Axumin 221 mCi/mL
Fluciclovine F-18 · INJECTION, SOLUTION · Blue Earth Diagnostics
Axumin is a injection, solution containing fluciclovine f-18 at 221 mCi/mL, taken intravenous. Manufactured by Blue Earth Diagnostics.
Key Facts
- Brand Name
- Axumin
- Generic Name
- Fluciclovine F-18
- NDC Code (Product)
69932-001- Manufacturer
- Blue Earth Diagnostics
- Strength
- 221 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA208054
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 05/27/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. 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 & Administration
2 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 ). 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 ( 5.3 ) ]. Use waterproof gloves and effective shielding, including syringe shields, when handling and administering Axumin. 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 …
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Adverse Reactions
6 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 or www.fda.gov/medwatch . Clinical Trials Experience 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 MBq 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.
Frequently Asked Questions
What is Axumin used for?
Axumin contains Fluciclovine F-18. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Axumin a controlled substance?
Axumin is not classified as a controlled substance by the DEA.
What is the generic name for Axumin?
The generic name for Axumin is Fluciclovine F-18. There are no other listed brand versions of Fluciclovine F-18.
What is the NDC code for Axumin 221 mCi/mL?
The NDC (National Drug Code) for Axumin 221 mCi/mL is 69932-001, listed by Blue Earth Diagnostics.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)