HEXVIX

Patient Information Leaflet

Hexvix 85 mg powder and solvent for intravesical solution

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

Contents of this leaflet:

1. What Hexvix is and what it is used for
2. What you need to know before using Hexvix
3. How to use Hexvix
4. Possible side effects
5. How to store Hexvix
6. Contents of the pack and other information

1. What Hexvix is and what it is used for

This medicinal product is for diagnostic use only. This medicine is used to help detect bladder cancer. Hexvix will be administered before your doctor begins examining the bladder with a special device called a "cystoscope". The cystoscope helps doctors identify possible tumours, thereby enabling the removal of more abnormal cells, which become visible under blue light after administration of Hexvix.

2. What you need to know before using Hexvix

Do not use Hexvix

• if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of HEXVIX, including the liquid used to dissolve it (see section 6, Other information).
• if you have porphyria (a rare inherited blood disorder).

Warnings and precautions
Before receiving Hexvix, consult your doctor:

• if you suspect you have a urinary tract infection or if you experience a burning sensation while urinating.
• if you have recently received BCG therapy for the bladder.
• if you have recently undergone bladder surgery. These conditions may cause local bladder reactions that could make it more difficult for the doctor to interpret findings during the examination.

Use of other medicines:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
Consult your doctor for advice regarding driving or operating machinery after administration of Hexvix.

3. How to use Hexvix

Hexvix must be prepared and administered only by a healthcare professional specifically trained for this purpose.
Hexvix is usually administered in a hospital or clinic setting.
Your doctor will administer Hexvix as follows:

1. A small tube called a "catheter" will be inserted into your bladder.
2. The bladder will be emptied through this tube.
3. Hexvix will be introduced into the bladder through the tube.
4. Hexvix will remain in the bladder for approximately 60 minutes.
5. The bladder will then be emptied again through the tube.
6. Using a device (cystoscope), the doctor will examine the bladder.

If you are given more Hexvix than you should have No adverse effects are expected if Hexvix remains in the bladder for longer than 60 minutes or if more Hexvix than necessary is used. If you are concerned about this, speak to your doctor or nursing staff.

4. Possible side effects

Like all medicines, Hexvix can cause side effects, although not everyone gets them. There is a risk of side effects related to the technique (cystoscopy) used to examine the bladder. The use of Hexvix as an adjunct procedure to cystoscopy for more accurate diagnosis of bladder tumour is generally well tolerated. Any side effects are usually related to the standard investigative technique, are generally not serious and do not last long. The investigational procedure with Hexvix may cause the following side effects:

Common (affects 1 to 10 patients in 100):

• Headache.
• Nausea (feeling unwell), vomiting.
• Diarrhoea.
• Constipation.
• Muscle spasms or pain around the stomach (abdomen).
• Pain and difficulty in urinating.
• Inability to empty the bladder (urinary retention).
• Presence of blood in the urine.
• Pain after the procedure.
• Fever (high temperature).

Uncommon (affects 1 to 10 patients in 1,000):

• Burning sensation when passing urine (caused by inflammation or infection of the bladder).
• Need to urinate frequently.
• Blood infection (septicaemia).
• Inability to sleep or difficulty in falling asleep.
• Pain in the tube called the “urethra”, through which urine passes.
• Feeling of needing to urinate immediately (urgency).
• Increase in white blood cell count, increase in bilirubin concentration (yellow pigment of bile), or increase in liver enzymes. All of these can be seen from blood laboratory test results.
• Decrease in the number of red blood cells in the blood (anaemia).
• Inflammation of the head of the penis (balanitis).
• Back pain.
• Gout.
• Skin rashes.

Frequency not known

• Anaphylactic shock (drop in blood pressure, increased heart rate, skin rash)

If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hexvix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton.
The expiry date refers to the last day of the month.
Powder and solvent: no special storage conditions are required for this product.
Solution (after mixing): store at 2°C – 8°C (in the refrigerator) for no longer than 2 hours.
Hospital staff will be responsible for storing and disposing of the product appropriately, ensuring that
the product is not used after the expiry date indicated on the outer carton.

6. Package contents and other information

What Hexvix contains

• The active substance is hexaminolevulinate hydrochloride.
• The excipients are: disodium phosphate dihydrate, potassium dihydrogen phosphate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of Hexvix and contents of the pack

• Each pack consists of a vial containing a powder ranging from white to off-white or pale yellow, which contains 85 mg of the active substance hexaminolevulinate, and a pre-filled syringe with or without the Mini-Spike transfer device, containing 50 ml of a clear, colourless liquid for dissolving the powder.
• The Hexvix powder is dissolved with the 50 ml of solution supplied in the pack. Mixing the powder and solvent results in a solution of 1.7 mg/ml hexaminolevulinate, equivalent to an 8 mmol/l hexaminolevulinate solution.

Marketing Authorisation Holder and Manufacturer
Photocure ASA,
Hoffsveien 4
NO 0275 Oslo
Norway
This medicinal product is authorised under the name Hexvix in the following European Economic Area Member States: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom.

This leaflet was last updated
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The following information is intended for medical and healthcare professionals only:
Instructions for handling
Hexaminolevulinate may cause skin sensitisation upon contact.
All steps of the procedure must be carried out using sterile equipment and under aseptic conditions.
Reconstitution procedure A: Powder and Solvent (for Hexvix) in pre-filled syringe

	1. Attach the plunger to the rubber stopper of the syringe by rotating the plunger clockwise until it stops. 2. Remove the cap from the syringe and keep it aside for later use. Attach a reconstitution needle to the syringe. Hold the syringe in an upright position and carefully push the plunger upward to remove air.
	3. Inject approximately 10 ml of solvent into the vial containing the powder. The vial should be filled to three-quarters full.
	4. Without removing the needle from the vial, firmly hold the powder vial and syringe and gently shake to ensure complete dissolution.
	5. Withdraw all of the dissolved solution from the powder vial into the syringe.
	6. Disconnect the empty vial from the syringe. Remove the needle from the syringe and discard it. Place the cap onto the syringe. Gently mix the contents of the syringe.

Reconstitution Procedure B: Powder and Solvent (for Hexvix) in Pre-filled Syringe with
Mini-Spike Transfer Device

	4. Without removing the Mini-Spike from the vial, hold the powder vial and syringe firmly and gently shake to ensure complete dissolution.
	5. Invert the vial and syringe and withdraw all of the dissolved solution from the powder vial into the syringe.
	6. Disconnect the empty vial and the Mini-Spike transfer device from the syringe, and discard the vial and Mini-Spike. Place the cap on the syringe. Gently mix the contents of the syringe.

slightly opalescent, ranging from colourless to pale yellow.
Add 2 hours to the reconstitution time and write the resulting expiry time and date on the
syringe label.
For single use only. Discard any unused product. No special precautions for disposal.
The solution is chemically and physically stable for 2 hours when stored at temperatures
between 2°C and 8°C. From a microbiological standpoint, the product should be used
immediately. If not used immediately, the storage times after opening and the storage
conditions prior to use are the responsibility of the user and normally should not exceed 2 hours at 2–8°C.