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【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.
【贮藏】 在冰箱中24个月有效。
Photofrin (Injection)
Photofrin (Injection) Drug and Prescription Information
Photofrin (Injection)
Photofrin (Injection) Medication Classification
PORFIMER (Injection)
Photofrin (Injection) Brandname
Photofrin
Photofrin (Injection) is used for the Treatment
Porfimer (POR-fi-mer) Treats symptoms of cancer in the esophagus or lungs. Also treats changes in the esophagus that might lead to cancer. These changes are called "Barrett's esophagus" or "BE." This medicine is always used with laser light therapy (photodynamic therapy).
When To Not Use Photofrin (Injection)
You should not use this medicine if you have had an allergic reaction to porfimer or other porphyrin medicines such as hemin (Panhematin®). Do not use this medicine if you have porphyria (a problem with enzymes in your body) or if you have a tumor that is causing problems with a blood vessel. You should not use this medicine if you have swollen veins, large ulcers (sores), or a hole in your esophagus or lungs.
How Should You Use Photofrin (Injection)
Injectable
- Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
- A nurse or other trained health professional will give you this medicine.
- You should receive laser light therapy 40 to 50 hours after you receive your dose of porfimer. The laser light will cause changes in the medicine so the medicine can destroy certain cells in your esophagus or lungs. The laser creates red light, not heat, so you should not feel any burning. You might need to have a second laser light treatment (but not more medicine) a few days after the first one.
- Your doctor might want you to receive one or two more treatments of medicine plus laser light. For cancer therapy, you will need to wait at least 30 days between treatments. For Barrett's esophagus therapy, you will need to wait at least 90 days between treatments. If a dose is missed:
- Call your doctor, pharmacist, or treatment clinic for instructions. It is very important for you to receive this medicine at the correct time. Drugs and Foods to Avoid: Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using any other medicine that could make you sensitive to light. This includes many antibiotic medicines, such as tetracyclines (doxycycline, minocycline, Vibramycin®), quinolones (Cipro®, Levaquin®), and sulfonamides or "sulfa" drugs (Bactrim®, Septra®). Some other medicines that cause light sensitivity are phenothiazines (such as Compazine®, Phenergan®, Serentil®, Thorazine®), some diabetes medicines (oral medicine such as glipizide, glyburide, Glucophage®, Glucotrol®), and diuretics or "water pills" (such as hydrochlorothiazide).
- Make sure your doctor knows if you are also receiving radiation therapy. You need to wait 2 to 4 weeks between phototherapy and radiation therapy. Warnings While Using This Medicine:
- Make sure your doctor knows if you are pregnant or breast feeding.
- This medicine will ma
Proper Photofrin (Injection) Storage
Store Photofrin (Injection) at room temperature away from sunlight and moisture unless otherwise stated by manufacturer's instructions or labelling. Keep Photofrin (Injection) and all medications out of the reach of children.
What To Avoid While Using Photofrin (Injection)
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using any other medicine that could make you sensitive to light. This includes many antibiotic medicines, such as tetracyclines (doxycycline, minocycline, Vibramycin®), quinolones (Cipro®, Levaquin®), and sulfonamides or "sulfa" drugs (Bactrim®, Septra®). Some other medicines that cause light sensitivity are phenothiazines (such as Compazine®, Phenergan®, Serentil®, Thorazine®), some diabetes medicines (oral medicine such as glipizide, glyburide, Glucophage®, Glucotrol®), and diuretics or "water pills" (such as hydrochlorothiazide).
- Make sure your doctor knows if you are also receiving radiation therapy. You need to wait 2 to 4 weeks between phototherapy and radiation therapy.
Photofrin (Injection) Warnings
- Make sure your doctor knows if you are pregnant or breast feeding.
- This medicine will make your skin and eyes more sensitive to light. Be very careful to avoid direct sunlight and bright lights, even when you are indoors. Sunscreen or sunblock will not protect you. Protect your self from light by wearing a wide-brimmed hat, gloves, socks, and long-sleeved shirt and pants whenever you go outside. Have curtains or shades covering your windows and skylights. Do not use a hair dryer that fits over your head, such as the hair dryers in beauty salons.
- Regular, indirect indoor light should not bother your skin or eyes. Some indoor light will be good for you, because it will help clear this medicine from your body faster.
- Your eyes and the skin around your eyes may be more sensitive to light than the rest of your skin. Wear dark sunglasses whenever you go outside. Be careful when driving, because bright headlights could also bother you.
- You will probably be sensitive to light for at least 30 days, and possibly even 90 days after receiving this medicine.
- Test your skin to see if you are still sensitive to sunlight after 30 days. One way you can do this is to cut a small hole in a paper bag, then put your hand in the bag and hold it in direct sunlight for 10 minutes. Keep your arm and the rest of your body covered and in the shade. If you have a skin reaction within the next 24 hours, then your skin is still sensitive. A reaction would be redness, swelling, or blistering (like a sunburn). If you have a skin reaction, keep protecting your eyes and skin for another 2 weeks, then try the test again. If you do not have a reaction within 24 hours, then you can gradually start being in the light again.
- Using this medicine by itself will not help the problems in your lungs or esophagus. You must also receive light therapy 40 to 50 hours after receiving this medicine. You might also need a special procedure to clean the treated area in your esophagus or lungs.
- You might have pain around your chest after your treatment. If you have pain, talk with your doctor about the best way to treat it.
- Your doctor will need to check your progress at regular visits after you receive these treatments. Be sure to keep all appointments.
Photofrin (Injection) Side Effects
Call your doctor right away if you notice any of these side effects:
- Coughing up blood.
- Severe skin blisters, burning, itching, peeling, or redness.
- Trouble breathing or chest tightness, especially with chest pain.
- Trouble swallowing.
- Uneven heart beat.
- Unusual bleeding, bruising, or weakness. If you notice these less serious side effects, talk with your doctor:
- Fever or sore throat.
- Mild chest, back, or stomach pain.
- Mild constipation, nausea, vomiting, diarrhea.
- Mild redness or pain where the IV is inserted, or medicine gets on your skin.
- Trouble sleeping.
Photofrin®
Porfimer Sodium Solution for injection
What is this medicine?
PORFIMER is a light sensitizing drug that is used in photodynamic therapy (PDT). This medicine stays in tumor cells longer than it does in most healthy cells. This targets the tumor cells for laser light therapy. It is used to treat Barrett's esophagus, esophageal cancer, and lung cancer.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
•esophageal fistulas, varices, or ulcers
•porphyria
•recent or ongoing radiation therapy
•tumors that are growing into major blood vessels
•an unusual or allergic reaction to porfimer, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding
How should I use this medicine?
This drug is given as an injection into a vein. It is administered in a hospital or clinic by a specially trained health care professional.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What may interact with this medicine?
•alcohol
•allopurinol
•aspirin
•beta-carotene
•bexarotene
•dimethyl sulfoxide
•isotretinoin
•formate
•mannitol
•medicines for blood pressure like amlodipine, felodipine, nifedipine
•medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
•other medicines that may make you sensitive to the sun like phenothiazines, some medicines for diabetes, thiazide diuretics, griseofulvin, tetracyclines, sulfonamide, and fluoroquinolone antibiotics
•steroid medicines like prednisone or cortisone
•vitamins A and E
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
This therapy will cause swelling and pain at the site of the tumor with more secretions and mucus in the lungs or throat. Contact your doctor right away if you have trouble breathing or swallowing. Tell your doctor if your symptoms do not go away or if they get worse.
This medicine will make you more sensitive to light. Sunscreens will NOT protect from this new sensitivity. You must avoid exposing skin and eyes to sunlight and bright indoor lights (unshaded light bulbs at close range) for at least 30 days. This medicine stays in the cells of your skin and eyes for 1 to 3 months. You should continue to expose your body to regular light bulb light. Regular exposure to normal indoor lighting will help to breakdown the medicine in your body. The level of light sensitivity will be different for different areas of the body. After 30 days test your skin sensitivity by getting direct sunlight or bright indoor light on a small area of skin for 10 minutes. If there is no skin reaction, no redness, no swelling, no blisters, within 24 hours, you may begin to spend more time in bright light. If a reaction occurs, wait another 2 weeks before trying again.
Your eyes will be more sensitive to light after taking this medicine. Light from the sun, bright lights, or car headlights may bother your eyes. Wear dark sunglasses for at least 30 days after taking this medicine.
Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•blisters, redness, swelling of skin (similar to a severe sunburn)
•breathing problems
•changes in vision
•chest or throat pain
•coughing up or vomiting blood
•dark or bloody stools
•fast, irregular heartbeat
•fever
•problems swallowing
•swelling of the ankles, feet, hands
•unusually high or low blood pressure
•unusually weak or tired
Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):
•constipation
•loss of appetite
•nausea, vomiting
•sensitive to the sun and bright lights
•stomach gas, upset
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
【-原产地英文商品名-】Photofrin
【-原产地英文药品名-】porfimer sodium
【-中文参考药品译名-】卟吩姆钠
【-临床试验期-】完成
【-中文适应病症参考-】食管发育异常
【-中文适应病症参考-】食道癌
【-中文适应病症参考-】癌症
【-生产厂家英文名-】Axcan Scandipharm
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