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Important Safety Information

Contraindications

• PHOTOFRIN^® is contraindicated in patients with porphyria
• Photodynamic therapy (PDT) is contraindicated in patients with an existing tracheoesophageal  or bronchoesophageal fistula
• PDT is contraindicated in patients with tumors eroding into a major blood vessel
• PDT is not suitable for emergency treatment of patients with severe acute respiratory distress caused by an obstructing endobronchial lesion because 40 to 50 hours are required between injection with PHOTOFRIN^® and laser light treatment
• PDT is not suitable for patients with esophagealor gastricvarices, or patients with esophagealulcers >1 cm in diameter

Warnings and Precautions

• Do not initiate PHOTOFRIN^® with PDT in patients with esophageal tumors eroding into the trachea or bronchial tree or  bronchial wall because of the high likelihood of tracheoesophageal or bronchoesophageal fistula
• Gastrointestinal perforation can occur
• High risk of bleeding in patients with esophageal varices
• High risk for fatal massive hemoptysis with endobronchial tumors that are large, centrally located; cavitating; extensive,  extrinsic to the bronchus
• All patients who receive PHOTOFRIN^® will be photosensitive and must observe precautions to avoid exposure of skin and  eyes to direct sunlight or bright indoor light for at least 30 days. Ocular sensitivity is also possible; instruct patients when out   doors to edema, bronchostenosis wear dark sunglasses. See full Prescribing Information
• Allow 2-4 weeks between PDT and subsequent radiotherapy• Substernalchestpainmayoccuraftertreatmentbecause of inflammatory responses within the area of treatment
• Treatment-induced inflammation can cause airway obstruction. Administer with caution to patients  with tumors in locations where treatment-induced inflammation can obstruct the main airway
• Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity• Thromboembolic events can occur following photodynamic therapy with PHOTOFRIN^®

Adverse Reaction Profile

• Most toxicities associated with PHOTOFRIN^® therapy are local effects seen in the area of illumination and occasionally in  surrounding tissues and are characteristic of an inflammatory response
• All patients who receive PHOTOFRIN^® will be photosensitive and must observe precautions listed in the Prescribing  Information
• Photosensitivity reactions occurred in approximately 20% of cancer patients treated with PHOTOFRIN^® in clinical studies
• Typically these reactions were mostly mild to moderate erythema but they also included swelling, pruritus, burning sensation,  feeling hot, or blisters. In a single study of 24 healthy subjects, some evidence of photosensitivity reactions occurred in all  subjects
• Other less common skin manifestations were also reported in areas where photosensitivity reactions had occurred, such as  increased hair growth, skin discoloration, skin nodules, increased wrinkles and increased skin fragility. These manifestations  may be attributable to a pseudoporphyria state (temporary drug-induced cutaneous porphyria)
• Conventional ultraviolet (UV) sunscreens will only protect against UV light-related photosensitivity and will be of no value in  protecting against induced photosensitivity reactions caused by visible light

Most Common Adverse Reactions

The following adverse reactions were reported in >10% of patients:

• Esophageal Cancer: Anemia, pleuraleffusion, pyrexia, constipation, nausea, chestpain, pain, abdominal pain, dyspnoea,  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