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Axumin is a brand name for Fluciclovine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
A PET scan with fluciclovine (18F) 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 (18F). Posology The recommended activity for an adult is 370 MBq fluciclovine (18F).
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 activity to be administered is required since an increased radiation exposure is possible in these patients.
Paediatric population There is no relevant use of fluciclovine (18F) in the paediatric population. Method of administration Axumin is for intravenous use. The activity of fluciclovine (18F) has to be measured with an activimeter immediately prior to injection.
Axumin should be administered as a bolus intravenous injection. The recommended maximum volume of injection of undiluted Axumin is 5 mL. 9%) solution for injection by a factor of 8. 9%) solution for injection to ensure full delivery of the dose.
Axumin is for multidose use. For instructions on dilution of the medicinal product before administration, see section 12. For patient preparation, see section
Summary of the safety profile Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 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 mediastinal disorders Parosmia General disorders and administration site conditions Injection site reactions 6 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.
4. Image acquisition The patient should be positioned supine with arms above the head. A computed tomography (CT) scan should be obtained for attenuation correction and anatomic correlation. PET scanning should begin from 3-5 minutes (target 4 minutes) after completion of the injection; an acquisition time of 3 minutes per bed position is recommended.
Increasing the duration of acquisition over the pelvis may increase the sensitivity of detection of disease. It is recommended that image acquisition should start from mid- thigh and proceed to the base of the skull. Typical total scan time is between 20-30 minutes.
4 Special warnings and precautions for use 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.
1, Pharmacodynamic properties). Renal impairment Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible. 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
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.
Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, should be considered where appropriate. The use of either intravenous iodinated CT contrast or oral contrast media is not required to interpret fluciclovine (18F) PET images.
The 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. Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
5 After the procedure The patient should be encouraged to drink sufficient amounts and void as often as possible during the first hours after the scan in order to reduce radiation exposure of the bladder. Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
Specific warnings This medicinal product contains up to 39 mg sodium in each injected dose, equivalent to 2% of the WHO recommended maximum daily intake of 2g sodium for an adult.