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