Based on the results of the phase III ARAMIS trial that demonstrated significant improvement in metastasis-free survival, the U.S. Food and Drug Administration approved darolutamide under priority review on July 30, 2019. Darolutamide is approved for nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy.
Multitargeted androgen receptor inhibitor
Nonmetastatic, castration-resistant prostate cancer in men receiving concurrent gonadotropin-releasing hormone therapy or who have had bilateral orchiectomy
The recommended dose is 600 mg (two 300 mg tablets) administered orally twice daily. Darolutamide should be used with caution with patients with severe renal or moderate hepatic impairment.
Administer orally with food.
The most common adverse events in patients receiving darolutamide were elevated AST (23%), decreased neutrophil count (20%), hyperbilirubinemia (16%) fatigue (16%), pain in extremities (6%), and rash (3%).
- Store darolutamide at room temperature.
- Avoid concomitant use with combined P-gp and strong or moderate CYP3A4 inducers.
- Assess oral adherence continually throughout treatment.
- Instruct patients to take the medication with food.
- Based on its mechanism of action, darolutamide can cause fetal harm and loss of pregnancy. Advise men and women to use contraception during treatment and for up to one week after the last dose.
- Educate patients to take any missed dose as soon as they remember prior to the next scheduled dose. Do not take two doses together to make up for a missed dose.
Because many older adults have comorbidities or are prescribed other pharmacologic agents, polypharmacy and concomitant medications should be considered. No overall differences in safety or effectiveness were seen in clinical trials between patients aged 65 years or older and younger patients.
Data regarding the hazardous potential of darolutamide are lacking, but it has been demonstrated to be embryotoxic. Healthcare workers who are pregnant or trying to conceive should use caution.
The Darolutamide User Drug Experience (DUDE) access service program can help patients with benefits verification, prior authorization assistance, and appeal support. Download a patient service request form at nubeqahcp.com or call 833-337-DUDE.