This is a summary of the European public assessment report (EPAR) for PhotoBarr. It explains how the
Because the number of patients with Barrett’s oesophagus is low, the disease is considered ‘rare’, and PhotoBarr was 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 should only be carried out or supervised by a doctor who has experience in laser treatment using an endoscope (a thin tube used to look into the body) and who has been trained in photodynamic therapy. PhotoBarr should also only be used if experienced staff and material for assessing and treating anaphylaxis (severe allergic reaction) are immediately available.
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How has PhotoBarr been studied?
How does PhotoBarr work?
Treatment with PhotoBarr is a
Patients who receive PhotoBarr must be given a special card that summarises the safety information on the medicine.
The active substance in PhotoBarr, porfimer sodium, is a photosensitisingauthorisedagent (a substance that
changes when exposed to light). When PhotoBarr is injected, porfimer is absorbed into cells throughout the body. When it is illuminated with laser light of a specific wavelength, it is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen called ‘singlet oxygen’. This kills the cells by reacting with and destroying their components, such as their proteins and DNA. By
restricting the illumination to the area of dysplasia, only cells in this area are damaged, leaving other areas of the body unaffected.longer
PhotoBarr has been studied in one main study involving 208 patients who had Barrett’s oesophagus with
measure of effectiveness was the number of patients who had no
What benefit has PhotoBarr shown during the studies?
Adding photodynamicMedicinaltherapy using PhotoBarr to omeprazole treatment increased the number of patients whose dysplasia was destroyed. After six months, 72% of the patients using PhotoBarr in
combination with omeprazole had no
What is the risk associated with PhotoBarr?
The most common side effects with PhotoBarr (seen in more than 1 patient in 10) are dehydration, oesophageal stenosis (narrowing of the oesophagus), vomiting, dysphagia (difficulty swallowing), constipation, nausea (feeling sick), photosensitivity reactions
PhotoBarr should not be used in people who may be hypersensitive (allergic) to porfimer sodium and other porphyrins, or to any of the other ingredients. PhotoBarr must not be used in patients with porphyria (an inability to break down porphyrins), severe problems with the liver or kidneys, varices (swollen veins) in the oesophagus or stomach, large ulcers in the oesophagus, fistulae (abnormal
passageways) between the oesophagus and either the trachea (windpipe) or the bronchi (airways in the lungs), or suspected damage to major blood vessels.
As all patients receiving PhotoBarr become more sensitive to light, they should take care to avoid exposure of their skin and eyes to bright light for at least three months after injection. See the package leaflet for full details.
Why has PhotoBarr been approved?
The CHMP decided that PhotoBarr’s benefits are greater than its risks and recommended that it be given marketing authorisation.
What measures are being taken to ensure the safe use of PhotoBarr?
prescribe or dispense the medicine are provided with information packs for healthcare workers and patients. The packs will include information on PhotoBarr and how it should be used safely.
The company that makes PhotoBarr is preparing educational materialsauthorisedin agreement with medicines regulatory authorities in Member States. This will ensure that all doctors and pharmacists who will
Other information about PhotoBarr
The European Commission granted a marketing authorisation valid throughout the European Union for PhotoBarr on 25 March 2004.
The full EPAR for PhotoBarr can be found on the Agency’s website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with PhotoBarr, read the package leafletno(also part of the EPAR) or contact your doctor or
The summary of the opinion of theproductCommittee for Orphan Medicinal Products for PhotoBarr can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/Rare disease
This summaryMedicinalwas last updated in