U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Porfimer is a photosensitizing agent used in the photodynamic therapy (PDT) of tumors. Porfimer sodium was approved under the brand name PHOTOFRIN 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. For the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). For the treatment of microinvasive endobronchial NSCLC in patients for whom surgery and radiotherapy are not indicated. In addition, for the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy. The cytotoxic and antitumor actions of PHOTOFRIN® are light and oxygen dependent. Photodynamic therapy with Porfimer sodium is a two-stage process. The first stage is the intravenous injection of the drug, which mainly is concentrated in the tumor tissues for a longer period. Illumination with 630 nm wavelength laser light constitutes the second stage of therapy. Cellular damage is a consequence of the propagation of radical reactions. Radical initiation may occur after porfimer absorbs light to form a porphyrin excited state. Tumor death also occurs through ischemic necrosis secondary to vascular occlusion that appears to be partly mediated by thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The necrotic reaction and associated inflammatory responses may evolve over several days.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Palliative
PHOTOFRIN

Approved Use

PHOTOFRIN is a photodynamic therapy drug indicated for: Esophageal Cancer (1.1) 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 Endobronchial Cancer (1.2) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett's Esophagus (1.3) Ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer 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. 1.2 Endobronchial Cancer 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. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett's Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.

Launch Date

1995
Palliative
PHOTOFRIN

Approved Use

PHOTOFRIN is a photodynamic therapy drug indicated for: Esophageal Cancer (1.1) 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 Endobronchial Cancer (1.2) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett's Esophagus (1.3) Ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer 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. 1.2 Endobronchial Cancer 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. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett's Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.

Launch Date

1995
Primary
PHOTOFRIN

Approved Use

PHOTOFRIN is a photodynamic therapy drug indicated for: Esophageal Cancer (1.1) 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 Endobronchial Cancer (1.2) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett's Esophagus (1.3) Ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer 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. 1.2 Endobronchial Cancer 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. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett's Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.

Launch Date

1995
Primary
PHOTOFRIN

Approved Use

PHOTOFRIN is a photodynamic therapy drug indicated for: Esophageal Cancer (1.1) 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 Endobronchial Cancer (1.2) Treatment of microinvasive endobronchial non-small-cell lung cancer (NSCLC) in patients for whom surgery and radiotherapy are not indicated Reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC High-Grade Dysplasia in Barrett's Esophagus (1.3) Ablation of high-grade dysplasia (HGD) in Barrett's esophagus (BE) patients who do not undergo esophagectomy 1.1 Esophageal Cancer 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. 1.2 Endobronchial Cancer 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. PHOTOFRIN is indicated for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial NSCLC. 1.3 High-Grade Dysplasia in Barrett's Esophagus PHOTOFRIN is indicated for the ablation of high-grade dysplasia in Barrett's esophagus patients who do not undergo esophagectomy.

Launch Date

1995
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
43.1 μg/mL
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
15.3 μg/mL
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
43105.6 ng/mL
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
41307.1 ng/mL
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
2937 μg × h/mL
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
974 μg × h/mL
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
2937444.7 ng × h/mL
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
3937582.7 ng × h/mL
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
410 h
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
250 h
2 mg/kg single, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
PORFIMER plasma
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
409.9 h
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
725 h
2 mg/kg 1 times / 5 weeks multiple, intravenous
dose: 2 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
PORFIMER serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
10%
PORFIMER serum
Homo sapiens
Doses

Doses

DosePopulationAdverse events​
2 mg/kg 1 times / month multiple, intravenous
Studied dose
Dose: 2 mg/kg, 1 times / month
Route: intravenous
Route: multiple
Dose: 2 mg/kg, 1 times / month
Sources:
unhealthy, ADULT
Health Status: unhealthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
Disc. AE: photosensitivity...
AEs leading to
discontinuation/dose reduction:
photosensitivity (3 patients)
Sources:
2 mg/kg single, intravenous
Studied dose
Dose: 2 mg/kg
Route: intravenous
Route: single
Dose: 2 mg/kg
Sources:
healthy, ADULT
Health Status: healthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
AEs

AEs

AESignificanceDosePopulation
photosensitivity 3 patients
Disc. AE
2 mg/kg 1 times / month multiple, intravenous
Studied dose
Dose: 2 mg/kg, 1 times / month
Route: intravenous
Route: multiple
Dose: 2 mg/kg, 1 times / month
Sources:
unhealthy, ADULT
Health Status: unhealthy
Age Group: ADULT
Sex: M+F
Food Status: UNKNOWN
Sources:
PubMed

PubMed

TitleDatePubMed
Heme oxygenase-1 protects tumor cells against photodynamic therapy-mediated cytotoxicity.
2006-06-08
Celecoxib and NS-398 enhance photodynamic therapy by increasing in vitro apoptosis and decreasing in vivo inflammatory and angiogenic factors.
2005-10-15
Erythropoietin restores the antitumor effectiveness of photodynamic therapy in mice with chemotherapy-induced anemia.
2002-05
Phototherapy of bladder cancer: dose/effect relationships.
1986-08
Patents

Patents

Sample Use Guides

Photodynamic therapy (PTD) with PHOTOFRIN (porfimer sodium)) 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, preceded by gentle debridement of residual tumor (see Administration of Laser Light).
Route of Administration: Intravenous
Photofrin (porfimer sodium) was evaluated through in vitro processes with human malignant melanoma cells (MMCs). MMCs incubated with Photofrin at a concentration of about 3.5 microg/ml and exposed to laser light at 630 nm with a power density of 100 mW/cm2, showed 50% cell killing. An electron microscopic study demonstrated significant destruction of the target after photodynamic therapy (PDT).
Name Type Language
Porfimer [WHO-DD]
Preferred Name English
PORFIMER
WHO-DD  
Common Name English
Classification Tree Code System Code
NDF-RT N0000009801
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
NDF-RT N0000010217
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
NCI_THESAURUS C1420
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
NDF-RT N0000175984
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
FDA ORPHAN DRUG 146601
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
Code System Code Type Description
DAILYMED
M15H03K69B
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
EVMPD
SUB03954MIG
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
DRUG CENTRAL
4021
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
FDA UNII
M15H03K69B
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
NCI_THESAURUS
C76306
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
SMS_ID
100000089408
Created by admin on Mon Mar 31 18:22:30 GMT 2025 , Edited by admin on Mon Mar 31 18:22:30 GMT 2025
PRIMARY
Display Structure of PORFIMER