Oncology Drug Reference Sheet: Darolutamide

January 26, 2023 by Chelsea Backler MSN, APRN, AGCNS-BC, AOCNS®, VA-BC

On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-tablets-metastatic-hormone-sensitive-prostate-cancer) (Nubeqa®) in combination with docetaxel in adults with metastatic hormone-sensitive prostate cancer (mHSPC). The approval was based on clinical trial findings demonstrating that the agent improved overall survival and significantly delayed time to pain progression compared to placebo.

Category/Class

Androgen receptor inhibitor

Mechanism of Action

Darolutamide competitively inhibits androgens from binding to their receptors (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf), restricting AR nuclear translocation as well as AR-mediated transcription, which decreases cancer cell proliferation and tumor growth.  

Indication

Adults with mHSPC or nonmetastatic castration-resistant prostate cancer (nmCRPC). Darolutamide is indicated in combination with docetaxel (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) in mHSPC only.

Dosing

600 mg orally twice daily (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) until patients experience disease progression or unacceptable toxicity

Administration

Take two tablets (300 mg each) by mouth with food, twice daily. For patients with mHSPC receiving combination treatment with docetaxel, administer the first docetaxel cycle (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) within six weeks of starting darolutamide.

Adverse Reactions

The package insert indicates warnings and precautions (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) for ischemic heart disease, seizures, and embryo-fetal toxicity.

Drug-Drug Interactions

Concomitant use with darolutamide may increase toxicities (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) from breast cancer–resistance protein (BCRP) substrates. Concomitant use of darolutamide with a combined P-gp and strong or moderate CYP3A4 inducer may decrease darolutamide activity (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf). Concomitant use of darolutamide with a combined P-gp and strong CYP3A4 inhibitor may increase risk of adverse reactions (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf). See the sidebar for more details.

Nursing Considerations

Administer a gonadotropin-releasing hormone analog (e.g., leuprolide, goserelin) concurrently (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) or verify that patients have had a bilateral orchiectomy (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf). Darolutamide has several drug-drug interactions (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) (see sidebar); assess patients regularly for other medications or supplements. Darolutamide dosing may be continued (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) even if a docetaxel cycle is delayed, interrupted, or discontinued.

Patient Education

Swallow the tablets whole with food (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf). Do not take two doses together (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) to make up for a missed dose. If you or your partner is of reproductive potential, use effective contraception (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) during treatment and for at least one week following your last dose. Darolutamide may impair fertility, and you may be at increased risk for seizure (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf). Avoid activities where a sudden loss of consciousness could harm yourself or others.

Oncology nurses can use ONS’s patient education sheet for darolutamide (https://www.oralchemoedsheets.com/index.php/sheet-library/24-available/generic/429-darolutamide) to guide their patient discussions.

Special Considerations

In the drug’s clinical trials, no differences in safety or efficacy (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) were found in patients older than age 65 compared to younger patients. Patients with severe renal or moderate hepatic impairment should receive (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) a reduced dose. Because of the possible impact on fertility, discuss preservation options (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) with patients of reproductive potential prior to initiating treatment.

Safe Handling

Educate patients about proper storage and safe handling (https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf) at home, particularly if caregivers assist administration.

Patient Assistance

Visit Access Services by Bayer (https://www.nubeqa-us.com/patient-assistance-support#support-services) or call 800-288-8374.


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