Dosing & Uses
Dosage Forms & Strengths
injectable solution
- 335-8200 MBq/mL (9-221 mCi/mL) in 30 mL multidose vials at calibration time and date
Prostate Cancer Imaging
Indicated for positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment
370 MBq (10 mCi) IV bolus (see Administration)
Safety and efficacy not established
Adverse Effects
<1%
Injection site pain
Injection site erythema
Dysgeusia
Warnings
Contraindications
None
Cautions
Hypersensitivity reactions, including anaphylaxis, may occur; emergency resuscitation equipment and personnel should be immediately available
Radiation risk: Use contributes to a patient’s overall long-term cumulative radiation exposure; long-term cumulative radiation exposure is associated with an increased risk for cancer; ensure safe handling to minimize radiation exposure to the patient and healthcare providers
Misinterpretation
- Image interpretation errors can occur with fluciclovine F 18 PET imaging; a negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of recurrent prostate cancer
- Performance of fluciclovine F 18 seems to be affected by PSA levels
- Not specific for prostate cancer and may occur with other types of cancer and benign prostatic hypertrophy in primary prostate cancer
- Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended
Pregnancy & Lactation
Pregnancy
Not indicated in females and there is not information on development outcomes in pregnant women or animals
Lactation
Not indicated for use in females and there is no information on the presence in human milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Synthetic amino acid that is labeled with the radioisotope F 18 for PET imaging
It is preferentially taken up by prostate cancer cells by transporters (eg, LAT-1, ASCT2), which are up-regulated in prostate cancer cells compared with surrounding normal tissues
Distribution
Liver 14%
Bone marrow (12%)
Lung 7%
Myocardium 4%
Pancreas 3%
With increasing time, fluciclovine F 18 distributes to skeletal muscle
Elimination
First 4 hr post injection: 3% excreted in urine
First 24 hr post injection: 5% excreted in urine
Administration
Patient Preparation
Avoid any significant exercise for at least 1 day before PET imaging
Advise patients not to eat or drink for at least 4 hr (other than small amounts of water for taking medications) prior to administration
IV Preparation
Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration
Use waterproof gloves and effective shielding, including syringe shields, when handling and administering
Inspect solution visually for particulate matter and discoloration before administration; do not use if the solution contains particulate matter or is discolored
Use aseptic technique and radiation shielding when withdrawing and administering
Calculate the necessary volume to administer based on calibration time and date, using a suitably calibrated instrument
The recommended maximum volume of injection of undiluted drug is 5 mL; may be diluted with NaCl 0.9%
IV Administration
After IV bolus injection, administer IV flush of sterile NaCl 0.9% to ensure full delivery of the dose
Dispose of any unused drug in a safe manner in compliance with applicable regulations
Image acquisition guidelines
- Position the patient supine with arms above the head
- Begin PET scanning 3-5 minutes after completion of the injection
- It is recommended that image acquisition should start from midthigh and proceed to the base of the skull
- Typical total scan time is 20-30 minutes
Image Display and Interpretation
Localization of prostate cancer recurrence in sites typical for prostate cancer recurrence is based on fluciclovine F 18 uptake in comparison with tissue background
Small lesions (<1cm in diameter): Focal uptake greater than blood pool should be considered suspicious for prostate cancer recurrence
Larger lesions: Uptake equal to or greater than bone marrow is considered suspicious for prostate cancer recurrence
Radiation dosimetry: See prescribing information
Storage
Store at controlled room temperature of 20-25°C (68-77°F)
Does not contain a preservative
Store within the original container in radiation shielding
Approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State
Images
Formulary
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