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 Prescribing Information

An informed treatment plan with POSLUMA

What’s a PET scan?

Whether you’ve been diagnosed with prostate cancer for the first time, or your prostate cancer has returned, your doctor needs the most accurate information about the location of the disease to determine an appropriate treatment plan.

This usually involves a PET scan.

First, an imaging agent−like POSLUMA−is injected into the body. Then, it binds to a target, such as cancer cells, to light it up. This can be seen on images from a PET scan, showing the location of the disease. Keep in mind that like all imaging agents, POSLUMA may not detect all prostate cancer.

POSLUMA is an advanced imaging agent that may help to reveal a more precise image of prostate cancer.

PET=positron emission tomography.

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How POSLUMA works

A PET scan with POSLUMA can reveal information your doctor needs to help develop the best treatment plan.

Silouette of a man with orange ovals representing prostate cancer identified through an imaging scan

The surface of most prostate cancer cells has elevated levels of a protein called prostate-specific membrane antigen, or PSMA.

As an advanced diagnostic imaging agent, POSLUMA is highly specific to PSMA and attaches to it, highlighting prostate cancer where it’s located.

POSLUMA icon

How POSLUMA works

A PET scan with POSLUMA can reveal information your doctor needs to help develop the best treatment plan.

The surface of most prostate cancer cells has elevated levels of a protein called prostate-specific membrane antigen, or PSMA.

Silouette of a man with orange ovals representing prostate cancer identified through an imaging scan

As an advanced diagnostic imaging agent, POSLUMA is highly specific to PSMA and attaches to it, highlighting prostate cancer where it’s located.

As with all diagnostic imaging tests, it’s possible that physicians may interpret POSLUMA PET scan results incorrectly. This means that a negative POSLUMA PET scan does not confirm or rule out the presence of prostate cancer.

What to expect with a POSLUMA PET scan

Before, during, and after your scan icon
Before your scan
Dinner plate icon

Fasting is not necessary, so you can stick to your normal diet

Water icon

Hydrate well. Make sure to urinate immediately before your scan

60 minute timer icon

POSLUMA will be injected ahead of time, about 60 minutes before your scan

During your scan
20 minute timer icon

The scan itself will take about 20 minutes

Body position icon

You may be asked to change body positions, but generally you will be on your back with your arms above your head

After your scan
Water icon

Continue to hydrate and urinate frequently for the first few hours

Results icon

You’ll review and discuss the results at your next doctor’s visit. Please note that it’s possible for physicians to interpret the results of an imaging scan incorrectly

POSLUMA was not associated with any serious adverse reactions in the clinical trials.

Talk to your doctor about how a POSLUMA PET scan might benefit you.

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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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