AXUMIN 3200 MBq/ML INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Axumin 1,600 MBq/ml Solution for Injection

Axumin 3,200 MBq/ml Solution for Injection

fluciclovine (18F)

Read all of this leaflet carefully before you are given 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 nuclear medicine doctor, who is supervising the procedure.
• If you experience side effects, ask your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Axumin and what is it used for
2. What you need to know before using Axumin
3. How to use Axumin
4. Possible side effects
5. Storage of Axumin
6. Package Contents and Further Information

1. What is Axumin and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Axumin contains the active substance fluciclovine (18F) and is administered so that doctors can perform a special type of imaging study called positron emission tomography (PET). If you have been previously treated for prostate cancer and other test information (e.g., prostate-specific antigen, PSA) indicates that the cancer may have returned, a PET study with Axumin may help your doctor locate the areas where the disease has returned.

You should discuss the test results with the doctor who requested the imaging study.

The use of Axumin involves exposure to small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of your exposure to radiation.

2. What you need to know before using Axumin

Axumin must not be used

• if you are allergic to fluciclovine (18F) or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Talk to your nuclear medicine doctor before Axumin is administered to you if you:

• have kidney problems
• are on a low-sodium diet (see the section "Axumin contains sodium").

Before Axumin is administered to you:

• you should avoid physical exercise for at least one day before the imaging study with Axumin;
• you should not eat or drink for at least 4 hours before the study (you can take your regular medications with a small amount of water);
• you may urinate up to 60 minutes before the Axumin injection, and you should avoid urinating until after the imaging study has finished.

Children and Adolescents

Talk to your nuclear medicine doctor if you are under 18 years of age. Axumin is not intended for use in children and adolescents under 18 years of age.

Other Medicines and Axumin

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as they may affect the interpretation of the images.

Pregnancy and Breastfeeding

This medicine is not indicated for use in women.

Driving and Using Machines

It is considered unlikely that Axumin will affect your ability to drive or use machines.

Axumin contains Sodium

This medicine contains up to 39 mg of sodium (a major component of cooking/table salt) per dose. This is equivalent to 2% of the maximum recommended daily sodium intake for an adult.

3. How to use Axumin

There are strict rules for the use, handling, and disposal of radiopharmaceuticals.

Axumin will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this medicine and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Axumin to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount to administer to an adult is 370 MBq (megabecquerel is the unit used to express radioactivity).

Administration of Axumin and Performance of the Procedure

Axumin is administered intravenously in the form of an injection into the vein, followed by a flush with a sodium chloride solution to ensure that you receive the complete dose.

Usually, one injection is sufficient to perform the study that your doctor needs.

Duration of the Procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure. The imaging study will usually start about 5 minutes after the administration of the Axumin injection.

After Axumin Administration

• avoid direct contact with small children and pregnant women for 12 hours after the injection.
• urinate frequently to eliminate the medicine from your body.

Your nuclear medicine doctor will inform you if you need to take any other precautions after receiving the medicine.

Ask your nuclear medicine doctor if you have any questions.

If you are given more Axumin than you should

Overdose is unlikely because you will receive a single dose of Axumin, precisely controlled by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure may provide you with ways to increase urine and feces elimination to facilitate the elimination of radioactivity from your body.

If you have any further questions about the use of Axumin, ask the nuclear medicine doctor supervising the procedure.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical trials, less than 1 in 100 patients who received the medicine reported side effects.

The following side effects of Axumin are common(may affect up to 1 in 100 people).

• Altered taste in the mouth, altered sense of smell, pain or rash at the injection site.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of Side Effects

If you experience side effects, ask your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Axumin

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist.

Axumin should not be used after the expiry date stated on the label of the shield after CAD.

6. Package Contents and Further Information

Composition of Axumin

• The active substance is fluciclovine (18F).

Axumin 1,600 MBq/ml Solution for Injection

Each ml of solution contains 1,600 MBq of fluciclovine (18F) at the date and time of calibration (ToC, time of calibration). The activity range per vial varies from 1,600 MBq to 16,000 MBq at the date and ToC.

Axumin 3,200 MBq/ml Solution for Injection

Each ml of solution contains 3,200 MBq of fluciclovine (18F) at the date and ToC. The activity range per vial varies from 3,200 MBq to 32,000 MBq at the date and ToC.

• The other components are sodium citrate, hydrochloric acid, sodium hydroxide, water for injections (see section 2 "Axumin contains sodium").

Appearance and Package Contents

Axumin is a clear and colorless solution packaged in a 10 ml or 15 ml glass vial.

Axumin 1,600 MBq/ml Solution for Injection

Each multidose vial contains 1 to 10 ml of solution, corresponding to 1,600 to 16,000 MBq at the date and ToC.

Axumin 3,200 MBq/ml Solution for Injection

Each multidose vial contains 1 to 10 ml of solution, corresponding to 3,200 to 32,000 MBq at the date and ToC.

Package size: 1 vial.

Marketing Authorisation Holder

Blue Earth Diagnostics Ireland Ltd, 6th Floor, 2 Grand Canal Square, Dublin 2, Ireland

Manufacturer

Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria.

Norsk medisinsk syklotronsenter AS, 0372 Oslo, Norway.

Advanced Accelerator Applications Molecular Imaging France, S.A.S., 13005 Marseille, France

Nucleis SA, 4000 Liège, Belgium

Advanced Accelerator Applications Molecular Imaging Italy, S.r.l., 47014, Meldola (FC), Italy

Advanced Accelerator Applications Molecular Imaging France, S.A.S., 92210 Saint-Cloud, France

Synektik Pharma Sp. z o.o., 96-320 Mszczonów, Poland

Advanced Accelerator Applications Molecular Imaging Ibérica, S.L.U. 08950, Esplugues de Llobregat, Spain

Date of the Last Revision of this Leaflet:

Other Sources of Information

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

The leaflet for this medicine is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

The Summary of Product Characteristics (SPC) of Axumin is included as a separate document in the medicine package, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. See the SPC. [The SPC should be included in the box]