Porfimer

PHOTOFRIN is a photoactivated radical generator indicated 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 (HGD) in Barrett’s esophagus (BE) patients who do not undergo esophagectomy

The cytotoxic and antitumor actions of PHOTOFRIN are light and oxygen dependent. Photodynamic therapy (PDT) with PHOTOFRIN is a two-stage process. The first stage is the intravenous administration of PHOTOFRIN. Clearance from a variety of tissues occurs over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system (including liver and spleen) retain PHOTOFRIN for a longer period. The second stage is the illumination with 630 nm wavelength laser light. Tumor selectivity in treatment occurs through a combination of selective retention of PHOTOFRIN and selective delivery of light. Cellular damage caused by PDT with PHOTOFRIN is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen.

PHOTOFRIN. PHOTOFRIN administration: 2 mg/kg intravenous Photoactivation. Esophageal Cancer Laser light dose of 300 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN, repeated, if needed, 96-120 hours after initial injection Endobronchial Cancer Laser light dose of 200 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN, repeated, if needed, after gentle debridement of residual tumor 96-120 hours after initial injection High-Grade Dysplasia in Barrett’s Esophagus Laser light dose of 130 J/cm of fiber optic diffuser length 40–50 hours following injection with PHOTOFRIN, repeated, if needed, with a light dose of 50 J/cm of fiber optic diffuser length 96-120 hours after initial injection

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 esophageal or gastric varices, or patients with esophageal ulcers >1 cm in diameter. Porphyria. Existing tracheoesophageal or bronchoesophageal fistula.

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.

The following clinically significant adverse reactions are described elsewhere in the labeling: Gastroesophageal Fistula and Perforation Pulmonary and Gastroesophageal Hemorrhage High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE) Photosensitivity Ocular Sensitivity Use Before or After Radiotherapy Chest Pain Airway Obstruction and Respiratory Distress Esophageal Strictures Thromboembolism Most common adverse reactions (>10%) 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.

Other Photosensitizing Agents: May increase the risk of photosensitivity reaction Use with Other Photosensitizing Agents PHOTOFRIN can cause photosensitivity. The concomitant use of PHOTOFRIN with other photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones) may increase the risk of a photosensitivity reaction. Avoid the concomitant use of PHOTOFRIN with other products known to cause photosensitivity.

Storage Store at Controlled Room Temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). As with therapeutic overdosage, any overexposed person must be protected from bright light.