Floretyrosine f-18

PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older. PIXCLARA is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

Floretyrosine F 18 is a radiolabeled derivative of tyrosine and a substrate for the Large Neutral Amino Acid Transporter 1 and 2 (LAT). LAT is a sodium-independent exchanger protein that transports large neutral amino acids (e.g., tyrosine, phenylalanine) across cell membranes, and it is highly expressed in the blood-brain barrier and glioma tumor tissue. Consequently, floretyrosine F 18 accumulates in cells that express LAT on their surface. Fluorine-18 is a β+ emitting radionuclide that enables positron emission tomography.

Adults: 185 MBq to 259 MBq (5 mCi to 7 mCi) as a bolus intravenous injection. Pediatric Patients 1 Month of Age and Older: 3 MBq/kg actual body weight (0.081 mCi/kg) with a minimum and maximum activity of 14 MBq (0.38 mCi) and 259 MBq (7 mCi), respectively, as a bolus intravenous injection. Fast for at least 4 hours prior to administration. Encourage patients to drink water during the fasting period and after administration, and to void, if possible, immediately prior to imaging and frequently after imaging. Acquire images 20 minutes to 30 minutes after administration for a duration of 20 minutes. See full prescribing information for additional patient preparation, administration, imaging, interpretation, and radiation dosimetry information.

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Risk for Misinterpretation: Image misinterpretation may occur. Interpret findings with caution and correlate with other diagnostic evaluations and clinical history. Radiation Risks: Ensure safe drug handling to protect patients and healthcare providers from unintentional radiation exposure.

The most commonly reported adverse reaction (incidence ≥0.5%) was headache.

Store PIXCLARA at 15°C to 25°C (59°F to 77°F) upright in the original container with radiation shielding.