fluciclovine F 18 (Rx)

<1%

Injection site pain

Injection site erythema

Dysgeusia

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

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.

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

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