Axumin · 4.8 Undesirable effects · 1

HOS-097837 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 8.2 mSv when the maximal recommended activity of 370 MBq is administered these adverse reactions are expected to occur with a low probability. Tabulated list of adverse reactions Adverse reactions were reported commonly (≥ 1/100 to < 1/10) during clinical studies. They are listed below by MedDRA body system organ class. MedDRA system organ class Adverse reactions Nervous system disorders Dysgeusia Respiratory thoracic and Parosmia mediastinal disorders General disorders and Injection site reactions administration site conditions 5 Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

HOS-097833 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

HOS-097832 · has-indication-information · PDF-Seite 2

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.

HOS-097835 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. The impact of anti-mitotic agents and colony stimulating factors on uptake of fluciclovine in patients with prostate cancer has not been studied.

HOS-097836 · has-pregnancy-information · PDF-Seite 5

Fluciclovine (18F) is not indicated for use in women. Fertility No studies on fertility have been performed.

HOS-097834 · has-warning-information · PDF-Seite 3

Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information. 3 The PSA value may affect the diagnostic performance of fluciclovine (18F) PET (see section 5.1, Pharmacodynamic properties). Renal impairment Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible. Paediatric population For information on use in the paediatric population, see section 4.2. Patient preparation It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan. Prior to administration of fluciclovine (18F), patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medicinal products). In order to mitigate the quantity and intensity of early excretion into the bladder, which may mask or mimic local prostate cancer recurrence, patients should be informed that they may void at the latest 60 minutes before injection of fluciclovine (18F), and should then refrain from voiding until after the scan has been completed. Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel. PET images with fluciclovine (18F) should be interpreted visually. Suspicion of cancer in sites typical for prostate cancer recurrence 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. The impact of quantitative/semiquantitative measurement of fluciclovine (18F) uptake as an aid to image interpretation has not been assessed. Image interpretation errors can occur with PET with fluciclovine (18F) (see section 5.1). 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 also described in association with an inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy. C

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