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Rx Item-AXUMIN- fluciclovine f-18 injection, solution

RX69932-001-30 Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Rx Item-AXUMIN- fluciclovine f-18 injection, solution

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NDC No. 69932-0001-30 69932-001-30 69932000130 6993200130 UPC/GTIN No.3-69932-00130-2 369932-001302 369932001302 MPN No 000130. Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, & Pharmacist, PA, Physical Therapist, Podiatrist, Research Co., Uni., VA, Vet & Wholesalers In Scope Of their Practice Can Order Rx Item.

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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 3-5 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 (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 multiple-dose vial containing 335-8200 MBq/mL (9-221 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).

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.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2016

RX69932-001-30
Rx Item-AXUMIN- fluciclovine f-18 inject
RX69932-001-30

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
Rx Item-AXUMIN- fluciclovine f-18 inject
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
AmericanPharmaWholesale.com
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop