Fluciclovine F-18 (Axumin)

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Trade Name: Axumin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Blue Earth Diagnostics

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 221 mCi/mL

Storage and handling

FLUCICLOVINE F-18 Radioactive Diagnostic Agent [EPC],Positron Emitting Activity [MoA]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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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 ().

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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 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 to 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 ().

Injection: supplied as a clear, colorless solution in a 30 mL multiple-dose vial containing 335 MBq/mL to 8200 MBq/mL (9 mCi/mL to 221 mCi/mL) fluciclovine F 18 at calibration time andndate.
Injection: clear, colorless solution in a 30 mL multiple-dose vial containing 335 MBq/mL to 8200 MBq/mL (9 mCi/mL to 221 mCi/mL)nfluciclovine F 18 at calibration time and date ().

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Image interpretation errors can occur with Axumin imaging ().
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 (, ).

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 u22641% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
Most commonly reported adverse reactions are injection site pain, erythema, and dysgeusia ().
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.

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In case of overdose of Axumin, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.

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The safety and efficacy of Axumin were evaluated in two studies (Study 1 and Study 2) in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy.
Study 1 evaluated 105 Axumin scans in comparison to histopathology obtained by biopsy of the prostate bed and biopsies of lesions suspicious by imaging. PET/CT imaging generally included the abdomen and pelvic regions. The Axumin images were originally read by on-site readers. The images were subsequently read by three blinded independent readers. Table 4 shows the performance of Axumin in the detection of recurrence in each patient scan and, specifically, within the prostatic bed and extra-prostatic regions, respectively. The results of the independent read were generally consistent with one another and confirmed the results of the on-site reads.
The detection rate of Axumin seems to be affected by PSA levels . In general, patients with negative scans had lower PSA values than those with positive scans. The detection rate (number with positive scans/total scanned) for patients with a PSA value of less than or equal to 1.78 ng/mL (1st PSA quartile) was 15/25, of which 11 were histologically confirmed as positive. In the remaining three PSA quartiles, the detection rate was 71/74, of which 58 were histologically confirmed. Among the 25 patients in the first PSA quartile, there were 4 false positive scans and 1 false negative scan. For the 74 patients with PSA levels greater than1.78 ng/mL, there were 13 false positive scans and no false negative scans.
Study 2 evaluated the concordance between 96 Axumin and C11 choline scans in patients with median PSA value of 1.44 ng/mL (interquartile range = 0.78 ng/mL to 2.8 ng/mL). The C 11 choline scans were read by on-site readers. The Axumin scans were read by the same three blinded independent readers used for Study 1. The agreement values between the Axumin and C11 choline reads were 61%, 67% and 77%, respectively.

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Marketed by Blue Earth Diagnostics Ltd. Oxford, UK OX4 4GAAxumin is a trademark of Blue Earth Diagnostics Ltd.u00a9 2016 Blue Earth Diagnostics Ltd u2013 all rights reserved.

Principal Display Panel - 30 mL Multiple-Dose Vial Label
Sterile
Axuminu2122
Non-pyrogenic
335 MBq/mL to 8,200 MBq/mL (9 mCi/mL to221 mCi/mL) at End of Synthesis (EOS)
Diagnostic - For Intravenous Use Only
Expires 10 hours after EOS
Batch #: ________________________________n
EOS Date: __________ EOS Time: __________n
Activity @ EOS: ___________________ mCin
Concentration: ___________________ mCi/mLn
Volume: ___________________ mLn
Exp. Date: __________ Exp. Time: __________n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Fluciclovine F-18 (Axumin) which is also known as Axumin and Manufactured by Blue Earth Diagnostics. It is available in strength of 221 mCi/mL.

Fluciclovine F-18 (Axumin) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.