PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is PhotoBarr?
PhotoBarr is a powder that is made up into a solution for injection. It contains the active substance porfimer sodium.
What is PhotoBarr used for?
PhotoBarr is used in photodynamic therapy (light therapy) for the ablation (removal) of high-grade dysplasia (abnormal cells at high risk of turning into a tumor) in patients with Barrett's esophagus. This disease is characterized by an alteration of the mucosa in the last section of the esophagus due to the damage caused by the acid coming from the stomach.
Given that the number of patients with Barrett's esophagus is low, the disease is considered "rare" and PhotoBarr has been designated an "orphan medicine" (a medicine used in rare diseases) on 6 March 2002.
The medicine can only be obtained with a prescription.
How is PhotoBarr used?
Photodynamic therapy with PhotoBarr must be performed or supervised by a doctor experienced in endoscopic procedures (the endoscope is a thin tube used for observation inside the body) with laser, which has received adequate training on photodynamic therapy .
PhotoBarr treatment is a two-step process: the drug is first administered and subsequently activated using a laser. PhotoBarr is given as a slow and accurate intravenous injection lasting 3-5 minutes at a dose of 2 mg per kilogram body weight. About two days later, dysplasia and small areas of surrounding and underlying normal tissue are illuminated with light emitted by a specific wavelength laser, using a fiber optic cable through an endoscope. The type of instrument used, as well as the duration of illumination, depend on the size of the area affected by the disease. If necessary, patients may be given a shorter second treatment 2-3 days later. It is possible to repeat the cycle (one injection and one or two laser treatments) a maximum of two more times, with an interval of at least three months, provided that the risk of narrowing the esophagus is taken into account.
PhotoBarr should not be used in patients under the age of 18 due to a lack of information on the safety and efficacy of the medicine in this category. To the patients to whom it comes
given PhotoBarr must be given a special card that contains a summary of information on the safety of the medicine.
How does PhotoBarr work?
The active ingredient in PhotoBarr, the porfimer sodium, is a photosensitizing agent (a substance that changes when exposed to light). After the PhotoBarr injection, porfimer is absorbed into cells throughout the body. Subsequently, when illuminated with laser light of specific wavelength, the porfimer is activated and reacts with the oxygen present in the cells, creating a type of highly reactive and toxic oxygen, called "singlet oxygen" (a free radical), which kills cells by reacting with their components, such as proteins and DNA, and destroying them. By limiting illumination to the area of dysplasia, only the cells in this area are damaged, without affecting other parts of the body.
What studies have been carried out on PhotoBarr?
PhotoBarr has been studied in a main study involving 208 patients with Barrett's esophagus with high-grade dysplasia. The effects of photodynamic therapy with PhotoBarr, used in combination with omeprazole (an antacid medicine), were compared with those of omeprazole alone. The main measure of effectiveness was the number of patients who no longer presented with high-grade dysplasia at least six months after the first course of treatment. Patients were observed for at least two years.
What benefit has PhotoBarr shown during the studies?
Photodynamic therapy with PhotoBarr added to omeprazole treatment resulted in an increase in the number of patients whose dysplasia was eliminated. After six months, 72% of patients treated with PhotoBarr in combination with omeprazole no longer showed signs of high-grade dysplasia, compared with 31% of subjects who took only omeprazole. Similar results were observed in the two groups after two years.
What is the risk associated with PhotoBarr?
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, esophageal stricture (narrowing of the esophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea, photosensitivity reactions (reactions similar to sunburn ) and pyrexia (fever). Because laser treatment causes difficulty in swallowing, including pain, nausea and vomiting, patients should only take liquid food for a few days after the course of treatment, in some cases up to four weeks. For the full list of all side effects reported with PhotoBarr, see the Package Leaflet.
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins or any of the other ingredients. PhotoBarr should not be used in patients with porphyria (inability to metabolize porphyrins), severe renal or hepatic insufficiency, esophageal or gastric varicose veins (swollen veins), large esophageal ulcers, fistulas (abnormal openings) between the esophagus and the trachea. bronchi or suspected erosion of the main blood vessels.
All patients taking PhotoBarr develop greater sensitivity to light and therefore should avoid exposing the skin and eyes to very bright light for at least three months after the injection. For more details, see the package leaflet.
Why has PhotoBarr been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that PhotoBarr's benefits are greater than its risks in photodynamic therapy for ablation of high-grade dysplasia in patients with Barrett's esophagus. The committee recommended issuing marketing authorization for PhotoBarr.
What measures are being taken to ensure the safe use of PhotoBarr?
The company that produces PhotoBarr is preparing informative material in agreement with the authorities of the Member States in the field of legislation on medicines. It will thus ensure that all doctors who prescribe the drug and all the pharmacists who sell it are provided with information packages for healthcare professionals and patients. These packages will contain information about PhotoBarr and how to use it safely.
More information about PhotoBarr:
On 25 March 2004, the European Commission issued a marketing authorization valid for the entire EU to PhotoBarr to Axcan Pharma International BV. The marketing authorization was renewed on 25 March 2009.
For a summary of the opinion of the Committee for Orphan Medicinal Products on PhotoBarr click here
For the full EPAR for PhotoBarr click here.
Last update of this summary: 03-2009.
