Porfimer

Porfimer
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Following injection with PHOTOFRIN® precautions must be taken to avoid exposure of skin and eyes to direct sunlight or bright indoor light (see PRECAUTIONS, GENERAL PRECAUTIONS AND INFORMATION FOR PATIENTS).

Esophageal Cancer

If the esophageal tumor is eroding into the trachea or bronchial tree, the likelihood of tracheoesophageal or bronchoesophageal fistula resulting from treatment is sufficiently high that PDT is not recommended.

Patients with esophageal varices should be treated with extreme caution. Light should not be given directly to the variceal area because of the high risk of bleeding.

Endobronchial Cancer

Patients should be assessed for the possibility that a tumor may be eroding into a pulmonary blood vessel (see CONTRAINDICATIONS). Patients at high risk for fatal massive hemoptysis (FMH) include those with large, centrally located tumors, those with cavitating tumors or those with extensive tumor extrinsic to the bronchus.

If the endobronchial tumor invades deeply into the bronchial wall, the possibility exists for fistula formation upon resolution of tumor.

Photodynamic therapy should be used with extreme caution for endobronchial tumors in locations where treatment-induced inflammation could obstruct the main airway, e.g., long or circumferential tumors of the trachea, tumors of the carina that involve both mainstem bronchi circumferentially, or circumferential tumors in the mainstem bronchus in patients with prior pneumonectomy.

High-Grade Dysplasia (HGD) in Barrett’s Esophagus (BE)

The long-term effect of PDT on HGD in BE is unknown. There is always a risk of cancer or abnormal epithelium that is invisible to the endoscopist beneath the new squamous cell epithelium; these facts emphasize the risk of overlooking cancer in such patients and the need for rigorous continuing surveillance despite the endoscopic appearance of complete squamous cell reepithelialization. It is recommended that endoscopic biopsy surveillance be conducted every three months, until four consecutive negative evaluations for HGD have been recorded; further follow-up may be scheduled every 6 to 12 months, as per judgment of physicians. The follow-up period of the pivotal study at the time of analysis was a minimum of two years (ranging from 2 to 3.6 years).

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.