Frequently Asked Questions

What is photodynamic therapy?

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Photodynamic therapy, or PDT as it is commonly referred to, is a treatment for certain types of lung and esophageal (food pipe) cancers. PDT uses a combination of a photoactive drug (a drug that is activated by light) and non contact, non thermal red light from a laser. Together they work to allow your doctor to specifically target and destroy abnormal cells while limiting damage to surrounding healthy tissue.

How does PDT work against certain types of lung and esophageal cancers?

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First, an injection of the photoactive drug PHOTOFRlN® (porfimer sodium) for injection is given. PHOTOFRIN® will be absorbed by body tissues, including abnormal cells. Over the next few days, the drug will largely be eliminated from most healthy tissue. However, it will remain in abnormal cells and certain other organs. Approximately 40 to 50 hours after the PHOTOFRlN® injection, light from a laser will be directed at the abnormal cells. The standard application of light takes 8 minutes and 20 seconds for endobronchial cancer and 12 minutes and 30 seconds for esophagael cancer. For many patients the entire procedure takes under 1 hour. The light will activate the drug present within those abnormal cells to help destroy them. PDT with PHOTOFRIN® can help shrink tumors by causing the cell damage that can cause them to die or by decreasing the blood flow to the tumor cells causing them to die.

Why can’t I just take PHOTOFRIN®, the drug?

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Neither the drug nor the red light alone can destroy the abnormal cells; they must be used in combination. The drug must be activated by the red light before it can work to destroy the abnormal cells.

Does the laser light burn?

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Low-power light from a laser is used, which is not the kind that is used for cutting in surgery. The light used in photodynamic therapy is nonthermal, meaning it does not burn.

How does the doctor administer the laser light?

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The doctor will direct the light to its target through an optical fiber. These optical fibers which are specially designed to conduct laser light are thin, flexible, transparent strands, similar to fishing lines. In treating certain types of esophageal cancer, the optical fiber is passed down the throat through an endoscope, a flexible tube.In treating certain types of lung cancer, the optical fiber is passed through a bronchoscope, a tubular illuminated instrument used for inspecting or passing instruments into the lung airways.

Is the procedure painful?

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As with any bronchoscopic procedure, patient discomfort varies, but a sedative can be given along with local or general anesthesia, so you should feel little or no discomfort during the procedure. Local swelling and inflammation in and around the treated area may cause physical discomfort or pain in that area after the treatment.

What precautions should I take to prevent a photosensitive (light- or sun-sensitive) reaction?

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You must be careful for at least 30 days after your injection to avoid bright indoor lights and direct sunlight. Some patients may remain photosensitive for up to 90 days or longer. However, you do not need to limit yourself to dark rooms. In fact, getting some indoor light can help break down the drug in your skin. The lighting in your home should not be a problem, but do stay away from direct sunlight, skylights, or undraped windows. Most indoor activities are fine including watching television or going to the movies. When reading, do not expose your skin to the light from a reading lamp and keep your skin covered. If at all possible, wait until sundown to do daily chores like shopping. If you go out during daylight hours, you must cover as much skin as possible. That means wearing a long-sleeved shirt, slacks, gloves, socks, shoes, and a wide-brimmed hat. Wear tightly woven, light-colored fabrics, if possible. You should also protect your eyes by wearing dark sunglasses with less than 4% white light transmittance. It is important for you to wear protective clothing and sunglasses even on cloudy days and while in a car. For at least 30 days after the injection, stay away from bright indoor lights, including examination lights, such as those found in a dentist’s office, and helmet-type hair dryers like those found in hair salons, as they can cause skin burns. Handheld hair dryers at low settings are a safer option.

Will sunscreens protect me from photosensitivity?

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No. Sunscreens will not protect against photosensitivity, no matter how high the SPF, because sunscreens protect against ultraviolet (UV) light. Photoactivation is caused by visible light, not UV light, which is invisible.

How do I know I am no longer sensitive to light?

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The duration of photosensitivity differs from person to person. After the first 30 days you should do a test by exposing a small portion of skin, maybe the back of your hand or arm, to sunlight. Avoid using your face to test for photosensitivity.One way is to cut a hole (about 2 inches) in a paper bag that you can put your hand into. Expose the unprotected patch to sunlight for 10 minutes. If a photosensitivity reaction (swelling, redness, or blistering) occurs within 24 hours of exposure, continue to protect yourself from the sun for another 2 weeks before re-testing. If no reaction occurs within 24 hours of exposure, you may gradually increase your exposure to sunlight.Continue to watch for any reaction as some patients may remain photosensitive for 90 days or more. Limit your time outdoors between 11 AM and 2 PM, when the sun is strongest. Do not limit yourself to dark rooms in your home as it is important to get some indoor light to help break down the drug in your skin faster, also known as photobleaching.

How will I know if I have had a photosensitive reaction and what should I do?

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A photosensitivity reaction will look like a sunburn. Your skin will appear red and may be swollen. Just as with a sunburn, there may be some blistering. If you see that you have experienced a reaction, call your doctor at once. Your doctor will be the best guide as to how to treat your reaction.

IMPORTANT SAFETY INFORMATION AND INDICATION

Do not take PHOTOFRIN® (porfimer sodium) for injection:

  • If you have a rare disorder with a blood component called porphyria
  • If you have an abnormal connection (fistula) between the esophagus and airways leading to the lungs
  • If you have a tumor extending into a major blood vessel
  • If you have life-threatening breathing failure due to an obstructing airway tumor that requires emergency treatment
  • If you have enlarged veins in the stomach or esophagus or large ulcers in the esophagus

What should I tell my healthcare provider before taking PHOTOFRIN®?

Before taking PHOTOFRIN®, tell your healthcare provider about all your medical conditions, including if you are:

  • Taking other medicines that are activated by light
  • Taking other medicines during your photodynamic treatment with PHOTOFRIN®
  • If you are pregnant or are a nursing mother

What is the most important information I should know about PHOTOFRIN®?

  • Sensitivity or allergic reaction to light should be expected; eye sensitivity is possible. This reaction is called phototoxicity, which has a sunburn-like effect and may be severe. All patients receiving PHOTOFRIN® will be sensitive to light and must take precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor light for at least 30 days, but it may be required for more than 90 days. The phototoxicity with PHOTOFRIN® is unique since it is activated, not only by UV light, but also by light visible to your eyes that is usually safe for humans. Phototoxicity reactions with PHOTOFRIN® can occur following the first exposure to direct sunlight or intense indoor light from within a few minutes to up to several hours after exposure; resulting skin damage can persist. After PHOTOFRIN® administration, when outside wear protective clothing and dark sunglasses which let less than 4% white light through.
  • An abnormal connection (fistula) can occur if an esophageal tumor is eroding into the main airway leading to the lungs or into one of its branches
  • Holes can develop through the wall of the organs in your digestive system where photodynamic therapy was applied (esophagus, stomach, small intestine, large bowel, rectum, gallbladder)
  • Bleeding can occur if you have enlarged veins in your esophagus
  • Some patients with treated lung cancer lesions are at high risk for coughing up life-threatening amounts of blood
  • If you are being treated for pre-cancerous cells (high-grade dysplasia) in Barrett’s esophagus, biopsy of your esophagus will be performed every 3 months and checked by your doctor until 4 consecutive biopsies are negative for high-grade dysplasia
  • If you require radiotherapy after treatment with PHOTOFRIN®, the radiotherapy should not be started until 2-4 weeks after your PHOTOFRIN® treatment
  • You may experience chest pain or breathing difficulty. Notify your doctor if you experience chest pain or any other side effects after treatment with PHOTOFRIN®. Your doctor may prescribe medication to help reduce the pain.
  • Photodynamic therapy for advanced lung cancer may block the main lung airway, leading to life-threatening difficulty breathing
  • Narrowing of the esophagus occurs frequently after treatment of pre-cancerous cells (high-grade dysplasia) in Barrett’s esophagus
  • If you have liver or kidney problems you may be need to take extra precautions regarding sensitivity to light and for a longer time period
  • Blockage of blood vessels from pieces of a blood clot can happen after treatment with PHOTOFRIN®
  • Embryo-Fetal Toxicity: May cause embryo-fetal toxicity. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What are the possible side effects of PHOTOFRIN®?

Sensitivity to light will occur in all patients. Allergic reaction to light may occur in all of the following indications:

  • For esophageal cancer (treatment of the esophagus): anemia, accumulation of fluid in the lungs, fever, constipation, nausea, chest pain, general pain, stomach pain, difficulty breathing, pneumonia (infection of the lung), vomiting, difficulty sleeping, back pain, inflammation of the throat
  • For obstructing endobronchial cancer (when cancer blocks the lungs airways): difficulty breathing, coughing with or without small amounts of blood, fever, coughing, pneumonia (infection of the lungs)
  • For superficial endobronchial tumors (when cancer slightly invades surrounding tissues): fluid leaking out of blood vessels into nearby tissue,  blockage of lung airways, swelling of tissue due to large fluid volume, narrowing of the main airway leading to lungs
  • High-grade dysplasia (pre-cancerous cells) in Barrett’s Esophagus (treatment of the esophagus): narrowing of the esophagus, vomiting, chest pain, nausea, fever, constipation, difficulty or pain when swallowing, abdominal pain, accumulation of fluid in the lungs, dehydration

These are not all the possible side effects of PHOTOFRIN®. For more information call your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Pinnacle Biologics, Inc. at 1-866-248-2039.

Indication

PHOTOFRIN® is used for:

  • Relieving symptoms of esophageal cancer when the cancer blocks the esophagus or when the cancer cannot be treated by laser alone.
  • Treating non-small-cell lung cancer that slightly invades surrounding tissues when the other usual treatments are not appropriate
  • Relieving symptoms and reducing obstruction of non-small-cell lung cancer in patients in whom the cancer blocks the lung airways
  • Removal of abnormal, pre-cancerous cells (high-grade dysplasia) in Barrett’s esophagus when there is no removal of the esophagus by surgery

Please see Full Prescribing Information.