Axumin

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.

• Use appropriate radiation safety handling measures (
  
  
  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

  ]. Use waterproof gloves and effective shielding, including syringe shields, when handling and administering Axumin.
  ).
  
• Aseptically withdraw Axumin from its container and administer 370 MBq (10 mCi) as a bolus intravenous injection. (
  
  
  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 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.
  ).
  
• Initiate imaging 3 minutes to 5 minutes after administration. Scanning should start from mid-thigh and proceed to base of skull, with a total scan time of approximately 20 minutes to 30 minutes (
  
  
  2.4 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.
  ).
  
• The (radiation absorbed) effective dose associated with 370 MBq (10 mCi) of injected activity of Axumin is approximately 8 mSv (0.8 rem) in an adult (
  
  
  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

  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)
  ).
  

Injection: supplied as a clear, colorless solution in a 30 mL or 50 mL multiple-dose vial containing 335 MBq/mL to 8,200 MBq/mL (9 mCi/mL to 221 mCi/mL) fluciclovine F 18 at calibration time and date.

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.

• Image interpretation errors can occur with Axumin imaging (
  
  
  5.1 Risk for Image Misinterpretation

  Image interpretation errors can occur with Axumin 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 Axumin seems to be affected by PSA levels

  [See Clinical Studies ]

  . Fluciclovine F 18 uptake is 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.
  ).
  
• Radiation risk: Axumin contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure (
  
  
  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

  ]. Use waterproof gloves and effective shielding, including syringe shields, when handling and administering Axumin.
  ,
  
  
  5.3 Radiation Risks

  Axumin 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 health care providers

  [see Dosage and Administration ]

  .
  ).