Print Page     Close Window     

SEC Filings

6-K
ADVANCED ACCELERATOR APPLICATIONS S.A. filed this Form 6-K on 05/30/2017
Entire Document
 
 

ABBREVIATED PRESCRIBING INFORMATION FOR AXUMIN IN EUROPE

 

BT_1000x858pxAxumin 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.

 

POM

 

Date of Preparation: May 2017

 

 


© -20 Advanced Accelerator Applications - All rights reserved .