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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 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 HGD in 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

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

Please see accompanying full Prescribing Information for Photofrin

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PHOTOFRIN®, Pinnacle Biologics™ and the logo of Pinnacle Biologics™ are trademarks of Pinnacle Biologics, Inc.

PHOTOFRIN® is manufactured by Jubilant Hollisterstier General Partnership and distributed in the United States by Pinnacle Biologics Inc.