Axumin Injection

Axumin is 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.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions were reported in =1% of subjects during clinical studies with Axumin.

The most common adverse reactions were

• injection site pain,
• injection site erythema and
• dysgeusia.

Radiation Safety - Drug Handling

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 Axumin.

Recommended Dose and Administration Instructions

The recommended dose is 370 MBq (10 mCi) administered as an intravenous bolus injection.

• Inspect Axumin visually for particulate matter and discoloration before administration. Do not use the drug if the solution contains particulate matter or is discolored.
• Use aseptic technique and radiation shielding when withdrawing and administering Axumin.
• 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 Axumin is 5mL.
• Axumin may be diluted with Sodium Chloride Injection, 0.9%.
• After the Axumin injection, administer an intravenous flush of sterile Sodium Chloride Injection, 0.9% to ensure full delivery of the dose.
• Dispose of any unused drug in a safe manner in compliance with applicable regulations.

Patient Preparation Prior to PET Imaging

• Advise the patient to avoid any significant exercise for at least one day prior to PET imaging.
• Advise patients not to eat or drink for at least 4 hours (other than small amounts of water for taking medications) prior to administration of Axumin.

Image Acquisition Guidelines

• Position the patient supine with arms above the head. Begin PET scanning 3 to 5 minutes after completion of the Axumin injection.
• It is recommended that image acquisition should start from midthigh and proceed to the base of the skull. Typical total scan time is between 20 to 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.
• For small lesions (less than 1cm in diameter) focal uptake greater than blood pool should be considered suspicious for prostate cancer recurrence.
• For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for prostate cancer recurrence.

Radiation Dosimetry

• The radiation absorbed doses estimated for adult patients following intravenous injection of Axumin are shown in Table 1.
• Values were calculated from human biodistribution data using OLINDA/EXM (Organ Level Internal Dose Assessment/Exponential Modeling) software.
• The (radiation absorbed) effective dose resulting from the administration of the recommended activity of 370 MBq of Axumin is 8 mSv.
• For an administered activity of 370 MBq (10 mCi), the highestmagnitude radiation doses are delivered to the pancreas, cardiac wall, and uterine wall: 38 mGy, 19 mGy, and 17 mGy, respectively.
• If a CT scan is simultaneously performed as part of the PET procedure, exposure to ionizing radiation will increase in an amount dependent on the settings used in the CT acquisition.

Table 1: Estimated Radiation Absorbed Doses in Various Organs /Tissues in Adults who Received Axumin

There are no known drug interactions with Axumin injection.

• Axumin is not indicated for use in females and there is no information on the risk of adverse development outcomes in pregnant women or animals with the use of fluciclovine F 18.
• Axumin is not indicated for use in females and there is no information of the presence of fluciclovine F 18 in human milk.