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IMPORTANT SAFETY INFORMATION AND INDICATION

Who should not take PHOTOFRIN? Do not take PHOTOFRIN?

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 can 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

What are the possible side effects of PHOTOFRIN?

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, sensitivity or allergic reaction to light, 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, sensitivity or allergic reaction to light, 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 nearby tissue, sensitivity or allergic reaction to light, blockage 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): sensitivity or allergic reaction to light, 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 Concordia Laboratories Inc. at 1-866-248-2039.

Indication

PHOTOFRIN is used for:

Esophageal Cancer

Palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy

Endobronchial Cancer

Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated
Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC

High-Grade Dysplasia in Barrett's Esophagus

Ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy

Please see Full Prescribing Information.

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PHOTOFRIN®, 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 manufactured for Concordia Laboratories Inc. and distributed in the United States by Pinnacle Biologics Inc. See more.

Important Safety Information About PHOTOFRIN®(porfimer sodium) for Injection

PHOTOFRIN® should not be used in patients with porphyria, existing tracheoesophageal or bronchoesophageal fistula, tumors eroding into a major blood vessel, emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection of PHOTOFRIN® and laser light treatment, and esophageal or gastric varices or esophageal ulcers >1 cm in diameter.

IMPORTANT WARNINGS AND PRECAUTIONS USING PHOTOFRIN® INCLUDE:

Gastroesophageal Fistula and Perforation: Do not initiate PHOTOFRIN with photodynamic therapy (PDT) in patients with esophageal tumors eroding into the trachea or bronchial tree or bronchial wall.

Pulmonary and Gastroesophageal Hemorrhage: Assess patients for tumors eroding into a pulmonary blood vessel and esophageal varices. Do not administer light directly to an area with esophageal varices.

High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE): After treatment of HGD in BE, conduct endoscopic biopsy surveillance every 3 months, until 4 consecutive negative evaluations for HGD have been recorded.

Photosensitivity and Ocular Photosensitivity: Observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light for at least 30 days. Instruct patients when outdoors to wear dark sunglasses which have an average light transmittance of <4% for at least 30 days and until ocular sensitivity resolves.

Use Before or After Radiotherapy: Allow 2-4 weeks between PDT and subsequent radiotherapy.

Chest Pain: Substernal chest pain can occur.

Airway Obstruction and Respiratory Distress: Administer with caution to patients with tumors in locations where treatment-induced inflammation can obstruct the main airway. Monitor patients closely between the laser light therapy and the mandatory debridement bronchoscopy for any evidence of respiratory distress.

Esophageal Strictures: Esophageal strictures can occur.

Hepatic and Renal Impairment: Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity.

Thromboembolism: Thromboembolic events can occur.

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.

MOST COMMON ADVERSE REACTIONS reported during clinical trials (>10% of patients) are:

Esophageal Cancer: Anemia, pleural effusion, pyrexia, constipation, nausea, chest pain, pain, abdominal pain, dyspnea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis.

Obstructing Endobronchial Cancer: Dyspnea, photosensitivity reaction, hemoptysis, pyrexia, cough, pneumonia.

Superficial Endobronchial Tumors: Exudate, photosensitivity reaction, bronchial obstruction, edema, bronchostenosis.

High-Grade Dysplasia in Barrett’s Esophagus: Photosensitivity reaction, esophageal stenosis, vomiting, chest pain, nausea, pyrexia, constipation, dysphagia, abdominal pain, pleural effusion, dehydration.

Other photosensitizing agents may increase the risk of photosensitivity reaction. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with PHOTOFRIN and for 5 months after the last dose.

Please see full Prescribing Information for PHOTOFRIN® (porfimer sodium) for Injection at: www.photofrin.com