Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
12. Axumin Fluciclovine F-18 5/27/2016 A new diagnostic imaging agent
to detect recurrent prostrate
cancer Press Release Drug trials Snapshot
Approved by FDA on 5/27/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
AXUMIN safely and effectively. See full prescribing information for AXUMIN.
AXUMIN (fluciclovine F 18) injection, for intravenous use
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
Axumin is a radioactive diagnostic agent indicated for positron emission
tomography (PET) imaging in men with suspected prostate cancer
recurrence based on elevated blood prostate specific antigen (PSA)
levels following prior treatment
Adverse Reaction:
ADVERSE REACTIONS
Most commonly reported adverse reactions are injection site pain,
erythema,and dysgeusia .
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Image interpretation errors can occur with Axumin imaging .
Radiation risk: Axumin contributes to a patients long-term
cumulative radiation exposure.
Ensure safe handling to protect patients and health care
workers from unintentional radiation exposure.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
Axumin is a radioactive diagnostic agent indicated for positron emission
tomography (PET) imaging in men with suspected prostate cancer
recurrence based on elevated blood prostate specific antigen (PSA)
levels following prior treatment
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety handling measures .
Aseptically withdraw Axumin from its container and administer
370 MBq (10 mCi) as a bolus intravenous injection. .
Initiate imaging 3-5 minutes after administration.
Scanning should start from mid-thigh and proceed to base of skull,
with a total scan time of approximately 20-30 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
DOSAGE FORMS AND STRENGTHS
Injection: clear, colorless solution in a 30 mL
multiple-dose vial containing 335-8200 MBq/mL (9-221 mCi/mL)
fluciclovine F 18 at calibration time and date
OVERDOSAGE
In case of overdose of Axumin, encourage patients to maintain hydration
and to void frequently to minimize radiation exposure.
Patient Information:
PATIENT COUNSELING INFORMATION
Instruct patients to avoid significant exercise for at least a day before the
PET scan.
Instruct patients not to eat or drink for at least 4 hours before the PET scan
(other than small amounts of water for taking medications).
Marketed by Blue Earth Diagnostics Ltd.
Oxford, UK OX4 4GA
AxuminTM is a trademark of Blue Earth Diagnostics Ltd.
© 2016 Blue Earth Diagnostics Ltd
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of action
Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell
membranes by amino acid transporters, such as LAT-1 and ASCT2, which are
upregulated in prostate cancer cells. Fluciclovine F 18 is taken up to a greater
extent in prostate cancer cells compared with surrounding normal tissues.
2 Pharmacokinetics
Distribution
Following intravenous administration, fluciclovine F 18 distributes to the liver
(14% of administered activity), pancreas (3%), lung (7%), red bone marrow (12%)
and myocardium (4%). With increasing time, fluciclovine F 18 distributes
to skeletal muscle.
Excretion
Across the first four hours post-injection, 3% of administered radioactivity was
excreted in the urine.
Across the first 24 hours post-injection, 5% of administered
radioactivity was excreted in the urine.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
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.
2. Lactation
Risk Summary
Axumin is not indicated for use in females and there is no information
of the presence of fluciclovine F 18 in human milk.
3. Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
4. Geriatric Use
Of the total number of patients in clinical studies of Axumin, the average
age was 66 years with a range of 21 to 90 years. No overall differences
in safety or effectiveness were observed between older subjects
and younger subjects.
5. OVERDOSAGE
In case of overdose of Axumin, encourage patients to maintain hydration
and to void frequently to minimize radiation exposure.
Manufacturer Details