Chemical formula: C₆₃H₉₉FN₁₂O₂₅Si Molecular mass: 1,471.612 g/mol PubChem compound: 166177191
Flotufolastat ¹⁸F interacts in the following cases:
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of flotufolastat (18F) in prostate cancer. The effect of these therapies on performance of flotufolastat (18F) PET has not been established.
Flotufolastat (18F) is not indicated for use in females. There are no available data on the use of flotufolastat (18F) 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 (18F). Radioactive drugs, including flotufolastat (18F), have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Flotufolastat (18F) is not indicated for use in females. There are no data on the presence of flotufolastat (18F) in human milk, the effect on the breastfed infant, or the effect on milk production.
Animal studies to assess the carcinogenicity or mutagenic potential of flotufolastat have not been conducted. However, flotufolastat (18F) has the potential to be mutagenic because of the F 18 radionuclide.
No studies in animals have been performed to evaluate potential impairment of fertility in males or females.
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 flotufolastat (18F) was evaluated in 747 patients with prostate cancer. All patients received a single administration of flotufolastat (18F) 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.
Adverse reactions in ≥0.4% of patients with prostate cancer receiving flotufolastat (18F):
| Adverse Reaction | Flotufolastat (18F) N=747 n (%) |
|---|---|
| Diarrhea | 5 (0.7%) |
| Blood pressure increase | 4 (0.5%) |
| Injection site pain | 3 (0.4%) |
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