PDT with PHOTOFRIN® is administered in three stages1
Day 1: In-office administration
PHOTOFRIN® (2 mg/kg) is slowly administered as an IV injection over 3 to 5 minutes.
Day 2-3: Procedure is performed by a PDT-trained bronchoscopist or endoscopist
PHOTOFRIN® is a photoactivated radical generator with a non-contact, non-thermal red light from a laser.
Day 4-5: Follow-up bronchoscopy or endoscopy
Cleanout debridement bronchoscopy or endoscopy is performed. An optional second red laser light application may be performed.
Please see Full Prescribing Information for complete instructions for preparation and administration
- PDT with PHOTOFRIN® is an endoscopic or bronchoscopic procedure that requires minimal endoscopic maneuvering.2 The procedure induces a photochemical, not a thermal effect.1
- Each course consists of one injection of PHOTOFRIN® followed by up to 2 red laser light applications: the first, 40 to 50 hours after injection; the second, if needed, 96 to 120 hours after injection1
- Up to 3 courses of PDT with PHOTOFRIN® can be given, each separated by a minimum of 30 days in endobronchial or esophageal cancer.1
Important Safety Information and Indication
- 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
Warnings and Precautions
- Tracheoesophageal or bronchoesophageal fistula can occur if esophageal tumor is eroding into trachea or bronchial tree
- 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
- After treatment of high-grade dysplasia (HGD) in Barrett’s esophagus (BE), monitor endoscopic biopsy every three months, until four consecutive negative evaluations for HGD have been recorded
- Photosensitivity can be expected; ocular sensitivity is possible
- Allow 2-4 weeks between PDT and subsequent radiotherapy
- Substernal chest pain may occur after 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
- Esophageal stenosis occurs frequently after treatment of HGD in BE
- Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity
- Thromboembolic events can occur following photodynamic therapy with PHOTOFRIN®
- 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, dyspnoea, photosensitivity reaction, pneumonia, vomiting, insomnia, back pain, pharyngitis
- Obstructing Endobronchial Cancer: Dyspnoea, 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
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 Pinnacle Biologics, Inc. at 1-866-248-2039.
PHOTOFRIN® is indicated for:
- 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
- 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
References: 1. PHOTOFRIN® (porfimer sodium for injection) [package insert]. Bannockburn, IL: Pinnacle Biologics.
Pinnacle Biologics™ and the logo of Pinnacle Biologics™ are trademarks of Pinnacle Biologics, Inc.
The PHOTOFRIN® trademark is owned by Concordia Laboratories Inc.
PHOTOFRIN® is distributed in the United States by Pinnacle Biologics Inc.
References: 1. PHOTOFRIN® (porfimer sodium) Injection [package insert]. Bannockburn, IL: Pinnacle Biologics. 2. 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.