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| {{DrugProjectFormSinglePage
| | #REDIRECT [[Porfimer]] |
| |authorTag={{KS}}
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| |aOrAn=a
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| |indicationType=treatment
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| |adverseReactions=<!--Black Box Warning-->
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| |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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| * Content
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| <!--Adult Indications and Dosage-->
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| <!--FDA-Labeled Indications and Dosage (Adult)-->
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| |fdaLIADAdult===Indications==
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| '''Esophageal Cancer'''
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| * PHOTOFRIN® is indicated for the 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.
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| '''Endobronchial Cancer'''
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| * PHOTOFRIN is indicated for the treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated.
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| * PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC.
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| '''High-Grade Dysplasia in Barrett's Esophagus'''
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| * PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.
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| ==DOSAGE==
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| * Photodynamic therapy (PDT) with PHOTOFRIN is a two- stage process requiring administration of both drug and light. The first stage of PDT is the intravenous injection of PHOTOFRIN at 2 mg/kg. Illumination with laser light 40–50 hours following injection with PHOTOFRIN constitutes the second stage of therapy. A second laser light application may be given 96-120 hours after injection. In clinical studies on endobronchial cancer, debridement via endoscopy was required 2-3 days after the initial light application. Standard endoscopic techniques are used for light administration and debridement. Practitioners should be fully familiar with the patient's condition and trained in the safe and efficacious treatment of esophageal or endobronchial cancer, or high-grade dysplasia (HGD) in Barrett's esophagus (BE) using PDT with PHOTOFRIN and associated light delivery devices. PDT with PHOTOFRIN should be applied only in those facilities properly equipped for the procedure.
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| * The laser system must be approved for delivery of a stable power output at a wavelength of 630 ± 3 nm. Light is delivered to the tumor by cylindrical OPTIGUIDE™ fiber optic diffusers passed through the operating channel of an endoscope/bronchoscope. Instructions for use of the fiber optic and the selected laser system should be read carefully before use. OPTIGUIDE™ cylindrical diffusers are available in several lengths. The choice of diffuser tip length depends on the length of the tumor or Barrett's mucosa to be treated. Diffuser length should be sized to avoid exposure of nonmalignant tissue to light and to prevent overlapping of previously treated malignant tissue. Refer to the OPTIGUIDE™ instructions for use for complete instructions concerning the fiber optic diffuser.
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| '''PHOTOFRIN'''
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| * PHOTOFRIN should be administered as a single slow intravenous injection over 3 to 5 minutes at 2 mg/kg of body weight. Reconstitute each vial of PHOTOFRIN with 31.8 mL of either 5% Dextrose Injection (USP) or 0.9% Sodium Chloride Injection (USP), resulting in a final concentration of 2.5 mg/mL. Shake well until dissolved. Do not mix PHOTOFRIN with other drugs in the same solution. PHOTOFRIN, reconstituted with 5% Dextrose Injection (USP) or with 0.9% Sodium Chloride Injection (USP), has a pH in the range of 7 to 8. PHOTOFRIN has been formulated with an overage to deliver the 75 mg labeled quantity. The reconstituted product should be protected from bright light and used immediately. Reconstituted PHOTOFRIN is an opaque solution, in which detection of particulate matter by visual inspection is extremely difficult. Reconstituted PHOTOFRIN, however, like all parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
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| * Precautions should be taken to prevent extravasation at the injection site. If extravasation occurs, care must be taken to protect the area from light. There is no known benefit from injecting the extravasation site with another substance.
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| '''Photoactivation'''
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| '''Esophageal Cancer'''
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| * Initiate 630 nm wavelength laser light delivery to the patient 40–50 hours following injection with PHOTOFRIN. A second laser light treatment may be given as early as 96 hours or as late as 120 hours after the initial injection with PHOTOFRIN. No further injection of PHOTOFRIN should be given for such retreatment with laser light. Before providing a second laser light treatment, the residual tumor may be debrided. The debridement is optional since the residua will be removed naturally by peristaltic action of the esophagus. Vigorous debridement may cause tumor bleeding.
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| * Photoactivation of PHOTOFRIN is controlled by the total light dose delivered. In the treatment of esophageal cancer, a light dose of 300 Joules/cm (J/cm) of diffuser length should be delivered. The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 12 minutes and 30 seconds.
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| * For the treatment of esophageal cancer, patients may receive a second course of PDT a minimum of 30 days after the initial therapy; up to three courses of PDT (each separated by a minimum of 30 days) can be given. Before each course of treatment, patients with esophageal cancer should be evaluated for the presence of a tracheoesophageal or bronchoesophageal fistula [see Contraindications (4)]. All patients should be evaluated for the possibility that the tumor may be eroding into a major blood vessel [see Contraindications (4)].
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| '''Endobronchial Cancer'''
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| * Initiate 630 nm wavelength laser light delivery to the patient 40–50 hours following injection with PHOTOFRIN. A second laser light treatment may be given as early as 96 hours or as late as 120 hours after the initial injection with PHOTOFRIN. No further injection of PHOTOFRIN should be given for such retreatment with laser light. Before providing a second laser light treatment, the residual tumor should be debrided. Vigorous debridement may cause tumor bleeding. For endobronchial tumors, debridement of necrotic tissue should be discontinued when the volume of bleeding increases, as this may indicate that debridement has gone beyond the zone of the PDT effect.
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| * Photoactivation of PHOTOFRIN is controlled by the total light dose delivered. In the treatment of endobronchial cancer, a light dose of 200 J/cm of diffuser length should be delivered. The total power output at the fiber tip is set to deliver the appropriate light dose using exposure times of 8 minutes and 20 seconds. For noncircumferential endobronchial tumors that are soft enough to penetrate, interstitial fiber placement is preferred to intraluminal activation, since this method produces better efficacy and results in less exposure of the normal bronchial mucosa to light. It is important to perform a debridement 2 to 3 days after each light administration to minimize the potential for obstruction caused by necrotic debris [see WARNINGS AND PRECAUTIONS (5.8)].
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| * For the treatment of endobronchial cancer, patients may receive a second course of PDT a minimum of 30 days after the initial therapy; up to three courses of PDT (each separated by a minimum of 30 days) can be given. In patients with endobronchial lesions who have recently undergone radiotherapy, sufficient time (approximately 4 weeks) should be allowed between the therapies to ensure that the acute inflammation produced by radiotherapy has subsided prior to PDT [see WARNINGS AND PRECAUTIONS (5.6)]. All patients should be evaluated for the possibility that the tumor may be eroding into a major blood vessel.
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| '''High-Grade Dysplasia (HGD) in Barrett's Esophagus (BE)'''
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| * Prior to initiating treatment with PHOTOFRIN PDT, the diagnosis of HGD in BE should be confirmed by an expert GI pathologist.
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| * Approximately 40-50 hours after PHOTOFRIN administration light should be delivered by a X-Cell Photodynamic Therapy (PDT) Balloon with Fiber Optic Diffuser. The choice of fiber optic/balloon diffuser combination will depend on the length of Barrett's mucosa to be treated (TABLE 1).
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| |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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| <!--FDA-Labeled Indications and Dosage (Pediatric)-->
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| |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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| |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
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| |clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
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| |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
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| =====Body as a Whole=====
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| |drugInteractions=*
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| |useInPregnancyFDA=* '''Pregnancy Category'''
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| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
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| |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
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| |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
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| |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
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| |useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
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| |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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| |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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| |useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
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| |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
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| |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
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| |useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
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| <!--Administration and Monitoring-->
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| |administration=* Oral
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| * Intravenous
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| |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
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| * Description
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| <!--IV Compatibility-->
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| |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
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| <!--Overdosage-->
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| |overdose====Acute Overdose===
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| ====Signs and Symptoms====
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| * Description
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| ====Management====
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| * Description
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| ===Chronic Overdose===
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| There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacology-->
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| <!--Drug box 2-->
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| |drugBox=<!--Mechanism of Action-->
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| |mechAction=*
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| <!--Structure-->
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| |structure=*
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| : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
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| <!--Pharmacodynamics-->
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| |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacokinetics-->
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| |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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| <!--Nonclinical Toxicology-->
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| |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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| <!--Clinical Studies-->
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| |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
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| <!--How Supplied-->
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| |howSupplied=*
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| |packLabel=<!--Patient Counseling Information-->
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| |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
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| <!--Precautions with Alcohol-->
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| |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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| <!--Brand Names-->
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| |brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
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| <!--Look-Alike Drug Names-->
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| |lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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| <!--Drug Shortage Status-->
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| |drugShortage=
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| }}
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| {{PillImage
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| |fileName=No image.jpg
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| {{LabelImage
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| |fileName={{PAGENAME}}11.png
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| }}
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| <!--Pill Image-->
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| <!--Label Display Image-->
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| <!--Category-->
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| [[Category:Drug]] | |