Version May 2024
Diagnostic imaging: IV: 370 MBq (10 mCi); begin PET scanning 3 to 5 minutes after completion of fluciclovine F 18 administration.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
1% to 10%:
Gastrointestinal: Dysgeusia (≤1%)
Local: Erythema at injection site (≤1%), pain at injection site (≤1%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions including anaphylaxis may occur in patients who receive fluciclovine F 18. Emergency resuscitation equipment and personnel should be immediately available.
• Radiation accumulation: Fluciclovine F 18 administration contributes to the 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 health care providers. If a CT scan is performed simultaneously as part of the PET procedure, exposure to ionizing radiation will increase in an amount dependent on the CT settings.
Special Handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use only under supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Imaging interpretation: Localization of prostate cancer recurrence is based on fluciclovine F 18 uptake compared to tissue background. For small lesions (diameter <1 cm), focal update greater than blood pool is considered suspicious for prostate cancer. For larger lesions, uptake equal to or greater than bone marrow is considered suspicious.
• Risk for misinterpretation: Image interpretation errors may 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. The performance of fluciclovine F 18 appears to be affected by PSA levels. Fluciclovine F 18 uptake is not specific for prostate cancer and may occur with other types of cancer and/or with benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Axumin: 335-8200 MBq/mL (9-221 mCi/mL) (1 ea)
No
Solution (Axumin Intravenous)
9-221 mci/mL (per each): $5,760.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as an intravenous bolus. May administer diluted (in NS) or undiluted. The maximum volume of undiluted fluciclovine F 18 is 5 mL. After administration, flush with NS to ensure full delivery of the dose.
For imaging, position patient supine with arms above head. Begin PET scanning 3 to 5 minutes after completion of fluciclovine F 18 administration. Image acquisition should start from mid-thigh and proceed to the base of the skull. Typical total scan time is 20 to 30 minutes.
Patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medications) prior to administration. Advise the patient to avoid any significant exercise for at least 1 day prior to PET imaging. Instruct patients to void ~30 to 60 minutes prior to administration and refrain from voiding until scan is complete.
Radiopharmaceutical; use appropriate precautions for handling and disposal. When handling and administering, follow appropriate safety measures to minimize radiation exposure during administration; use waterproof gloves and effective shielding, including syringe shields.
Diagnostic imaging: Positron emission tomography (PET) in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment
Fluciclovine F18 may be confused with florbetaben F18, florbetapir F18, fludeoxyglucose f18, flutemetamol F 18
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patients and healthcare personnel. Use under supervision of experienced personnel. Should be stored in original lead container or adequate radiation shield.
None known.
There are no known significant interactions.
Fluciclovine F 18 is not indicated for use in women; animal reproduction studies were not conducted.
Fluciclovine F 18 is not indicated for use in women; it is not known if fluciclovine F 18 is excreted in breast milk.
Monitor for signs/symptoms of hypersensitivity.
Fluciclovine F 18 is a radioactive diagnostic agent; localization of prostate cancer recurrence is based on fluciclovine F 18 uptake in prostate cancer cells in comparison to surrounding background tissue.
Onset: Tumor-to-normal tissue contrast is highest 4 to 10 minutes following administration.
Duration: Imaging: A 61% reduction in mean tumor uptake occurs at 90 minutes following administration.
Distribution: 14% of the total dose distributed to the liver, 12% to red bone marrow, 7% to lung, 4% to myocardium, 3% to pancreas; with increasing time, fluciclovine F 18 distributes to skeletal muscle. The highest magnitude radiation doses are delivered to the pancreas, cardiac wall, and uterine wall.
Half-life, elimination: Physical half-life: 109.7 minutes
Excretion: Urine (3% [4 hours post-injection]; 5% [24 hours post-injection])
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