Muscle
0.006 0.012 0.005 0.028 0.114 * 0.01 0.002 0.012 0.083 0.012 0.065 * 0.148 * 0.005
Osteogenic cells
Ovaries Pancreas
Parotid glands Red bone marrow
Skin
Small intestine
Spleen
Stomach wall Sublingual glands
Submandibular glands
Testes
Thymus gland
0.01 0.01
Thyroid
Urinary bladder wall
0.006 **
Uterus
0.011
Effective dose (mSv/MBq) 0.014 ** * The absorbed dose value reflects self-irradiation only; no dose contribution from other regions to the glands is added. ** A 1-hour bladder voiding interval is assumed.
3 DOSAGE FORMS AND STRENGTHS Injection: 296 MBq/mL to 5,846 MBq/mL (8 mCi/mL to 158 mCi/mL) as flotufolastat F 18 gallium in approximately 25 mL at end of synthesis supplied as a clear, colorless solution in a multiple-dose vial.
4 CONTRAINDICATIONS None.
5 WARNINGS AND PRECAUTIONS 5.1 Risk of Image Misinterpretation
Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping [See Clinical Studies (14.1)] . The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels [See Clinical Studies (14.2)] . Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region [see Clinical Studies (14.2)]. Because of the associated risk of false positive
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Reference ID: 5180081
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