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Important Safety Information and Indication
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 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.
Adverse Reactions
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:
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 in Barrett’s esophagus patients who do not undergo esophagectomy
Please see accompanying full Prescribing Information for Photofrin®