ABBREVIATED PRESCRIBING INFORMATION FOR AXUMIN IN EUROPE
1600 MBq/ml solution for injection/ Axumin 3200 MBq/ml solution for injection (fluciclovine, 18F)
Indication: 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.
Dosage: 370 MBq fluciclovine (18F)
Method of use: Diagnostic use only. I.V. administration.
Refer to SmPC for dilution instructions prior to dosing and information on image acquisition.
Contraindications: Patients with hypersensitivity
to active substance or excipients.
Common Adverse Reactions (reported in ≥ 1/100
to < 1/10 patients): Injection site reactions, dysgeusia and paraosmia.
Special Warnings and Precautions: Individual
benefit/risk justification: Radiation exposure of patient must be justifiable by likely benefit. Consider possible increased
radiation exposure risk in patients with renal impairment. PSA value may affect the diagnostic performance.
Patient preparation: Patients should avoid exercise for
at least a day before and not eat or drink for at least 4 hours prior to administration. Afterwards, encourage patients to drink
water and void as often as possible during first hours to reduce radiation exposure of the bladder. Restrict close contact with
infants and pregnant women for 12 hours after administration.
Interpretation of fluciclovine (18F) images and
limitations of use: Images should be interpreted visually by appropriately trained personnel. Suspicion of cancer is based
on fluciclovine (18F) uptake in comparison with tissue background. For small lesions (<1 cm diameter) focal uptake greater than
blood pool should be considered suspicious for cancer. For larger lesions, uptake equal to or greater than bone marrow is considered
suspicious for cancer. Image interpretation errors can occur; fluciclovine (18F) uptake is not specific for prostate
cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia. False-positive cases have been described
with inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy. Clinical
correlation, which may include histopathological evaluation, should be considered where appropriate. Iodinated CT contrast or oral
contrast media is not required to interpret images. Detection of prostate cancer recurrence in prostate/prostate bed, regional
lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported.
Specific warnings: Contains up to 39 mg sodium per dose;
to be taken into consideration by patients on a controlled sodium diet. Not indicated for use in women or children.
MA Number: EU/1/17/1186/001-002
MA Holder: Blue Earth Diagnostics Ltd, 215 Euston
Road, London, NW1 2BE UK.
Date of Preparation: May 2017