Foscan 4 mg/ml solution for injection

Foscan is a porphyrin photosensitising medicine.

Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies.

Do not use Foscan

• if you are hypersensitive (allergic) to temoporfin or any of the ingredients of Foscan,
• if you are hypersensitive (allergic) to porphyrins,
• if you have porphyria, or any other disease that is made worse by light,
• if the tumour being treated goes through a large blood vessel,
• if you are going to have an operation in the next 30 days,
• if you have an eye disease which needs examination with bright light in the next 30 days,
• if you are already being treated with a photosensitising agent.

Take special care with Foscan
Foscan will make you sensitive to light for about 15 days after your injection. This means that normal daylight or bright indoor lighting could give you skin burns. To stop this, you MUST follow carefully the instructions for gradual exposure to increasing light levels indoors over the first week and outdoor, shaded light during the second week after treatment. Please speak to your doctor about this before you go home after being injected with Foscan. Sunscreen creams will not prevent this sensitivity. You will gradually become less sensitive to light. Normally, people are able to begin to return to normal outdoor lighting after 15 days.
You must not let an optician or ophthalmologist examine your eyes with bright lights for 30 days after Foscan injection.
You must not use UV sunbeds or sunbathe for 3 months after Foscan injection.
For 6 months following Foscan treatment, avoid prolonged direct sunlight exposure of the injection site arm. As a precautionary measure, if prolonged outdoor activity is planned, protect your injection arm by wearing a long sleeved, coloured shirt.

The table of instructions tells you what to do to prevent skin burns. You must follow these instructions carefully.

Please ask your doctor, nurse or pharmacist if you are not sure about anything. What should I do to prevent burns Time after Foscan Injection Day 1 0-24 hours Stay indoors in a darkened room. Keep the curtains drawn and use light bulbs of 60W or less. Avoid exposure to direct sunlight. Days 2-7 You can gradually return to normal indoor lighting. Remember to avoid direct sunlight coming through the window or direct light from household appliances such as reading lamps. You may watch television. You can go outdoors after dusk. If it is absolutely necessary to go outdoors during the hours of daylight, you must be careful to cover up all your skin including your face and hands and wear dark glasses. The type of clothes you must wear are Wide-brimmed hat for head, neck, nose and ears. Scarf for head and neck. Sunglasses with side panels for eyes and skin around eyes. Long sleeved top for upper bodyarms. Long trousers for lower bodylegs. Gloves for hands, wrist and fingers. Socks for feet and ankles. Closed shoes for feet. Do not wear very thin clothing because it will not protect you from strong light. Wear dark, closely woven clothing. If you expose yourself to light by mistake, you may get a prickly or burning feeling on the skin. You must get out of the light immediately. Your eyes may be very sensitive to bright lights during this week. You may get eye pain or headache when lights are switched on. If you have this problem, wear dark glasses. Days 8-14 You can now begin to go outside during daylight hours. Stay in shaded areas or go out when it is cloudy. Continue to wear dark, closely woven clothing. Start on Day 8 with 10-15 minutes outdoors. If you do not see any skin redness in the next 24 hours, you can gradually increase your time outdoors during the week. Avoid direct sunlight or strong indoor lighting. Stay in the shade. Day 15 onward Your sensitivity to light is gradually getting back to normal. You must test this carefully by exposing the back of your hand to the sun for 5 minutes. Wait 24 hours to see if there is any redness. If there is redness, you should avoid direct sunlight for another 24 hours. You can then repeat the test. If there is no redness, you can gradually increase your exposure to sunlight day by day. Do not stay in the sunlight for more than 15 minutes the first time. Most people will be able to go back to their normal routine by Day 22. On the first day after the skin test, you can stay in direct sunlight for 15 minutes. You can increase your exposure by another 15 minutes each day i.e. second day 30 minutes, third day 45 minutes, fourth day 60 minutes and so on. If at any time you notice a prickly or burning feeling or see skin reddening after exposure to sun, wait until this disappears before exposing your skin to light for this length of time again. For 30 days following Foscan treatment, avoid eye tests that use bright lights. For 3 months following Foscan treatment, avoid UV tanning beds. Do not sunbathe. For 6 months following Foscan treatment, care should be taken to avoid direct prolonged sunlight exposure of the arm used for Foscan injection. As a precautionary measure, if prolonged outdoor activity is planned, the injection arm should be protected by wearing a long sleeved, coloured shirt.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Foscan with food and drink:
Your normal food and drink will not affect your treatment with Foscan

Pregnancy

You must avoid becoming pregnant for 3 months after Foscan treatment.
Ask you doctor or pharmacist for advice before taking any medicine if you are pregnant

Breast-feeding
Do not breastfeed for at least 1 month after Foscan injection.

Driving and using machines

In the light conditions recommended for the first 15 days after Foscan injection, driving is not recommended, and it may not be practical to operate machines.

Important information about some of the ingredients of Foscan
WARNING: This product contains 48 vol % ethanol (alcohol), i.e up to 1 g per dose, equivalent to 21 ml of beer, 9 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Your doctor or nurse will give you Foscan by injection into a vein.

If necessary, your doctor or nurse may give you another injection at least 4 weeks later.

Four days after your injection, your doctor will treat your cancer with laser light.

If you are given more Foscan than you should
You may not be given the laser treatment. You may be sensitive to light for more than 15 days. You must follow carefully the instructions on preventing skin burns.

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

Everyone who takes Foscan will become sensitive to light for about 15 days after injection. You must follow the instructions given to you to avoid sunlight and bright indoor light. These instructions are written in this leaflet. Your doctor will also tell you what to do. If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.

Very common side effects (likely to occur in more than 1 in 10 patients)

You may feel some pain when Foscan is injected. After the laser treatment, you may feel pain in your face and pain around the treatment area. There may also be bleeding, ulcers, swelling, and scarring. These effects may make it difficult to eat and drink. You may get constipation.

Common side effects (likely to occur in more than 1 in 100 patients)

There may be some irritation, a burning sensation or skin damage where Foscan is injected, but this will not last long. You may also get ulcers, blisters, skin redness, or skin darkening. Other effects may be vomiting, fever, nausea, anaemia, light sensitivity, sunburn, burns, difficulty with swallowing or giddiness. There may be swelling or may have a stiff jaw. Some people may get an infection in the treated area.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not use after the expiry date stated on the label and the carton.
Foscan will be stored at the hospital pharmacy.
Do not store above 25 oC.
Store in the original package in order to protect from light.

What Foscan contains

• The active substance is temoporfin. Each ml contains 4 mg of temoporfin.
• The other ingredients are ethanol anhydrous (E1510) and propylene glycol (E1520).

What Foscan looks like and contents of the pack

Foscan solution for injection is a dark purple solution in an amber glass vial.
Each pack contains 1 glass vial and a filter contained in a polyethylene cover.

Marketing Authorisation Holder and Manufacturer

biolitec pharma ltd.
United Drug House
Magna Drive
Dublin 24
Ireland

This leaflet was last approved in

The following information is intended for medical or healthcare professionals only

Foscan 4 mg/ml solution for injection
Temoporfin

1. PACK CONTENTS

Each pack provides 1 vial containing 3.5 ml or 5 ml solution for injection. The active substance is temoporfin. Each ml of solution contains 4 mg of temoporfin. The excipients are ethanol anhydrous and propylene glycol. A filter with Luer lock connections for syringe and cannula is provided.

Each vial represents a single dose and any unused solution must be discarded.

2. CALCULATION OF DOSE

Calculate the required dose of Foscan according to the bodyweight of the patient. The dose is 0.15 mg/kg bodyweight.

3. ADMINISTRATION OF FOSCAN (96 hours prior to laser illumination of treatment site)

Foscan must be administered intravenously via an in-dwelling cannula in a large proximal limb vein, preferably in the antecubital fossa. The patency of the in-dwelling cannula should be tested before injection.

The dark purple colour of the solution together with the amber vial makes a visual check for particulates impossible. Thus, an in-line filter must be used as a precautionary measure and is provided in the package.

Draw up the entire contents of the vial containing Foscan into a syringe and expel air (Figure 1).

Figure 1

Attach the filter to the syringe (Figure 2).

Figure 2

Press the syringe plunger to fill all dead space within the filter. Continue pressing the plunger to expel excess Foscan until the required volume is left in the syringe, allowing sufficient to cover the dead space in the intravenous cannula (Figure 3).

Figure 3

Attach the syringe and filter to the cannula. Administer the required dose of Foscan by slow intravenous injection, over not less than 6 minutes (Figure 4).

Figure 4

Remove the intravenous cannula immediately following the injection. Do NOT flush with aqueous solutions such as sodium chloride 0.9% solution for injection or water for injections.

Special care should be taken to prevent extravasation at the injection site. If extravasation occurs, protect the area from light for at least 3 months. There is no known benefit from injecting the extravasation site with another substance.

Foscan is photosensitive. Once removed from its packaging it should be administered immediately. Where delay is unavoidable, the solution must be protected from light.

4. LASER ILLUMINATION OF TREATMENT SITE

Please refer to the laser user manual, and to the microlens fibre-optic user leaflet.

96 hours after the administration of Foscan, the treatment site is to be illuminated with light at 652 nm from an approved laser source. Light must be delivered to the entire surface of the tumour using an approved microlens fibre-optic. Wherever possible, the illuminated area must extend beyond the tumour margin by a distance of 0.5cm.

Light must be administered not less than 90 hours and not more than 110 hours after Foscan injection.

The incident light dose is 20J/cm 2, delivered by the microlens fibre-optic in a circular field to the tumour surface at an irradiance of 100mW/cm 2, implying an illumination time of 200 seconds.

Each field is to be illuminated once only at each treatment. Multiple non-overlapping fields may be illuminated. Care must be taken to ensure that no area of tissue receives more than the specified light dose. Tissue outside the target area must be shielded completely to avoid photoactivation by scattered or reflected light.

5. SAFETY INFORMATION

Foscan is non-irritant