The Food and Drug Administration has approved darolutamide (Nubeqa), an androgen receptor inhibitor, for the treatment of nonmetastatic castration-resistant prostate cancer. The drug is administered orally twice a day with food. Patients prescribed darolutamide should concurrently receive a gonadotropin-releasing hormone analog or have had bilateral orchiectomy.

Darolutamide was evaluated in a multicenter, double-blind, placebo-controlled clinical trial of 1,509 patients with nonmetastatic castration-resistant prostate cancer. Those who received darolutamide had significantly longer metastasis-free survival than those who received placebo (a median of 40.4 versus 18.4 months).

Because darolutamide may cause fetal harm, men who have female partners of childbearing age should use contraception during treatment and for at least a week after the last darolutamide dose. Impairment of male fertility is also a risk. The most common adverse effects (seen in 2% or more of patients) are fatigue, pain in the extremity, and rash.

Nurses should teach patients to take darolutamide with food, as this increases the bioavailability of the drug. Because darolutamide may interact with other medications, nurses should use a drug database to check for interactions between darolutamide and the patient's other prescribed medications.

For complete prescribing information for darolutamide, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212099Orig1s000lbl.pdf.