During Treatment

Patient Guide

PDT is usually performed as an outpatient procedure.There are 2 stages to your photodynamic therapy.

Stage 1 (Injection)

You will be given an injection into a vein in your arm of the photosensitizing drug PHOTOFRIN^® 2 days before the procedure.This takes 3 to 5 minutes.1You will be photosensitive for at least 30 days following injection of PHOTOFRIN^®.This means that your skin and eyes will be sensitive to bright lights (sunlight and bright indoor light).

Stage 2 (Light application)

Just prior to the procedure, you may be given a sedative and/ or a local or general anesthetic, so you should feel little or no discomfort.These medicines may make you feel sleepy. However, patients are often awake while PDT with PHOTOFRIN^® is administered.2,3

Your doctor will direct the laser light through a fiber optic endoscope, a flexible tube that is placed down the throat. Forty to 50 hours after the PHOTOFRIN^® injection, light from a laser will activate the drug within the lung or esophageal abnormal cells and destroy them. Light application may be repeated if needed.This is usually done 96 to 120 hours after a PHOTOFRIN^® injection.1

Your doctor will continue regular checkups of your condition. PDT with PHOTOFRIN^® may be repeated and may be used with other therapies such as radiation, surgery, or chemotherapy.

References: 1. PHOTOFRIN^{^®} (porfimer sodium) Injection US Prescribing Information, August 2008. 2. Merriam-Webster Medical Dictionary Online. Available at http://merriam-webster.com/medical/endoscope Accessed 4/20/10. 3. Heier SK. Photodynamic therapy for esophageal malignancies. In: Barkin JS, O’Phelan CA, eds. Advanced Therapeutic Endoscopy. 2nd ed. New York; NY Raven Press; 1994;57-65. 4. Lightdale CJ, Heier SK, Marcon NE, et al. Photodynamic therapy with porfimer sodium versus thermal ablation therapy with Nd:YAG laser for palliation of esophageal cancer: a multicenter randomized trial. Gastrointest Endosc. 1995;42;507-512.

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