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AstraZeneca

PhotoBarr
porfimer sodium

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.


PhotoBarr should not be used in children and adolescents below 18 years of age, due to lack of experience.

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.


  1. HOW TO USE PHOTOBARR


    Medicinal product no longer authorised

    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:

    • 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.

      Medicinal product no longer authorised

    • 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.


  2. 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


      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

    Medicinal product no longer authorised

    - 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.


  3. 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 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.


  4. FURTHER INFORMATION


What PhotoBarr contains


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


Medicinal product no longer authorised

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.

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