Axumin

Package leaflet: Information for the patient

Axumin 1.600 MBq/mL injectable solution, 3.200 MBq/mL injectable solution

fluciclovine ( F)
Please read this leaflet carefully before receiving this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

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

1. What Axumin is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Axumin contains the active substance fluciclovine (F) and is administered to allow the physician to perform a special imaging procedure called positron emission tomography (PET) scan. If you have previously undergone treatment for prostate cancer and results from other tests (e.g., prostate-specific antigen, PSA) suggest a possible recurrence of cancer, a PET scan with Axumin can help your doctor locate sites where the cancer has returned.

You should discuss the results of this examination with the doctor who requested it.
Use of Axumin involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine physician have determined that the benefit of this procedure with the radiopharmaceutical outweighs the risks associated with radiation exposure.

2. What you should know before using Axumin

Axumin must not be used

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

Warnings and precautions
Talk to your nuclear medicine physician before being administered Axumin if:

• you have kidney problems
• you are on a low-sodium diet (see section “Axumin contains sodium”)

Before administration of Axumin, you must:

• avoid physical exercise for at least one day before the Axumin scan
• refrain from eating and drinking for at least 4 hours before the scan (except for small amounts of water to take medications)
• urinate no later than 60 minutes before the Axumin injection and avoid urinating again until after the scan has been completed.

Children and adolescents
Please consult your nuclear medicine physician if you are under 18 years of age. The use of Axumin is not intended in children and adolescents under 18 years of age.
Other medicines and Axumin
Inform your nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of the images.
Pregnancy and breastfeeding
This medicinal product is not indicated for use in women.
Driving and using machines
It is unlikely that Axumin will affect your ability to drive or operate machinery.
Axumin contains sodium
This medicinal product contains up to 39 mg of sodium (a main component of table salt) per dose. This corresponds to 2% of the maximum daily recommended intake of sodium for an adult.

3. How to use Axumin

Radiopharmaceuticals are subject to strict regulations governing their use, handling, and disposal.
Axumin will be used only in areas under special control. This medicine will be handled and administered only by trained and qualified personnel who are experienced in its safe use. These professionals will take particular care to ensure its safe use and will provide you with explanations during administration.
The nuclear medicine physician supervising the procedure will determine the amount of Axumin to be used in your case. The smallest possible amount needed to obtain the required information will be used. The generally recommended administered dose for an adult is 370 MBq (the megabecquerel is the unit used to express radioactivity).

Administration of Axumin and performance of the procedure
Axumin is administered intravenously, i.e. by injection into a vein, followed by a flush with sodium chloride solution to ensure that you receive the complete dose.
Generally, a single injection is sufficient to perform the examination required by the physician.

Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure. Scanning typically begins approximately 5 minutes after the injection of Axumin.

After receiving Axumin, you must:

• avoid any close contact with young children and pregnant women during the 12 hours following injection
• empty your bladder frequently to help eliminate the product from your body.

The nuclear medicine physician will inform you if any additional special precautions are necessary after you have received this medicine. If you have any doubts, please consult your nuclear medicine physician.

If you have been given more Axumin than you should have
Cases of overdose are unlikely because you will receive only a single dose of Axumin carefully controlled by the nuclear medicine physician supervising the procedure.
However, in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine physician in charge of the procedure may instruct you to empty your bladder and bowel more frequently to facilitate the elimination of radioactivity from your body.
If you have any questions about the use of Axumin, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody experiences
them. In clinical studies, adverse reactions were reported in fewer than 1 in
100 patients who received the medicine.
The following side effects of Axumin are classified as uncommon (may affect up to
1 in 100 people):

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

This radiopharmaceutical emits low amounts of ionizing radiation associated with a minimal risk of
cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your nuclear
medicine physician. You may also report side effects directly through the national reporting system
listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Axumin

You will not have to store this medicine. The medicine is stored under the responsibility of a specialist in appropriate locations. Radiopharmaceuticals must be stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for the specialist.
This medicine must not be used after the expiry date stated on the label of the shielded container after Exp.

6. Package contents and other information

What Axumin contains

• The active substance is fluciclovine (F). Axumin 1,600 MBq/mL injectable solution: Each mL of solution contains 1,600 MBq of fluciclovine (F) at the date and time of calibration (ToC, time of calibration). The activity per vial ranges from 1,600 MBq to 16,000 MBq at the date and ToC. Axumin 3,200 MBq/mL injectable solution: Each mL of solution contains 3,200 MBq of fluciclovine (F) at the date and ToC. The activity per vial ranges from 3,200 MBq to 32,000 MBq at the date and ToC.
• The other components are sodium citrate, concentrated hydrochloric acid, sodium hydroxide and water for injections (see section 2 “Axumin contains sodium”).

Description of the appearance of Axumin and contents of the pack
Axumin is a clear, colourless solution stored in a 10 mL or 15 mL glass vial.
Axumin 1,600 MBq/mL injectable solution
Each multidose vial contains 1–10 mL of solution, corresponding to 1,600–16,000 MBq at the date and ToC.
Axumin 3,200 MBq/mL injectable solution
Each multidose vial contains 1–10 mL of solution, corresponding to 3,200–32,000 MBq at the date and ToC.
Pack: 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.
Nucleis SA, 4000 Liège, Belgium.
Advanced Accelerator Applications Molecular Imaging Italy S.r.l., 47014 Meldola (FC), Italy.
Synektik Pharma Sp. z o.o., 96-320 Mszczonów, Poland.
Pharmazac S.A., 351 50 Lamia, Greece.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

The following information is intended exclusively for healthcare professionals:

The full SmPC of Axumin is provided as a separate document within the medicinal product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC [the SmPC must be inserted in the box].