Adult Dosing
Esophageal cancer
- 2 mg/kg IV x 1 followed by laser light 40-50 hrs post-injection
- A 2nd session of laser light therapy may be given 96–120 hrs post-injection and may be preceded by gentle tumor debridement
- May repeat photodynamic therapy after minimum 30 days
- Up to three treatments may be given, 30-day minimum interval between treatments
Endobronchial cancer
- 2 mg/kg IV x 1 followed by laser light 40-50 hrs post-injection
- A 2nd session of laser light therapy may be given 96–120 hrs after porfimer and may be preceded by gentle tumor debridement
- May repeat photodynamic therapy after minimum 30 days
- Up to three treatments may be given, 30-day minimum interval between treatments
Barrett's esophagus; high grade dysplasia
- 2 mg/kg IV x 1 followed by laser light 40-50 hrs post-injection
- May repeat laser light 96-120 hrs post-injection
- May repeat photodynamic therapy after minimum 90 days
- Up to three treatments may be given, 90-day minimum interval between treatments
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Tracheoesophageal or bronchoesophageal fistula may occur if esophageal tumor is eroding into trachea or bronchial tree. Photodynamic therapy is not recommended
- High risk of bleeding in patients with esophageal varices. Use with extreme caution. Avoid light directly to the variceal area because of the high risk of bleeding
- Assess patients for tumors eroding into a pulmonary blood vessel. Patients at high risk for fatal massive hemoptysis are those with endobronchial tumors that are: large and centrally located, cavitating, or extensive tumor extrinsic to the bronchus. Fistula formation may occur upon resolution of the tumor if the endobronchial tumor invades deep into the bronchial wall. Use PDT with extreme caution for endobronchial tumors in locations where treatment-induced inflammation could obstruct the main airway
- After treatment of high-grade dysplasias (HGD) in Barrett's Esophagus, monitor endoscopic biopsy q3 months, until four consecutive negative evaluations for HGD have been recorded; conduct follow-up q 6-12 months
- Esophageal strictures as a result of PDT of high-grade dysplasia in Barrett's esophagus can occur
- Photosensitivity can occur; conduct residual photosensitivity test in patients before exposing any area of skin to direct sunlight or bright indoor light
- Allow 2-4 wks between PDT and subsequent radiotherapy
- Substernal chest pain may occur after treatment and may require short-term opiate analgesics
- Life-threatening respiratory distress can occur. Monitor patients between the laser light therapy and the mandatory debridement bronchoscopy for any evidence of respiratory distress
- Patients with hepatic or renal impairment may need longer precautionary measures for photosensitivity
- Avoid extravasation at the site of injection
- Ocular sensitivity may occur
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Avoid exposure to direct sunlight/bright indoor light (photosensitivity may occur)
- Large centrally located endobronchial tumor
- Cavitating endobronchial tumor
- Extensive endobronchial tumor extrinsic to bronchus
- Long or circumferential tracheal tumor
- Circumferential carinal tumor incl. both bronchi
- Circumferential mainstem bronchial tumor with prior pneumonectomy
Supplemental Patient Information
- Advise patients to observe precautions to avoid exposure of skin and eyes to direct sunlight or bright indoor light for at least 30 days
- Encourage patients to expose their skin to ambient indoor light
- Advise patients to wear dark sunglasses as ocular sensitivity can occur
- Inform patients with liver or renal impairment that the period requiring precautionary measures for photosensitivity may be > 90 days
Pregnancy Category:C
Breastfeeding: Possibly unsafe; As many drugs are excreted in breastmilk and due to the potential for possible serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
