomach ulcer, blockage of the intestine due to paralysis of intestinal muscles, yellowing of the skin, inflammation of abdominal lining, bacterial infection of the blood, chest pain, slow heart rate, heart attack, various abnormal heart rhythms, fast heart rate, inflammation of the airways, abnormal contraction of main airway leading to lungs, watery/ fluid retention producing swollen vocal cords, inflammation of lung tissue, bleeding from the lungs, fluid in the lungs, your lung being unable to breath, abnormal high-pitched breathing sound, inflammation of the middle section of the chest cavity, abnormal vision, double-vision, eye pain and excessive eye sensitivity to light. Treatment of the lung: When cancer obstructs (or blocks) the airway: Blood clot in the lung, blockage of the main artery of the lung or one of its branches, localized infection in the lung, your heart being unable to pump the blood properly, bacterial infection of the blood, stroke. When cancer slightly invades surrounding tissues: Inflammation of the main airway tract lining, life-threatening shortness of breath, narrowing of the main airway to the lungs that requires stent placement, coughing up large amounts of blood that is life-threatening.