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Foscan (temoporfin) – Package leaflet - L01XD05

Updated on site: 07-Oct-2017

Medication nameFoscan
ATC CodeL01XD05
Substancetemoporfin
ManufacturerBiolitec Pharma Ltd

Package leaflet: Information for the patient

Foscan 1 mg/ml solution for injection

Temoporfin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor or nurse.

-If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Foscan is and what it is used for

2.What you need to know before you use Foscan

3.How to use Foscan

4.Possible side effects

5.How to store Foscan

6.Contents of the pack and other information

1.What Foscan is and what it is used for

The active ingredient in Foscan is temoporfin.

Foscan is a porphyrin photosensitising medicine, which increases your sensitivity to light and is activated by light from a laser in a treatment called photodynamic therapy.

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

2. What you need to know before you use Foscan

Do not use Foscan

-if you are allergic to temoporfin or any of the other ingredients of this medicine (listed in section 6),

-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.

Warnings and precautions

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 see the table at the end of this leaflet).

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.

Do not let an optician or ophthalmologist examine your eyes with bright lights for 30 days after Foscan injection.

Do 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 long sleeved, coloured clothing.

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

Please ask your doctor or nurse if you are not sure about anything.

Time after

 

What should I do to prevent burns?

Foscan Injection

 

 

Day 1 (0-24

Stay indoors in a darkened room. Keep the curtains drawn and use light bulbs of

hours)

60 W or less.

 

Avoid exposure to direct sunlight.

 

 

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 body/arms.

 

 

Long trousers: for lower body/legs.

 

 

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 long sleeved, coloured clothing.

Other medicines and Foscan

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy and breast-feeding

You must avoid becoming pregnant for 3 months after Foscan treatment.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.

Do not breast-feed for at least 1 month after Foscan injection.

Driving and using machines

The amount of alcohol in this medicine may impair your ability to drive or use machines for a few hours after injection.

It is not recommended to drive or operate machines for the first 15 days after Foscan injection, because of the recommended light exposure restrictions

Foscan contains ethanol (alcohol):

This product contains 48 vol % ethanol (alcohol), i.e up to 4.2 g per dose, equivalent to 84 ml of beer, 35 ml wine per dose. This product is also harmful for those suffering from alcoholism. Pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy are also at risk.

The amount of alcohol in this product may alter the effects of other medicines.

3.How to use Foscan

Your doctor or nurse will give you Foscan by a slow injection into a vein, which will take approximately 6 minutes.

Four days after your injection, your doctor will treat your cancer with laser light. Your doctor will cover the normal tissue surrounding your cancer and then shine the laser light directly at the cancer for about 5 minutes. The laser light is not hot and will not burn.

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.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.Possible side effects

Like all medicines, Foscan can cause side effects.

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.

Most of the side effects related with photodynamic therapy are local effects seen as consequence of triggering the Foscan with the laser. You may feel pain after the laser treatment. This pain will be controlled with painkillers. Please let your doctor or nurse know if you have pain or if the painkillers you have been given are not taking the pain away. Furthermore you will probably notice swelling and reddening around the area that has been treated. You may be given some medicine to reduce the swelling. After 2 to 4 days, the treated area will turn black. This blackness is caused by dead cancer cells (necrosis). Foscan may also damage the tissue that is surrounding the tumour.

Very common side effects (may affect more than 1 in 10 people):

You may feel some pain when Foscan is injected.

After the laser treatment, you may feel pain in the treated area, e.g. pain in your face or headache.

There may also be bleeding, ulcers, swelling in the treated area like swelling of your face or tongue, and scarring.

You may get constipation.

These effects may make it difficult to eat and drink.

Common side effects (may affect up to 1 in 10 people):

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.

Vomiting

Fever

Nausea

Anaemia

Light sensitivity

Sunburn

Burns

Difficulty with swallowing

Giddiness

There may be swelling or you may have a stiff jaw. Some people may get an infection in the treated area, e.g. inflammation of the throat or mouth.

Events occurring at a frequency not known (frequency cannot be estimated from the available data):

Airway blocking as consequence of swelling in the treated area

Fistula in the treated area

Sepsis

Vascular rupture

Serious side effects such as inflammation of bile duct or gallbladder, liver abscess or perforation in the treated area have been reported when used in other cancer than head and neck. Talk to your doctor for more information.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Foscan

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

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. Once removed from its package, this medicine must be used immediately.

Each vial is a single dose and any unused medicine must be discarded.

6. Contents of the pack and other information

What Foscan contains

-The active substance is temoporfin. Each ml contains 1 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, containing 1 ml, 3 ml or 6 ml of solution.

Each pack contains 1 glass vial and a filter. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

biolitec Pharma Ltd. Otto-Schott-Str. 15 07745 Jena Germany

Tel.: +49 3641 5195330 Fax: +49 3641 5195331

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

The following information is intended for medical or healthcare professionals only

Foscan 1 mg/ml solution for injection

Temoporfin

1. PACK CONTENTS

The active substance is temoporfin. Each ml of solution contains 1 mg of temoporfin. The excipients are ethanol anhydrous and propylene glycol. A filter with Luer lock connections for syringe and cannula is provided.

Each pack provides 1 vial containing 1 ml, 3 ml or 6 ml solution for injection.

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 9 mg/ml (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 0.5 cm.

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

The incident light dose is 20 J/cm2, delivered by the microlens fibre-optic in a circular field to the tumour surface at an irradiance of 100 mW/cm2, 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.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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