AXUMIN- fluciclovine f-18 injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

FLUCICLOVINE F-18 (UNII: 38R1Q0L1ZE) (FLUCICLOVINE F-18 - UNII:38R1Q0L1ZE)

Dostopno od:

Blue Earth Diagnostics

INN (mednarodno ime):

Fluciclovine F-18

Sestava:

Fluciclovine F-18 221 mCi in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. None 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. 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. Safety and effectiveness have not been established in pediatric patients. 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.

Povzetek izdelek:

Axumin is supplied as a clear, colorless injection in a 30 mL or 50 mL multiple-dose glass vial containing approximately 26 mL solution of 335 MBq/mL to 8,200 MBq/mL (9 mCi/mL to 221 mCi/mL) fluciclovine F 18 at calibration time and date. 30 mL sterile multiple-dose vial: NDC 69932-001-30 50 mL sterile multiple-dose vial: NDC 69932-001-50 Store Axumin at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Axumin does not contain a preservative. Store Axumin within the original container in radiation shielding. Do not use Axumin more than 10 hours after end of synthesis and dispose of in accordance with institutional guidelines. This preparation is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State.

Status dovoljenje:

New Drug Application

Lastnosti izdelka

AXUMIN- FLUCICLOVINE F-18 INJECTION, SOLUTION
BLUE EARTH DIAGNOSTICS
----------
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 ( 1).
DOSAGE AND ADMINISTRATION
Use appropriate radiation safety handling measures ( 2.1).
Aseptically withdraw Axumin from its container and administer 370 MBq
(10 mCi) as a bolus
intravenous injection. ( 2.2).
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).
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).
DOSAGE FORMS AND STRENGTHS
Injection: 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 ( 3).
CONTRAINDICATIONS
None ( 4)
WARNINGS AND PRECAUTIONS
Image interpretation errors can occur with Axumin imaging ( 5.1).
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, 5.3).
ADVERSE REACTIONS
Most commonly reported adverse reactions are injection site pain,
erythema, and dysgeusia ( 6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BLUE EARTH DIAGNOSTICS,
LTD AT 1-855-
AXUMIN1 (1-855-298-6461) OR FDA AT 1-800-FDA-1088
ORwww.fda.gov/medwatch.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7