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 Prescribing Information
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Call Siemens’ PETNET Solutions Inc., a Siemens Healthineers company, at 1-877-473-8638

POSLUMA:
Precision PSMA targeting

For imaging of newly diagnosed or recurrent prostate cancer

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MECHANISM OF ACTION

POSLUMA has a precise
PSMA-targeting mechanism of action1,2

PSMA ligand 18 F PSMA receptor Radiolabeling with the 18F radioisotopecan enhance positron emission tomography (PET) scan resolution, improving lesion delineation3,4 POSLUMA binds to and is internalized by cells that express prostate-specific membrane antigen (PSMA), including prostate cancer cells, the majority of which overexpress PSMA1 PSMA receptor
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How POSLUMA works

Explore POSLUMA’s precise PSMA-targeting mechanism of action
  • The molecular structure of POSLUMA uses radiohybrid™ technology, with a DOTAGA complex with nonradioactive gallium and radioactive F 18 covalently bound to silicon1,5
  • The DOTAGA complex in radiohybrid™ technology can be labeled with alpha- or beta-emitting radiometals5,6
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IS SOMETHING OBSCURING YOUR PSMA SCANS?

Activity in the urinary bladder can impact the assessment of tumors and lymph nodes local to the prostate region (the most common site of recurrence), sometimes producing halo artifacts that deteriorate image quality.7-9

Low urinary bladder activity

With POSLUMA, urinary bladder activity interference is limited, which may enhance clinical visualization7,10

POSLUMA DEMONSTRATED LOW URINARY BLADDER ACTIVITY1,10

Line graph showing low urinary bladder activity with POSLUMA

In preclinical and Phase 1 studies, low radioactivity in the urinary bladder improved tumor-to-background ratio and may enhance confidence in image interpretation in the prostate bed and surrounding areas.7,10

Images of prostate-bed visualization following administration of POSLUMA10

PET image of healthy volunteer 1 minute after administration of POSLUMA

1 min

PET image of healthy volunteer 32 minutes after administration of POSLUMA

32 min

START PET IMAGING
~60 MINUTES POST ADMINISTRATION1

PET image of healthy volunteer 48 minutes after administration of POSLUMA

48 min

PET image of healthy volunteer 76 minutes after administration of POSLUMA

76 min

PET image of healthy volunteer 150 minutes after administration of POSLUMA

150 min

PET image of healthy volunteer 220 minutes after administration of POSLUMA

220 min

PET images of a healthy volunteer after administration of POSLUMA.

The first scan session was at 1 to 90 minutes after injection, the second was at 150 to 178 minutes, and the third was at 220 to 248 minutes. Subject was permitted to leave PET scanner and void urine between sessions.

POSLUMA PET scan showing uptake in the internal iliac lymph node

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SPOTLIGHT study

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References: 1. POSLUMA. Package insert. Blue Earth Diagnostics Ltd; 2023. 2. Donin NM, Reiter RE. Why targeting PSMA is a game changer in the management of prostate cancer. J Nucl Med. 2018;59(2):177-182. doi:10.2967/jnumed.117.191874 3. Werner RA, Derlin T, Lapa C, et al. 18F-labeled, PSMA-targeted radiotracers: leveraging the advantages of radiofluorination for prostate cancer molecular imaging. Theranostics. 2020;10(1):1-16. doi:10.7150/thno.37894 4. Rowe SP, Drzezga A, Neumaier B, et al. Prostate-specific membrane antigen–targeted radiohalogenated PET and therapeutic agents for prostate cancer. J Nucl Med. 2016;57(suppl 3):90S-96S. doi:10.2967/jnumed.115.170175 5. Jani AB, Ravizzini GC, Gartrell BA, et al. Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in men with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Urol. Published online April 26, 2023. doi:10.1097/JU.0000000000003493 6. Wurzer A, Di Carlo D, Schmidt A, et al. Radiohybrid ligands: a novel tracer concept exemplified by 18F- or 68Ga-labeled rhPSMA inhibitors. J Nucl Med. 2020;61(5):735-742. doi:10.2967/jnumed.119.234922 7. Knorr K, Oh S, Krönke M, et al. Preclinical biodistribution and dosimetry and human biodistribution comparing 18F rhPSMA 7 and single isomer 18F rhPSMA 7.3. EJNMMI Res. 2022;12(8):8. doi:10.1186/s13550-021-00872-w 8. Expert Panel on Urologic Imaging; Froemming AT, Verma S, Eberhardt SC, et al. ACR Appropriateness Criteria® Post-treatment Follow-up Prostate Cancer. J Am Coll Radiol. 2018;15(5S):S132-S149. 9. Oh SW, Wurzer A, Teoh EJ, et al. Quantitative and qualitative analyses of biodistribution and PET image quality of a novel radiohybrid PSMA, 18F-rhPSMA-7, in patients with prostate cancer. J Nucl Med. 2020;61(5):702-709. doi:10.2967/jnumed.119.234609 10. Tolvanen T, Kalliokoski K, Malaspina S, et al. Safety, biodistribution, and radiation dosimetry of 18F-rhPSMA-7.3 in healthy adult volunteers. J Nucl Med. 2021;62(5):679-684. doi:10.2967/jnumed.120.252114

Indication

POSLUMA® (flotufolastat F 18) injection is 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

INDICATION | IMPORTANT SAFETY INFORMATION

INDICATION

POSLUMA® (flotufolastat F 18) injection is 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

IMPORTANT SAFETY INFORMATION

  • 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. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. 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. Because of the 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.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

  • 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. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. 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. Because of the 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.
  • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
  • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
  • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

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