Porfimer
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Steven Bellm, M.D. [2]
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Overview
Porfimer is a Photosensitizing Agent that is FDA approved for the treatment of obstructive esophageal cancer, completely or partially obstructing endobronchial non-small-cell lung cancer (NSCLC), Barrett’s esophagus. Common adverse reactions include Abdominal pain (20% ), Constipation (11% to 24% ), Dysphagia (10% to 22% ), Esophageal stricture (32% to 37% ), Anemia (32% ), Backache (11% ), Insomnia (14% ), Bronchitis (10% ), Dyspnea (7% to 30% ), Obstruction of bronchus (21% ), Pharyngitis (11% ), Stenosis of bronchus (11% ), Fever (8% to 31% ), Pain (22% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Barrett's esophagus, Ablation of high-grade dysplasia in patients not undergoing surgery: 2 mg/kg IV over 3 to 5 minutes followed by local application of laser light (630 nanometers wavelength) to the tumor 40 to 50 hours later; a second laser light application may be given 96 to 120 hours after administration of porfimer; patients may receive an additional course a minimum of 90 days after therapy; MAX number of courses is 3 (each separated by 90 days).
- Barrett's esophagus, Ablation of high-grade dysplasia in patients not undergoing surgery: The manufacturer recommends a light dose of 130 Joules/centimeter; acceptable light intensity for the balloon/diffuser combinations are 200 to 270 milliwatts/centimeter of diffuser. If repeated, use a light dose of 50 Joules/centimeter of fiber optic diffuser length 96 to 120 hours after initial injection.
- Carcinoma of esophagus, Completely or partially obstructed disease in patients ineligible for Nd/YAG laser therapy (palliative): 2 mg/kg IV over 3-5 minutes followed by local application of laser light (630 nanometers wavelength) to the tumor 40 to 50 hours later. A second laser light application may be given 96 to 120 hours after administration of porfimer, preceded by careful debridement of residual tumor; patients may receive an additional course a minimum of 30 days after therapy; max. number of courses is 3 (each separated by 30 days).
- Carcinoma of esophagus, Completely or partially obstructed disease in patients ineligible for Nd/YAG laser therapy (palliative): The manufacturer recommends 300 Joules/centimeter (J/cm) of tumor length with the fiber tip set to deliver the light dose using exposure times of 12 minutes and 30 seconds.
- Cholangiocarcinoma of biliary tract, Unresectable, after double stenting: 2 mg/kg IV administered 48 hours before laser activation was used in a clinical trial; photoactivation was performed at 630 nanometers using a light dose of 180 joules/cm(2).
- Non-small cell lung cancer, Completely or partially obstructing endobronchial disease: 2 mg/kg IV over 3 to 5 minutes followed by local application of laser light (630 nanometers wavelength) to the tumor 40 to 50 hours later; a second laser light application may be given 96 to 120 hours after administration of porfimer, preceded by careful debridement of residual tumor; patients may receive an additional course a minimum of 30 days after therapy; MAX number of courses is 3 (each separated by 30 days).
- Non-small cell lung cancer, Microinvasive endobronchial disease; in patients ineligible for surgery or radiotherapy: 2 mg/kg IV over 3 to 5 minutes followed by local application of laser light (630 nanometers wavelength) to the tumor 40 to 50 hours later; a second laser light application may be given 96 to 120 hours after administration of porfimer, preceded by careful debridement of residual tumor; patients may receive an additional course a minimum of 30 days after therapy; MAX number of courses is 3 (each separated by 30 days)
- Non-small cell lung cancer, Microinvasive endobronchial disease; in patients ineligible for surgery or radiotherapy: The manufacturer recommends 200 Joules/centimeter (J/cm) of tumor length for both palliation and treatment; with the fiber tip set to deliver the light dose using exposure times of 8 minutes and 20 seconds.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Porfimer in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Porfimer in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Porfimer FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Porfimer in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Porfimer in pediatric patients.
Contraindications
PHOTOFRIN® is contraindicated in patients with porphyria or in patients with known allergies to porphyrins.
Photodynamic therapy is contraindicated in patients with an existing tracheoesophageal or bronchoesophageal fistula.
Photodynamic therapy is contraindicated in patients with tumors eroding into a major blood vessel.
Photodynamic therapy 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.
Photodynamic therapy is not suitable for patients with esophageal or gastric varices, or patients with esophageal ulcers >1 cm in diameter.
Warnings
There is limited information regarding Porfimer Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Porfimer Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Porfimer Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Porfimer Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Porfimer in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Porfimer in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Porfimer during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Porfimer in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Porfimer in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Porfimer in geriatric settings.
Gender
There is no FDA guidance on the use of Porfimer with respect to specific gender populations.
Race
There is no FDA guidance on the use of Porfimer with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Porfimer in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Porfimer in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Porfimer in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Porfimer in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Porfimer Administration in the drug label.
Monitoring
There is limited information regarding Porfimer Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Porfimer and IV administrations.
Overdosage
There is limited information regarding Porfimer overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Porfimer Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Porfimer Mechanism of Action in the drug label.
Structure
There is limited information regarding Porfimer Structure in the drug label.
Pharmacodynamics
There is limited information regarding Porfimer Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Porfimer Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Porfimer Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Porfimer Clinical Studies in the drug label.
How Supplied
There is limited information regarding Porfimer How Supplied in the drug label.
Storage
There is limited information regarding Porfimer Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Porfimer Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Porfimer interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Porfimer Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Porfimer Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.