flotufolastat F 18 (Rx)

Brand and Other Names:Posluma

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, solution

  • 296-5,846 MBq/mL (8-158 mCi/mL) in ~25 mL multidose vials at calibration time and date

Prostate Cancer Imaging

Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Recommended dose: 296 MBq (8 mCi) IV bolus (see Administration)

Safety and efficacy not established

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Interactions

Interaction Checker

and flotufolastat F 18

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    Contraindicated

      Serious - Use Alternative

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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (6)

                • abiraterone

                  abiraterone, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                • bicalutamide

                  bicalutamide, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                • degarelix

                  degarelix, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                • enzalutamide

                  enzalutamide, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                • flutamide

                  flutamide, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                • nilutamide

                  nilutamide, flotufolastat F 18. Other (see comment). Use Caution/Monitor. Comment: Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer. Effects of these therapies on performance of flotufolastat F 18 PET has not been established.

                Minor (0)

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                  Adverse Effects

                  <1%

                  Diarrhea (0.7%)

                  Increased blood pressure (0.5%)

                  Injection site pain (0.4%)

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                  Warnings

                  Contraindications

                  None

                  Cautions

                  Misinterpretation

                  • Image interpretation errors can occur with flotufolastat F 18 PET imaging
                  • A negative image does not rule out presence of recurrent prostate cancer, and a positive image does not confirm presence of recurrent prostate cancer
                  • Performance of flotufolastat F 18 for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by PSA levels and risk grouping
                  • Not specific for prostate cancer and may occur with other types of cancer, in nonmalignant processes, and in normal tissue
                  • Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, is recommended
                  • Interpretation may differ depending on imaging readers, particularly in prostate/prostate bed region
                  • Because of associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline

                  Radiation Risk

                  • Use contributes to a patient’s overall long-term cumulative radiation exposure
                  • Long-term cumulative radiation exposure associated with increased risk for cancer
                  • Ensure safe handling to minimize radiation exposure to patient and clinicians

                  Drug interaction overview

                  • Therapies targeting androgen pathway
                    • Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway (eg, androgen receptor antagonists) can result in changes in uptake of flotufolastat F 18 in prostate cancer
                    • Effects of these therapies on performance of flotufolastat F 18 PET has not been established
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                  Pharmacology

                  Mechanism of Action

                  Binds to PSMA (IC50 = 4.4 nM) expressed on cells, including prostate cancer cells, and is internalized

                  Prostate cancer cells usually overexpress PSMA

                  Fluorine-18 is a beta-positive–emitting radionuclide that can be detected using positron emission tomography

                  Distribution

                  Liver: 15.8%

                  Heart blood pool: 7.4%

                  Kidneys: 3.2%

                  Metabolism

                  Does not undergo metabolism up to 50 minutes post injection

                  Elimination

                  First 2 hr post injection: ~7% excreted in urine

                  First 4.5 hr post injection: ~15% excreted in urine

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                  Administration

                  Patient Preparation

                  Instruct to drink water before administration to ensure adequate hydration

                  Continue drinking and voiding frequently for first few hours after administration to reduce radiation exposure

                  IV Preparation

                  Handle radioactive drug with appropriate safety measures to minimize radiation exposure during administration

                  Use waterproof gloves and effective shielding, including syringe shields, when handling and administering

                  Inspect solution visually for particulate matter and discoloration before administration; discard if solution contains particulate matter or is discolored

                  Use aseptic technique and radiation shielding when withdrawing and administering

                  Calculate necessary volume to administer based on calibration time and date; assay dose using a suitably calibrated instrument

                  Recommended maximum volume of injection of undiluted drug is 5 mL; may be diluted with NaCl 0.9%

                  IV Administration

                  After IV bolus injection, administer IV flush of sterile NaCl 0.9% to ensure full delivery of the dose

                  Dispose of any unused drug in a safe manner in compliance with applicable regulations

                  Image acquisition guidelines

                  • Have patient void immediately before imaging
                  • Position patient supine with arms above head
                  • Begin PET scanning ~60 minutes after injection
                  • Image acquisition should start from mid-thigh and proceed to base of skull
                  • Scan duration ~20 minutes depending on number of bed positions and acquisition time per bed position (typically 3 minutes)
                  • Adapt imaging technique according to equipment used and patient characteristics to obtain the best image quality possible

                  Image Display and Interpretation

                  Localization of prostate cancer recurrence in sites typical for prostate cancer recurrence is based on flotufolastat F 18 uptake in comparison with tissue background

                  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 that do not express PSMA will not be visualized; increased uptake in tumors is not specific for prostate cancer

                  Radiation dosimetry: See prescribing information

                  Storage

                  Store at controlled room temperature of 20-25°C (68-77°F)

                  Does not contain a preservative

                  Store in original container with radiation shielding

                  Expiration date and time are provided on container label

                  Use within 10 hr from end of synthesis

                  Dispose of any unused drug in a safe manner in compliance with applicable regulations

                  Approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State

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                  Images

                  No images available for this drug.
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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.