Nubeqa

Question 1

8.1 Pregnancy

Accepted Answer

The safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy based on its mechanism of action. However, animal embryo-fetal developmental toxicology studies were not conducted with darolutamide. There are no human data on the use of NUBEQA in pregnant females.

Question 2

8.2 Lactation

Accepted Answer

The safety and efficacy of NUBEQA have not been established in females. There is no available data on the presence of darolutamide or its metabolites in human milk, the effect on the breastfed child, or the effect on milk production.

Question 3

8.3 Females and Males of Reproductive Potential - Contraception (Males)

Accepted Answer

Male patients with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose of NUBEQA based on the mechanism of action.

Question 4

8.3 Females and Males of Reproductive Potential - Infertility (Males)

Accepted Answer

Based on animal studies, NUBEQA may impair fertility in males of reproductive potential.

Question 5

8.4 Pediatric Use

Accepted Answer

Safety and effectiveness of NUBEQA in pediatric patients have not been established.

Question 6

8.5 Geriatric Use

Accepted Answer

In clinical studies, a significant proportion of patients were 65 years and older, and no overall differences in safety or efficacy were observed between these patients and younger patients.

Question 7

8.6 Renal Impairment

Accepted Answer

Patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m²) not receiving hemodialysis have a higher exposure to NUBEQA, and dose reduction is recommended. No dose reduction is needed for patients with mild or moderate renal impairment (eGFR 30-89 mL/min/1.73 m²). The effect of end-stage renal disease (eGFR ≤15 mL/min/1.73 m²) on darolutamide pharmacokinetics is unknown.

Question 8

8.7 Hepatic Impairment

Accepted Answer

Patients with moderate hepatic impairment (Child-Pugh Class B) have a higher exposure to NUBEQA, and dose reduction is recommended. No dose reduction is needed for patients with mild hepatic impairment. The effect of severe hepatic impairment (Child-Pugh C) on darolutamide pharmacokinetics is unknown.