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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
To see the mechanism of action for Photofrin, click here

Please see Full Prescribing Information.

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Pinnacle Biologics™ and the logo of Pinnacle Biologics™ are trademarks of Pinnacle Biologics, Inc. See more.

The PHOTOFRIN® trademark is owned by Concordia Laboratories Inc.

PHOTOFRIN® is distributed in the United States by Pinnacle Biologics Inc. See more.

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