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What is Axumin, and how does it work?
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.
What are the side effects of Axumin?
- 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.
- The clinical trial database for Axumin includes data from 877 subjects including 797 males diagnosed with prostate cancer.
- Most patients received a single administration of Axumin, a small number of subjects (n = 50) received up to five administrations of the drug.
- The mean administered activity was 370 MBq (range, 163 to 485 MBq).
- 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.
What is the dosage for Axumin?
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
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)
What drugs interact with Axumin?
- No Information Provided
Is Axumin safe to use while pregnant or breastfeeding?
- 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.