POSLUMA Solution for injection Ref.[109999] Active ingredients: Flotufolastat ¹⁸F

5.1 Risk of Image Misinterpretation

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 [See Clinical Studies (14.1)]. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels [See Clinical Studies (14.2)]. 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 [see Clinical Studies (14.2)]. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.

5.2 Radiation Risks

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 [see Dosage and Administration (2.1, 2.2)].

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of POSLUMA was evaluated in 747 patients with prostate cancer [see Clinical Studies (14.1, 14.2)]. All patients received a single administration of POSLUMA with an administered radioactivity (mean ± SD) of 307 ± 23 MBq (8.3 ± 0.6 mCi). The mean age of patients was 67 years (range: 43 to 86 years); distribution by race was 78% White, 12% Black or African American, 2% other, and 7% unreported; and distribution by ethnicity was 5% Hispanic/Latino, 87% non-Hispanic/Latino, and 8% unreported.

The adverse reactions reported in ≥0.4% of patients are shown in Table 2.

Table 2. Adverse Reactions in ≥0.4% of Patients with Prostate Cancer Receiving POSLUMA:

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can 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.

Risk Summary

POSLUMA is not indicated for use in females. There are no available data on the use of POSLUMA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with flotufolastat F 18. Radioactive drugs, including POSLUMA, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

Risk Summary

POSLUMA is not indicated for use in females. There are no data on the presence of flotufolastat F 18 in human milk, the effect on the breastfed infant, or the effect on milk production.

The safety and effectiveness of POSLUMA have not been established in pediatric patients.

Among the total number of patients receiving POSLUMA in clinical studies of prostate cancer, 463 (62%) were 65 years of age and older, while 118 (16%) were 75 years of age and older [see Clinical Studies (14.1, 14.2)]. No overall differences in safety or effectiveness were observed between these patients and younger adult patients.