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Axumin Dosage

Generic name: FLUCICLOVINE F-18 221mCi in 1mL
Dosage form: injection, solution
Drug class: Diagnostic radiopharmaceuticals

Medically reviewed by Last updated on Jul 31, 2023.

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.

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 0.9% Sodium Chloride Injection, USP.
  • After the Axumin injection, administer an intravenous flush of sterile 0.9% Sodium Chloride Injection, USP 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 sips of water for taking medications) prior to administration of Axumin.
  • Advise patients to void approximately 30 minutes to 60 minutes prior to administration of Axumin and then refrain from voiding until after the scan has been completed

Image Acquisition Guidelines

Position the patient supine with arms above the head. Begin PET scanning 3 minutes 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 minutes 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 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
Organ/Tissue Mean Absorbed Dose per Unit Administered Activity (microGy/MBq)
Adrenal glands 16
Brain 9
Breasts 14
Gallbladder wall 17
Lower large intestine wall 12
Small intestine wall 13
Stomach wall 14
Upper large intestine wall 13
Heart wall 52
Kidneys 14
Liver 33
Lungs 34
Muscle 11
Ovaries 13
Pancreas 102
Red bone marrow 25
Osteogenic cells 23
Skin 8
Spleen 24
Testes 17
Thymus gland 12
Thyroid 10
Urinary bladder wall 25
Uterus 45
Total body 13
Effective dose 22 (microSv/MBq)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.