PDT with PHOTOFRIN® (porfimer sodium) for Injection

A biophysical treatment that causes vascular shutdown, cell apoptosis, and tumor cell death1

Achieve the following clinical improvements in endobronchial cancer

  • Objective Tumor Response: In studies of patients with late-stage obstructing endobronchial cancer vs: Nd:YAG Laser therapy, PHOTOFRIN PDT showed objective tumor response rates (CR + PR), which demonstrated reduction of obstruction, and atelectasis improvement.

table-11-a Note: Source PHOTOFRIN (porfimer sodium for injection) [package insert]

 

  • The PDT effect on Dyspnea, Cough and Hemoptysis Symptoms: In a study of patients with late-stage obstructing endobronchial cancer, the following results were observed:

Screen Shot 2016-04-28 at 12.55.45 PM Note: Source PHOTOFRIN (porfimer sodium for injection) [package insert]

 

Achieve clinically significant treatment results in esophogeal cancer

Table-10Note: Source PHOTOFRIN (porfimer sodium for injection) [package insert]

 

  • Improvement in dysphagia: In patients with completely obstructing esophogeal cancer 76% of patients experienced some palliation of their dysphagia in either Week 1 or Month 1 assessments.

Important Safety Considerations

  • Before each course of treatment, patients should be evaluated for tracheo-esophageal or bronchoesophageal fistula, which are contraindications to PDT. PDT is also contraindicated in patients with tumors eroding into a major blood vessel. PHOTOFRIN® is contraindicated in patients with porphyria.1
  • 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.1
  • All patients who receive PHOTOFRIN® will be photosensitive and must observe precautions listed in the Prescribing Information.

 

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

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 Concordia Laboratories 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

References: 1. PHOTOFRIN® (porfimer sodium for injection) [package insert]. Chicago, IL: Pinnacle Biologics.