Piflufolastat ¹⁸F

Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible.

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of piflufolastat (¹⁸F) in prostate cancer. The effect of these therapies on performance of piflufolastat (¹⁸F) PET has not been established.

Piflufolastat (¹⁸F) is not intended for use in women.

Piflufolastat (¹⁸F) is not intended for use in women.

Fertility

No studies on fertility have been performed.

Piflufolastat (¹⁸F) has no or negligible influence on the ability to drive and use machines.

Summary of safety profile

The overall safety profile is based on data from its administration to 797 patients from three clinical studies and spontaneous reporting. In the clinical studies, each patient received a single administration with a median administered activity of 330 MBq. Adverse reactions have been reported during clinical development and are listed below by MedDRA body system organ class.

Tabulated list of adverse reactions

The frequencies of adverse reactions are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10), Uncommon (≥1/1 000 to <1/100), Rare (≥1/10 000 to <1/1 000), Very rare (<1/10 000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Adverse reactions observed with piflufolastat (¹⁸F):

^* Adverse reactions derived from spontaneous reporting with a not known frequency.

Description of selected adverse reactions

A total of 108 treatment emergent adverse events (TEAEs) were reported in 69 (8.6%) patients, with headache (1.4%), dysgeusia (1.0%), and fatigue (0.5%) being the most frequent. Three serious drugrelated adverse events (hypersensitivity, headache, and paresthesia) were reported, all experienced by one patient and only hypersensitivity was assessed as drug-related in this patient who had a significant history of allergic reactions. All three serious drug-related adverse events were resolved.

Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects.

As the effective dose is 4.2 mSv when the maximal recommended activity of 360 MBq is administered in a 70 kg-weighted patient, these adverse reactions are expected to occur with a low probability.