Version May 2024
Diagnostic imaging: IV: 296 MBq (8 mCi); after injection, administer an IV NS flush to ensure full delivery of the dose; begin positron emission tomography (PET) scanning 60 minutes after completion of flotufolastat F18 administration.
Imaging prior to initial definitive or suspected recurrence therapy: Lesions should be considered suspicious if uptake is greater than physiologic uptake in that tissue or greater than adjacent background if no physiologic uptake is expected. Tumors not containing prostate-specific membrane antigen will not be visualized; increased uptake in tumors is not specific for prostate cancer.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
<1%:
Cardiovascular: Increased blood pressure
Gastrointestinal: Diarrhea
Local: Pain at injection site
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Malignancy: Patients are exposed to some radiation during treatment; large cumulative amounts of radiation exposure may increase the risk of cancer.
Special handling:
• Radiopharmaceutical: Use appropriate precautions for handling, disposal, and minimizing exposure to patient and health care personnel. Use only under the supervision of individuals with experience/training in the handling of radioactive materials approved by the applicable regulatory authority.
Other warnings/precautions:
• Image misinterpretation in suspected prostate recurrence: Due to the risk of false positive interpretations consider multidisciplinary consultation and histopathological confirmation when clinical decision making relies on flotufolastat F18 uptake only in prostate/prostate bed region or when uptake is interpreted as borderline.
• Risk for misinterpretation and errors: Image interpretation errors may occur with flotufolastat F18 positron emission tomography (PET) imaging. Uptake of flotufolastat F18 is not specific to prostate cancer, and may occur with other types of cancer and nonmalignant processes and in normal tissues. A negative image does not rule out the presence of recurrent prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of flotufolastat F18 for imaging pelvic lymph nodes in patients prior to initial definitive therapy appears to be affected by prostate-specific antigen (PSA) levels and risk grouping. The performance for imaging patients with biochemical evidence of recurrence also appears affected by PSA levels. Clinical correlation, which may include histopathological evaluation, is recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Posluma: 296-5846 MBq/mL (8-158 mCi/mL) (1 ea) [contains alcohol, usp]
No
Solution (Posluma Intravenous)
296-5846 mbq/ml (per each): $5,730.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
IV: Administer as an IV bolus. May administer diluted in NS or undiluted. The maximum volume of undiluted flotufolastat F18 is 5 mL. Immediately prior to administration, measure and verify the radioactivity in the syringe with a dose calibrator to ensure radioactivity administered. After administration, flush with NS to ensure full delivery of the dose. Refer to product labeling for further details.
Patients should void immediately prior to start of imaging. For imaging, position patient supine with arms above head. Begin positron emission tomography (PET) scanning ~60 minutes after completion of flotufolastat F18 administration. Image acquisition should start from midthigh and proceed to the base of the skull. Typical total scan time is ~20 minutes.
Patients should drink a sufficient amount of water to ensure adequate hydration prior to administration and in the first hours following administration; void frequently for the first few hours following administration to reduce radiation exposure.
Radiopharmaceutical; use appropriate precautions for handling and disposal. Waterproof gloves should be worn and effective shielding should be used during handling and administration.
Diagnostic imaging: Use with positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen level.
Flotufolastat F18 may be confused with Florbetaben F18, Florbetapir F18, Flortaucipir F18, Fluciclovine F18, Fludeoxyglucose F18, Fluoroestradiol F18, Flutemetamol F18.
Radiopharmaceutical: Use appropriate precaution for handling, disposal, and minimizing exposure to patient and health care personnel. Use under supervision of experienced personnel. Should be store in original lead container or adequate radiation shield.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Androgen Deprivation Therapy Agents: May diminish the diagnostic effect of Flotufolastat F18. Management: Androgen deprivation therapy (ADT) may result in changes in the uptake of flotufolastat F18 in prostate cancer. The impact of ADT on the performance of flotufolastat F18 is unknown, but use of alternative agents should be considered. Risk D: Consider therapy modification
Antiandrogens: May diminish the diagnostic effect of Flotufolastat F18. Management: Therapies targeting the androgen pathway may result in changes in the uptake of flotufolastat F18 in prostate cancer. The impact of these therapies on the performance of flotufolastat F18 is unknown; consider use of alternative agents. Risk D: Consider therapy modification
Animal reproduction studies have not been conducted.
Flotufolastat F18 is not indicated for use in patients who could become pregnant.
It is not known if flotufolastat F18 is present in breast milk.
Flotufolastat F 18 is a radioactive diagnostic agent. Flotufolastat F18 binds to cells that express prostate-specific membrane antigen, including prostate cancer cells. Tumors that do not express prostate-specific membrane antigen will not be visualized by imaging.
Distribution: Distributes to the liver (15.8%), heart blood pool (7.4%), and kidneys (3.2%).
Metabolism: Does not undergo metabolism up to 50 minutes post injection.
Excretion: Urine (~7% [2 hours post injection]; ~15% [4.5 hours post injection]).
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