PhotoBarr 75 mg powder for solution for injection

PhotoBarris 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).

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 ?W hat 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.

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

PhotoBarrshould 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.

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 90days 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 PhotoBarris 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 PhotoBarrinjection, 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.

Like all medicines, PhotoBarr can cause side effects, although not everybody gets them.

All patients who receive PhotoBarrwill 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

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.

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, PhotoBarrsolutionshould 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.

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

Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, 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.