Fluciclovine f-18

FDA label, Blue Earth Diagnostics, intravenous, effective 2025-03-05. Full label on DailyMed

Patient handout

Looking up MedlinePlus…

From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Radioactive Diagnostic Agent

Dosing in kidney impairment

Table 1: Estimated Radiation Absorbed Doses in Various Organs/Tissues in Adults who Received Axumin
Organ/TissueMean Absorbed Dose per Unit Administered Activity (microGy/MBq)
Adrenal glands16
Brain9
Breasts14
Gallbladder wall17
Lower large intestine wall12
Small intestine wall13
Stomach wall14
Upper large intestine wall13
Heart wall52
Kidneys14
Liver33
Lungs34
Muscle11
Ovaries13
Pancreas102
Red bone marrow25
Osteogenic cells23
Skin8
Spleen24
Testes17
Thymus gland12
Thyroid10
Urinary bladder wall25
Uterus45
Total body13
Effective dose22 (microSv/MBq)

Preparation and administration

Prepare this dose

Your numbers for fluciclovine f-18. Take vial strength, diluent, and limits from the label below.

Basis

Enter a dose to see draw volume, final concentration, and rates.

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

Contraindications

None None ( 4 )

Safety data

Reported adverse events (FAERS)

Loading
Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for fluciclovine f-18. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary 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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Drug shortage status

Loading

Recalls (last 24 months)

Loading

Therapeutic equivalence (Orange Book)

Loading

Price ladder

Not the price at the counter
Loading

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

Loading

Recruiting clinical trials

Loading