PhotoBarr

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS  
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
PhotoBarr 15 mg powder for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 15 mg porfimer sodium. After reconstitution, each ml solution contains 2.5 mg 
porfimer sodium. 
 
For a full list of excipients, see 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for solution for injection. 
 
A dark red to reddish brown lyophilised powder or cake. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Photodynamic therapy (PDT) with PhotoBarr is indicated for ablation of high-grade dysplasia (HGD) 
in patients with Barrett's Oesophagus (BO). 
 
4.2 Posology and method of administration 
 
Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a 
physician with experience in endoscopic laser procedures. The medicinal product should only be 
administered when material and personnel experienced in evaluating and treating anaphylaxis are 
immediately available. 
 
Posology 
The recommended dose of PhotoBarr is 2 mg/kg body weight.  
 
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight 

2.5 mg/ml 
 
After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution. 
 
Only a solution without particles should be used and without visible signs of deterioration. 
 
Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both 
medicinal product and light. One course of PDT consists of one injection plus one or two light 
applications.  
 
In case of persistence of HGD, further treatment courses (up to a maximum of three courses) may be 
given (separated by a minimum of 90 days) to increase the response rate. This has to be balanced 
against the increased rate of stricture formation (see section 4.8 and section 5.1). 
 
Progression to cancer was related to the number of PDT courses administered. Patients who received 
one course of PDT had a greater risk of progression to cancer than patients who received two or three 
courses of PDT (50% vs. 39% and 11% respectively) 



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Method of administration 
For instructions on reconstitution prior to administration, see section 6.6.  
 
Physicians should be trained in the use of PDT. The first stage of PDT is the slow intravenous 
injection of PhotoBarr. The second stage of therapy is illumination with laser light 40-50 hours 
following injection with PhotoBarr. Patients may receive a second laser light application 96-120 hours 
after administration.  
 
PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes. If 
accidentally injected paravenously there may be damage to paravenous tissue. Therefore, care should 
be taken to prevent extravasation at the injection site. If extravasation does occur, the area should be 
protected from light for a minimum of 90 days. There is no known benefit from injecting the 
extravasation site with another substance. 
 
Approximately 40-50 hours after PhotoBarr administration, light should be delivered by a fibre optic 
diffuser passed through the central channel of a centring balloon. The choice of fibre optic/balloon 
diffuser combination will depend on the length of oesophagus to be treated (Table 1). 
 
Table 1.  Fibre optic diffuser/balloon combinationa 

Treated Barrett's 
mucosa length (cm) 

Fibre optic diffuser size 
(cm) 

Balloon window size 
(cm) 

6-7 9 7 
4-5 7 5 
1-3 5 3 
a Whenever possible, the BO segment selected for treatment should include normal 
tissue margins of a few millimetres at the proximal and distal ends. 

 
Light doses 
Photoactivation is controlled by the total light dose delivered. The objective is to expose and treat all 
areas of HGD and the entire length of BO. The light dose administered will be 130 Joules/cm (J/cm) of 
diffuser length using a centring balloon. Based on preclinical studies, acceptable light intensity for the 
balloon/diffuser combination ranges from 175-270 mW/cm of diffuser. 
 
To calculate the light dose, the following specific light dosimetry equation applies for all fibre optic 
diffusers:   
 
The light dose (J/cm) =  power output from diffuser (W) x treatment time (sec) 

    Diffuser length (cm) 
 
Table 2 provides the settings that would be used to deliver the dose within the shortest time (light 
intensity of 270 mW/cm). A second option (light intensity of 200 mW/cm) has also been included 
where necessary to accommodate lasers with a total capacity that does not exceed 2.5 W. 
 
Table 2.  Fibre optic power outputs and treatment times required to deliver 130 J/cm of diffuser length 

using the centring balloon 
Balloon 
Window 
Length (cm) 

Diffuser 
Length 
(cm) 

Light 
Intensity 
(mW/cm) 

Required Power 
Output from 
Diffusera (W) 

Treatment 
Time (sec) 

Treatment 
Time 
(min:sec) 

3 5 270 1.35 480 8:00 
5 7 270 

200 
1.90 
1.40 

480 
650 

8:00 
10:50 

7 9 270 
200 

2.44 
1.80 

480 
650 

8:00 
10:50 



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a As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the 
laser power. Note: No more than 1.5 times the required diffuser power output should be needed from 
the laser. If more than this is required, the system should be checked. 
 
Short fibre optic diffusers (< 2.5 cm) are to be used to pretreat nodules with 50 J/cm diffuser length 
prior to regular balloon treatment in the first laser light session or for the retreatment of "skip" areas 
after the first light session. For this treatment, the fibre optic diffuser is used without a balloon, and a 
light intensity of 400 mW/cm should be used. Table 3 lists appropriate fibre optic power outputs and 
treatment times using a light intensity of 400 mW/cm. 
 
Table 3.  Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/cm of 
diffuser length at a light intensity of 400 mW/cm 

Diffuser 
length (cm) 

Required power 
output from diffusera 

(W) 

Treatment time 
(sec) 

Treatment time 
(min:sec) 

1.0 0.4 125 2:05 
1.5 0.6 125 2:05 
2.0 0.8 125 2:05 
2.5 1.0 125 2:05 

aAs measured by immersing the diffuser into the cuvette in the power meter and slowly 
increasing the laser power. Note: No more than 1.5 times the required diffuser power 
output should be needed from the laser. If more than this is required, the system should 
be checked. 

 
First light application 
A maximum of 7 cm of Barrett's mucosa is treated at the first light session using an appropriate size of 
centering balloon and fibre optic diffuser (Table 1). Whenever possible, the segment selected for the 
first light application should include all the areas of HGD. Also, whenever possible, the BO segment 
selected for the first light applications should include normal tissue margin of a few millimetre at the 
proximal and distal ends. Nodules are to be pre-treated at a light doses of 50 J/cm of diffuser length 
with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard 
balloon application as described above. 
 
Repeat light application 
A second laser light application may be given to a previously treated segment that shows a 'skip' area, 
(i.e., an area that does not show sufficient mucosal response) using a short < 2.5 cm fibre optic diffuser 
at the light dose of 50 J/cm of diffuser length (see Table 3). The treatment regimen is summarized in 
Table 4.  Patients with BO > 7 cm, should have the remaining untreated length of Barrett's epithelium 
treated with a second PDT course at least 90 days later. 
 
Table 4.  High-grade dysplasia in Barrett's oesophagus of < 7 cm 
 

Procedure Study day Light delivery Devices Treatment intent 
PhotoBarr 
Injection 

Day 1 NA Uptake of  
photosensitiser 

Laser Light 
Application 

Day 3a 3, 5 or 7 cm balloon 
(130 J/cm) 

Photoactivation 

Laser Light 
Application 

Day 5 Short (< 2.5 cm) fibre 
optic diffuser (50 J/cm) 

Treatment of "skip" 
areas only 

 aDiscrete nodules will receive an initial light application of 50 J/cm (using short diffuser) 
before the balloon light application. 

 
Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to 
three courses of PDT (each injection separated by a minimum of 90 days) should be given to a 
previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment 



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was >7 cm in length. Both residual and additional segments may be treated in the same light session(s) 
if the total length of the segments treated with the balloon/diffuser combination is not greater than 7 
cm. In the case of a previously treated oesophageal segment, if it has not sufficiently healed and/or 
histological assessment of biopsies is not clear, the subsequent course of PDT may be delayed for an 
additional 1-2 months. 
 
Special care to ensure accurate PhotoBarr dosing and/or light dose is crucial, since miscalculation of 
either medicinal product or light dose may lead to a less effective treatment or cause detrimental effect 
to the patient. Photodynamic therapy with PhotoBarr should be applied by physicians trained in 
endoscopic use of PDT and only in those facilities properly equipped for the procedure. 
 
Special populations 
 
Paediatric patients 
 PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety 
and efficacy. 
 
Elderly patients (≥ 65 years old) 
Dose modification based upon age is not required. 
 
Renal impairment 
The influence of renal impairment on exposure to porfimer sodium has not been evaluated (see section 
4.3). 
 
Hepatic impairment  
The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see 
section 4.3 and 4.4). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance, other porphyrins or to any of the excipients. 
 
Porphyria.  
 
Severe renal and/or hepatic impairment. 
 
Oesophageal or gastric varices or patients with oesophageal ulcers >1 cm in diameter. 
 
Tracheo-oesophageal or broncho-oesophageal fistula. 
 
Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage. 
 
4.4 Special warnings and precautions for use 
 
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with 
contraindications to, or not being eligible for, oesophagectomy. Photodynamic therapy with PhotoBarr 
has exclusively been studied in patients not suffering from severe medical conditions, such as 
congestive heart failure of advanced stage or serious pulmonary conditions that might impair the 
eligibility of patients for surgical procedures. 
 
In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning 
mucosal ablative therapy. Safety and efficacy in patients with treatment failure of other local mucosal 
ablative therapy has not been evaluated. 
 



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Elderly 
Patients older than 75 years may be at a higher risk of respiratory related adverse events such as 
pleural effusion and dyspnoea. 
 
Pulmonary or cardiac disorders 
Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with 
caution. These patients may be at higher risk for the development of cardiac and pulmonary related 
adverse events such as heart rhythm disorders, angina pectoris, dyspnoea, cough, pleural effusion, 
pharyngitis, atelectasis and events like dehydration (see also section 4.8). 
 
Photosensitivity 
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid 
exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including 
dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at 
least 90 days after treatment, as some patients may remain photosensitive for up to 90 days or more.   
During this period, patients should wear dark sunglasses, which have an average white light 
transmittance of < 4% when outdoors. The photosensitivity is due to residual photoactive substances, 
which will be present in all parts of the skin. Exposure of the skin to ambient indoor light is, however, 
beneficial because the remaining medicinal product will be inactivated gradually through a photo-
bleaching reaction. Therefore, patients should not stay in a darkened room during this period and 
should be encouraged to expose their skin to ambient indoor light. The level of photosensitivity will 
vary for different areas of the body, depending on the extent of previous exposure to light.  
Before exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for 
residual photosensitivity. A small area of skin should be exposed to sunlight for 10 minutes. The tissue 
around the eyes may be more sensitive, and therefore, it is not recommended that the face be used for 
testing. If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the 
patient can gradually resume normal outdoor activities, initially continuing to exercise caution and 
gradually allowing increased exposure. If some photosensitivity reaction occurs with the limited skin 
test, the patient should continue exercising precautions for another 2 weeks before retesting.  
If patients travel to a different geographical area with greater sunshine, they should retest their level of 
photosensitivity. Conventional UV (ultraviolet) sunscreens are of no value in protecting against 
photosensitivity reactions because photoactivation is caused by visible light. 
 
Hepatic impairment 
No pharmacokinetic and safety data in patients with hepatic impairment are available. Based on 
evidence for a primarily hepatic/biliary elimination of photoactive substances, severity of phototoxic 
reactions and duration of the period of photosensitivity in patients with any grade of hepatic 
impairment may be increased.  PhotoBarr is contraindicated in patients with severe hepatic 
impairment. Patients with mild to moderate hepatic impairment should be clearly instructed that the 
period requiring the precautionary measures described below may be longer than 90 days.   
 
Ocular sensitivity 
Patients should be advised to consult their ophthalmologist if they notice any vision changes after 
treatment with PhotoBarr PDT. 
 
Hypersensitivity 
Acute hypersensitivity reactions including anaphylaxis have been reported. In case of an allergic 
reaction, appropriate measures (standard of care) should be taken and the PDT treatment should not be 
repeated.  The medicinal product should only be administered when material and personnel 
experienced in evaluating and treating anaphylaxis are immediately available. 
 
Non Cardiac Chest Pain 
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory 
responses within the area of treatment. Such pain may be of sufficient intensity to warrant the short-
term prescription of opiate analgesics. 
 



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Oesophageal Stenosis 
Prophylactic use of corticosteroids to reduce stricture formation should be avoided during PDT as its 
use has shown not to reduce, and may worsen, stricture formation.  
 
Nutrition in Patients 
PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting. Therefore, patients 
should be advised to receive liquid food during the first days (up to 4 weeks) after the laser light 
application. If intake of food and/or drink becomes impossible or repeated vomiting occurs, patients 
should be advised to return to the clinic for evaluation and to receive intravenous fluids if needed. 
 
Use Before or After Radiotherapy 
If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the 
therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to 
commencement of the second treatment.  
 
Thrombo-embolism 
There may be an increase in the risk of thrombo-embolic events especially in patients with 
prolonged immobilization, post major surgery and other thromboembolic risk factors. 
Follow-up procedure 
Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment. Also, 
treating physicians should be aware of the possibility of squamous overgrowth and the risk of 
overlooking cancer. Therefore, adequate and rigorous surveillance should be continued despite 
possible endoscopic partial or complete restitution of the normal squamous mucosa. In the clinical 
studies with PhotoBarr, follow-up surveillance was done every three months, or every six months after 
four consecutive biopsy results had shown no more high-grade dysplasia (see section 5.1). Available 
treatment and surveillance guidelines should be considered. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic 
interactions with other medicinal products.  
 
A study investigating pharmacodynamic interactions has demonstrated that corticosteroids given 
before or concomitant with PDT to decrease formation of strictures may decrease the safety of 
treatment. 
 
It is possible that concomitant use of other photosensitising agents (e.g., tetracyclines, sulphonamides, 
phenothiazines, sulphonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and 
fluoroquinolones) could increase the photosensitivity reaction. 
 
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage 
intracellular membranes and mitochondria. Tissue damage also results from ischaemia secondary to 
vasoconstriction, platelet activation and aggregation and clotting. Research in animals and in cell 
culture has suggested that many active substances could influence the effects of PDT, possible 
examples of which are described below. There are no human data available to support or rebut these 
possibilities. Compounds that quench active oxygen species or scavenge radicals, such as dimethyl 
sulphoxide, b-carotene, ethanol, formate and mannitol would be expected to decrease PDT activity. 
Preclinical data also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some 
prostaglandin synthesis inhibitors could interfere with PhotoBarr PDT. Medicinal products that 
decrease clotting, vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could 
decrease the efficacy of PDT.  



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4.6 Fertility, Pregnancy and lactation 
 
Pregnancy 
There are no clinical data on exposed pregnancies available for porfimer sodium. Animal studies are 
insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal 
development (see section 5.3). The potential risk for humans is unknown. Porfimer sodium should not 
be used during pregnancy, unless clearly necessary. Women of child-bearing potential should use 
effective contraception before, during and for at least 90 days after treatment. 
 
Lactation 
It is not known whether porfimer sodium is excreted into human breast milk. In rats, porfimer sodium 
passed into breast milk. Breast-feeding should be terminated prior to treatment. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
For the PDT procedure, sedation may be required, and consequently caution should be taken. Patients 
should not drive or use machines after the light treatment if they have been sedated for the procedure. 
 
4.8 Undesirable effects 
 
a. Summary of the safety profile 
 
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid 
sunlight and bright indoor light (see section 4.4). In an open label pharmacokinetic study, all 
24 healthy subjects experienced photosensitivity reactions, which were characteristically represented 
by erythematous rash and oedema and were mild to moderate in intensity. The photosensitivity 
reactions occurred primarily on the face, hands, and neck regions, which are the areas of the skin that 
are most susceptible to accidental sunlight exposure. Other less common skin manifestations were 
reported in areas where photosensitivity reactions had occurred, such as increased hair growth, skin 
discolouration, skin nodules, skin wrinkling and skin fragility. These manifestations may be 
attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria). 
The frequency and nature of the photosensitivity reactions experienced in this study are unlike the 
documented incidence seen in previous clinical studies in cancer patients (approx. 20%) or the 
spontaneously reported incidence from commercial use of PhotoBarr (< 20%). It is possible that 
prolonged exposure to light at the clinical research unit or accidental sunlight exposure after discharge 
may be responsible for the high frequency of photosensitivity reactions. The more active lifestyle of 
the healthy and relatively younger subjects compared with cancer patients may have been a 
contributing factor to these photosensitivity reactions. 
 
PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with 
omeprazole alone (OM only), in the BO with HGD controlled clinical trial. In the PDT + OM group, 
133 patients were treated. The most frequently reported adverse reactions were photosensitivity 
reactions (69%), oesophageal stenosis (40%), vomiting (32%), chest pain of non-cardiac origin (20%), 
pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%). The 
majority of these reported adverse reactions were mild to moderate in intensity. 
 
b.Tabulated summary of adverse reactions 
 
Adverse reactions reported are listed below in Table 5 by organ class and frequency. Frequencies are 
defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not 
known (cannot be estimated from the available data).  
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 



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Table 5.  Summary of adverse reactions with porfimer sodium  
Infections and infestations 
Uncommon:   Bronchitis, nail fungal infection, sinusitis, skin infection  
Not known: Pneumonia 

Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Uncommon:   Basal cell carcinoma, lentigo 

Blood and lymphatic system disorders 
Uncommon:   Leukocytosis 
Not known:  Anaemia 

Immune system disorders  
Not known: Hypersensitivity 

Metabolism and nutrition disorders 
Very common:   Dehydration* 
Common:   Appetite decreased, electrolyte imbalance 
Uncommon:   Hypokalaemia 

Psychiatric disorders 
Common:   Anxiety, insomnia 
Uncommon:   Restlessness 

Nervous system disorders 
Common:   Headache, paraesthesia, dysgeusia 
Uncommon:  Dizziness, hypoaesthesia, tremor 

Eye disorders 
Uncommon:  Eye irritation, eye oedema 
Not known: Cataract 

Ear and labyrinth disorders 
Uncommon:  Deafness, tinnitus, tinnitus aggravated 

Cardiac disorders 
Common:   Tachycardia, chest pain 
Uncommon:  Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort 

Vascular disorders 
Uncommon:   Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension 
Not known:  Embolism, Deep vein thrombosis, Phlebitis 

Respiratory, thoracic and mediastinal disorders 
Common:   Pleural effusion, pharyngitis, atelectasis, dyspnoea 
Uncommon:   Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion,     

pneumonia aspiration, productive cough, respiratory depression, respiratory 
tract congestion, wheezing 

Gastrointestinal disorders 
Very common:   Oesophageal stenosis acquired*, vomiting*, dysphagia, constipation,                     
 nausea* 
Common:   Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain 

upper*, abdominal pain, haematemesis, oesophageal pain, eructation, melaena 
(haematocheznia), oesophageal disorder, regurgitation of food, abdominal 
rigidity, oesophageal spasm, oesophagitis. 

Uncommon:   Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal 
distension, abdominal pain lower, acquired pylori stenosis, chapped lips, 
colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal 
haemorrhage, oesophageal perforation. 

Not known:  Tracheo-oesophageal fistula, Gastrointestinal necrosis  
Skin and subcutaneous tissue disorders 



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Very common:   Photosensitivity reaction 
Common:   Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis 

 exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin 
hyperpigmentation, skin lesion, skin nodule, urticaria  

Uncommon:   Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, 
keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab, 
scar pain, vitiligo. 

Musculoskeletal and connective tissue disorders 
Common:   Back pain, pain in the limb 
Uncommon:   Joint contracture, joint range of motion decreased, musculoskeletal chest pain, 

plantar fascitis 

Renal and urinary disorders: 
Uncommon: Urinary retention 
Reproductive system and breast disorders 
Uncommon:   Gynaecomastia 

Congenital, and familial and genetic disorders 
Uncommon:   Pigmented naevus  

General disorders and administration site conditions 
Very common:   Pyrexia 
Common:   Rigors, fatigue 
Uncommon:   Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, 

pitting oedema, temperature intolerance, weakness 

Investigations 
Common:   Weight decreased, body temperature increased 
Uncommon:   Blood albumin decreased, blood chloride increased, blood urea increased, 

haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, 
protein total decreased 

Injury poisoning, and procedural complications 
Common:   Post procedural pain, abrasion 
Uncommon:   Blister, post procedural haemorrhage 

* see section c. 
 
c. Description of selected adverse reactions 
 
Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered 
associated with the treatment. The most frequently reported treatment-associated serious adverse 
reaction (SAR) was dehydration (4%), experienced by 5 patients. The majority of the SARs were 
gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), vomiting (3% - 4 
patients) and upper abdominal pain (2% - 2 patients). 
 
The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and 
oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity 
(92%). All incidences of strictures were considered associated with treatment of which 1% was 
considered serious.  
 
An occurrence rate of 12% for oesophageal strictures was observed during the first course of 
treatment. The occurrence rate rose to 32% when a second course of therapy was given, especially in 
the areas where second treatment overlaps the first and amounted to 10% for those who received a 
third treatment course. The majority of these was mild to moderate in intensity and could be managed 
through 1-2 dilatations. Eight percent were severe, requiring multiple (6 - >10) dilatations. The 
formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids. 
 



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4.9 Overdose 
 
PhotoBarr  
There is no information on overdose of PhotoBarr. The recommended 2 mg/kg dose, instead of the 
recommended single administration, was given twice two days apart (10 patients) and three times 
within two weeks (1 patient), without any notable adverse reactions being reported. The effects of an 
overdose on the duration of photosensitivity are unknown. Laser treatment should not be given if an 
overdose of PhotoBarr is administered. In the event of an overdose, patients should protect their eyes 
and skin from direct sunlight or bright indoor lights for 90 days. At this time, patients should test for 
residual photosensitivity (see section 4.4).  
Porfimer sodium is not dialyzable. 
 
Laser light 
Light doses of two to three times the recommended dose have been administered to a few patients with 
superficial endobronchial tumours. One patient experienced life-threatening dyspnoea and the others 
had no notable complications. Increased symptoms and damage to normal tissue might be expected 
following an overdose of light. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: 
L01XD01 
 
Mechanism of action 
Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight 
units The cytotoxic actions of porfimer sodium are light and oxygen-dependent. Photodynamic 
therapy with PhotoBarr is a 2-stage process. The first stage is the intravenous injection of PhotoBarr. 
Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the 
reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period. 
Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of 
therapy. Tumour and dysplastic tissue selectivity in treatment may occur partly through selective 
retention of porfimer sodium but mainly through a selective delivery of light. Cellular damage caused 
by porfimer sodium PDT is a consequence of the propagation of free radical reactions. Radical 
initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin 
transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. Subsequent 
free radical reactions can form superoxide and hydroxyl radicals. Tumour cell death also occurs 
through ischaemic 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 response evolve over several days. 
 
Clinical efficacy 
In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183)was 
compared to a group of patients receiving OM only (n=70). Eligible patients for this study were to 
have biopsy-proven HGD in Barrett's oesophagus (BO). Patients were excluded from the study if there 
was a presence of invasive oesophageal cancer, if they had a history of cancer other than non-
melanoma skin cancer or if they had received prior PDT to the oesophagus. Other exclusion criteria 
were patients in whom omeprazole therapy was contraindicated. 
 



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Patients randomised to treatment with PDT received PhotoBarr at a dose of 2 mg/kg body weight 
through slow intravenous injection over 3 to 5 minutes. One or 2 laser light treatments were 
administered following PhotoBarr injection. The first laser light session occurred 40-50 hours after 
injection and a second session, if indicated, occurred 96-120 hours after injection. Co-administration 
of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection. Patients randomised to 
the OM only group received orally omeprazole 20 mg BID for the duration of the study.   
 
Patients were followed every 3 months until 4 consecutive, quarterly follow-up endoscopic biopsy 
results were negative for HGD, and then biannually until the last enrolled patient had completed a 
minimum of 24 months of follow-up evaluations after randomisation.    
 
PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO. At final analysis, 
performed at a minimum of 24 months follow-up, a statistically significant percentage of patients 
(77%) in the PhotoBarr PDT + OM group demonstrated complete HGD ablation compared to 39% of 
patients in the OM alone group (p<0.0001). Fifty-two percent of patients in the PDT + OM group 
showed normal squamous cell epithelium while 59% had absence of dysplasia compared to 7% and 
14% in the OM alone group, respectively (p<0.0001). These results confirm those observed after a 
minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr 
PDT + OM group compared to 31% in the OM only group. Forty-one percent of patients showed 
normal squamous cell epithelium and 49% had absence of dysplasia. 
 
By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had 
progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population. 
The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was 
statistically lower than in the OM only group (p=0.0060). The survival curves indicated that, by the 
end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of 
being cancer-free as compared to a 53% chance for patients in the OM only group. Comparison 
between the survival curves of the two treatment arms using the log rank test showed a statistically 
significant difference between the curves of the two groups in the ITT population (p=0.0014), 
indicating a significant delay in the progression to cancer. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of porfimer sodium have been studied in 12 patients with endobronchial cancer 
and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium  through slow 
intravenous injection. Plasma samples were obtained out to 56 days (patients) or 36 days (volunteers) 
post-injection.  
 
In patients, the mean peak plasma concentration (Cmax) was 79.6 μg/ml (CV 61%, range 39-222), 
whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml. 
 
Distribution 
In vitro binding of porfimer sodium to human serum protein is around 90% and independent of 
concentration between 20 and 100 μg/ml. 
 
Elimination 
Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/h/kg (CV 53%) in 
patients. The serum decay was bi-exponential, with a slow distribution phase and a very long 
elimination phase that started approximately 24 hours after injection. The mean elimination half-life 
(t1/2) was 21.5 days (CV 26 %, range 264-672) in patients and 17 days in volunteers.  
 
Special populations 
The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated 
(see sections 4.2, 4.3 and 4.4).  
 



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Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 
1.5 hours in women and 0.17 hours in men. At the time of intended photoactivation 40-50 hours after 
injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar. 
 
5.3 Preclinical safety data 
 
Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light. With light 
activation, porfimer sodium was mutagenic in some in-vitro tests.  
 
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during 
pregnancy, as no light activation had been used. In these studies foetotoxicity, but not teratogenicity, 
occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and 
at greater frequency (daily) compared in the clinical use. 
 
Preclinical studies indicate that the excretion of porfimer sodium components occurs primarily via the 
faecal route. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Hydrochloric acid (for pH-adjustment)  
Sodium hydroxide (for pH-adjustment)  
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
Powder: 3 years. 
 
After reconstitution: use immediately (within 3 hours). 
 
After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected 
from light. Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C. From a 
microbiological point of view, the product should be used immediately. If not used immediately, 
in-use storage time and conditions prior to use are the responsibility of the user. 
 
6.4 Special precautions for storage 
 
Keep out of the reach and sight of children. 
 
Do not use after the expiry date stated on the carton and vial after EXP.   
 
Do not store above 25°C. 
Keep the vial in the outer carton in order to protect from light.  
 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
 



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6.5 Nature and contents of container 
 
15 mg powder in a vial (glass type I, 7 ml capacity) with a grey butyl stopper.  
Pack size:  1 vial. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for reconstitution 
PhotoBarr 15 mg vial should be reconstituted with 6.6 ml of 5% glucose solution for injection 
resulting in a final porfimer sodium concentration of 2.5 mg/ml in the solution for injection.  
 
Do not use other diluents. Do not mix PhotoBarr with other medicinal products in the same solution.  
 
Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/kg.  
For most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice. A PhotoBarr 15 mg vial will 
be needed for every additional 7.5 kg body weight. 
 
Spills and disposal 
Spills of PhotoBarr should be wiped up with a damp cloth.  Skin and eye contact should be avoided 
due to the potential for photosensitivity reactions upon exposure to light; use of rubber gloves and eye 
protection is recommended.  
PhotoBarr is for single use only and any unused solution should be discarded. 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
Accidental exposure  
PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.  However, because of its 
potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of 
bright light.  It is important to avoid contact with the eyes and skin during preparation and/or 
administration.  As with therapeutic overdose, any accidentally overexposed person must be protected 
from bright light.’ 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pinnacle Biologics B.V. 
p/a Trust Company Amsterdam B.V. 
Crystal Tower 21st Floor, 
Orlyplein 10, 1043 DP Amsterdam 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/04/272/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 25 March 2004 
Date of latest renewal: 4 March 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 



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Detailed information on this product is available on the website of the European Medicines Agency 
http://www.ema.europa.eu



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1. NAME OF THE MEDICINAL PRODUCT 
 
PhotoBarr 75 mg powder for solution for injection. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each vial contains 75 mg porfimer sodium.  After reconstitution, each ml solution contains 2.5 mg 
porfimer sodium. 
 
For a full list of excipients, see 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for solution for injection. 
 
A dark red to reddish brown lyophilised powder or cake. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Photodynamic therapy (PDT) with PhotoBarr is indicated for: 
 
- ablation of high-grade dysplasia (HGD) in patients with Barrett's Oesophagus (BO). 
 
4.2 Posology and method of administration 
 
Photodynamic therapy with PhotoBarr should be performed only by, or under the supervision of, a 
physician with experience in endoscopic laser procedures. The medicinal product should only be 
administered when material and personnel experienced in evaluating and treating anaphylaxis are 
immediately available. 
 
Posology 
The recommended dose of PhotoBarr is 2 mg/kg body weight.  
 
Reconstituted PhotoBarr solution (ml) = Patient's weight (kg) x 2 mg/kg = 0.8 x patient's weight 

2.5 mg/ml 
 
After reconstitution, PhotoBarr is a dark red to reddish brown, opaque solution. 
 
Only a solution without particles should be used and without visible signs of deterioration. 
 
Photodynamic therapy with PhotoBarr is a two-stage process requiring administration of both 
medicinal product and light. One course of PDT consists of one injection plus one or two light 
applications.  
 
In case of persistence of HGD, further treatment courses (up to a maximum of three courses) may be 
given (separated by a minimum of 90 days) to increase the response rate. This has to be balanced 
against the increased rate of stricture formation (see section 4.8 and section 5.1). 
 



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Progression to cancer was related to the number of PDT courses administered. Patients who received 
one course of PDT had a greater risk of progression to cancer than patients who received two or three 
courses of PDT (50% vs. 39% and 11% respectively) 
 
Method of administration 
For instructions on reconstitution prior to administration, see section 6.6 
 
Physicians should be trained in the use of PDT. The first stage of PDT is the slow intravenous 
injection of PhotoBarr. The second stage of therapy is illumination with laser light 40-50 hours 
following injection with PhotoBarr. Patients may receive a second laser light application 96-120 hours 
after administration.  
 
 PhotoBarr should be administered as a single slow intravenous injection over 3 to 5 minutes at 2 
mg/kg body weight. If accidentally injected paravenously there may be damage to paravenous tissue. 
Therefore, care should be taken to prevent extravasation at the injection site. If extravasation does 
occur, the area should be protected from light for a minimum of 90 days. There is no known benefit 
from injecting the extravasation site with another substance. 
 
Approximately 40-50 hours after PhotoBarr administration, light should be delivered by a fibre optic 
diffuser passed through the central channel of a centring balloon. The choice of fibre optic/balloon 
diffuser combination will depend on the length of oesophagus to be treated (Table 1). 
 
Table 1.  Fibre optic diffuser/balloon combinationa 
 

Treated Barrett's 
Mucosa Length (cm) 

Fibre Optic Diffuser 
Size (cm) 

Balloon Window Size 
(cm) 

6-7 9 7 
4-5 7 5 
1-3 5 3 
a Whenever possible, the BO segment selected for treatment should include normal 
tissue margins of a few millimetres at the proximal and distal ends. 

 
Light doses 
Photoactivation is controlled by the total light dose delivered. The objective is to expose and treat all 
areas of HGD and the entire length of BO. The light dose administered will be 130 Joules/cm (J/cm) of 
diffuser length using a centring balloon. Based on preclinical studies, acceptable light intensity for the 
balloon/diffuser combination ranges from 175-270 mW/cm of diffuser. 
 
To calculate the light dose, the following specific light dosimetry equation applies for all fibre optic 
diffusers:   
 
The light dose (J/cm)=  power output from diffuser (W) x treatment time (sec) 

    Diffuser length (cm) 
 
Table 2 provides the settings that would be used to deliver the dose within the shortest time (light 
intensity of 270 mW/cm). A second option (light intensity of 200 mW/cm) has also been included 
where necessary to accommodate lasers with a total capacity that does not exceed 2.5 W. 
 
Table 2.  Fibre optic power outputs and treatment times required to deliver 
130 J/cm of diffuser length using the centring balloon 
 
Balloon 
window 
length (cm) 

Diffuser 
length (cm) 

Light 
intensity 
(mW/cm) 

Required power 
output from 
diffusera (W) 

Treatment 
time (sec) 

Treatment 
time 
(min:sec) 

3 5 270 1.35 480 8:00 



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5 7 270 
200 

1.90 
1.40 

480 
650 

8:00 
10:50 

7 9 270 
200 

2.44 
1.80 

480 
650 

8:00 
10:50 

a As measured by immersing the diffuser into the cuvette in the power meter and slowly increasing the 
laser power. Note: No more than 1.5 times the required diffuser power output should be needed from 
the laser. If more than this is required, the system should be checked. 
 
Short fibre optic diffusers (< 2.5 cm) are to be used to pretreat nodules with 50 J/cm diffuser length 
prior to regular balloon treatment in the first laser light session or for the retreatment of "skip" areas 
after the first light session. For this treatment, the fibre optic diffuser is used without a balloon, and a 
light intensity of 400 mW/cm should be used. Table 3 lists appropriate fibre optic power outputs and 
treatment times using a light intensity of 400 mW/cm. 
 
Table 3.  Short fibre optic diffusers to be used without a centering balloon to deliver 50 J/cm of 
diffuser length at a light intensity of 400 mW/cm 
 

Diffuser 
length (cm) 

Required power 
output from diffusera 

(W) 

Treatment time 
(sec) 

Treatment time 
(min:sec) 

1.0 0.4 125 2:05 
1.5 0.6 125 2:05 
2.0 0.8 125 2:05 
2.5 1.0 125 2:05 

aAs measured by immersing the diffuser into the cuvette in the power meter and slowly 
increasing the laser power. Note: No more than 1.5 times the required diffuser power 
output should be needed from the laser. If more than this is required, the system should 
be checked. 

 
First light application 
A maximum of 7 cm of Barrett's mucosa is treated at the first light session using an appropriate size of 
centering balloon and fibre optic diffuser (Table 1). Whenever possible, the segment selected for the 
first light application should include all the areas of HGD. Also, whenever possible, the BO segment 
selected for the first light applications should include normal tissue margin of a few millimetre at the 
proximal and distal ends. Nodules are to be pre-treated at a light doses of 50 J/cm of diffuser length 
with a short (< 2.5 cm) fibre optic diffuser placed directly against the nodules followed by standard 
balloon application as described above. 
 
Repeat light application 
A second laser light application may be given to a previously treated segment that shows a 'skip' area, 
(i.e., an area that does not show sufficient mucosal response) using a short < 2.5 cm fibre optic diffuser 
at the light dose of 50 J/cm of diffuser length (see Table 3). The treatment regimen is summarized in 
Table 4. Patients with BO > 7 cm, should have the remaining untreated length of Barrett's epithelium 
treated with a second PDT course at least 90 days later. 
 
Table 4.  High-grade dysplasia in Barrett's oesophagus of < 7 cm 
 

Procedure Study day Light delivery devices Treatment intent 
PhotoBarr 
Injection 

Day 1 NA Uptake of  
photosensitiser 

Laser Light 
Application 

Day 3a 3, 5 or 7 cm balloon 
(130 J/cm) 

Photoactivation 

Laser Light 
Application 

Day 5 Short (< 2.5 cm) fibre 
optic diffuser (50 J/cm) 

Treatment of "skip" 
areas only 



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 aDiscrete nodules will receive an initial light application of 50 J/cm (using short diffuser) 
before the balloon light application. 

 
Patients may receive a second course of PDT a minimum of 90 days after the initial therapy; up to 
three courses of PDT (each injection separated by a minimum of 90 days) should be given to a 
previously treated segment which still shows HGD or to a new segment if the initial Barrett's segment 
was >7 cm in length. Both residual and additional segments may be treated in the same light session(s) 
if the total length of the segments treated with the balloon/diffuser combination is not greater than 7 
cm. In the case of a previously treated oesophageal segment, if it has not sufficiently healed and/or 
histological assessment of biopsies is not clear, the subsequent course of PDT may be delayed for an 
additional 1-2 months. 
 
Special care to ensure accurate PhotoBarr dosing and/or light dose is crucial, since miscalculation of 
either medicinal product or light dose may lead to a less effective treatment or cause detrimental effect 
to the patient. Photodynamic therapy with PhotoBarr should be applied by physicians trained in 
endoscopic use of PDT and only in those facilities properly equipped for the procedure. 
 
Special populations 
 
Paediatric patients 
PhotoBarr is not recommended for use in children below age 18 years due to a lack of data on safety 
and efficacy. 
 
Elderly patients(≥ 65 years old) 
Dose modification based upon age is not required. 
 
Renal impairment 
The influence of renal impairment on exposure to porfimer sodium has not been evaluated. (see 
section 4.3). 
 
Hepatic impairment  
The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see 
section 4.3 and 4.4). 
 
4.3 Contraindications 
 
- Hypersensitivity to the active substance, other porphyrins or to any of the excipients. 
 
- Porphyria.  
 
- Severe renal and/or hepatic impairment. 
 
- Oesophageal or gastric varices or patients with oesophageal ulcers >1 cm in diameter. 
 
- Tracheo-oesophageal or broncho-oesophageal fistula. 
 
- Suspected erosion of major blood vessels due to risk of massive, potentially fatal haemorrhage. 
 
4.4 Special warnings and precautions for use 
 
Efficacy and especially safety of PDT with PhotoBarr have not been established in patients with 
contraindications to, or not being eligible for, oesophagectomy. Photodynamic therapy with PhotoBarr 
has exclusively been studied in patients not suffering from severe medical conditions, such as 
congestive heart failure of advanced stage or serious pulmonary conditions that might impair the 
eligibility of patients for surgical procedures. 



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In clinical trials, PhotoBarr PDT has only been tested in patients being treatment naive concerning 
mucosal ablative therapy. Safety and efficacy in patients with treatment failure of other local mucosal 
ablative therapy has not been evaluated. 
 
Elderly 
Patients older than 75 years may be at a higher risk of respiratory related adverse events such as 
pleural effusion and dyspnoea 
 
Pulmonary or cardiac disorders 
Patients with pulmonary or cardiac medical illness or a history of such illness should be treated with 
caution. These patients may be at higher risk for the development of cardiac and pulmonary related 
adverse events such as heart rhythm disorders, angina pectoris, dyspnoea, cough, pleural effusion, 
pharyngitis, atelectasis and events like dehydration (see also section 4.8). 
 
Photosensitivity 
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid 
exposure of skin and eyes to direct sunlight or bright indoor light (from examination lamps, including 
dental lamps, operating room lamps, unshaded light bulbs at close proximity, neon lights, etc.) for at 
least 90 days after treatment as some patients may remain photosensitive for up to 90 days or more.  
During this period, patients should wear dark sunglasses, which have an average white light 
transmittance of <4% when outdoors. The photosensitivity is due to residual photoactive substances, 
which will be present in all parts of the skin. Exposure of the skin to ambient indoor light is, however, 
beneficial because the remaining medicinal product will be inactivated gradually through a photo-
bleaching reaction. Therefore, patients should not stay in a darkened room during this period and 
should be encouraged to expose their skin to ambient indoor light. The level of photosensitivity will 
vary for different areas of the body, depending on the extent of previous exposure to light. Before 
exposing any area of skin to direct sunlight or bright indoor light, the patient should test it for residual 
photosensitivity. A small area of skin should be exposed to sunlight for 10 minutes. The tissue around 
the eyes may be more sensitive, and therefore, it is not recommended that the face be used for testing. 
If no photosensitivity reaction (erythema, oedema, blistering) occurs within 24 hours, the patient can 
gradually resume normal outdoor activities, initially continuing to exercise caution and gradually 
allowing increased exposure. If some photosensitivity reaction occurs with the limited skin test, the 
patient should continue exercising precautions for another 2 weeks before retesting. If patients travel 
to a different geographical area with greater sunshine, they should retest their level of photosensitivity. 
Conventional UV (ultraviolet) sunscreens are of no value in protecting against photosensitivity 
reactions because photoactivation is caused by visible light. 
 
Hepatic Impairment 
No pharmacokinetic and safety data in patients with hepatic impairment are available.  Based on 
evidence for a primarily hepatic/biliary elimination of photoactive substances, severity of phototoxic 
reactions and duration of the period of photosensitivity in patients with any grade of hepatic 
impairment may be increased.  PhotoBarr is contraindicated in patients with severe hepatic 
impairment.  Patients with mild to moderate hepatic impairment should be clearly instructed that the 
period requiring the precautionary measures described below may be longer than 90 days.   
 
Ocular sensitivity 
Patients should be advised to consult their ophthalmologist if they notice any vision changes after 
treatment with PhotoBarr PDT. 
 
Hypersensitivity 
Acute hypersensitivity reactions including anaphylaxis have been reported. In case of an allergic 
reaction, appropriate measures (standard of care) should be taken and the PDT treatment should not be 
repeated.  The medicinal product should only be administered when material and personnel 
experienced in evaluating and treating anaphylaxis are immediately available. 



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Non Cardiac Chest Pain 
As a result of PDT treatment, patients may complain of substernal chest pain because of inflammatory 
responses within the area of treatment. Such pain may be of sufficient intensity to warrant the short-
term prescription of opiate analgesics. 
 
Oesophageal Stenosis  
Prophylactic use of corticosteroids to reduce stricture formation should be avoided during PDT as its 
use has shown not to reduce, and may worsen, stricture formation.  
 
Nutrition in Patients 
PhotoBarr PDT regularly causes dysphagia, odynophagia, nausea and vomiting. Therefore, patients 
should be advised to receive liquid food during the first days (up to 4 weeks) after the laser light 
application. If intake of food and/or drink becomes impossible or repeated vomiting occurs, patients 
should be advised to return to the clinic for evaluation and to receive intravenous fluids if needed. 
 
Use Before or After Radiotherapy 
If PDT is to be used before or after radiotherapy, sufficient time should be allowed between the 
therapies to ensure that the inflammatory reaction produced by the first treatment has subsided prior to 
commencement of the second treatment. 
 
Thrombo-embolism 
There may be an increase in the risk of thrombo-embolic events especially in patients with prolonged 
immobilization, post major surgery and other thromboembolic risk factors. 
 
Follow-up procedure 
Data on the long-term effect of PhotoBarr (beyond two years) are not available at the moment. Also, 
treating physicians should be aware of the possibility of squamous overgrowth and the risk of 
overlooking cancer. 
 
Therefore, adequate and rigorous surveillance should be continued despite possible endoscopic partial 
or complete restitution of the normal squamous mucosa. 
 
In the clinical studies with PhotoBarr, follow-up surveillance was done every three months, or every 
six months after four consecutive biopsy results had shown no more high-grade dysplasia (see section 
5.1). 
Available treatment and surveillance guidelines should be considered. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No formal interaction studies have been performed with PhotoBarr investigating pharmacokinetic 
product interactions with other medicinal products.  
 
A study investigating pharmacodynamic interactions has demonstrated that corticosteroids given 
before or concomitant with PDT to decrease formation of strictures may decrease the safety of 
treatment. 
 
It is possible that concomitant use of other photosensitising agents (e.g., tetracyclines, sulphonamides, 
phenothiazines, sulphonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin and 
fluoroquinolones) could increase the photosensitivity reaction. 
 
PhotoBarr PDT causes direct intracellular damage by initiating radical chain reactions that damage 
intracellular membranes and mitochondria. Tissue damage also results from ischaemia secondary to 
vasoconstriction, platelet activation and aggregation and clotting. Research in animals and in cell 
culture has suggested that many active substances could influence the effects of PDT, possible 



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examples of which are described below. There are no human data available to support or rebut these 
possibilities. 
 
Compounds that quench active oxygen species or scavenge radicals, such as dimethyl sulphoxide, b-
carotene, ethanol, formate and mannitol would be expected to decrease PDT activity. Preclinical data 
also suggest that tissue ischaemia, allopurinol, calcium channel blockers and some prostaglandin 
synthesis inhibitors could interfere with PhotoBarr PDT. Medicinal products that decrease clotting, 
vasoconstriction or platelet aggregation, e.g., thromboxane A2 inhibitors, could decrease the efficacy 
of PDT.  
 
4.6 Fertility, Pregnancy and lactation 
 
Pregnancy 
There are no clinical data on exposed pregnancies available for porfimer sodium. Animal studies are 
insufficient with respect to effects on pregnancy, embryo/foetal development, parturition and postnatal 
development (see section 5.3). The potential risk for humans is unknown. Porfimer sodium should not 
be used during pregnancy unless clearly necessary. 
Women of child-bearing potential should use effective contraception before, during and for at least 
90 days after treatment. 
 
Lactation 
It is not known whether porfimer sodium is excreted into human breast milk. In rats porfimer sodium 
passed into breast milk. Breastfeeding should be terminated prior to treatment. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
For the PDT procedure, sedation may be required and consequently caution should be taken. Patients 
should not drive or use machines after the light treatment if they have been sedated for the procedure. 
 
4.8 Undesirable effects 
 
a. Summary of safety profile 
 
All patients who receive PhotoBarr will be photosensitive and must observe precautions to avoid 
sunlight and bright indoor light (see section 4.4). In an open label pharmacokinetic study, all 
24 healthy subjects experienced photosensitivity reactions, which were characteristically represented 
by erythematous rash and oedema and were mild to moderate in intensity. The photosensitivity 
reactions occurred primarily on the face, hands, and neck regions, which are the areas of the skin that 
are most susceptible to accidental sunlight exposure. Other less common skin manifestations were 
reported in areas where photosensitivity reactions had occurred, such as increased hair growth, skin 
discolouration, skin nodules, skin wrinkling and skin fragility. These manifestations may be 
attributable to a pseudoporphyria state (temporary medicinal product-induced cutaneous porphyria). 
The frequency and nature of the photosensitivity reactions experienced in this study are unlike the 
documented incidence seen in previous clinical studies in cancer patients (approx. 20%) or the 
spontaneously reported incidence from commercial use of PhotoBarr (< 20%). It is possible that 
prolonged exposure to light at the clinical research unit or accidental sunlight exposure after discharge 
may be responsible for the high frequency of photosensitivity reactions. The more active lifestyle of 
the healthy and relatively younger subjects compared with cancer patients may have been a 
contributing factor to these photosensitivity reactions. 
 
PhotoBarr PDT plus omeprazole (PDT + OM) treatment was compared to a group treated with 
omeprazole alone (OM only), in the BO with HGD controlled clinical trial. In the PDT + OM group, 
133 patients were treated. The most frequently reported adverse reactions were photosensitivity 
reactions (69%), oesophageal stenosis (40%), vomiting (32%), chest pain of non-cardiac origin (20%), 



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pyrexia (20%), dysphagia (19%), constipation (13%), dehydration (12%) and nausea (11%). The 
majority of these reported adverse reactions were mild to moderate in intensity. 
 
b Tabulated summary of adverse events 
Adverse reactions reported are listed below in Table 5 by organ class and frequency. Frequencies are 
defined as: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); not 
known (cannot be estimated from the available data). 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Table 5.  Summary of adverse reactions with porfimer sodium  

 
Infections and infestations 
Uncommon:   Bronchitis, nail fungal infection, sinusitis, skin infection  
Not known: Pneumonia 

Neoplasms benign, malignant and unspecified (incl cysts and polyps) 
Uncommon:   Basal cell carcinoma, lentigo 

Blood and the lymphatic system disorders 
Uncommon:   Leukocytosis 
Not known:  Anaemia 

Immune system disorders  
Not known:  Hypersensitivity 
Metabolism and nutrition disorders 
Very common:   Dehydration* 
Common:   Appetite decreased, electrolyte imbalance 
Uncommon:   Hypokalaemia 

Psychiatric disorders 
Common:   Anxiety, insomnia 
Uncommon:   Restlessness 

Nervous system disorders 
Common:   Headache, paraesthesia, dysgeusia 
Uncommon:  Dizziness, hypoaesthesia, tremor 

Eye disorders 
Uncommon:  Eye irritation, eye oedema 
Not known: Cataract 

Ear and labyrinth disorders 
Uncommon:  Deafness, tinnitus, tinnitus aggravated 

Cardiac disorders 
Common:   Tachycardia, chest pain 
Uncommon:  Angina pectoris, atrial fibrillation, atrial flutter, chest discomfort 

Vascular disorders 
Uncommon:   Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension 
 Not known:  Embolism, Deep vein thrombosis, Phlebitis 

Respiratory, thoracic and mediastinal disorders 
Common:   Pleural effusion, pharyngitis, atelectasis, dyspnoea 
Uncommon:   Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion,      
  pneumonia aspiration, productive cough, respiratory depression, respiratory  
  tract congestion, wheezing 



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Gastrointestinal disorders 
Very common:   Oesophageal stenosis acquired*, vomiting*, dysphagia, constipation,                    
  nausea* 
Common:   Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain 

upper*, abdominal pain, haematemesis, oesophageal pain, eructation, melaena 
(haematocheznia), oesophageal disorder, regurgitation of food, abdominal 
rigidity, oesophageal spasm, oesophagitis. 

Uncommon:   Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal 
distension, abdominal pain lower, acquired pylori stenosis, chapped lips, 
colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal 
haemorrhage, oesophageal perforation. 

 Not known:  Tracheo-oesophageal fistula, Gastrointestinal necrosis  
Skin and subcutaneous tissue disorders 
Very common:   Photosensitivity reaction 
Common:   Pruritus, rash, skin fragility, skin discolouration, skin ulcer, dermatitis   
  exfoliative, dry skin, milia, rash maculo-papular, rash papular, scar, skin  
  hyperpigmentation, skin lesion, skin nodule, urticaria  
Uncommon:   Cold sweat, dermatitis, hair growth abnormal, increased tendency to bruise, 

keloid scar, night sweats, photosensitive rash, rash macular, rash scaly, scab, 
scar pain, vitiligo. 

Musculoskeletal and connective tissue disorders 
Common:   Back pain, pain in the limb 
Uncommon:   Joint contracture, joint range of motion decreased, musculoskeletal chest pain, 

plantar fascitis 

Renal and urinary disorders: 
Uncommon: Urinary retention 
Reproductive system and breast disorders 
Uncommon:   Gynaecomastia 

Congenital and familial and genetic disorders 
Uncommon:   Pigmented naevus  

General disorders and administration site conditions 
Very common:   Pyrexia 
Common:   Rigors, fatigue 
Uncommon:   Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, 

pitting oedema, temperature intolerance, weakness 

Investigations 
Common:   Weight decreased, body temperature increased 
Uncommon:   Blood albumin decreased, blood chloride increased, blood urea increased, 

haematocrit decreased, haemoglobin decreased, oxygen saturation decreased, 
protein total decreased 

Injury, poisoning, and procedural complications 
Common:   Post procedural pain, abrasion 
Uncommon:   Blister, post procedural haemorrhage 

* see section c. 
 
c. Description of selected adverse reactions 
 
Of the serious adverse events (SAEs) in the PhotoBarr PDT + OM group, 44 (23.1%) were considered 
associated with the treatment. The most frequently reported treatment-associated serious adverse 
reaction (SAR) was dehydration (4%), experienced by 5 patients. The majority of the SAEs 
experienced were gastrointestinal disorders (8% - 11 patients), specifically nausea (3% - 4 patients), 
vomiting (3% - 4 patients) and upper abdominal pain (2% - 2 patients). 



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The majority of treatment-associated oesophageal stenosis (which includes oesophageal narrowing and 
oesophageal strictures) reported in the PhotoBarr PDT + OM group were of mild or moderate intensity 
(92%). All incidences of strictures were considered associated with treatment of which 1% was 
considered serious.  
 
An occurrence rate of 12% for oesophageal strictures was observed during the first course of 
treatment. The occurrence rate rose to 32% when a second course of therapy was given, especially in 
the areas where second treatment overlaps the first and amounted to 10% for those who received a 
third treatment course. The majority of these was mild to moderate in intensity and could be managed 
through 1-2 dilatations. Eight percent were severe, requiring multiple (6 - >10) dilatations. The 
formation of oesophageal stenosis cannot be reduced or eliminated by the use of steroids. 
 
 
 
4.9 Overdose 
 
PhotoBarr  
There is no information on overdose of PhotoBarr.  The recommended 2 mg/kg dose, instead of the 
recommended single administration, was given twice two days apart (10 patients) and three times 
within two weeks (1 patient) without any notable adverse reactions being reported. The effects of an 
overdose on the duration of photosensitivity are unknown. Laser treatment should not be given if an 
overdose of PhotoBarr is administered. In the event of an overdose, patients should protect their eyes 
and skin from direct sunlight or bright indoor lights for 90 days. At this time, patients should test for 
residual photosensitivity (see section 4.4). Porfimer sodium is not dialyzable. 
 
Laser light  
Light doses of two to three times the recommended dose have been administered to a few patients with 
superficial endobronchial tumours. One patient experienced life-threatening dyspnoea and the others 
had no notable complications. Increased symptoms and damage to normal tissue might be expected 
following an overdose of light. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Sensitizers used in photodynamic/radiation therapy, ATC code: 
L01XD01 
 
Mechanism of action 
Porfimer sodium is a mixture of porphyrin units, which are linked together in chains of two to eight 
units. The cytotoxic actions of porfimer sodium are light and oxygen-dependent. Photodynamic 
therapy with PhotoBarr is a 2-stage process. The first stage is the intravenous injection of PhotoBarr. 
Clearance from a variety of tissues occurs over 40-72 hours, but tumours, skin, and organs of the 
reticuloendothelial system (including liver and spleen) retain porfimer sodium for a longer period. 
Illumination of the target area with 630 nm wavelength laser light constitutes the second stage of 
therapy. Tumour and dysplastic tissue selectivity in treatment may occur partly through selective 
retention of porfimer sodium but mainly through a selective delivery of light. Cellular damage caused 
by porfimer sodium PDT is a consequence of the propagation of free radical reactions. Radical 
initiation may occur after porfimer sodium absorbs light to form a porphyrin excited state. Spin 
transfer from porfimer sodium to molecular oxygen may then generate singlet oxygen. Subsequent 
free radical reactions can form superoxide and hydroxyl radicals. Tumour cell death also occurs 
through ischaemic necrosis secondary to vascular occlusion that appears to be partly mediated by 



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thromboxane A2 release. The laser treatment induces a photochemical, not a thermal, effect. The 
necrotic reaction and associated inflammatory response evolve over several days. 
 
Clinical efficacy 
In a controlled clinical trial, a PhotoBarr PDT + OM (omeprazole) patient group (n=183) was 
compared to a group of patients receiving OM only (n=70). Eligible patients for this study were to 
have biopsy-proven HGD in Barrett’s oesophagus (BO). Patients were excluded from the study if 
there was a presence of invasive oesophageal cancer, if they had a history of cancer other than non-
melanoma skin cancer or if they had received prior PDT to the oesophagus. Other exclusion criteria 
were patients in whom omeprazole therapy was contraindicated. 
 
Patients randomised to treatment with PDT received PhotoBarr at a dose of 2 mg/kg body weight 
through slow intravenous injection over 3 to 5 minutes. One or 2 laser light treatments were 
administered following PhotoBarr injection. The first laser light session occurred 40-50 hours after 
injection and a second session, if indicated, occurred 96-120 hours after injection. Co-administration 
of omeprazole (20 mg BID) began at least 2 days before PhotoBarr injection. Patients randomised to 
the OM only group received orally omeprazole 20 mg BID for the duration of the study.   
 
Patients were followed every 3 months until 4 consecutive, quarterly follow-up endoscopic biopsy 
results were negative for HGD, and then biannually until the last enrolled patient had completed a 
minimum of 24 months of follow-up evaluations after randomisation.    
 
PhotoBarr PDT + OM was effective in eliminating HGD in patients with BO. At final analysis, 
performed at a minimum of 24 months follow-up, a statistically significant percentage of patients 
(77%) in the PhotoBarr PDT + OM group demonstrated complete HGD ablation compared to 39% of 
patients in the OM alone group (p<0.0001). Fifty-two percent of patients in the PDT + OM group 
showed normal squamous cell epithelium while 59% had absence of dysplasia compared to 7% and 
14% in the OM alone group, respectively (p<0.0001). These results confirm those observed after a 
minimum of 6 months follow-up which showed HGD ablation in 72% of patients in the PhotoBarr 
PDT + OM group compared to 31% in the OM only group. Forty-one percent of patients showed 
normal squamous cell epithelium and 49% had absence of dysplasia. 
 
By the end of the minimum follow-up of two years, 13% in the PhotoBarr PDT + OM group had 
progressed to cancer compared to 28% in the OM only group in the intent-to-treat (ITT) population. 
The proportion of patients who progressed to cancer in the PhotoBarr PDT + OM group was 
statistically lower than in the OM only group (p=0.0060). The survival curves indicated that, by the 
end of the entire follow-up period, patients in the PhotoBarr PDT + OM group had a 83% chance of 
being cancer-free as compared to a 53% chance for patients in the OM only group. Comparison 
between the survival curves of the two treatment arms using the log rank test showed a statistically 
significant difference between the curves of the two groups in the ITT population (p=0.0014) 
indicating a significant delay in the progression to cancer. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of porfimer sodium have been studied  in 12 patients with endobronchial cancer 
and 23 healthy subjects (11 men and 12 women), given 2 mg/kg porfimer sodium through slow 
intravenous injection. Plasma samples were obtained up to 56 days (patients) or 36 days (volunteers)  
post injection.   
 
In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), 
whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml. 
 
Distribution 
In vitro binding of porfimer sodium to human serum protein is around 90% and independent of 
concentration between 20 and 100 μg/ml. 



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Elimination 
Porfimer sodium is cleared slowly from the body, with a mean CLT of 0.859 ml/h/kg (C.V. 53%) in 
patients. 
 
The serum decay was bi-exponential, with a slow distribution phase and a very long elimination phase 
that started approximately 24 hours after injection. The mean elimination half-life (t1/2) was 21.5 days 
(CV 26 %, range 264-672) in patients and 17 days in volunteers. 
 
Special populations 
The influence of renal and hepatic impairment on exposure to porfimer sodium has not been evaluated 
(see sections 4.2, 4.3 and 4.4).  
 
Gender had no effect on pharmacokinetic parameters except for tmax, which was approximately 
1.5 hours in women and 0.17 hours in men. At the time of intended photoactivation 40-50 hours after 
injection, the pharmacokinetic profiles of porfimer sodium in men and women were very similar. 
 
5.3 Preclinical safety data 
 
Porfimer sodium was not mutagenic in standard genotoxicity tests in the absence of light. With light 
activation, porfimer sodium was mutagenic in some in-vitro tests.  
 
Reproductive toxicology studies were insufficient to support the safety of porfimer sodium during 
pregnancy, as no light activation had been used. In these studies foetotoxicity, but not teratogenicity, 
occurred in rats and rabbits only at evaluated intravenous doses (greater than of equal to 4 mg/kg) and 
at greater frequency (daily) compared in the clinical use. 
 
Preclinical studies indicate that the excretion of PhotoBarr components occurs primarily via the faecal 
route 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Hydrochloric acid (for pH-adjustment) 
Sodium hydroxide (for pH-adjustment)  
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
Powder: 3 years. 
 
After reconstitution: use immediately (within 3 hours). 
 
After it has been reconstituted, PhotoBarr should be used immediately (within 3 hours) and protected 
from light. Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C. From a 
microbiological point of view, the product should be used immediately. If not used immediately, in-
use storage time and conditions prior to use are the responsibility of the user. 
 



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6.4 Special precautions for storage 
 
Keep out of the reach and sight of children. 
 
Do not use after the expiry date stated on the carton and vial after the EXP.   
 
Do not store above 25°C. 
Keep the vial in the outer carton in order to protect from light.  
 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
75 mg powder in a vial (glass type I, 40 ml capacity) with a grey butyl stopper.  
Pack size:  1 vial. 
 
6.6 Special precautions for disposal and other handling  
 
Instructions for reconstitution 
PhotoBarr 75 mg vial should be reconstituted with 31.8 ml of 5% glucose solution for injection, 
resulting in a final porfimer sodium concentration of 2.5 mg/ml in the solution for injection.  
 
Do not use other diluents. Do not mix PhotoBarr with other medicinal products in the same solution.  
Sufficient vials of PhotoBarr should be reconstituted to provide the patient with a dose of 2 mg/kg. For 
most patients (up to 75 kg) two vials of PhotoBarr 75 mg will suffice. A PhotoBarr 15 mg vial will be 
needed for every additional 7.5 kg body weight. 
 
Spills and disposal 
Spills of PhotoBarr should be wiped up with a damp cloth.  Skin and eye contact should be avoided 
due to the potential for photosensitivity reactions upon exposure to light; use of rubber gloves and eye 
protection is recommended.  
 
PhotoBarr is for single use only and any unused solution should be discarded. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
Accidental exposure  
PhotoBarr is neither a primary ocular irritant nor a primary dermal irritant.  However, because of its 
potential to induce photosensitivity, PhotoBarr might be an eye and/or skin irritant in the presence of 
bright light.  It is important to avoid contact with the eyes and skin during preparation and/or 
administration.  As with therapeutic overdose, any accidentally overexposed person must be protected 
from bright light.’ 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Pinnacle Biologics B.V. 
p/a Trust Company Amsterdam B.V. 
Crystal Tower 21st Floor, 
Orlyplein 10, 1043 DP Amsterdam 
The Netherlands 
 



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8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/04/272/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 25 March 2004 
Date of latest renewal: 4 March 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this product is available on the website of the European 
Medicines Agency http://www.ema.europa.eu 



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ANNEX II 

 
A. MANUFACTURING AUTHORISATION HOLDER 

RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 



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A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer responsible for batch release 
 
Axcan Pharma SAS 
Route de Bû 
78550 Houdan 
France 
 

 
B CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 

Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 

 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 

The MAH shall agree the details of educational materials with the National Competent 
Authorities to ensure that all health care professionals who intend to prescribe and/or dispense 
PhotoBarr are provided with the following: 

• Prescriber guide 
• Prescriber slide kit 
• Healthcare professionals administration and monitoring guide 
• Patient alert card 
• Patient guide 

 
The following key elements should be included in the educational materials: 
 
Prescriber guide and Prescriber slide kit 

− The educational tools are designed to aid physicians in optimising the benefit-risk 
ratio of porfimer treatment. 

− Patients should NOT be treated with porfimer if: 
o they have severe hepatic disease. 
o they have trachea or broncho-oesophageal fistulas. 
o they have suspected erosions of major blood vessels. 

 
− Caution should be exercised if patients have moderate hepatic disease 
 
− Before initiating therapy, 

o The patient should be screened for skin type 
o Patients should be aware of the long half-life of porfimer and that the 

compound gets activated by light. 
o Patients should avoid being exposed to light for 60-90 days post-exposure. 
o all patients should know that UV blocking is not effective in blocking visible 

light which activates porfimer.  
o Patients should be aware of potential risk factors (skin phototype and hepatic 

impairment). 
o Patients should be instructed to seek medical advice if signs/symptoms 

suggestive of photosensitivity occur during or after therapy with porfimer. 
 

Healthcare professionals administration and monitoring guide 



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− It is important to follow exactly the correct steps for reconstitution and 
administration of porfimer. 

− It is important to have an appropriate light dose and a proper setting for the laser. 
− Any unused product or waste material should be disposed of in accordance with 

local requirements. 
− Healthcare professionals should be aware of side effects that may arise during or 

shortly after treatment, and how to treat them. 
− Patients should be warned of the possibility of long term side effects, especially 

photosensitivity, and the need to seek medical assistance if they arise. 
− Record the patient’s skin type and the date of injection on the patient alert card 
 
 

Patient alert card 
− The need to show this card to any doctor treating them 
− That PhotoBarr 

o Remains in your body for 60-90 days after receiving the injection 
o Is activated by visible light 
o There is an increased risk of photosensitivity (sensitivity to light) 
o Exposed skin will become red and cause discomfort in most cases but severe 

cases of photosensitivity are possible 
o Commercially available sun blocks are not effective in preventing sensitivity 

due to light 
o Photosensitivity can only be prevented by avoiding exposure to the sun for 90 

days after receiving the PhotoBarr injection 
 
− You should not be treated with PhotoBarr if you have severe liver disease (eg 

cirrhosis) 
− You should be screened for skin type 
− Area in card for physician to record skin type and date of injection. 
 
 

Patient guide 
− Brief background and introduction to Barrett’s oesophagus and high grade 

dysplasia 
− What photodynamic therapy is 
− Patients should inform their doctor before they start treatment if they have severe 

hepatic disease. 
− That PhotoBarr 

o Remains in your body for 60-90 days after receiving the injection 
o Is activated by visible light 
o There is an increased risk of photosensitivity (sensitivity to light) 
o Exposed skin will become red and cause discomfort in most cases but severe 

cases of photosensitivity are possible 
o Commercially available sun blocks are not effective in preventing sensitivity 

due to light 
− Photosensitivity can only be prevented by avoiding exposure to the sun for 90 days 

after receiving the PhotoBarr injection 
− It is important that patients tell their doctor if they get exposed to sunlight after 

receiving treatment with PhotoBarr. 
− There are a number of potential side effects that patients should be aware of. 
 

 
 

 



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• OTHER CONDITIONS  
 
Risk Management Plan  
The MAH commits to performing the studies and additional pharmacovigilance activities 
detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan 
(RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any 
subsequent updates of the RMP agreed by the CHMP.  
 
As per the CHMP Guideline on Risk Management Systems for medicinal products of human 
use, the updated RMP should be submitted at the same time as the next Periodic Safety Update 
Report (PSUR).  
 
In addition, an updated RMP should be submitted:  
 

− When new information is received that may impact on the current Safety Specification, 
Pharmacovigilance Plan or risk minimisation activities  

− Within 60 days of an important (pharmacovigilance or risk minimisation) milestone 
being reached  

− At the request of the EMEA  
 

 
 



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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Carton - 15 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
PhotoBarr 15 mg powder for solution for injection 
Porfimer sodium 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 15 mg  porfimer sodium. After reconstitution, each ml solution contains 2.5 mg 
porfimer sodium. 
 
3. LIST OF EXCIPIENTS 
 
Hydrochloric acid, sodium hydroxide (for pH adjustment). 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection. 
1 vial 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
Keep the vial in the outer carton in order to protect from light. 
After reconstitution, protect from light and use within 3 hours. 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 



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Pinnacle Biologics B.V. 
p/a Trust Company Amsterdam B.V. 
Crystal Tower 21st Floor, 
Orlyplein 10, 1043 DP Amsterdam 
The Netherlands 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/272/001 
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
16.  INFORMATION IN BRAILLE 
 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Vial 15 mg - 7 ml  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
PhotoBarr 15 mg powder for solution for injection 
Porfimer sodium 
Intravenous use 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
15 mg 
 
6. OTHER 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Carton – 75 mg 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
PhotoBarr 75 mg powder for solution for injection 
Porfimer sodium 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One vial contains 75 mg porfimer sodium  
After reconstitution, each ml solution contains 2.5 mg porfimer sodium. 
 
3. LIST OF EXCIPIENTS 
 
Hydrochloric acid, sodium hydroxide (for pH adjustment). 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder for solution for injection.1 vial 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intravenous use 
Read the package leaflet before use. 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C. 
Keep the vial in the outer carton in order to protect from light  
After reconstitution, protect from light and use immediately within 3 hours.   
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Pinnacle Biologics B.V. 



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p/a Trust Company Amsterdam B.V. 
Crystal Tower 21st Floor, 
Orlyplein 10, 1043 DP Amsterdam 
The Netherlands 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/04/272/002 
 
13. BATCH NUMBER 
 
Lot:  
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 



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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Vial  75 mg - 40 ml  
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
PhotoBarr 75 mg powder for solution for injection 
Porfimer sodium 
Intravenous use 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
3. EXPIRY DATE 
 
EXP 
 
4. BATCH NUMBER 
 
Lot  
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
75 mg 
 
6. OTHER 



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B. PACKAGE LEAFLET 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

PhotoBarr 15 mg powder for solution for injection 
Porfimer sodium 

 
 
Read all of this leaflet carefully before you start using this medicine. 
- Keep this leaflet. You may need to read it again 
- If you have any further questions, please ask your doctor or pharmacist. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 
please tell your doctor or pharmacist. 
 
In this leaflet: 
1. What PhotoBarr is and what it is used for 
2. Before you use PhotoBarr  
3. How to use PhotoBarr 
4. Possible side effects 
5 How to store PhotoBarr  
6. Further information 
 
 
1. WHAT PHOTOBARR IS AND WHAT IT IS USED FOR 
 
PhotoBarr is a light-activated medicine used in photodynamic therapy (PDT) in combination with a 
non-burning red laser light. PDT specifically targets and destroys abnormal cells.  
 
PhotoBarr is used to remove high-grade dysplasia (cells with atypical changes that increase the risk of 
developing cancer) in patients with Barrett's oesophagus (gullet). 
 
 
2. BEFORE YOU USE PHOTOBARR 
 
Do not use PhotoBarr 
- if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other 

ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains’) 
- if you have porphyria 
- if you have an opening (fistula) between the oesophagus and the airways 
- if you suffer from varices of your oesophageal veins or erosion of other major blood vessels 
- if you have ulcers in your oesophagus 
- if you have severe liver or kidney problems 
 
Take special care with PhotoBarr 
Tell your doctor if any of the following applies to you: 
- you are taking any other medicines (see below), 
- you have a liver or kidney problems 
- you have a family history of cataracts 
- you are 75 years or older, 
- you have or have had heart or lung disease 
 
PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of 
experience. 
 



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Using other medicines 
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including 
medicines obtained without a prescription. Some other medicines may increase the risk for 
photosensitivity reactions for example antibiotics or antidiabetic medicines. 
 
Using PhotoBarr with food and drink  
The laser light application will induce difficulties with swallowing (pain, nausea and vomiting). 
Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks). 
If eating or drinking becomes impossible or if you keep vomiting, please return to the clinical for 
medical attention. 
 
Pregnancy and breast-feeding 
PhotoBarr should not be used during pregnancy unless clearly necessary.   
Women of childbearing age should take adequate contraceptive precautions whilst and up to 90 days 
after receiving PhotoBarr.  
 
You should stop breast-feeding before using PhotoBarr. 
 
Driving and using machines 
No studies on the effects on the ability to drive and use machines have been performed. 
During your light treatment you may receive sedation. In this case, you should avoid any activities that 
require mental alertness such as driving a car or using any machine.  
 
 
3. HOW TO USE PHOTOBARR 
 
How does photodynamic therapy (PDT) work? 
One course of PDT consists of one injection of PhotoBarr plus one or two laser light applications.  
To increase your response rate, you may need up to three PDT courses, separated by at least 90 days. 
 
PhotoBarr injection: You will receive one intravenous injection of PhotoBarr (2 mg per kg of body 
weight), 40 to 50 hours before laser light treatment. The reddish-brown solution is slowly injected, 
over 3 to 5 minutes, into a vein. 
 
Laser light treatment: Your doctor will apply the red laser light (not a burning laser) to the involved 
area using an endoscope (a device used to see inside certain parts of the body). You may receive a 
second laser light treatment 96-120 hours after the initial injection of PhotoBarr.  
You will be given a sedative along with a local anaesthetic to minimise discomfort. 
 
If you miss the laser light treatment 
Both the medicine and laser light are necessary for the therapy to work. If you realise that you have 
missed your appointment for the laser treatment, contact your doctor immediately. Your doctor will 
decide how to proceed with the treatment. 
 
How to prevent a photosensitivity reaction 
Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 
3). They consist mainly of sunburn-like reactions, mild redness on exposed skin, usually the face and 
hands. For 90 days following your PhotoBarr injection, you must take precautions to avoid exposure 
of skin and eyes to light. If you have liver problems, this period might be longer. 
 
Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not 
protect you against photosensitivity reactions. 
 



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Direct sunlight:  
Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in 
your home to keep out bright sunlight. If you go out during daylight hours (even on cloudy days and 
while travelling in a vehicle), you should take the following precautions:  
- cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves 

and a wide brimmed hat 
- protect your eyes with dark sunglasses. 
- remember to take protective clothing and sunglasses with you to your appointment, as you will 

be photosensitive once the injection has been given. 
 
Indoor light:  
Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded 
light bulbs at close proximity or neon lights.  
However, to speed up the natural process of inactivating the medicine in your body, it is good to 
expose the skin to normal levels of indoor light. You do not need to stay in a darkened room.  
 
Photosensitivity skin test 
About 90 days after the PhotoBarr injection, you should test the photosensitivity of your skin as 
follows: 
Cut a 2-inch hole in a paper bag, put it on your hand or elbow (not your face).  
Expose a small area of skin to sunlight for 10 minutes.  
Check for the appearance of red marks, swelling or blistering after one day.  
- if none of these appear on the exposed area, then you can gradually return to your normal 

outdoor activities, limiting exposure to the sun during the midday hours.  
- if any of these signs are seen, then continue to protect yourself from bright light for 2 more 

weeks, then repeat the skin test.  
If you go on holiday to an area with more sunshine, remember to repeat the skin test, especially if 
some areas of skin have not been exposed to sunlight since your PhotoBarr treatment. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them. 
 
All patients who receive PhotoBarr will be photosensitive (sensitive to light) and must observe 
precautions to avoid direct sunlight and bright indoor light (see above ‘How to prevent a 
photosensitivity reaction’). 
 
Tell your doctor immediately: 
- if you notice a change in your eyesight. You should visit your eye specialist. 
- if you are not able to swallow at all or repeated vomiting occurs 
 
Side effects may occur with certain frequencies, which are defined as follows: 
Very common: affects more than 1 user in 10 
Common: affects 1 to 10 users in 100 
Uncommon: affects 1 to 10 users in 1,000 
Rare: affects 1 to 10 users in 10,000  
Very rare: affects less than 1 user in 10,000 
Not known: frequency cannot be estimated from the available data. 
 



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Very common side effects  
 
- fever 
- photosensitivity reactions (see section 3) 
- vomiting, nausea  
- tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain 
- constipation, dehydration  
 

Common side effects  
 
- back pain, pain in arms and legs, pain due to treatment 
- headache, feeling nervous, tingling feeling, problems sleeping   
- abdominal stiffness, stomach pain, vomiting blood  
- disorders of the gullet such as ulcer, irritation or constriction 
- loose stools, passing dark tarry stool, sore throat, hiccups, belching  
- fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills  
- loss of weight, decrease in appetite, feeling tired, loss of taste 
- skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on 

the skin, very small cysts in the skin, dry and fragile skin  
 
Uncommon side effects  
 
- difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in 

airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, 
coughing up blood, stuffy nose 

- lung infection, sinus infection 
- chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort 
- abnormal blood test results, including increase in white blood cells, low potassium levels  
- bleeding, loss of blood, increased tendency to bruise  
- over development of breasts in men, inability to urinate, temperature intolerance, cold sweats, 

night sweats 
- general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the 

heel  
- shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell 
- loss of hearing, ringing in the ears, swelling of the eye, eye pain  
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,  

overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal 
hair growth  

 
Frequency not known side effects 
 
- lung infection 
- lower number of red cells in your blood 
- cataract  
- lesion in intestine, abnormal opening between the wind pipe and the food pipe  
- allergic reaction  
- blood clots in your vessels, blockage of blood arteries, inflammation of a vein  
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 
your doctor or pharmacist. 
 
 
5. HOW TO STORE PHOTOBARR 
 
Keep out of the reach and sight of children.   
 



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Do not use PhotoBarr after the expiry date which is stated on the carton and vial after EXP.   
 
Do not store above 25°C.   
Keep the vial in the outer carton in order to protect from light.  
 
After reconstitution, PhotoBarr solution should be protected from light and used immediately (within 3 
hours). Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C. From a 
microbiological point of view, the product should be used immediately. If not used immediately, 
in-use storage time and conditions prior to use are the responsibility of the user. 
 
 
6. FURTHER INFORMATION 
 
What PhotoBarr contains 
- The active substance is porfimer sodium. Each vial contains 15 mg of porfimer sodium. After 

reconstitution, each ml solution contains 2.5 mg porfimer sodium. 
- The other ingredients are hydrochloric acid and sodium hydroxide (for pH adjustment). 
 
What PhotoBarr looks like and contents of the pack 
PhotoBarr is a reddish brown powder for solution for injection.  
One single-use vial per pack.  
 
Marketing Authorisation Holder 
Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 
10, 1043 DP Amsterdam, The Netherlands 
 
Manufacturer 
Axcan Pharma SAS, Route de Bû, 78550 Houdan, France 
 
This leaflet was last approved in  
 
 
For any information about this medicine, please contact the Marketing Authorisation Holder. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

PhotoBarr 75 mg powder for solution for injection 
Porfimer sodium 

 
 

Read all of this leaflet carefully before you start using this medicine. 
 
- Keep this leaflet. You may need to read it again 
- If you have any further questions, please ask your doctor or pharmacist. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
 
1. What PhotoBarr is and what it is used for 
2. Before you use PhotoBarr  
3. How to use PhotoBarr 
4. Possible side effects 
5 How to store PhotoBarr  
6. Further information 
 
 
1. WHAT PHOTOBARR IS AND WHAT IT IS USED FOR 
 
PhotoBarr is a light-activated medicine used photodynamic therapy (PDT)in combination  with a  
non-burning, red laser light. PDT specifically targets and destroys abnormal cells.  
PhotoBarr is used to remove high-grade dysplasia (cells with atypical changes that increase the risk of 
developing cancer) in patients with Barrett's oesophagus (gullet). 
 
 
2. BEFORE YOU USE PHOTOBARR 
 
Do not use PhotoBarr 
 
- if you are allergic (hypersensitive) to porfimer sodium other porphyrins or to any other 

ingredients of PhotoBarr (listed in section 6 “What PhotoBarr contains”) 
- if you have porphyria 
- if you have an opening (fistula) between the oesophagus and the airways 
- if you suffer from varices of your oesophageal veins or erosion of other major blood vessels 
- if you have ulcers in your oesophagus 
- if you have severe liver of kidney problems 

 
Take special care with PhotoBarr 
Tell your doctor if any of the following applies to you: 
- you are taking any other medicines (see below), 
- you have liver or kidney problems 
- you have a family history of cataracts, 
- you are 75 years or older, 
- have or have had heart or lung disease 

 
Using other medicines 
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including 
medicines obtained without a prescription. Some other medicines may increase the risk for 
photosensitivity reactions for example antibiotics or antidiabetic medicines. 



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Using PhotoBarr with food and drink  
The laser light application will induce difficulties with swallowing (pain, nausea and vomiting). 
Therefore, you should take liquid food only for a few days (in some cases up to 4 weeks). 
 
If eating or drinking becomes impossible or if you keep vomiting, please return to the clinical for 
medical attention. 
 
Pregnancy and breast-feeding 
PhotoBarr should not be used during pregnancy unless clearly necessary.   
Women of childbearing age should take adequate contraceptive precautions whilst and up to 90 days 
after receiving PhotoBarr. 
 
You should stop breast-feeding before using PhotoBarr.  
 
Driving and using machines: 
No studies on the effects on the ability to drive and use machines have been performed. 
During your light treatment you may receive sedation.  In this case, you should avoid any activity that 
requires mental alertness such as driving a car or using any machine.  
 
 
3. HOW TO USE PHOTOBARR 
 
How does photodynamic therapy (PDT) work? 
 
One course of PDT consists of one injection of PhotoBarr plus one or two laser light applications.  
To increase your response rate, you may need up to three PDT courses, separated by at least 90 days. 
 
PhotoBarr injection: You will receive one intravenous injection of PhotoBarr (2 mg per kg of body 
weight) 40 to 50 hours before laser light treatment. The reddish-brown solution is slowly injected, 
over 3 to 5 minutes, into a vein. 
 
Laser light treatment: Your doctor will apply the red laser light(not a burning laser) to the involved 
area using an endoscope (a device used to see inside certain parts of the body).. You may receive a 
second laser light treatment 96-120 hours after the initial injection of PhotoBarr. You will be given a 
sedative along with a local anaesthetic, to minimise discomfort  
 
If you miss the laser light treatment  
Both the medicine and laser light are necessary for the therapy to work. If you realise that you have 
missed your appointment for the laser treatment, contact your doctor immediately. Your doctor will 
decide how to proceed with the treatment. 
 
How to prevent a photosensitivity reaction 
Photosensitivity reactions are very common side effects of PhotoBarr (affecting more than 2 users in 
3). They consist mainly of sunburn-like reactions, mild redness on exposed skin, usually the face and 
hands. For 90 days following your PhotoBarr injection, you must take precautions to avoid exposure 
of skin and eyes to light. If you have liver problems, this period might be longer. 
 
Since PhotoBarr is activated by the red part of light, sunscreens for UV (ultraviolet) light will not 
protect you against photosensitivity reactions. 
 
Direct sunlight:  
Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in 
your home to keep out bright sunlight. If you go out during daylight hours (even on cloudy days and 
while travelling in a vehicle), you should take the following precautions:  



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- cover as much skin as possible by wearing a long-sleeved shirt, trousers, socks, shoes, gloves 
and a wide brimmed hat 

- protect your eyes with dark sunglasses. 
- remember to take protective clothing and sunglasses with you to your appointment, as you will 

be photosensitive once the injection has been given. 
 
Indoor light:  
Avoid direct exposure to bright indoor lights, including dental lamps, operating room lamps, unshaded 
light bulbs at close proximity or neon lights.  
However, to speed up the natural process of inactivating the medicine in your body, it is good to 
expose the skin to normal levels of indoor light. You do not need to stay in a darkened room.  
 
Photosensitivity skin test 
About 90 days after the PhotoBarr injection, you should test the photosensitivity of your skin as 
follows: 
Cut a 2-inch hole in a paper bag, put it on your hand or elbow (not your face).  
Expose a small area of skin to sunlight for 10 minutes.  
Check for the appearance of red marks, swelling or blistering after one day.  
- if none of these appear on the exposed area, then you can gradually return to your normal 

outdoor activities, limiting exposure to the sun during the midday hours.  
- if any of these signs are seen, then continue to protect yourself from bright light for 2 more 

weeks, then repeat the skin test.  
If you go on holiday to an area with more sunshine, remember to repeat the skin test, especially if 
some areas of skin have not been exposed to sunlight since your PhotoBarr treatment. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, PhotoBarr can cause side effects, although not everybody gets them. 
 
All patients who receive PhotoBarr will be photosensitive (sensitive to light) and must observe 
precautions to avoid direct sunlight and bright indoor light (see above ‘How to prevent a 
photosensitivity reaction’).  
 
Tell your doctor immediately: 
- if you notice a change in your eyesight. You should visit your eye specialist. 
- if you are not able to swallow at all or repeated vomiting occurs 
 
Side effects may occur with certain frequencies, which are defined as follows: 
Very common: affects more than 1 user in 10 
Common: affects 1 to 10 users in 100 
Uncommon: affects 1 to 10 users in 1,000 
Rare: affects 1 to 10 users in 10,000  
Very rare: affects less than 1 user in 10,000 
Not known: frequency cannot be estimated from the available data. 
 
Very common side effects  
 
- fever 
- photosensitivity reactions (see section 3) 
- vomiting, nausea  
- tightening of the gullet (oesophagus), difficulty in swallowing that may cause pain 
- constipation, dehydration  



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Common side effects  
 
- back pain, pain in arms and legs, pain due to treatment 
- headache, feeling nervous, tingling feeling, problems sleeping   
- abdominal stiffness, stomach pain, vomiting blood  
- disorders of the gullet such as ulcer, irritation or constriction 
- loose stools, passing dark tarry stool, sore throat, hiccups, belching  
- fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills  
- loss of weight, decrease in appetite, feeling tired, loss of taste 
- skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on 

the skin, very small cysts in the skin, dry and fragile skin  
 
Uncommon side effects  
 
- difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in 

airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, 
coughing up blood, stuffy nose 

- lung infection, sinus infection 
- chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort 
- abnormal blood test results, including increase in white blood cells, low potassium levels  
- bleeding, loss of blood, increased tendency to bruise  
- over development of breasts in men, inability to urinate, temperature intolerance, cold sweats, 

night sweats 
- general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the 

heel  
- shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell 
- loss of hearing, ringing in the ears, swelling of the eye, eye pain  
- rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin,  

overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal 
hair growth  

 
Frequency not known side effects 
 
- lung infection 
- lower number of red cells in your blood 
- cataract 
- lesion in intestine, abnormal opening between the wind pipe and the food pipe  
- allergic reaction  
- blood clots in your vessels, blockage of blood arteries, inflammation of a vein  
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 
your doctor or pharmacist. 
 
 
5. HOW TO STORE PHOTOBARR 
 
Keep out of the reach and sight of children.   
 
Do not use PhotoBarr after the expiry date which is stated on the carton and vial after EXP.   
 
Do not store above 25°C.   
Keep the vial in the outer carton in order to protect from light.  
 
After reconstitution, PhotoBarr solution should be protected from light and used immediately (within 3 
hours). Chemical and physical in-use stability has been demonstrated for 3 hours at 23°C. From a 



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microbiological point of view, the product should be used immediately. If not used immediately, 
in-use storage time and conditions prior to use are the responsibility of the user. 
 
 
6. FURTHER INFORMATION 
 
What PhotoBarr contains 
- The active substance is porfimer sodium. Each vial contains 75 mg of porfimer sodium. After 
reconstitution, each ml solution contains 2.5 mg porfimer sodium. 
- The other ingredients are hydrochloric acid and/or sodium hydroxide (for pH adjustment). 
 
What PhotoBarr looks like and contents of the pack 
PhotoBarr is a reddish brown powder for solution for injection.  
One single-use vial per pack.  
 
Marketing Authorisation Holder 
Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 
10, 1043 DP Amsterdam, The Netherlands 
 
Manufacturer 
Axcan Pharma SAS, Route de Bû, 78550 Houdan, France 
 
This leaflet was last approved in  
 
 
For any information about this medicine, please contact the Marketing Authorisation Holder. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 
 
 


	ANNEX I
	PhotoBarr 15
	1. NAME OF THE MEDICINAL PRODUCT
	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
	3. PHARMACEUTICAL FORM
	4. CLINICAL PARTICULARS
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	4.3 Contraindications
	4.4 Special warnings and precautions for use
	4.5 Interaction with other medicinal products and other forms of interaction
	4.6 Pregnancy and lactation
	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	4.9 Overdose

	5. PHARMACOLOGICAL PROPERTIES
	5.1 Pharmacodynamic properties
	5.2 Pharmacokinetic properties
	5.3 Preclinical safety data

	6. PHARMACEUTICAL PARTICULARS
	6.1 List of excipients
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal and other handling

	7. MARKETING AUTHORISATION HOLDER
	8. MARKETING AUTHORISATION NUMBER(S)
	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
	10. DATE OF REVISION OF THE TEXT

	PhotoBarr 75
	1. NAME OF THE MEDICINAL PRODUCT
	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
	3. PHARMACEUTICAL FORM
	4. CLINICAL PARTICULARS
	4.1 Therapeutic indications
	4.2 Posology and method of administration
	4.3 Contraindications
	4.4 Special warnings and precautions for use
	4.5 Interaction with other medicinal products and other forms of interaction
	4.6 Pregnancy and lactation
	4.7 Effects on ability to drive and use machines
	4.8 Undesirable effects
	4.9 Overdose

	5. PHARMACOLOGICAL PROPERTIES
	5.1 Pharmacodynamic properties
	5.2 Pharmacokinetic properties
	5.3 Preclinical safety data

	6. PHARMACEUTICAL PARTICULARS
	6.1 List of excipients
	6.2 Incompatibilities
	6.3 Shelf life
	6.4 Special precautions for storage
	6.5 Nature and contents of container
	6.6 Special precautions for disposal and other handling

	7. MARKETING AUTHORISATION HOLDER
	8. MARKETING AUTHORISATION NUMBER(S)
	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
	10. DATE OF REVISION OF THE TEXT


	ANNEX II
	A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCHRELEASE
	B CONDITIONS OF THE MARKETING AUTHORISATION

	ANNEX III
	A. LABELLING
	B. PACKAGE LEAFLET
	PhotoBarr 15
	1. WHAT PHOTOBARR IS AND WHAT IT IS USED FOR
	2. BEFORE YOU USE PHOTOBARR
	3. HOW TO USE PHOTOBARR
	4. POSSIBLE SIDE EFFECTS
	5. HOW TO STORE PHOTOBARR
	6. FURTHER INFORMATION

	PhotoBarr 75
	1. WHAT PHOTOBARR IS AND WHAT IT IS USED FOR
	2. BEFORE YOU USE PHOTOBARR
	3. HOW TO USE PHOTOBARR
	4. POSSIBLE SIDE EFFECTS
	5. HOW TO STORE PHOTOBARR
	6. FURTHER INFORMATION