A new support program for Patients and Healthcare Professionals
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.
You are encouraged to report negative side effects of prescription drugs to Pinnacle Biologics, Inc. or the FDA. Call Pinnacle Biologics, Inc. at 1-866 -248-2039, visit http://www.fda.gov/medwatch/ or call 1-800-FDA-1088.
Reference: 1. PHOTOFRIN® (porfimer sodium) Injection US Prescribing Information, August 2008.
