AXUMIN Solution for injection Ref.[10080] Active ingredients: Fluciclovine ¹⁸F

2.1 Radiation Safety – Drug Handling

Axumin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.3)]. Use waterproof gloves and effective shielding, including syringe shields, when handling and administering Axumin.

2.2 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.

2.3 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.

2.4 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 mid-thigh and proceed to the base of the skull. Typical total scan time is between 20 to 30 minutes.

2.5 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.

2.6 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 highest-magnitude 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:

In case of overdose of Axumin, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.

Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Axumin does not contain a preservative. Store Axumin within the original container in radiation shielding.

This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.