Axumin

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Fluciclovine (18F)

Available from:

Blue Earth Diagnostics Ireland Ltd

ATC code:

V09IX12

INN (International Name):

fluciclovine (18F)

Therapeutic group:

Diagnostic radiopharmaceuticals

Therapeutic area:

Prostatic Neoplasms; Radionuclide Imaging

Therapeutic indications:

This medicinal product is for diagnostic use only.Axumin is indicated for Positron Emission Tomography (PET) imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2017-05-21

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AXUMIN 1,600 MBQ/ML SOLUTION FOR INJECTION
AXUMIN 3,200 MBQ/ML SOLUTION FOR INJECTION
fluciclovine (
18
F)
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 will supervise the
procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Axumin is and what it is used for
2.
What you need to know before you use 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 medicine is a radiopharmaceutical product for diagnostic use
only.
Axumin contains the active substance fluciclovine (
18
F) and is given so that doctors can perform a
special type of scan called a positron emission tomography (PET) scan.
If you have previously had
treatment for prostate cancer and information from other tests (e.g.
prostate specific antigen, PSA)
indicates that the cancer may have returned, an Axumin PET scan can
help your doctor find the
locations where the cancer has come back.
You should discuss the results of the test with the doctor that
requested the scan.
The use of Axumin does involve exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the benefit of this
procedure with the
radiopharmaceutical outweighs the risk of being exposed to radiation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AXUMIN
_ _
AXUMIN MUST NOT BE USED
-
if you are allergic to fluciclovine (
18
F) or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your nuclear medicine doctor before you are given Axumin if
you:
-
have
KIDNEY PROBLEMS
-
are on a
LOW SO

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Axumin 1,600 MBq/mL solution for injection
Axumin 3,200 MBq/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Axumin 1,600 MBq/mL solution for injection
Each mL of solution contains 1,600
MBq of fluciclovine (
18
F) at the date and time of calibration
(ToC).
The activity per vial ranges 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 (
18
F) at the date and ToC.
The activity per vial ranges from 3,200 MBq to 32,000 MBq at the date
and ToC.
Fluorine (
18
F) decays to stable oxygen (
18
O) with a half-life of 110 minutes by emitting a positronic
radiation of maximum energy of 634 keV, followed by photonic
annihilation radiations of 511 keV.
Excipients with known effect
Each mL of solution contains 7.7 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Axumin is indicated for positron emission tomography (PET) imaging to
detect recurrence of prostate
cancer in adult men with a suspected recurrence based on elevated
blood prostate specific antigen
(PSA) levels after primary curative treatment.
For the limitations in the interpretation of a positive scan, see
section 4.4 and 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A PET scan with fluciclovine (
18
F) should be administered by appropriately qualified healthcare
professionals.
3
Images should only be interpreted by readers trained in the
interpretation of PET images with
fluciclovine (
18
F).
Posology
The recommended activity for an adult is 370 MBq fluciclovine (
18
F).
_ _
_Special populations _
_ _
_Elderly _
No dose adjustment required.
_Renal and hepatic impairment _
Axumin has not been studied in patients with renal or hepatic
impairment.
Careful consideration of the activi