FOSCAN 4 mg /Ml Injectable Solution

Зміст інструкції

1. Foscan 1 mg/ml injectable solution
   1. What is Foscan and what is it used for
   2. What you need to know before using Foscan
   3. How to use Foscan
   4. Possible side effects
   5. How to store Foscan
   6. Contents of the pack and other information
   7. PACKAGE CONTENTS
   8. DOSE CALCULATION
   9. ADMINISTRATION OF FOSCAN (96 hours before laser illumination of the treatment site
2. Foscan is photosensitive. Once removed from its packaging, it must be administered
   1. LASER ILLUMINATION OF THE TREATMENT SITE
   2. SAFETY INFORMATION

Foscan 1 mg/ml injectable solution

Temoporfina

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of 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 is Foscan and what is it used for

The active ingredient contained in Foscan is temoporphin.
Foscan is a medicine consisting of a photosensitizing porphyrin, which increases its sensitivity
to light and is activated by the light emitted by 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 using Foscan

Do not use Foscan

• if you are allergic to temoporphin or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic (hypersensitive) to porphyrins,
• if you suffer from porphyria or any other disease that is aggravated by light,
• if the tumor being treated passes through a large blood vessel,
• if you are going to undergo surgery in the next 30 days,
• if you suffer from an eye condition that requires an assessment with bright light in the next 30 days,
• if you are already being treated with a photosensitizing agent.

Warnings and precautions

• Foscan will make you sensitive to light for about 15 days after the injection. This means that normal daylight or bright indoor lighting could cause skin burns. To prevent this, you mustcarefully follow the instructions for gradual exposure to increasing levels of light in indoor environments in the first week and outdoors, shaded light in the second week after treatment (see the table at the end of this leaflet).
• Talk to your doctor before returning home after receiving the Foscan injection.
• Sunscreen creams do notprevent this type of sensitivity.
• You will gradually become less sensitive to light. Normally, people are able to start returning to normal light outdoors after 15 days.
• Do nothave your eyes examined with bright lights by opticians or ophthalmologists for 30 days after the Foscan injection.
• Do notuse UV tanning beds or sunbathe for 3 months after the Foscan injection.
• For the 6 months following treatment with Foscan, avoid prolonged exposure of the arm used for the injection to sunlight. As a precaution, if prolonged outdoor activity is planned, the injection site must be protected by long-sleeved, colored clothing.

The table of instructions tells you what to do to prevent skin burns. You must follow these
instructions carefully.
Ask your doctor or nurse if you are unsure about anything.

Other medicines and Foscan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding

• For three months after treatment with Foscan, you must avoid pregnancy.
• Consult your doctor or pharmacist before taking any medicine if you are pregnant.

Do notbreastfeed for at least 1 month after the Foscan injection.

Driving and operating machinery

• The amount of alcohol in this medicine may impair your ability to drive vehicles and operate machinery for several hours after the injection.
• Due to the recommended limitations on light exposure, for the first 15 days after the Foscan injection, it is notrecommended to drive vehicles or operate machinery.

Foscan contains ethanol (alcohol):

• This product contains 48 vol% ethanol (alcohol), which is up to 4.2 g per dose, equivalent to 84 ml of beer or 35 ml of wine per dose. This medicine is also hazardous for people with alcohol problems. Those at risk include women who are pregnant or breastfeeding, children and high-risk groups, such as people with liver disease or epilepsy. The amount of alcohol in this product may alter the effects of other medicines.

3. How to use Foscan

• Your doctor or nursing staff will administer Foscan by slow injection into a vein, which will take approximately 6 minutes.
• Four days after the injection, your doctor will treat the tumor with laser light. The doctor will cover the normal tissue surrounding the tumor and then irradiate the laser light directly onto the tumor for about 5 minutes. The laser light is not hot and will not burn.

If you receive 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 will need to carefully follow instructions on how to prevent skin burns.

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

4. Possible side effects

Like all medicines, Foscan can cause side effects.

• Anyone receiving Foscan becomes light-sensitive for approximately 15 days after the injection.
• You must follow the instructions given to you to avoid sunlight and bright light indoors.
• These instructions are written in this leaflet. Your doctor will also tell you what you need to do. If you do not follow these instructions, you may experience severe sunburns that can lead to permanent scarring.

Most side effects related to photodynamic therapy are local effects, observed as a result of Foscan activation with the laser. You may experience pain after laser treatment. This pain will be controlled with analgesics. Tell your doctor or nurse if you experience pain or if the analgesics you have been given do not relieve the pain. You will also likely notice swelling and redness around the treated area. Medicines may be given to you to reduce the swelling. After 2-4 days, the treated area will turn black. The blackening is caused by the death of cancer cells (necrosis). Foscan can also damage the tissue surrounding the tumor.

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

• You may feel pain when Foscan is injected.
• After laser treatment, you may experience pain in the treated area, such as facial pain or headache.
• Bleeding, ulcers, swelling in the treated area, such as swelling of the face or tongue, and scarring may also occur.
• Constipation may occur. These effects can make it difficult to drink and eat.

Common side effects (may affect more than 1 in 100 people):

• Irritation, burning sensation, or skin damage may appear where Foscan is injected, but these are transient phenomena.
• You may also experience ulcers, blisters, redness or darkening of the skin
• Vomiting
• Fever
• Nausea
• Anemia
• Light sensitivity
• Sunburn
• Burns
• Difficulty swallowing
• Dizziness
• There may be swelling or stiffness of the jaw. Some people may develop an infection in the treated area, such as inflammation of the throat or mouth.

Adverse reactions with unknown frequency (frequency cannot be estimated based on
available data):

• Blockage of the airways due to swelling in the treated area
• Fistula in the treated area
• Sepsis
• Vascular rupture

Serious side effects, such as inflammation of the bile ducts or gallbladder, liver abscess, or perforation in the treated area, have been reported with use for tumor types other than those of the head and neck. For further information, please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or nurse. You can also report side effects directly through the
national reporting system as detailed in Annex 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.

Donot use this medicine after the expiry date which is stated on the label and the packaging. The
expiry date refers to the last day of that month.
Foscan will be stored at the hospital pharmacy.

Donot store at a temperature above 25 °C.
Store in the original packaging to protect the medicine from light. Once removed from the
packaging, 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 ingredient is temoporphin. Each ml contains 1 mg of temoporphin.
• The other ingredients are anhydrous ethanol (E1510) and propylene glycol (E1520).

Description of the appearance of Foscan and contents of the pack
Foscan injectable solution is a dark violet 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
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu
The following information is intended exclusively for healthcare professionals:

Foscan 1 mg/ml Injectable Solution
Temoporphin

1. PACKAGE CONTENTS

The active substance is temoporphin. Each ml of solution contains 1 mg of temoporphin. The excipients
are anhydrous ethanol and propylene glycol. A filter with Luer lock connections for syringe and
cannula is provided.
Each package provides 1 vial containing 1 ml, 3 ml or 6 ml of injectable solution.
Each vial constitutes a single dose and any unused solution residue must be
discarded.

2. DOSE CALCULATION

Calculate the required dose of Foscan according to the patient's body weight. The dose is 0.15 mg/kg of
body weight.

3. ADMINISTRATION OF FOSCAN (96 hours before laser illumination of the treatment site

of treatment)
Foscan must be administered intravenously via a cannula positioned in a large proximal vein of the limb, preferably in the antecubital fossa. The patency of the intravenous cannula positioned in the vessel must be checked before injection.
The dark purple-red color of the solution together with the amber color of the vial makes it impossible to visually check for suspended particles. For this reason, a filter, which is supplied in the package, must be used as a precaution in the infusion line.
Draw the entire contents of the vial containing Foscan into a syringe and expel the air. (Figure 1).

Figure 1
Connect the filter to the syringe (Figure 2).

Figure 2
Press the syringe plunger to fill all the dead space in the filter. Continue to press the plunger to expel excess Foscan until the required volume remains in the syringe, allowing for a sufficient amount to cover the dead space in the intravenous cannula (Figure 3).

Figure 3
Connect the syringe and filter to the cannula. Administer the required dose of Foscan for slow intravenous injection, over a period of no less than 6 minutes (Figure 4).

Figure 4

Remove the intravenous cannula immediately after the injection. DO NOT flush with aqueous solutions such as sodium chloride 9 mg/ml (0.9 %) injectable solution or water for injectable preparations.
Particular care must be taken to prevent extravasation at the injection site. If extravasation occurs, the area must be protected from light for at least 3 months. There is no known benefit to injecting the extravasation site with other substances.

Foscan is photosensitive. Once removed from its packaging, it must be administered

immediately. When a delay is unavoidable, the solution must be protected from light.

4. LASER ILLUMINATION OF THE TREATMENT SITE

Please refer to the laser user manual and the instructions for use of the fiber optic equipment with microlens.
96 hours after the administration of Foscan, the treatment site must be illuminated with light at 652
nm generated by an approved laser source. The light must be transmitted to the entire surface of the
tumor using approved fiber optic equipment with microlens. Where possible,
the illuminated area should extend beyond the tumor margin by a distance of 0.5 cm.
The light must be administered no less than 90 hours and no more than 110 hours after the injection of Foscan.
The incident light dose is 20 J/cm², administered by the fiber optic equipment with microlens
in a circular field at the surface of the tumor with an irradiance of 100 mW/cm², implying an
illumination time of 200 seconds.
Each field must be illuminated only once per treatment. Multiple
fields that do not show overlap can be illuminated. Care must be taken to ensure that no area
of tissue receives a light dose greater than that specified. The tissue outside the target
area must be completely shielded to avoid photoactivation from diffuse or reflected light.

5. SAFETY INFORMATION

Foscan is not irritating.
Unused medicine and waste derived from this medicine must be disposed of in accordance
with current local regulations.