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 详细处方信息以本药内容附件PDF文件（20146423192017.pdf）的“原文Priscribing Information”为准
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部分中文卟吩姆钠处方资料（仅供参考）

【英文名】Porfimer sodium（Photofrin）

【结构式】本品是以猪血中的血叶琳二盐酸盐为原料合成的叶琳醚及酯结合成的聚合物。

【作用特点】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。

【功能主治】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。

【不良反应】有时有皮肤光敏反应、色素沉着、红斑、皮疹及颜面潮红、水肿等。有时GOT、GPT、ALP升高及血清总蛋白减低。

【注意事项】
    由于本品可引起光敏症，应用本品后至少1个月以内避免日光或集中光线直接照射，宜在微暗的室内（ 100～ 300勒克司）。
    本疗法必须以激光准确照射病变部位，因此必须由熟练的内窥镜医师操作，而已要选择无转移的对光照疗法敏感的病人。若有淋巴结转移应并用或改用其它疗法。为避免激光照射部位穿孔，而且激光要充分达到肿瘤浸润的深度，必须以CT、超声、活检等确定肺癌不超过支气管软骨层，胃癌不超过粘膜下层为宜。
    应用本品1个月后将手背皮肤暴露于直射日光下5分钟，若发生红斑、水泡等光敏反应时，须继续避光2周，再重复进行试验，直到无异常为止。
    为治疗其它肿瘤需再次应用本品时，必须要有充分的停药间隔（直到不引起光敏反应）再开始使用。
    应用激光照射后，往往发生以下情况须适当处置：
1.早期肺癌可有咳嗽、咯痰、血痰、呼吸困难、肺不张、咽痛、恶心、呕吐、食欲不振、发热等。
2.表浅性食管癌可有病灶出血、疼痛、贫血、胸痛、发热等。
3.表浅性早期胃癌可有病灶出血、恶心、呕吐、食欲不振、胃痛、贫血、发热等。
4.初期宫颈癌及癌前期病变，可见分泌物增多。
下列患者禁用本法治疗：
    对本品成分有严重过敏史者；卟啉症患者；肺癌已浸润到支气管软骨外侧（激光可能穿孔）；肺癌，较粗气管广泛病灶或引起气管狭窄的患者（有发生呼吸困难、窒息的危险）。食管全周性肿瘤（可能引起食管狭窄）。
下列部位肿瘤激光难以照射：①早期肺癌在次级支气管远端。②表浅性食管瘤位于食管入口处或食管、胃接合部。③表浅性早期胃癌位于食管、胃接合处或幽门环处。④宫颈初期癌及癌前病变，用阴道窥器不能确定扁平柱状上发界限的上限者。
下列患者慎用本疗法：并用其它有光敏作用的药物者和老年人。
下列药物或食品可有致光敏作用，应用本品期间应避免使用：四环素类、磺胺类、酚噻嗪类、磺脲类降糖药、噻嗪类利尿剂、喹诺酮类抗菌药、非类固醇类消炎镇痛剂、氟脲嘧啶类抗癌药、氨甲喋呤、灰黄霉素、甲基补骨酯及其它易引起光敏的药物和食品（如小球藻制品等）。

【制剂规格】冻干粉针剂：每支含本品75mg。

【贮藏】在冰箱中24个月有效

IMPORTANT SAFETY INFORMATION PERTAINING TO PHOTOFRIN®1
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.

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 详细处方信息以本药内容附件PDF文件（20146423192017.pdf）的“原文Priscribing Information”为准
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