NUBEQA® (darolutamide)
Safety
Adding NUBEQA® to ADT did not increase the discontinuation rate due to AEs vs ADT
In the phase 3 ARAMIS trial, there was no increase in discontinuation due to AEs with NUBEQA + ADT vs ADT (8.9% vs. 8.7%).
Fatigue was the only AE to occur at an incidence of ≥10% with NUBEQA
Adapted from Fizazi K et al. 2019.
ARAMIS is a double-blind, randomised, placebo-controlled, multicentre phase 3 study in 1,509 nmCRPC patients with PSA doubling time of
Safety Profile:
- The most frequently observed adverse reactions in patients receiving NUBEQA were fatigue/asthenic conditions (≥1/10) and rash, pain in the extremity, musculoskeletal pain, fractures, ischaemic heart disease and heart failure (≥1/100)
- Three laboratory test abnormalities were reported more frequently with NUBEQA + ADT than ADT:
- Neutrophil count decreased (19.6% vs. 9.4%)
- Bilirubin increased (16.4% vs. 6.9%)
- AST increased (22.5% vs. 13.6%)
- With the exception of hypertension and urinary retention, there was very low incidence (<1%) of grade 3 or 4 AEs with NUBEQA + ADT
- NUBEQA + ADT vs. ADT alone: Hypertension (3.1% vs. 2.2%); urinary retention (1.6% vs. 2.0%)
- With extended follow-up, the safety profile NUBEQA was favourable and consistent with the primary anaylsis
Abbreviations:
ADT, androgen deprivation therapy; AE, adverse event; AST, aspartate aminotransferase
PP-NUB-IE-0268-1 | December 2025