Usual Adult Dose for Gastroesophageal Reflux Disease

2 mg/kg via slow IV injection over 3 to 5 minutes.

Duration of Therapy: May give up to 3 courses (the first one 30 to 90 days after initial treatment and subsequent treatments each separated by a minimum of 30 to 90 days); consult the manufacturer product information.

Comments:

• Photodynamic therapy (PDT) with this drug is a two-stage process requiring administration of both drug and light; one PDT course consists of 1 drug injection plus 1 or 2 laser light applications.
• The first PDT stage is drug administration; the second stage is illumination: 630 nm wavelength laser light 40 to 50 hours following drug injection; a second laser light application may be given 96 to 120 hours after injection.
• Photoactivation of this drug is controlled by the total light dose of fiber optic diffuser length delivered: 300 Joules/cm (esophageal cancer); 200 Joules/cm (endobronchial cancer); 130 Joules/cm (Barrett's esophagus).

• Esophageal Cancer: Palliation of patients with completely obstructing esophageal cancer, or patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy.
• Endobronchial Non-Small Cell Lung Cancer (NSCLC): Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not inclined, and reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.
• Barrett's Esophagus: Ablation of high-grade dysplasia in patients who do not undergo esophagectomy.

Usual Adult Dose for Non-Small Cell Lung Cancer

2 mg/kg via slow IV injection over 3 to 5 minutes.

Duration of Therapy: May give up to 3 courses (the first one 30 to 90 days after initial treatment and subsequent treatments each separated by a minimum of 30 to 90 days); consult the manufacturer product information.

Comments:

• Photodynamic therapy (PDT) with this drug is a two-stage process requiring administration of both drug and light; one PDT course consists of 1 drug injection plus 1 or 2 laser light applications.
• The first PDT stage is drug administration; the second stage is illumination: 630 nm wavelength laser light 40 to 50 hours following drug injection; a second laser light application may be given 96 to 120 hours after injection.
• Photoactivation of this drug is controlled by the total light dose of fiber optic diffuser length delivered: 300 Joules/cm (esophageal cancer); 200 Joules/cm (endobronchial cancer); 130 Joules/cm (Barrett's esophagus).

• Esophageal Cancer: Palliation of patients with completely obstructing esophageal cancer, or patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy.
• Endobronchial Non-Small Cell Lung Cancer (NSCLC): Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not inclined, and reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.
• Barrett's Esophagus: Ablation of high-grade dysplasia in patients who do not undergo esophagectomy.

Usual Adult Dose for Esophageal Carcinoma

2 mg/kg via slow IV injection over 3 to 5 minutes.

Duration of Therapy: May give up to 3 courses (the first one 30 to 90 days after initial treatment and subsequent treatments each separated by a minimum of 30 to 90 days); consult the manufacturer product information.

Comments:

• Photodynamic therapy (PDT) with this drug is a two-stage process requiring administration of both drug and light; one PDT course consists of 1 drug injection plus 1 or 2 laser light applications.
• The first PDT stage is drug administration; the second stage is illumination: 630 nm wavelength laser light 40 to 50 hours following drug injection; a second laser light application may be given 96 to 120 hours after injection.
• Photoactivation of this drug is controlled by the total light dose of fiber optic diffuser length delivered: 300 Joules/cm (esophageal cancer); 200 Joules/cm (endobronchial cancer); 130 Joules/cm (Barrett's esophagus).

• Esophageal Cancer: Palliation of patients with completely obstructing esophageal cancer, or patients with partially obstructing esophageal cancer who cannot be satisfactorily treated with Nd:YAG laser therapy.
• Endobronchial Non-Small Cell Lung Cancer (NSCLC): Treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not inclined, and reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.
• Barrett's Esophagus: Ablation of high-grade dysplasia in patients who do not undergo esophagectomy.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

This drug is not dialyzable.

Other Comments

Administration Advice:

• Debridement of the residual tumor before a second laser light treatment may be necessary; consult the manufacturer product information.
• Consult the manufacturer product information for instructions on proper use of the fiber optic diffusers (including light dose calculation) and selected laser system.
• If extravasation occurs during drug administration, protect the area from light for at least 30 days and up to 90 days or more.
• Endobronchial NSCLC: Do not administer any further injection of this drug after initial treatment with laser light.
• Barrett's Esophagus: Consult the manufacturer product information for instructions on nodule pretreatment and treatment of "skip" (i.e., areas that do not show sufficient mucosal response) areas.

• Do not mix this drug with other drugs in the same solution.

• Data is not available on overdosage situations involving this drug.
• Hydrochloric acid and/or sodium hydroxide may be added during manufacture to adjust the pH.

• Photosensitivity
• Respiratory distress
• Tumor erosion into a major blood vessel
• Esophageal cancer: Evaluate patients for the presence of a tracheoesophageal or bronchoesophageal fistula before each PDT treatment course.